comply'' with OMB's guidelines. OMB's initial guidelines, as corrected,
were published in February 2002. ``Guidelines for Ensuring and
Maximizing the Quality, Objectivity, Utility, and Integrity of
Information Disseminated by Federal Agencies; Republication'' (67 FR
8452, February 22, 2002) (``OMB Guidelines''). HHS's guidelines, which
include the FDA guidelines, were published in September 2002 and have
been periodically updated (``HHS/FDA Guidelines'').\14\
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    \13\ Section 515 of the Treasury and General Government
Appropriations Act, 2001, Public Law 106-554 (2000) (codified at 44
U.S.C. 3516 note).
    \14\ These are available at https://aspe.hhs.gov/reports/hhs-guidelines-ensuring-maximizing-quality-objectivity-utility-integrity-information-disseminated.
---------------------------------------------------------------------------

    In 2005, OMB published its Final Information Quality Bulletin for
Peer Review, which addressed ``peer review of scientific information
disseminations that contain findings or conclusions that represent the
official position of one or more agencies of the Federal government''
(70 FR 2664 at 2666, January 14, 2005). In 2019, OMB issued a
Memorandum entitled ``Improving Implementation of the Information
Quality Act'' (``Improving Implementation Memorandum''),\15\ the
purpose of which was to ``reinforce, clarify, and interpret agency
responsibilities with regard to responsibilities under the Information
Quality Act (IQA).''
---------------------------------------------------------------------------

    \15\ M-19-15 (April 24, 2019).
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    As an initial matter, the IQA ``orders the Office of Management and
Budget to draft guidelines concerning information quality and specifies
what those guidelines should contain.'' Salt Inst. v. Leavitt, 440 F.3d
156, 159 (4th Cir. 2006). The IQA does not require pre-dissemination
review. Nevertheless, to the extent pre-dissemination review may be
required under the OMB Guidelines, it would not apply here, as

FDA did not disseminate the referenced information.
    The specific source this comment asserted required pre-
dissemination review is ANSI/CTA-2051, a voluntary consensus standard
established by the ANSI and the CTA. In the proposal, FDA explained
that the Agency is basing its proposed output limits on physiological
data and stakeholder input. ANSI/CTA-2051:2017 is one of the scientific
sources FDA has considered. Other data and scientific sources
considered are described in the proposal and include a national
workplace safety guideline from the National Institute for Occupational
Safety and Health, comments from speakers at a 2017 public workshop
meeting held by NASEM, and public comments stemming from a 2016 FDA
public workshop (Refs. 14 and 15).
    The IQA and associated information quality guidelines concern only
information ``disseminated'' by a Federal agency. ANSI/CTA-2051:2017 is
not within the scope of the IQA and OMB guidelines because it is
disseminated by ANSI and CTA, not a Federal agency. See, e.g., HHS
Guidelines section I.D.2.h. (`` `Dissemination' means agency initiated
or sponsored distribution of information to the public.''). Because a
Federal agency did not develop or disseminate ANSI/CTA-2051:2017, ANSI/
CTA-2051:2017 is not within the scope of the IQA or any information
quality guidelines, and is not subject to any pre-dissemination review
requirements arising under them.
    FDA is committed to using and developing high quality information
and follows the applicable requirements and guidelines. See, e.g., 67
FR 8452 at 8459 (``Agencies shall treat information quality as integral
to every step of an agency's development of information, including
creation, collection, maintenance, and dissemination.''). Additionally,
as discussed elsewhere in this document and as discussed in the
proposal (see 86 FR 58150 at 58163-64), FDA believes the performance
specifications for OTC hearing aids, having taken into account ANSI/
CTA-2051:2017, will provide reasonable assurance of safety and
effectiveness of these devices.
    (Comment 102) A comment stated that FDA has denied the right of a
work group, composed of several third-party trade groups and/or
professional associations, to seek or secure adoption of a purported
voluntary consensus standard it has put forth (``work group's
standard''). This comment stated that the National Technology Transfer
and Advancement Act, OMB Circular No. A-119, the Administrative
Procedure Act, the Information Quality Act, and Executive Order 12866
give this work group that right. The comment further stated that, to
remedy the alleged violation(s), FDA must incorporate the work group's
standard into an amended notice of proposed rulemaking or the final
rule.
    (Response) None of the authorities this comment cited require FDA
to adopt the work group's standard.
    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) states that ``all Federal agencies and departments
shall use technical standards that are developed or adopted by
voluntary consensus standards bodies'' unless their use is
``inconsistent with applicable law or otherwise impractical.'' Public
Law 104-113, section 12(d)(1), (3) (1996). Office of Management and
Budget Circular No. A-119, as revised (Circular A-119), implements
NTTAA section 12(d) by establishing policies on Federal use of
voluntary consensus standards, among other things. Contrary to this
comment's assertion, the work group's standard does not fit within
Circular A-119's definition of a ``voluntary consensus standard.''
According to this comment, the work group's standard was created by
several trade groups and/or professional associations. So the work
group's standard is not a voluntary consensus standard within the
meaning of Circular A-119, because it was not ``developed or adopted''
by an organization that ``plan[s], develop[s], establish[es], or
coordinate[s] voluntary consensus standards using agreed-upon
procedures.'' Circular A-119 section 4.A., 4.A.1. But even if the work
group's standard were a voluntary consensus standard, nothing in NTTAA
or Circular A-119 would require FDA to choose it over ANSI/CTA-
2051:2017, the voluntary consensus standard FDA included in the
proposal. As explained in the proposal, ANSI/CTA-2051:2017 is, to FDA's
knowledge, the first voluntary consensus standard to describe
performance characteristics for hearing amplifiers. In the proposal,
FDA proposed to establish as requirements a subset of specifications
from ANSI/CTA-2051:2017, in conjunction with other proposals. FDA's
actions are consistent with NTTAA and Circular A-119. Indeed, Circular
A-119 states that it ``does not establish a preference among standards
developed in the private sector.'' Id. section 6.g.
    This comment did not identify any language in the Administrative
Procedure Act (APA) or IQA it claimed would require FDA to adopt the
work group's standard. And these statutes do not require FDA to adopt
any particular standard. These are procedural statutes that do not
demand specific substantive outcomes, let alone use by FDA of any
commenter's preferred standard.
    Finally, this comment asserted that the ``compelling need
requirement'' set forth in Executive Order 12866 prohibits FDA's
consideration of ANSI/CTA-2051. Under Executive Order 12866, Federal
agencies should issue only such regulations as are required by law, are
necessary to interpret the law, or are made necessary by compelling
public need, such as material failures of private markets to protect or
improve the health and safety of the public, the environment, or the
well-being of the American people. Regulatory Planning and Review,
section 1, 58 FR 51735 (September 30, 1993). FDA has complied with this
provision of Executive Order 12866 because the regulation it is issuing
is ``required by law.'' See FDARA, section 709(b) (2017). In any event,
Executive Order 12866 ``reaffirm[s] the primacy of Federal agencies in
the regulatory decision-making process,'' gives ``due regard to the
discretion that has been entrusted to the Federal agencies,''
recognizes that ``Federal agencies are the repositories of significant
substantive expertise and experience,'' and does not ``displac[e] the
agencies' authority or responsibilities, as authorized by law.''
Executive Order 12866 pmbl., sections 2(a), 9; see In re United Mine
Workers of Am. Int'l Union, 190 F.3d 545, 551 (D.C. Cir. 1999) (stating
that Executive Order 12866 ``does not purport'' to ``set aside
congressional legislation''). Executive Order 12866 certainly does not
prohibit or require adoption of any particular standard. See Helicopter
Ass'n Int'l, Inc. v. FAA, 722 F.3d 430, 439 (D.C. Cir. 2013)
(explaining that Executive Order 12866 does not ``create[] private
rights'').
    (Comment 103) A comment stated that a third party provided a
standard to FDA in advance of the proposal, and that FDA's alleged
failure to consider that standard before issuing the proposal is
arbitrary and capricious and therefore a violation of the
Administrative Procedure Act.
    (Response) The APA's notice-and-comment procedures provide the
requirements that govern this rulemaking, and do not require the kind
of pre-proposal special consideration this comment discussed.
    Consistent with the APA, FDA published in the Federal Register, a
``[g]eneral notice of proposed rulemaking'' that included, among other
things, ``the terms or substance of the

proposed rule or a description of the subjects and issues involved.'' 5
U.S.C. 553(b)(3). The APA states that, ``[a]fter notice required''
thereby, the agency ``shall give interested persons an opportunity to
participate in the rule making through submission of written data,
views, or arguments.'' Id. section 553(c). FDA has complied with this
provision by, in the proposal, soliciting public comment.
    FDA has considered the comments received in response to the
proposal, and is in this preamble responding as appropriate. But the
APA's notice-and-comment procedures, which require that the public be
given an opportunity to participate in the rule making only ``[a]fter''
publication of the notice of proposed rulemaking (NPRM), id., do not
require that FDA consider or respond to any comments received in
advance of the NPRM.

G. Conditions for OTC Sale (Sec.  800.30(g))

    Many comments on the conditions for sale of OTC hearing aids sought
more stringent conditions or enforcement to prevent possible misuses of
OTC hearing aids. Although FDA is attentive to these concerns, we are
also mindful of unduly impeding access by creating barriers rather than
removing them if appropriate (see also 86 FR 58150 at 58166).
    (Comment 104) Some comments suggested that FDA require any seller
of OTC hearing aids to staff customer support in the United States with
licensed persons, for customers to meet with them via telemedicine
technology.
    (Response) FDA is not adopting these suggestions because this would
require the involvement of a licensed person in the sale of an OTC
hearing aid, contrary to section 520(q)(1)(A)(v) of the FD&C Act and
section 709(b)(2)(D) of FDARA. Further, the requirements in this
rulemaking will provide reasonable assurance of safety and
effectiveness of OTC hearing aids without the involvement of a licensed
person. In any case, FDA would expect such a requirement to entail
substantial, perhaps prohibitive, costs for sellers in addition to a
significant amount of time to develop or contract for such services.
Neither would be compatible with the purposes of this rulemaking,
including the purpose of broadening the kinds of sellers that can offer
OTC hearing aids.
    (Comment 105) Multiple comments proposed a requirement for age
verification prior to the sale or delivery of an OTC hearing aid.
Similarly, comments proposed a requirement for purchasers to affirm
that they are at least 18 years old at the time of purchase. Some of
these additionally proposed that purchasers acknowledge or agree that
the OTC hearing aid is not for use by anyone younger than 18 years old.
    (Response) FDA is not adopting these suggestions. While people
younger than 18 should not use hearing aids without the involvement of
a licensed person, such as an ear-nose-throat doctor, we do not agree
that the risk warrants age verification at this time.
    We considered other purchases that require age verification and
found that, in such cases, the risks to individuals and the public
health were significantly greater than the risks posed by the use of
OTC hearing aids by people younger than 18. Furthermore, we do not
expect that OTC hearing aids will be as attractive for purchase by
people younger than 18 as other age-restricted products that do require
verification. Thus, the benefit of mandatory age verification would
likely be small relative to the risks posed to the individual by OTC
hearing aids compared to the benefit of restricting and risks posed by
other age-restricted products.
    At the same time, we would expect mandatory age verification, or
similar processes like certifications or acknowledgments, to increase
the difficulty or complexity of purchases by people who are the
intended users, and can benefit from the use, of OTC hearing aids.
Since one of the purposes of this rulemaking is to promote the public
health by reducing or eliminating barriers to access for such people,
we considered which approach is likely to benefit the public health
more. In this case, lower-income people or people who live in
relatively isolated conditions (for example, in rural areas) are more
likely to benefit from broadened access while at the same time being
less able to present official documentation of their age (for example,
because they lack a driver's license or are buying hearing aids by
mail). We have determined that the public health is better served at
this time by not imposing requirements for age verification,
certification, or acknowledgment.
    The above considerations also took into account that we are
finalizing requirements to improve the warnings against use of OTC
hearing aids by people younger than 18. We are also finalizing the
condition for sale that will prohibit sale of OTC hearing aids to or
for people younger than 18 under new Sec.  800.30(g)(1). These
requirements, along with the others in this rule, will help provide
reasonable assurance of safety and effectiveness of OTC hearing aids
for the intended users without the need for age verification. We expect
that sellers will likely adopt their own practices, tailored to their
business models, to prevent violating this condition for sale and/or
engaging in a prohibited act. Such practices may, but are not required
to, entail age verification by checking a government-issued
photographic identification. However, in some cases, the seller may not
need to check a government-issued photographic identification, for
example, when the seller has personal knowledge of the purchaser's age
or may otherwise be certain that the purchaser is 18 or older.
    (Comment 106) Several comments proposed that FDA enhance
enforcement of legal requirements for labeling, sales, or other
provisions for legally marketing hearing aids. Similar comments
suggested that FDA enhance enforcement for selling non-compliant
products as hearing aids, for example, by making false or misleading
statements or improperly avoiding premarket requirements for devices.
Other such comments urge in any case that FDA monitor the sales of OTC
hearing aids and/or non-compliant consumer electronics marketed as
hearing aids.
    (Response) FDA intends to apply existing practices for monitoring
the market and will take action, including enforcement as necessary and
appropriate. Should stakeholders wish to call FDA's attention to
potential concerns that we may not otherwise learn, including potential
regulatory misconduct, they may file a report sometimes known as a
trade complaint. Anyone may file such a report (a complaint), and we
encourage people to include supporting and contact information for
possible followup questions. However, the reports can be anonymous.
More information about the process is available on FDA's website:
https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct. See also the response to Comment 122
regarding the role of State authorities in enforcing requirements
applicable to OTC hearing aids.
    Moreover, we are finalizing labeling requirements that describe the
process of reporting adverse events to FDA (see final Sec. Sec.
800.30(c)(2)(iii)(F) and 801.422(c)(2)(ii)(E)). Section 709(d) of FDARA
directs FDA to report on an analysis of adverse events relating to OTC
hearing aids not later than 2 years after the date we issue this final
rule. FDA expects this information to be helpful in identifying and
analyzing device risk trends, and it will likely inform enforcement
prioritization.

    (Comment 107) Comments suggested that FDA impose a penalty on
persons who sell an OTC hearing aid that is used by a child.
    (Response) The FD&C Act sets forth penalties for prohibited acts
respecting devices and electronic products as described in section IV
of this document (see 21 U.S.C. 331, 333, 360oo and 360pp(b)).
Prohibited acts include, among other things, doing or causing a variety
of acts involving adulterated and/or misbranded devices (see, e.g., 21
U.S.C. 331(a)-(c), 331(k)). In turn, a device is deemed adulterated
and/or misbranded for a variety of reasons (see 21 U.S.C. 351 and 352).
For example, an OTC hearing aid sold to or for a person younger than 18
would not, among other deficiencies, bear adequate directions for use
for such users. The hearing aid would be deemed misbranded (see 21
U.S.C. 352(f)), and certain activities with respect to the misbranded
device (for example, the introduction of the misbranded device into
interstate commerce) would be a prohibited act in that example and
subject to the penalties under the FD&C Act.
    (Comment 108) Several comments suggested that FDA establish a
variety of post-sale requirements on manufacturers or sellers of OTC
hearing aids. Such proposals included requirements that manufacturers
or sellers: accept returns for a certain minimum period (either for
money back or credit), warrant certain features or components for a
given period, guaranty products or services in some way, and/or provide
a minimum rescission period (a period in which a buyer could cancel the
purchase).
    Many of these comments mentioned user satisfaction and that, if
users buy an unsatisfactory device and are unable to return or exchange
it, such users could incur unnecessary expenses to obtain a
satisfactory OTC hearing aid or forego hearing aid use entirely. Other
such comments described a benefit or need to establish a national
standard, as opposed to one that varies by State, to encourage broader
availability of the devices. The proposed time periods for the
application of such requirements varied but were generally 30, 45, 60,
or 90 days after purchase.
    (Response) FDA is not establishing the suggested post-sale
requirements on manufacturers or sellers of OTC hearing aids. We are
finalizing a requirement for OTC hearing aid labeling to provide notice
of the manufacturer's return policy. We believe this adequately
addresses the concern mentioned in the comments that the risk of
obtaining an unsatisfactory OTC hearing aid may result in people
foregoing hearing aid use entirely, and that additional requirements in
this regard are not necessary to provide a reasonable assurance of
safety and effectiveness for OTC hearing aids. To the extent the post-
sale requirements proposed in the comments are aimed at consumer
protection rather than providing a reasonable assurance of safety and
effectiveness for OTC hearing aids, we note that there may be other
Federal laws, administered by other agencies that provide this type of
consumer protection. Likewise, many States have existing requirements
that also address these types of consumer protection concerns. See the
response to Comment 122 regarding the applicability of State consumer
protection requirements.
    (Comment 109) A comment proposed that FDA prohibit the resale of
OTC hearing aids by consumers. The comment expressed a need for
appropriate disinfection of used hearing aids and the need to apply
labeling required for used hearing aids. The comment asserted that used
OTC hearing aids should be returned by the vendor to the manufacturer
for it to take the necessary steps to market a used OTC hearing aid.
    (Response) Although FDA agrees that all used hearing aids should be
labeled as required and adequately reprocessed regardless of the type
of reseller, we are declining to revise the proposed rule to
incorporate this suggestion. We are finalizing the requirement that if
the OTC hearing aid is used or rebuilt, the outside package must
declare that fact, and we have modified the design requirements for OTC
hearing aids to specify that if the OTC hearing aid is used or rebuilt,
it must be adequately reprocessed for the next user prior to sale. OTC
hearing aids must meet these requirements regardless of the type of
reseller. We believe that the requirements that we are finalizing for
OTC hearing aids provide for reasonable assurance of safety and
effectiveness, and prohibiting resale of an OTC hearing aid by a
consumer will not add anything and will likely be impractical to
enforce.
    (Comment 110) Comments proposed that FDA require referrals to
physicians for prescription hearing aids when a user or prospective
user manifests any of the ``red flag'' conditions. However, one such
comment proposed an option for waivers since, it asserted, most people
with a ``red flag'' condition have already been advised to seek or
previously sought an examination by a physician.
    (Response) FDA is declining this suggestion because it would
require the involvement of a licensed person in the use of OTC hearing
aids in some cases, and it is not necessary for reasonable assurance of
safety and effectiveness of OTC hearing aids. We believe that the
required prominent warnings and other statements in the labeling of OTC
hearing aids are sufficient to advise users and prospective users to
consult hearing health care providers, including ENT doctors, in
certain circumstances, such as when experiencing certain pathological
(``red flag'') conditions. For these reasons, we are not including an
examination or waiver requirement for the OTC category of hearing aids.
    (Comment 111) Some comments urged FDA to establish generally more-
stringent requirements for the sale of OTC hearing aids. These comments
reasoned that because hearing aids are medical devices, are
technologically complex, and/or intended to compensate for a complex
condition, they should not be as easily available as other devices such
as bandages (see, e.g., 21 CFR 880.5075, classifying elastic bandages).
    (Response) Except as explained elsewhere in this document, FDA is
declining this suggestion. We are establishing requirements that are
sufficiently stringent to provide reasonable assurance of safety and
effectiveness of OTC hearing aids. We have taken into account, among
other considerations, the seriousness of hearing impairment as well as
the complexity of both the impairment and the technology intended to
compensate for it. More stringent requirements are not necessary to
provide reasonable assurance of safety and effectiveness, and the
requirements we are establishing generally do not depend on the sales
environment, provided the environment does not cause the device to be
adulterated, misbranded, or otherwise out of compliance with applicable
requirements (see, e.g., 21 U.S.C. 351(a)(2)(A) regarding adulteration
if held under insanitary conditions).
    Moreover, the extent to which the availability of OTC hearing aids
is comparable to that of elastic bandages does not suggest the devices
themselves are otherwise similar. Similarly, the broad availability of
elastic bandages does not cause the devices to be less safe and
effective for their intended use(s), and the same would be true for OTC
hearing aids. The purposes of this rule include promoting broader
availability of OTC hearing aids while establishing requirements that
will provide reasonable assurance of safety and effectiveness, which is

incompatible with establishing unnecessarily stringent regulations.
    (Comment 112) Comments suggested that sellers of OTC hearing aids
be required to keep the devices behind the counter or in a locked
cabinet to prevent people younger than 18 from purchasing the devices.
    (Response) FDA is declining this suggestion because we are allowing
flexibility for sellers to determine how to comply with the condition
for sale that prohibits the sale of OTC hearing aids to or for people
younger than 18. FDA intends this flexibility to minimize regulatory
burdens while promoting access to safe and effective devices. If a
seller determines that it can comply with the condition for sale
without special storage provisions, then it need not make such storage
provisions. Mandating special storage provisions for such sellers of
OTC hearing aids would add unnecessary burdens. However, a seller may
decide keeping the devices in a locked display case and verifying the
purchaser's age with a form of photographic identification will be the
most practical approach for its circumstances. (See also the response
to Comment 105 regarding age verification.) Although we are not
mandating a specific approach to ensure that OTC hearing aids are not
sold to people younger than 18, FDA expects that sellers will implement
an approach appropriate for their circumstances.
    (Comment 113) A comment suggested pairing the purchase of an OTC
hearing aid with membership in an organization that could serve first-
time hearing aid users, for example, by assisting with or explaining
the initial selection and purchase of an OTC hearing aid.
    (Response) FDA is not adopting this suggestion as condition for
sale of OTC hearing aids. Although such organizations can provide
useful and valuable services for users and prospective users of hearing
aids, FDA proposed and is finalizing requirements for OTC hearing aids
that would provide reasonable assurance of safety and effectiveness
without the involvement of a licensed person. Requiring the involvement
of such an organization is neither necessary for reasonable assurance
of safety and effectiveness nor consistent with the approach we are
taking to establish the OTC category for hearing aids to promote
broader availability of OTC hearing aids.
    Further, as we explained in the proposal, we expect this final rule
to lower costs of hearing aids by unbundling the purchase of hearing
aids from professional services, including professional advice,
fitting, adjustment, or maintenance to make the devices available over
the counter (see 86 FR 58150 at 58172). Requiring membership in an
organization with the purchase of OTC hearing aids would be contrary to
our intent of unbundling services and device purchases. In that vein,
we would expect that membership with such an organization would present
costs to users, either directly, as in a membership fee, or indirectly,
as in increasing the purchase price of a device. Thus, although users
and prospective users may choose to seek membership with organizations
to obtain related benefits, we do not agree that such membership should
be required with the purchase of an OTC hearing aid.
    (Comment 114) A comment proposed that FDA require sellers of OTC
hearing aids to obtain certifications for relevant standards developed
by the ISO as well as comply with appropriate Quality System
requirements. For example, dispensers might conform to ISO 21388:2020,
``Acoustics--Hearing aid fitting management.''
    (Response) FDA is not requiring sellers of OTC hearing aids that
are not manufacturers to comply with part 820 requirements for a
Quality System or conform to consensus standards. An OTC hearing aid,
by definition, is a device that, among other qualities, allows the user
to control and customize it to the user's hearing needs, without the
involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(iii) and
(v)). Further, multiple provisions of this rule are intended to ensure
that persons do not incur special licensing obligations or the
equivalent (certifications, for example) on account of commercial
activity involving OTC hearing aids (see, e.g., final Sec.
800.30(h)(2)(i)). As such, requiring a seller of OTC hearing aids to be
specially licensed or certified is both unnecessary for reasonable
assurance of safety and effectiveness of OTC hearing aids and
inconsistent with the approach we are taking to establish the OTC
category for hearing aids.
    Additionally, the scope of part 820 extends to manufacturers of
finished devices, as Sec.  820.3(o) defines the term, but generally not
other persons (see Sec.  820.1(a)(1)), and the requirements of part 820
are not intended to extend to sellers who are not manufacturers.
Instead, part 820 specifies that, among other controls, manufacturers
must ensure that device labeling, packaging and shipping containers
maintain label and device integrity during customary conditions of
processing, storage, handling, and distribution (see Sec. Sec.
820.120(a) and 820.130).
    We likewise observe that the consensus standard ISO 21388:2020
applies to hearing aid fitting management (see clause 1), but not non-
licensed persons (i.e., non-hearing aid professionals). As such, this
standard is not likely to apply to sellers of OTC hearing aids who are
not licensed persons. As we explained above, sellers of OTC hearing
aids are not required to have a specialized license or the equivalent.
    Nevertheless, FDA acknowledges that quality management may also be
useful to many persons who are not manufacturers or hearing aid
professionals (as ISO 21388:2020 defines the term). Some concepts in
part 820, ISO 21388:2020, or ISO 13485:2016, for example, may help
inform such other person's determination of best practices. A number of
standards exist for other persons to implement quality management
systems, for example, ISO 9001:2015, ``Quality management systems--
Requirements,'' and those persons may wish to obtain related
certifications and advertise as such. However, FDA has determined that
special licensing (or its equivalent) is not necessary, as explained,
and we are not requiring sellers of OTC hearing aids that are not
manufacturers to comply with part 820 or conform to ISO 21388:2020, ISO
13485:2016, or any other consensus standard.
    (Comment 115) A comment proposed that FDA protect consumers from
predatory practices throughout the supply chain for OTC hearing aids.
It specifically referred to unnecessarily collecting or sharing private
information by or with several kinds of persons: manufactures,
retailers, medical practitioners, payment processors, service
providers, device monitoring and configuration providers, data
aggregators, computer hosting services, and platforms.
    (Response) FDA is declining this proposal because it is not
necessary for reasonable assurance of safety and effectiveness of OTC
hearing aids. Moreover, although certain deceptive practices would be
prohibited under the FD&C Act, other Federal and State agencies
establish and enforce such requirements as those concerning protection
of private information. For example, if a seller were to modify the
labeling of an OTC hearing aid to mislead prospective purchasers, that
would constitute misbranding of a device while held for sale in
interstate commerce, which is prohibited under the FD&C Act (see, e.g.,
21 U.S.C. 331(k)). Deceiving prospective purchasers in such a way may
additionally violate Federal and/or State requirements that FDA is not

responsible for administering or enforcing. For more information about
the kinds of health fraud issues FDA addresses, which includes unlawful
sales of medical products, you may visit our website: https://www.fda.gov/consumers/health-fraud-scams.
    However, FDA does not generally administer or enforce requirements
respecting predatory commercial practices that do not involve the
safety or effectiveness of FDA-regulated products. Should stakeholders
wish to raise concerns for deceptive practices not related to
requirements that FDA administers or enforces, they should approach the
appropriate Federal or State agencies. For example, stakeholders may
wish to report fraud to the Federal Trade Commission's Bureau of
Consumer Protection. More information is available online: https://www.ftc.gov/about-ftc/bureaus-offices/bureau-consumer-protection.
    (Additional Revision 4) FDA is finalizing a condition for sale for
OTC hearing aids that sellers may not sell the devices over the counter
unless the principal display panel of the outside package labeling bear
prominent marks identifying the device as ``OTC'' and a ``hearing
aid.'' As explained in Additional Revision 2 (section III.D.3), FDA is
finalizing a requirement for the outside package labeling to bear the
marks to assist purchasers and others, including retailers and State
agencies. However, in some cases, purchasers may not view the principal
display panel of the package prior to purchase. For example, a person
shopping online may filter a list of the devices offered by the seller
with ``OTC'' and view only pictures of the device itself. This
condition for sale will help ensure that only OTC hearing aids are sold
as such, particularly for purchasers who shop online or by mail. This
is necessary for reasonable assurance of safety and effectiveness of
OTC hearing aids because it provides assurances that non-OTC hearing
aids or non-hearing aids will not be sold as or confused for OTC
hearing aids.

H. Preemption Provisions (Sec.  800.30(h))

    Most comments on preemption sought clarification on the effects of
this rule on State and local requirements, including consumer
protections and professional licensing requirements. Many strongly
supported preserving States' roles in protecting prospective and
current hearing aid users.
    (Comment 116) Several comments suggested that FDA define ``restrict
or interfere'' in the FDARA preemption provision because these terms
are ambiguous. Specifically, one suggestion was that FDA define
``restrict or interfere'' to pertain only to State and local laws that
prevent or create an obstacle to a commercial activity involving OTC
hearing aids so that State consumer protection laws that pertain to
commercial activity involving OTC hearing aids, such as a warranty
requirement and mandatory returns for OTC hearing aids, would not be
preempted. Another suggestion was that FDA define ``restrict or
interfere'' to mean ``present actual legal or procedural impediment to
the exclusion of business disincentives.'' One comment expressed
concerns that return requirements could be viewed as interfering with
distribution of OTC hearing aids because such requirements make
distribution chains more complicated and potentially more expensive;
warranty requirements would, by mandating servicing of OTC hearing
aids, interfere with the servicing of the devices; and both kinds of
requirements could be viewed as discouraging the sale of OTC hearing
aids by increasing prices for patients.
    (Response) FDA declines to include the definitions suggested by
comments because the Agency is concerned that the suggested definitions
may not be consistent with ``restrict or interfere with'' in section
709(b)(4) of FDARA. For example, the dictionary defines ``restrict'' to
mean ``to confine within bounds,'' Merriam-Webster at https://www.merriam-webster.com/dictionary/restrict, and this definition seems
somewhat different from ``prevent or create an obstacle'' or ``present
actual legal or procedural impediments.''
    Instead of adopting the definitions proposed by the comments or
some other definition, in assessing whether a State or local
requirement would ``restrict or interfere with'' commercial activity
involving OTC hearing aids, FDA intends to consider, among other
things, the ordinary meaning of these terms in the context of section
709 of FDARA, including the objectives of section 709, and the specific
facts, such as the specific language of the State or local requirement
and the effects of the requirement on commercial activity involving OTC
hearing aids.
    One of the reasons for the proposed definitions of ``restrict or
interfere'' in the comments appears to be the concern that State
consumer protection laws, such as those that provide for a return
period or warranty for hearing aids, would be preempted under section
709(b)(4) of FDARA. For a discussion of this topic, see the response to
Comment 122.
    FDA notes that ``restrict or interfere with'' is just one element
of the FDARA preemption provision in section 709(b)(4). In other words,
there are other elements to consider in assessing whether a State or
local requirement is preempted under section 709(b)(4) of FDARA, such
as whether the State or local requirement is ``specifically related to
hearing products.'' As discussed in the proposal, we do not interpret
FDARA to preempt generally applicable requirements, i.e., requirements
that relate to other products in addition to hearing products, to
services not specific to hearing products, or to unfair trade practices
in which the requirements are not limited to hearing products. See 86
FR 58150 at 58167 for further discussion.
    (Comment 117) A comment suggested that FDA consider requests from
States for exemption from Federal preemption as OTC devices enter the
market. Another comment suggested that FDA state in the final rule that
the existing processes in Sec.  808.20 (21 CFR 808.20) (which relate to
requests for exemption from Federal preemption under section 521 of the
FD&C Act) will continue to apply, and that FDA will find against
preemption when consistent with the statutory language and ``in the
public interest.''
    (Response) As discussed in the proposal, section 709(b)(4) of FDARA
established preemption specific to OTC hearing aids that is different
from the general rule for preemption under section 521 of the FD&C Act.
See 86 FR 58150 at 58166. Unlike section 521 of the FD&C Act, section
709(b)(4) of FDARA does not provide for any exemptions for State or
local requirements that fall within this provision. Therefore, FDA is
unable to provide exemptions from preemption for State or local
requirements that fall within the scope of section 709(b)(4).
    Section 521 of the FD&C Act does provide for exemption from
preemption for State or local requirements that fall within this
provision, and the procedures for requesting and granting or denying an
exemption are provided in part 808, subpart B (21 CFR part 808, subpart
B). Section 808.20 will continue to apply to State or local
requirements that fall within section 521 of the FD&C Act, such as
requirements for prescription hearing aids. FDA did not propose any
changes to Sec.  808.20.
    FDA intends to assess preemption consistent with the statutory
language of section 709(b)(4) of FDARA for State or local requirements
that fall within this provision. We believe this approach to assessing
preemption is consistent with the Supreme Court's approach to Federal
preemption. See, e.g., Puerto

Rico v. Franklin Cal. Tax-Free Trust, 579 U.S. 115, 125 (2016)
(explaining that ``because the statute contains an express preemption
clause, we do not invoke any presumption against preemption but instead
focus on the plain wording of the clause, which necessarily contains
the best evidence of Congress' pre-emptive intent.'' (citations and
internal quotations omitted)). Additionally, FDA believes that this
approach will achieve the objectives of section 709 of FDARA, which
include promoting access to safe and effective OTC hearing aids for
adults with perceived mild to moderate hearing impairment, and in so
doing, will be in the public interest. FDA also intends to assess
preemption consistent with section 521 of the FD&C Act for State or
local requirements that fall within this provision, and consider
exemption from preemption when requested in accordance with Sec.
808.20. As indicated in Sec.  808.20, FDA considers, among other
things, information on how the public health may be benefitted if an
exemption is granted.
    (Comment 118) A comment suggested that FDA set up an informal
process by which States could request feedback from the Agency about
whether specific requirements are preempted under section 709(b)(4) of
FDARA. Another comment requested that FDA specify in the final rule
that the process in Sec.  808.5(a) (21 CFR 808.5(a)) apply to State and
local requirements concerning hearing products because this process
would increase transparency.
    (Response) At this time, FDA does not believe it is necessary to
set up a separate informal process for States or localities to request
feedback from the Agency about whether specific requirements are
preempted under section 709(b)(4) of FDARA because there are existing
informal processes that States or localities can use to make such
requests. For example, State or localities that have questions about
preemption may contact the Center for Devices and Radiological Health
(CDRH)'s Ombudsman at [email protected] or FDA's
Intergovernmental Affairs Staff at [email protected]. (CDRH's Division of
Industry and Consumer Education can also answer general questions
regarding device regulation.) Additionally, we note that Sec.  808.5(a)
does not set forth a separate process but rather relies on the advisory
opinion process in Sec.  10.85 (21 CFR 10.85). States or localities may
request an advisory opinion under Sec.  10.85 with respect to whether
FDA regards a particular State or local requirement as preempted under
section 709(b)(4) of FDARA.
    (Comment 119) Two comments noted that part 808 includes a list of
the types of State or local requirements that are not preempted, and
requested that FDA expand this list with additional examples pertaining
to hearing aids, such as requirements that relate to warranties,
returns, and the sale of hearing aids for users under 18 years of age.
    (Response) The list in part 808 of the types of State or local
requirements that are not preempted pertains to preemption under
section 521 of the FD&C Act. Specifically, Sec.  808.1(d) provides
examples of the types of State or local requirements that are not
preempted by section 521 of the FD&C Act, including examples of State
or local requirements that are not considered ``requirements applicable
to a device'' under section 521 of the FD&C Act.
    However, providing general categories of State or local requirement
on hearing aids that are not preempted under section 709(b)(4) of FDARA
would be challenging because preemption under this section depends in
part on whether the requirement would ``restrict or interfere with''
commercial activity involving OTC hearing aids. Whether a State or
local requirement would ``restrict or interfere with'' commercial
activity involving OTC hearing aids will depend on the specific facts,
including the specific language of the State or local requirement and
the effects of the requirement.
    We note that in the proposal, we did provide specific examples of
State or local requirements that we believe would or would not be
preempted under section 709(b)(4) of FDARA. See 86 FR 58150 at 58167-
68. Additionally, as discussed in the proposal, we do not interpret
section 709(b)(4) of FDARA to preempt generally applicable
requirements, i.e., requirements that relate to other products in
addition to hearing products, to services not specific to hearing
products, or to unfair trade practices in which the requirements are
not limited to hearing products. See 86 FR 58150 at 58167 for further
discussion. However, we noted that if a State or local requirement
appears on its face to be generally applicable, but in practice it was
specifically related to hearing products and would restrict or
interfere with commercial activity involving OTC hearing aids, the
requirement would be preempted. See 86 FR 58150 at 58167.
    Further, State or local requirements specifically related to
hearing products would not be preempted under section 709(b)(4) of
FDARA if they would not restrict or interfere with commercial activity
involving OTC hearing aids. For example, we believe that reasonable
return or warranty requirements for OTC hearing aids would likely
promote, rather than restrict or interfere with, commercial activity
involving OTC hearing aids by reducing the financial risk to
purchasers. For further discussion of this topic, see the response to
Comment 122.
    We also note that section 709(b)(5) of FDARA specifies, ``[n]othing
in this section shall be construed to modify or otherwise affect the
ability of any person to exercise a private right of action under any
State or Federal product liability, tort, warranty, contract, or
consumer protection law.'' Therefore, laws that fall within the scope
of this savings clause would not be preempted under section 709(b)(4)
of FDARA provided that they do not conflict with the OTC Hearing Aid
Controls or frustrate the purposes and objectives of section 709 of
FDARA. See, e.g., Am. Tel. and Tel. Co. v. Central Office Tel., Inc.,
524 U.S. 214, 226 (1998) (holding that a remedies savings clause in the
Communications Act of 1934 did not save State laws that were
inconsistent with Federal law); Automobile Importers of America, Inc.
v. Minnesota, 871 F.2d 717, 722 (8th Cir. 1989) (although the relevant
Federal statute had a broad savings clause, the court stated ``State
legislation is preempted if compliance with the state law frustrates
the purposes and objectives of federal law'').
    States or localities that have questions about preemption may
contact CDRH's Ombudsman at [email protected] or FDA's
Intergovernmental Affairs Staff at [email protected], or they may request
an advisory opinion under Sec.  10.85 with respect to whether FDA
regards a particular State or local requirement as preempted under
section 709(b)(4) of FDARA.
    The OTC Hearing Aid Controls in Sec.  800.30 do not apply to
hearing aids intended for users under 18 years of age. Hearing aids
intended for users under 18 years of age would be considered
prescription hearing aids as defined in Sec. Sec.  800.30(b) and
801.422(b). State or local requirements governing the sale of hearing
aids for users under 18 years of age would fall within the scope of
section 521 of the FD&C Act, and therefore, that section and part 808
would continue to apply. To the extent that a State or local
requirement is preempted under section 521 of the FD&C Act, the State
or political subdivision may apply for exemption from preemption in
accordance with part 808, subpart B.
    (Comment 120) A comment from an association of State Attorneys
General

stated that ``the proposed rule includes broad language that could be
interpreted to repeal virtually all the state-requested exemptions from
preemption issued by the FDA since 1980--even those related exclusively
to non-OTC hearing aids'' and that this could create confusion and
unnecessary litigation.
    (Response) While we are removing most of the regulations codifying
the exemption decisions, we are doing so because we are repealing or
revising the specific counterpart Federal regulations that preempted
State and local requirements respecting devices. In addition,
preemption specific to OTC hearing aids would generally nullify the
exemptions to the extent the State or local requirements would apply to
OTC hearing aids except in certain specific circumstances.
    With respect to OTC hearing aids, as discussed in the proposal,
section 709(b)(4) of FDARA established preemption specific to OTC
hearing aids that is different from the general rule for preemption
under section 521 of the FD&C Act. See 86 FR 58150 at 58166. The FDARA
preemption provision preempts State and local requirements specifically
related to hearing products that would restrict or interfere with
commercial activity involving OTC hearing aids, and that are different
from, in addition to, or otherwise not identical to regulations issued
under FDARA section 709(b). Unlike section 521 of the FD&C Act, section
709(b)(4) of FDARA does not provide for any exemptions for State or
local requirements that fall within this provision. Therefore, FDA is
unable to continue in effect any previously granted exemptions from
preemption for State or local requirements that fall within the scope
of section 709(b)(4) of FDARA.
    With respect to prescription hearing aids and other State and local
requirements for hearing aids not otherwise preempted by FDARA section
709(b)(4), FDA is removing all of the regulations in part 808 related
to hearing aids; that is, almost all regulations codifying the previous
decisions in Sec. Sec.  808.53 through 808.101, except for the portions
of Sec.  808.55 (California) that do not relate solely to hearing aids.
As discussed in the proposal, those exemptions are no longer applicable
because this final rule repeals or revises the underlying Federal
requirements from which those exemptions were granted. See 86 FR 58150
at 58170. In addition, FDA is aware that several States have modified
their requirements that were the subject of the exemption decisions
since they applied for exemptions, in which case the exemption decision
may no longer be applicable.
    We note that removal of these exemptions does not itself mean that
those State or local laws are now preempted given that we are repealing
or revising the specific counterpart regulations. For example, the
repeal of the conditions for sale in Sec.  801.421 means that State or
local requirements that differed from, or were in addition to, the
repealed counterpart Federal requirements will no longer be preempted
under section 521(a) of the FD&C Act (see Sec.  808.1(d)). However,
some of the new requirements we are establishing in this rule would
implicate preemption under section 521(a) of the FD&C Act. For example,
the prescription hearing aid labeling requirements set forth in Sec.
801.422 will preempt certain State or local requirements that are
different from, or in addition to, those Federal requirements. These
new requirements are similar but not identical to those in Sec.
801.420 and include substantive changes. To the extent that any
previously granted petitions for exemptions related to labeling
requirements, any such exemptions would be rendered inapplicable due to
changes in the underlying Federal requirements from which the
exemptions were granted.
    States or localities that have questions about preemption may
contact CDRH's Ombudsman at [email protected] or FDA's
Intergovernmental Affairs Staff at [email protected], or they may request
an advisory opinion under Sec.  10.85 with respect to whether FDA
regards a particular State or local requirement as preempted.
    (Comment 121) A comment from the Rhode Island Department of Health
noted that Rhode Island General Laws sections 5-49-2.1 and 2.2 contain
provisions that would require consumers or purchasers to obtain a
certificate of need from a physician who attests that the individual is
in need of a hearing aid, and therefore requested that FDA retain Sec.
808.89, which denied Rhode Island's request for exemption from
preemption. Doing so, the comment said, would align with FDA's approach
of authorizing non-physician licensed hearing professionals to make
determinations of need and would also benefit consumers by reducing
unnecessary costs and added time to the process of obtaining a hearing
aid.
    (Response) FDA has decided not to retain Sec.  808.89, because the
repeal of the conditions for sale in Sec.  801.421 substantively
changes the underlying Federal requirements against which the previous
denial of exemption from preemption was made. The repeal of Sec.
801.421 means Rhode Island General Laws sections 5-49-2.1 and 2.2 are
no longer preempted under section 521(a) of the FD&C Act, because no
counterpart Federal requirement exists (see Sec.  808.1(d)). Without
that preemption, the previous denial would have no effect even were we
to retain the regulation.
    However, section 709(b)(4) of FDARA would separately preempt the
Rhode Island provisions to a certain extent, regardless of our previous
exemption decisions and whether or not Sec.  808.89 were retained. For
example, to the extent the Rhode Island laws require a certificate of
need from a physician for the sale of OTC hearing aids, they are now
preempted by FDARA section 709(b)(4), because they are specifically
related to hearing products, would restrict or interfere with
commercial activity involving OTC hearing aids, and are different from,
in addition to, or otherwise not identical to, FDA's regulations issued
under FDARA section 709(b).
    (Comment 122) Some comments expressed concern that State consumer
protections would be preempted. For example, one comment stated that
many States tie consumer protections, such as return requirements, for
purchasers of hearing aids to licensing requirements, and stated that
these protections would be preempted under the proposed rule. To
address the concern, comments recommended that Federal consumer
protections, such as requiring that hearing aid sales be accompanied by
a receipt, information relating to warranty, and mandatory return or
trial period, be established, for example as conditions for sale under
Sec.  800.30(g).
    (Response) FDA declines to include the requirements suggested by
comments because at this time, the Agency believes requiring that OTC
hearing aid sales be accompanied by a receipt, information relating to
warranty, and mandatory return or trial period is not necessary to
provide reasonable assurance of the safety and effectiveness of OTC
hearing aids.
    FDA notes that the preemption provision in Sec.  800.30(h)(1) is
intended to incorporate the preemption provision in section 709(b)(4)
of FDARA. In other words, the preemption provision in Sec.
800.30(h)(1) simply reflects the statute, which expresses clear
Congressional intent to preempt certain State and local requirements.
As explained in the proposal, FDA decided to codify the FDARA
preemption provision in the regulations to assist stakeholders in
understanding the legal framework for OTC hearing aids given that the
FDARA

preemption provision was not incorporated into the FD&C Act (a process
known as U.S. Code classification). 86 FR 58150 at 58166. In this
response, FDA focuses on the express preemption provision in section
709(b)(4) of FDARA but notes that there are other types of preemption
that may apply such as conflict preemption. See, e.g., Nat'l Fedn. of
the Blind v. United Airlines, Inc., 813 F.3d 718, 724 (9th Cir. 2016)
(describing conflict preemption in addition to express preemption).
    Whether a State or local requirement is preempted under section
709(b)(4) of FDARA would depend on the specific facts, including the
language of the requirement and the effects of the requirement on
commercial activity involving OTC hearing aids. However, FDA believes
that many State or local consumer protection requirements would not be
preempted under section 709(b)(4) of FDARA because they are not
``specifically related to hearing products'' or would not ``restrict or
interfere with'' commercial activity involving OTC hearing aids. As
discussed in the proposal, we do not interpret FDARA to preempt
generally applicable requirements, i.e., requirements that relate to
other products in addition to hearing products, to services not
specific to hearing products, or to unfair trade practices in which the
requirements are not limited to hearing products. See 86 FR 58150 at
58167. For example, generally, we would not consider a State or local
warranty requirement for assistive devices to be ``specifically related
to hearing products'' under section 709(b)(4) of FDARA because the
requirement relates to other products (e.g., wheelchairs) in addition
to hearing products.
    Whether a State or local consumer protection requirement that
specifically related to hearing products would ``restrict or interfere
with'' commercial activity involving OTC hearing aids would depend on
the specific facts. However, generally, FDA believes that State or
local requirements that provide for a reasonable warranty or return
period for hearing aids (e.g., 60-day period) would likely promote,
rather than restrict or interfere with, commercial activity involving
OTC hearing aids. Such requirements may help to encourage people who
could benefit from an OTC hearing aid to purchase the device by
reducing their financial risk. As discussed in the proposal, despite
the high prevalence and public health impact of hearing loss, only
about one-fifth of people who could benefit from a hearing aid seek
intervention, likely due to barriers such as high cost. 86 FR 58150 at
58151. An important objective of section 709 is to lower some of the
barriers and improve access to these devices for people who could
benefit from them. See id.; see also ``FDA User Fee Agreements:
Improving Medical Product Regulation and Innovation for Patients, Part
I,'' Hearing before the Comm. on Health, Education, Labor, and
Pensions, 115th Cong. 115-255 (2017), at 74 (Remarks by Sen. Elizabeth
Warren regarding S. 670, the Over-the-Counter Hearing Aid Act of 2017,
which was largely incorporated into section 709 of FDARA, indicating
that this legislation was intended to improve access and affordability
to safe and effective OTC hearing aids for millions of consumers who
could benefit from these devices); ``Examining Improvements to the
Regulation of Medical Technologies,'' Hearing before the Subcomm. on
Health of the H. Comm. on Energy and Commerce, 115th Cong. 115-28
(2017), at 3 (Statement of Rep. Michael C. Burgess regarding H.R. 1652,
the Over-the-Counter Hearing Aid Act of 2017, which was largely
incorporated into section 709 of FDARA, stating that this bill was
introduced ``to safely increase access and affordability in the hearing
aid market for millions of Americans from whom it would benefit.'').
    Additionally, State or local requirements that provide for
reasonable disclosure of the terms of sale in a receipt or similar
document would likely promote, rather than restrict or interfere with,
commercial activity involving OTC hearing aids by providing important
information in writing, such as return or warranty information, to help
people with mild to moderate hearing impairment make fully informed
purchasing decisions.
    Congress also recognized the importance of maintaining certain
State consumer protection laws as reflected in section 709(b)(5) of
FDARA. Specifically, section 709(b)(5) states, ``Nothing in this
section shall be construed to modify or otherwise affect the ability of
any person to exercise a private right of action under any State or
Federal product liability, tort, warranty, contract, or consumer
protection law.'' Therefore, laws that fall within this savings clause
would not be preempted unless they conflict with the OTC Hearing Aid
Controls or frustrate the purposes and objectives of section 709 of
FDARA. See, e.g., Am. Tel. and Tel. Co. v. Central Office Tel., Inc.,
524 U.S. 214, 226 (1998) (holding that a remedies savings clause in the
Communications Act of 1934 did not save state laws that were
inconsistent with federal law); Automobile Importers of America, Inc.
v. Minnesota, 871 F.2d 717, 722 (8th Cir. 1989) (although the relevant
Federal statute had a broad savings clause, the court stated ``State
legislation is preempted if compliance with the state law frustrates
the purposes and objectives of federal law'').
    With regard to State or local requirements that tie consumer
protections to licensing requirements, the consumer protections are not
necessarily preempted. As we explained in the proposal, under section
709(b)(4) of FDARA, a State or local government cannot require persons
engaged in commercial activity involving OTC hearing aids to undertake
special licensing or equivalent activities solely on that basis (see 86
FR 58150 at 58158). However, such persons who voluntarily identify as a
licensed person would be subject to corresponding State or local
requirements for such licensed persons, including consumer protection
requirements, to the extent that the State or local requirements do not
restrict or interfere with commercial activity involving OTC hearing
aids (see section 709(b)(4) of FDARA; see also the discussion in 86 FR
58150 at 58158).
    Therefore, the issue is not necessarily that the consumer
protections are preempted, but rather the issue is that the consumer
protections are tied to the licensing requirements. Thus, to the extent
that consumers purchase OTC hearing aids from non-licensed persons,
they may not get the additional consumer protections they would get if
they purchased the OTC hearing aid from a licensed person. However,
Congress made clear that any State or local requirement for the
involvement or intervention of a licensed person for consumers to
access OTC hearing aids is preempted under section 709(b)(4) of FDARA.
Even if certain consumer protections are not required as part of the
sale of OTC hearing aids by non-licensed persons, we do not believe
that consumers who purchase OTC hearing aids from non-licensed persons
will be left without consumer protections. In addition to consumer
protection laws administered by the Federal Trade Commission, many
States have generally applicable consumer protection requirements that
would not be preempted under section 709(b)(4) of FDARA, such as those
that address unfair and deceptive business practices, false or
misleading advertising, warranties, etc.
    (Comment 123) A comment suggested that FDA preempt State
requirements for hearing aids as they apply to OTC hearing aids but
that such requirements

should continue to apply to prescription hearing aids. Another comment
expressed concern that State hearing aid laws that are not severable
could be preempted as applied to all hearing aids.
    (Response) If a State requirement does not fall within section
709(b)(5) of FDARA and is preempted under section 709(b)(4) of FDARA,
FDA would consider it to be preempted to the extent that it applies to
OTC hearing aids. Such State requirement may continue to apply to
prescription hearing aids unless the requirement is preempted under
section 521 of the FD&C Act.
    (Comment 124) A comment noted that there are State statutes and
rules that refer to Sec. Sec.  801.420 and 801.421 or incorporate the
same or similar language contained in those provisions, and requested
input on whether such State laws would continue to apply or whether
they would be preempted by the new Federal rules. The comment also
encouraged FDA to consider using the existing sections to capture the
new labeling requirements or special controls because using the
existing sections may be beneficial for State laws that refer to those
sections.
    (Response) State laws or rules that incorporate language that is
the same as, or substantially identical to, the language contained in
former Sec.  801.421 may continue in effect as applied to prescription
hearing aids. However, one exception is the statement that was required
under Sec.  801.421(a)(2)(iii). Specifically, Sec.  801.421(a)(2)(iii)
required that the hearing aid dispenser affords the prospective user
the opportunity to sign the following statement: ``I have been advised
by (Hearing aid dispenser's name) that the Food and Drug Administration
has determined that my best health interest would be served if I had a
medical evaluation by a licensed physician (preferably a physician who
specializes in diseases of the ear) before purchasing a hearing aid. I
do not wish a medical evaluation before purchasing a hearing aid.''
State or local laws or rules that require this statement would no
longer be in effect because this statement was based on the waiver of
the medical evaluation that was required under Sec.  801.421, which FDA
is repealing.
    Because Sec.  801.420 was issued under section 520(e) of the FD&C
Act (among other authorities), and FDA is not relying on this authority
for the revised labeling requirements for prescription hearing aids,
FDA has decided to establish the revised labeling requirements in new
Sec.  801.422. In the labeling requirements for prescription hearing
aids in Sec.  801.422, FDA has retained in substance most of the
labeling requirements that were in Sec.  801.420 but also made some
revisions. Whether State hearing aid labeling requirements that
incorporate language from Sec.  801.420 are preempted as applied to
prescription hearing aids due to the new labeling requirements in Sec.
801.422 depends on whether they are different from, or are in addition
to, the new requirements. If they are equal to, or substantially
identical to, the requirements in Sec.  801.422, they would not be
preempted as applied to prescription hearing aids. See Sec.
808.1(d)(2). State hearing aid labeling requirements incorporating
language from Sec.  801.420 would be preempted as applied to OTC
hearing aids if they are different from, in addition to, or otherwise
not identical to, the OTC hearing aid labeling requirements in Sec.
800.30. See section 709(b)(4) of FDARA.
    We note that the requirements in Sec. Sec.  801.420 and 801.421
were considered general controls that applied to all hearing aids
regardless of the device's classification. In other words, these
requirements were not special controls under section 513(a)(1)(B) of
the FD&C Act. Similarly, the labeling requirements for prescription
hearing aids in Sec.  801.422 are considered general controls that
apply to all prescription hearing aids regardless of the device's
classification. Special controls apply to class II devices and the
special controls for a class II hearing aid are specified in the
particular classification for the hearing aid (e.g., Sec.  874.3305).
    (Comment 125) Comments requested that FDA clarify the types of
State or local requirements for an audiological or medical evaluation,
prior to purchasing a prescription hearing aid, that this rule would
not preempt. Many of these comments conveyed uncertainty about the
effects on existing State and local requirements with the withdrawal of
previous exemption decisions that allowed States and localities to
establish and continue in effect requirements respecting hearing aids.
    (Response) State or local requirements that were preempted solely
because they differed from or were in addition to the conditions for
sale requirements in Sec.  801.421 and for which FDA previously granted
exemptions from Federal preemption may continue in effect with respect
to prescription hearing aids after the withdrawal of the previous
exemption decisions. This is because State or local requirements are
preempted under section 521(a) of the FD&C Act only when FDA has
established specific counterpart regulations or there are other
specific requirements applicable to a particular device that make State
or local requirements applicable to the device different from, or in
addition to, the specific Federal requirements (see Sec.  808.1(d)).
The repeal of Sec.  801.421 will remove this specific counterpart
regulation that currently makes State or local requirements different
from, or in addition to, the specific Federal requirements therein. As
such, the State requirements that were preempted solely because they
differed from or were in addition to the requirements in Sec.  801.421
and for which FDA previously granted exemptions will no longer be
preempted under section 521(a) of the FD&C Act. They may therefore
continue in effect for prescription hearing aids, without an exemption,
so FDA is removing the exemption decisions that will become
unnecessary.
    As a result, if a State establishes or continues in effect a
requirement that, for example, people younger than 18 must have a
medical evaluation by an ear-nose-throat doctor to obtain a
prescription hearing aid, then that requirement would, as a general
matter, no longer be ``different from, or in addition to,'' the
examination and waiver requirements in Sec.  801.421 that we are
repealing. Similarly, a State could establish or continue in effect a
requirement, for example, that a licensed hearing instrument specialist
refer an adult prescription hearing aid candidate for a medical
examination if the specialist observes a Red Flag condition. However, a
State could not establish or continue in effect such a referral
requirement for OTC hearing aids, as explained elsewhere in this
document.
    Additionally, as explained elsewhere in this document, FDA is
revising the labeling requirements in Sec.  801.420 by, among other
things, moving them to new Sec.  801.422 and applying them to
prescription hearing aids. State or local requirements with respect to
prescription hearing aids that differ from, or are in addition to, the
requirements in Sec.  801.422 would be preempted under section 521(a)
of the FD&C Act.

I. Repeal of Restrictions and Modifications for Prescription Labeling
(Sec. Sec.  801.420, 801.421, 801.422)

    Many comments related to repealing the conditions for sale for
hearing aids expressed concerns for maintaining the involvement of a
licensed person in the adoption and use of hearing aids. One result of
this rulemaking is that non-OTC air-conduction hearing aids will be
prescription hearing aids, which will require the order (prescription)
of a

practitioner licensed by State law, as we explain elsewhere in this
document. Thus, the repeal of Sec.  801.421 does not imply the removal
of a licensed person from hearing health care with respect to
prescription hearing aids.
    Other comments communicated a desire for regulatory consistency
and/or continuity. While FDA would agree these are legitimate
interests, we generally declined to maintain the restrictions on those
bases. However, we note that final Sec.  801.422 retains many of the
labeling requirements under Sec.  801.420, and we have made the
labeling requirements for prescription hearing aids consistent with
that for OTC hearing aids to the extent appropriate.
    (Comment 126) One comment expressed concern that with the repeal of
the hearing aid restrictions, the previous preemption decisions would
no longer apply. The comment stated that while many State laws that had
been denied an exemption have since been repealed, some unrepealed laws
that have been unenforceable would now be enforceable, including those
that would restrict and/or impede the sale of hearing aids.
    (Response) FDA is repealing Sec.  801.421 which sets forth the
conditions for sale of hearing aids, and revising the labeling
requirements under Sec.  801.420 by, among other things, applying them
to prescription hearing aids only and moving them to new Sec.  801.422.
We assume that the comment is referring to the repeal of Sec.  801.421
given that the labeling requirements, although revised and moved to new
Sec.  801.422, would continue to exist and apply to prescription
hearing aids. FDA is repealing Sec.  801.421 because the Agency
believes these requirements are no longer necessary to provide
reasonable assurance of safety and effectiveness of prescription
hearing aids. FDA had been exercising enforcement discretion by
generally not enforcing most of the requirements in Sec.  801.421 since
late 2016. Additionally, we note that prescription hearing aids will
require a written or oral authorization from a practitioner licensed by
law to administer the device (see Sec.  801.109). This requirement,
along with the revised labeling requirements for prescription hearing
aids, will help provide reasonable assurance of safety and
effectiveness of these devices. State or local requirements that were
previously preempted under section 521 of the FD&C Act solely on the
basis that they were different from, or were in addition to, the
requirements in Sec.  801.421 would no longer be preempted as applied
to prescription hearing aids.
    We note that State or local requirements would be preempted under
section 709(b)(4) of FDARA if they: specifically related to hearing
products; would restrict or interfere with the sale of, or other
commercial activity involving, OTC hearing aids; are different from, in
addition to, or otherwise not identical to, the OTC Hearing Aid
Controls; and do not fall within section 709(b)(5) of FDARA.
    (Comment 127) Several comments proposed that prescription hearing
aids remain restricted devices. Many of these comments expressed
concerns about the role of licensed persons in fitting and dispensing
hearing aids, and a desire to ensure that prescription hearing aids
would only be sold pursuant to the written authorization of a qualified
hearing aid professional or, in some cases, a physician specifically.
Such comments, sometimes referring to ``special controls,'' also sought
to retain oversight of licensed persons.
    (Response) Although FDA agrees that the selection and use of
prescription hearing aids should involve a licensed person, we are not
maintaining the device restrictions because the restrictions are
unnecessary to ensure the involvement of a licensed person in the use
of prescription hearing aids.
    Under final Sec.  800.30(b), a prescription hearing aid is one that
does not meet the definition of ``over-the-counter hearing aid'' or
does not meet the requirements of the OTC Hearing Aid Controls. Any
hearing aid that is not OTC is a prescription device. A prescription
hearing aid is subject to Sec.  801.109 regarding prescription devices
(explained in the proposal, 86 FR 58150 at 58168). Among other
requirements, Sec.  801.109 specifies that prescription devices are
those to be sold only to or on the prescription or other order of a
practitioner licensed by law to use or order the use of the devices in
the course of professional practice (see Sec.  801.109(a)(2)). Further,
Sec.  801.109 requires labeling indicating that the device is only for
prescription use (see Sec.  801.109(b)(1)). A prescription hearing aid
that lacks this labeling would be misbranded (see final Sec.
801.422(c)(6)). Marketing a misbranded device, for example, by
introducing it into interstate commerce, and other activities with
respect to misbranded devices are prohibited acts (see, e.g., 21 U.S.C.
331(a)-(c), 331(k)).
    FDA notes that, in some circumstances, requirements on prescription
hearing aids once this rule is in effect may be more stringent than
under former Sec.  801.421 which allowed a prospective hearing aid user
18 or older to waive the requirement for a medical evaluation (former
Sec.  801.421(a)(2)). Further, as we explained in the proposal, FDA had
expressed that we do not intend to enforce the medical evaluation,
waiver, or recordkeeping requirements with respect to prospective
purchasers who are 18 or older (see 86 FR 58150 at 58154). However,
once this rule repeals those restrictions, any hearing aid that meets
the definition of a prescription hearing aid will be subject to
requirements for prescription devices, such as those in Sec.
801.109(a)(2). That is, such devices may be sold only to or on the
prescription or other order of a licensed practitioner. We also note
that States, not FDA, generally determine the licensing requirements
for practitioners to use or order the use of a prescription device.
Thus, States may, for example, require that prescription hearing aids
be ordered by physicians (medical doctors) or audiologists, which may
involve a medical or audiological evaluation of the prospective user,
including someone who is 18 or older. (See also the response to Comment
128.)
    (Comment 128) A few comments suggested that FDA apply device
restrictions to OTC hearing aids. A comment suggested that FDA make
both OTC and prescription hearing aids restricted devices. The comment
argued this would ensure regulatory consistency between categories as
well as supporting complementary State and local consumer protections.
    (Response) FDA is declining to take these suggestions. We are not
making OTC hearing aids restricted devices under section 520(e) of the
FD&C Act, and we are repealing the existing restrictions on hearing
aids. For OTC and prescription hearing aids, at this time we believe
the authorities that we are relying on, including those described in
section IV of this document, are adequate. Because we are not relying
on our restricted device authority at this time, neither OTC hearing
aids nor prescription hearing aids would be restricted devices under
section 520(e) of the FD&C Act. Therefore, there would be regulatory
consistency between these categories in this respect.
    Further, to the extent the comment is requesting that FDA maintain
the restrictions in Sec.  801.421, the restrictions that we are
repealing do not in themselves enable or support complementary State
and local consumer protections. Indeed, many of the State requirements
for hearing aids for which FDA had granted exemptions from Federal
preemption were

preempted because of the restrictions (they were different from, or
were in addition to, the restrictions), and the State requirements
continued in effect because the States applied for, and FDA granted,
exemptions. Absent the restrictions, those State requirements, many of
which related to patient or consumer protection, likely would not have
been preempted (all else being equal) and could have continued in
effect without FDA acting to exempt them.
    Moreover, section 709(b)(4) of FDARA would continue to apply to OTC
hearing aids and, as described elsewhere, would still preempt certain
State and local requirements pertaining to a wide range of commercial
activity involving OTC hearing aids, regardless of whether or not OTC
hearing aids are restricted devices. Additionally, FDA would not expect
that making OTC hearing aids restricted devices would augment State and
local consumer protections that would continue in effect. (See also the
response to Comment 127.)
    (Comment 129) Some comments proposed that prescription hearing aids
remain restricted devices to ensure that FDA retain the added
regulatory authority over advertising material for restricted devices.
These comments asserted that advertising has falsely or misleadingly
suggested that products were hearing aids, inducing people to use
products that were not safe or effective options to address or
compensate for hearing loss. The use of unsafe or ineffective products,
instead of hearing aids, has an increased risk of impairing the user's
remaining hearing or convincing users not to seek safer, more effective
options.
    (Response) FDA is not accepting this proposal because as explained
in the response above, at this time we believe the authorities that we
are relying on, including those described in section IV of this
document, are adequate.
    Additionally, restricted device authority is not necessary for FDA
regulation of products that are marketed as hearing aids but do not
comply with applicable requirements. The intended use of an article
(not just restricted devices) may be shown by, among other indicia, the
circumstances surrounding distribution as well as advertising matter
(see Sec.  801.4). Should such circumstances or advertising show that
the article is intended to compensate for hearing loss, then it would
be subject to labeling and other requirements for hearing aids. Failure
to meet these requirements would render the article adulterated and/or
misbranded (see 21 U.S.C. 351 and 352). Marketing (for example, by
introducing such articles into interstate commerce) and other
activities with respect to such articles would constitute prohibited
acts even though prescription hearing aids would not be restricted
devices (see, e.g., 21 U.S.C. 331(a)-(c), 331(k)).
    (Additional Revision 5) FDA has identified additional revisions
that would provide for clarity and consistency upon the removal of
Sec.  801.420 and the repeal of Sec.  801.421. We proposed to amend
Sec.  874.3950 (21 CFR 874.3950), the classification regulation for
transcutaneous air-conduction hearing aid systems, by specifying that
the devices would be subject to new Sec.  801.422. This would clarify
that the devices are prescription hearing aids and subject to
corresponding labeling requirements.
    However, the regulation currently specifies that transcutaneous
air-conduction hearing aid systems are subject to special controls
described by the document, ``Class II Special Controls Guidance
Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS);
Guidance for Industry and FDA,'' issued on November 7, 2002 (see Sec.
874.3950(b)).\16\ That document in turn currently refers to Sec. Sec.
801.420 and 801.421. Further, in reviewing the document for consistency
with this rulemaking, we observed that its Scope section refers
incorrectly to Sec.  874.3340, which is not the correct citation for
the classification regulation for transcutaneous air-conduction hearing
aid systems.
---------------------------------------------------------------------------

    \16\ The document is available online at: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/transcutaneous-air-conduction-hearing-aid-system-tachas-class-ii-special-controls-guidance-document.
---------------------------------------------------------------------------

    For clarity and consistency, in addition to the amendment that we
proposed to Sec.  874.3950(a), we are revising the special controls
document by replacing references to Sec. Sec.  801.420 and 801.421 with
Sec.  801.422 for both. We also are correcting the reference to the
incorrect classification regulation to the correct one, which is Sec.
874.3950. To indicate these revisions, we are adding a statement to the
special controls document that we revised the document. We will publish
the special controls document with the revisions on or around the
effective date of this final rule. However, we are not revising the
substance of the special controls document, and as such, we are not
updating the date on which the document was issued. The revisions to
the special controls document will appear on FDA's website.

J. Other Amendments

    (Comment 130) One comment suggested that FDA include a misbranding
provision for OTC hearing aids with respect to labeling, similar to the
provision included for prescription hearing aids (final Sec.
801.422(c)(6)).
    (Response) FDA declines to include a similar misbranding provision
for OTC hearing aids under Sec.  800.30. As provided in Sec. Sec.
800.30(a) and (b) and 801.422(a) and (b), any hearing aid that does not
satisfy the requirements of Sec.  800.30, including the labeling
requirements of that section, is a prescription hearing aid, and as
such, must meet the requirements of Sec. Sec.  801.422 and 801.109. In
other words, a hearing aid that fails to meet the labeling requirements
of Sec.  800.30 would be subject to Sec. Sec.  801.422 and 801.109. In
turn, failure to meet the labeling requirements of Sec. Sec.
801.422(c) and 801.109 would render the product misbranded, as stated
in final Sec.  801.422(c)(6). In other words, hearing aids that fail to
comply with the requirements in Sec.  800.30 would be prescription
hearing aids and would be misbranded if they fail to comply with
Sec. Sec.  801.422 and 801.109. For example, such a hearing aid would
be misbranded under section 502(f)(1) of the FD&C Act in that its
labeling would fail to bear adequate directions for use and it would
not be exempt from this requirement.
    (Comment 131) A comment proposed that FDA develop a national
standard to sell prescription hearing aids via telemedicine visits with
licensed persons to people who are 18 years of age or older. The
comment suggested that the standard could include calibrated in-home
tests for both air-conduction and bone-conduction devices.
    (Response) Although FDA establishes performance standards for
devices, among other general and special controls, in appropriate
circumstances, FDA does not generally establish standards for medical
practice, including telemedicine. However, we note that in-home hearing
tests may meet the definition of ``device'' and be subject to the
provisions of, and regulatory controls under, the FD&C Act, including
those described in section IV of this document. Classification of a
hearing test would establish the controls necessary to provide
reasonable assurance of safety and effectiveness of the device for its
intended use(s), and these would apply to the devices nationally. (See
also section X describing the implications of federalism.)

    (Additional Revision 6) FDA has decided not to realign the
classification regulations by sound conduction mode as proposed.
Combining the existing regulations may have suggested to stakeholders
that only a single device type was appropriate for OTC availability or
vice versa. However, as explained elsewhere, for example, in the
response to Comment 2, that is not the case. To reduce the potential
for this kind of confusion, we are keeping the various air-conduction
generic types in their existing regulations. However, we are proceeding
to separate bone-conduction hearing aids into their own classification
regulation, new Sec.  874.3302, including the reassignment of product
codes. We are also proceeding with the other proposed minor revisions
to the air-conduction classification regulations, including the
revisions to the special controls as provided in proposed Sec.
874.3305(b) and clarifying the applicability of requirements under
either final Sec.  800.30 or Sec.  801.422 for the various generic
types.

VI. Effective and Compliance Dates

    (Comment 132) FDA received several comments proposing that the
compliance date be the same for hearing aids that have and have not
been offered for sale prior to the effective date of this final rule.
These comments provided various reasons, including that: new entrants
into the hearing aid market need time to make pre-launch adjustments to
their marketing and devices they plan to introduce and need more than
the 60 days proposed; that FDA takes longer than 60 days to review
510(k)s; and that different compliance dates for different
manufacturers would be unfair. Most such comments proposed a compliance
date of 240 days after the publication of this final rule.
    (Response) FDA is not establishing the same compliance dates
because hearing aids that are not offered for sale, that is, not on the
market, are not similarly situated as hearing aids offered for sale,
that is, on the market, prior to the effective date. The compliance
date is not the date by which new entrants must start marketing, and if
new entrants find they need additional time prior to marketing their
devices, they may take it. Moreover, should a new entrant need to
obtain 510(k) clearance, it could not market the device until it
obtains clearance, regardless of the compliance date.
    We acknowledge that hearing aids on the market will have a
different timeframe for compliance. However, the consequences of
noncompliance with the new requirements are different for hearing aids
that are on the market from those not on the market when this rule
takes effect. For hearing aids that are on the market, they are subject
to enforcement actions if they do not comply with the new requirements
as well as other applicable requirements. Given this, they need
sufficient time to come into compliance. Hearing aids that are not on
the market do not face these consequences--as discussed above, if such
hearing aids do not comply with the new requirements and other
applicable requirements, manufacturers may take whatever time they need
to bring the devices into compliance. As such, the same compliance
timeframe is not appropriate in this case. See the response to Comment
133 about considerations for 510(k)s for marketed devices.
    (Comment 133) Some comments regarding marketed devices also raised
concerns that FDA may take too long to review 510(k)s, and devices
could be out of compliance even if a manufacturer submitted a 510(k)
soon after the publication of this final rule. They sought
clarification and/or a change in the compliance date.
    (Response) In consideration of the comments, for hearing aids
legally offered for sale prior to the effective date, FDA intends not
to enforce the requirement for a 510(k) in certain situations, as
discussed in the compliance date section below.
    (Comment 134) Some comments questioned how soon hearing aids could
be made available OTC, including whether manufacturers would need to
wait 60 days (until the effective date).
    (Response) Generally, hearing aids could not be available OTC
within the meaning of section 520(q)(1)(A)(v) of the FD&C Act until the
effective date of this final rule.

A. Effective Date

    This final rule will be effective 60 days after the publication in
the Federal Register. We are finalizing the following compliance dates:

B. Compliance Date for Hearing Aids Not Legally Offered for Sale Prior
to the Effective Date

    For hearing aids that have not been offered for sale prior to the
effective date of the final rule, or have been offered for sale but are
required to submit a new 510(k) under Sec.  807.81(a)(3) due to changes
unrelated to this rule (an example of such is the addition of self-
fitting technology to a wireless air-conduction hearing aid),
compliance with the new or revised requirements applicable to the
hearing aid, and obtaining 510(k) clearance if applicable, must be
achieved before marketing the device on or after the effective date of
this final rule. If a person (e.g., manufacturer) markets such a device
without complying with the new or revised requirements or if
applicable, obtaining 510(k) clearance, then FDA would consider taking
action against such person under our usual enforcement policies.

C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to
the Effective Date

    For hearing aids that have been legally offered for sale prior to
the effective date of the final rule, including those that already have
a 510(k) clearance, compliance with the new or revised requirements
that apply to the hearing aid must be achieved 180 days after the
effective date of the final rule (i.e., 240 days after the publication
of the final rule). After that date, if a person (e.g., manufacturer)
continues to market such a device but does not comply with the new or
revised requirements that apply to the device, then FDA would consider
taking action against such person under our usual enforcement policies.
    However, FDA does not intend to enforce the requirement to submit a
510(k) and obtain 510(k) clearance where a hearing aid is legally
offered for sale prior to the effective date; the changes that require
a new 510(k) are made on or before the compliance date and are made
solely to satisfy the OTC Hearing Aid Controls; the changes do not
adversely affect device safety or effectiveness; the device is
otherwise in compliance with applicable requirements; and on or before
the compliance date, the manufacturer documents the changes and its
determination that the changes do not adversely affect device safety or
effectiveness.
    At present, legacy and wireless air-conduction hearing aids are
exempt from section 510(k) (21 U.S.C. 360(k)) of the FD&C Act, subject
to the limitations of exemption described in Sec.  874.9. (Legacy
hearing aids are class I devices and are 510(k) exempt under section
510(l)(1) of the FD&C Act.) See the response to Comment 5 for more
about considerations for when to submit a 510(k).

VII. Economic Analysis of Impacts

    We have examined the impacts of this final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all

costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). This rule is an economically significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the estimated annualized cost over 10 years is $0.009
million per firm, which is unlikely to represent more than three
percent to five percent of the revenue of an affected manufacturer, we
certify that this final rule will not have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $165 million, using the most current (2021) Implicit
Price Deflator for the Gross Domestic Product. This final rule will
result in an expenditure in at least one year that meets or exceeds
this amount.
    This rule defines a new regulatory category for OTC hearing aids
and makes corresponding changes to the existing regulatory framework,
including defining hearing aids not meeting the OTC requirements as
prescription medical devices, as well as providing new labeling
requirements for both OTC and prescription hearing aids. This rule
would generate potential cost savings for consumers with perceived mild
to moderate hearing impairment who wish to buy lower cost hearing aids
not bundled with professional services and not requiring professional
advice, fitting, adjustment, or maintenance but who are currently
unable to buy such products online because of State regulations or
because they do not shop online. This rules also generates costs for
hearing aid manufacturers for changing labeling of existing hearing
aids as well as for reading the rule and revising internal standard
operating procedures in response to the rule. Table 1 summarizes our
estimate of the annualized costs and the annualized benefits of this
final rule.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ------------------------------------
                   Category                       Primary       Low        High                               Period                  Notes
                                                 estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars    rate  (%)    (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.......         $63          $6        $147        2020           7          10  ................................
                                                        63           6         147        2020           3          10
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................  Potential increase in hearing aid   ..........  ..........  ..........  ................................
                                                and hearing technology use,
                                                leading to associated health
                                                benefits, potential fostering of
                                                innovation in hearing aid
                                                technology. Potential increase in
                                                consumer utility, derived from
                                                reduced health risks, from
                                                inability to buy some existing
                                                hearing aids under existing
                                                conditions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.......           1           1           2        2020           7          10  ................................
                                                         1           1           2        2020           3          10
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................  Potential loss of consumer utility  ..........  ..........  ..........  ................................
                                                from inability to buy existing
                                                hearing aids under existing
                                                conditions, including consumers of
                                                online hearing aids that do not
                                                meet OTC requirements. Costs to
                                                manufacturers of hearing aids sold
                                                online that do not meet OTC
                                                requirements to render their
                                                products and sales methods
                                                consistent with the requirements
                                                of either OTC or prescription
                                                hearing aids.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/     ..........  ..........  ..........  ..........           7  ..........  ................................
     year.                                                                                3
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year.  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                3
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................

    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
    Distributional effects are also possible that would favor general retailers and new manufacturers entering into the hearing aid market who do not
     have relations with current specialty retail suppliers and disfavor specialty retail suppliers and associated workers including hearing healthcare
     professionals, and established manufacturers with relations with those suppliers..
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of this rule. The full analysis of economic
impacts is available in the docket for this rule (Ref. 16) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental impact of
this final rule and of possible alternative actions. In doing so, the
Agency focused on the environmental impacts of its action as a result
of increased use and eventual disposal of OTC hearing aids that will
need to be handled after the effective date of this final rule.
    The environmental assessment (EA) considers environmental impacts
related to additional waste to landfills at municipal solid waste (MSW)
facilities. The selected action will likely increase the availability
and use of hearing aid devices, which would result in additional waste
from increased disposal of these devices and their associated
batteries, as well as an increase in industrial waste associated with
any domestic production to meet market demand for the new devices.
Overall, given the current limited use of these devices, projected slow
growth with increase in availability, and the small mass of waste
material to be disposed or recycled, the selected action is not
expected to have a significant impact on MSW, landfill facilities, and
the environment.
    The Agency has concluded that the final rule will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's FONSI and the evidence
supporting that finding, contained in an EA prepared under 21 CFR
25.40, are on display with the Dockets Management Staff (see ADDRESSES)
and are available for viewing by interested persons between 9 a.m. and
4 p.m., Monday through Friday; they are also available electronically
at https://www.regulations.gov.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by OMB under the PRA (44 U.S.C. 3501-3521). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual reporting, recordkeeping, and third-party
disclosure burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    Title: Medical Device Labeling Regulations; OMB Control Number
0910-0485--Revision.
    Description: FDA is establishing a regulatory category for OTC
hearing aids and making related amendments to update the regulatory
framework for hearing aids. Among other amendments described in this
rulemaking, we amend the existing labeling requirements for hearing
aids. In creating a regulatory category for OTC hearing aids and
amending existing rules, we intend to provide reasonable assurance of
safety and effectiveness for hearing aids as well as foster access to,
and innovation in, hearing aid technology, thereby protecting and
promoting the public health.
    Description of Respondents: Respondents to the information
collection are manufacturers of hearing aids.
    We estimate the burden of the collection of information as follows:

                                                       Table 2--Estimated One-Time Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
                        Activity                             Number of      records per    Total annual     burden per      Total hours    Total capital
                                                           recordkeepers   recordkeeper       records      recordkeeping                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Understanding and implementing new regulatory                        105               1             105             290          30,450      $4,100,000
 requirements from hearing aids rule....................
Hearing aids relabeling.................................             105               8             840              68          57,120       6,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.

                             Table 3--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Activity; 21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Labeling disclosures under                   105               8             840               1             840
 800.30(c)(2) and 801.422(c)(2);
 Hearing aids; electronic
 version of user instructional
 brochure.......................
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.

                         Table 4--Estimated Annual Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
    Activity; 21 CFR section        respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
OTC Hearing Aid Controls--800.30             105               7             735              19          13,965
Prescription Hearing Aid                     105               1             105              19           1,995
 Labeling--801.422..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,960
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.

    Our burden estimate is based on FDA Uniform Registration and
Listing System data; FDA's Operational and Administrative System for
Import Support data; informal communications with industry; and our
knowledge of and experience with information collection pertaining to
medical device labeling. We intend the burden estimates to be
consistent with our Final Regulatory Impact Analysis (FRIA) for this
rulemaking (Ref. 16).
    Estimated One-Time Burden: Understanding and implementing new
regulatory requirements from hearing aids rule--one-time burden
(Recordkeeping): As noted in the FRIA for this rulemaking, we estimate
it will take 5 hours each for an executive, a lawyer, and a marketing
manager to read and understand the rule. Also included in our estimate
is time for revising guidelines or standard operating procedures. We
assume this may take up to 25 hours for one executive, up to 100 hours
for one marketing manager, and up to 150 hours for one technical
writer. Therefore, we estimate a one-time recordkeeping burden of 290
hours for each manufacturer.
    Hearing aids relabeling--one-time burden (Third-Party Disclosure):
The rulemaking necessitates the relabeling of all current hearing aids
(approximately 840). The labeling cost model used in the FRIA suggests,
based on a compliance date 240 days after publication of the final
rule, a one-time estimated third-party disclosure burden for relabeling
of about 68 hours per product.
    Estimated Annual Burden: Over-the-Counter Hearing Aid Controls--
Sec.  800.30 (Recordkeeping and Third-Party Disclosure): Section 800.30
sets forth labeling requirements for OTC hearing aids. Section
800.30(c)(1) describes the warnings and other important information
that the outside package must bear. Manufacturers must include on the
outside package label: certain specified warnings and statements; a
weblink to all labeling and any additional resources; contact
information to request a paper copy of the labeling; their return
policy or absence thereof; if the OTC hearing aid is used or rebuilt,
they must declare that fact; the principal display panel must bear the
marks ``OTC'' and ``hearing aid''; battery information; and control
platform information if applicable.
    Section 800.30(c)(2) describes device-specific requirements for
labeling, inside the package. Among the labeling requirements listed
are a user instructional brochure, an electronic version of which is to
be made available for download; additional warnings; caution and
notices for users; other specified information; and any other
information necessary for adequate directions for use as defined in
Sec.  801.5. Also required under proposed Sec.  800.30(c)(2) is the
identification of any known physiological side effects associated with
the use of the OTC hearing aid that may warrant consultation with a
physician; the technical specifications required by Sec.  800.30(c)(4);
a description of commonly occurring, avoidable events that could
adversely affect or damage the OTC hearing aid; if applicable,
information relating to electromagnetic compatibility and wireless
technology and human exposure to non-ionizing radiation; information
regarding repair service or replacements; and, if applicable, a summary
of all clinical or non-clinical studies conducted to support the
performance of the OTC hearing aid.
    Section 800.30(c)(3) provides requirements for the labeling on an
OTC hearing aid itself, specifically, serial number, information
regarding the battery and, if the OTC hearing aid is used or rebuilt,
the manufacturer must physically attach a removable tag to the hearing
aid declaring that fact.
    Section 800.30(c)(5) provides requirements related to software
device labeling.
    We include no estimate for provisions under proposed Sec.
800.30(c)(1)(i)(A) through (D), (c)(2)(i)(A) through (C), and
(c)(2)(iii)(A) through (F) because we consider the labeling to be
``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public,'' consistent with 5 CFR 1320.3(c)(2). Thus, those labeling
provisions are not within the definition of collection of information.
    The FRIA for this rulemaking estimates that 105 firms manufacture
air-conduction hearing aids sold in the United States, based on FDA
Medical Device Registration data. We estimate that each manufacturer
has an average of eight products that would need relabeling.
    For each hearing aid product, we assume a 1-hour annual
recordkeeping burden for maintaining the electronic version of the user
instructional brochure (under Sec. Sec.  800.30(c)(2) and
801.422(c)(2)).
    The rulemaking would necessitate the relabeling of all current
hearing aids (approximately 840) according to either the OTC or
prescription hearing aid labeling requirements. While we lack specific
data regarding what portion of hearing aids will be relabeled as
prescription devices and what portion will be relabeled as OTC hearing
aids, for this analysis, we assume that 10 percent will be relabeled as
prescription medical devices (about 1 product per manufacturer) and 90
percent as OTC hearing aids (about 7 products per manufacturer). The
labeling cost model used in the FRIA suggests an annual estimated
third-party disclosure burden of about 19 hours per product.
    Prescription Hearing Aid Labeling--Sec.  801.422 (Third-Party
Disclosure): Section 801.422(c) sets forth labeling requirements for
prescription hearing aids. However, as with some of the provisions
under proposed Sec.  800.30(c), we include no estimate for provisions
under Sec.  801.422(c)(1)(i)(A) through (C), (c)(2)(i)(A) through (C),
and (c)(2)(ii)(A) through (F) because we consider the labeling to be
``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public,'' consistent with 5 CFR 1320.3(c)(2).
    Section 801.422(c)(1) provides the warnings and notice that must be
on the

outside package labeling; if applicable, that the prescription hearing
aid is used or rebuilt; battery information; and if applicable, control
platform information.
    Section 801.422(c)(2) describes requirements for prescription
hearing aid labeling, inside the package. Among the labeling
requirements listed are a user instructional brochure, an electronic
version of which is to be made available for download; warnings;
caution and notices for users; and additional information that must be
included in the user instructional brochure.
    Section 801.422(c)(3) provides the requirements for the labeling on
a prescription hearing aid itself, specifically, serial number;
information regarding the battery if applicable; and if the
prescription hearing aid is used or rebuilt, the manufacturer must
physically attach a removable tag to the hearing aid declaring that
fact.
    Section 801.422(c)(4) provides the technical specification elements
that must appear in the user instructional brochure or in separate
labeling that accompanies the device.
    Section 801.422(c)(5) provides requirements related to software
device labeling.
    The FRIA estimates that 105 firms manufacture air-conduction
hearing aids sold in the United States, based on FDA Medical Device
Registration data. We estimate that each manufacturer has an average of
eight products that would need relabeling.
    For each hearing aid product, we assume a 1-hour annual
recordkeeping burden for maintaining the electronic version of the user
instructional brochure (under Sec. Sec.  800.30(c)(2) and
801.422(c)(2)).
    The rulemaking would necessitate the relabeling of all current
hearing aids (approximately 840) according to either the OTC or
prescription hearing aid labeling requirements. While we lack specific
data regarding what portion of hearing aids will be relabeled as
prescription devices and what portion will be relabeled as OTC hearing
aids, for this analysis, we assume that 10 percent will be relabeled as
prescription medical devices (about 1 product per manufacturer) and 90
percent as OTC hearing aids (about 7 products per manufacturer). The
labeling cost model used in the FRIA suggests an annual estimated
third-party disclosure burden of about 19 hours per product.
    As required by section 3506(c)(2)(B) of the PRA, FDA provided an
opportunity for public comment on the information collection
requirements of the proposed rule.
    We received more than 1,000 comments on the proposed rule. We
describe and respond to the comments in section V of this document,
``Comments on the Proposed Rule and FDA's Responses.'' Comments and
responses related to the provisions that underlie the information
collection are described in the following sections: III.B, regarding
scope; III.D, regarding labeling; and III.F, regarding other device
requirements. We have not made changes to the estimated burden as a
result of those comments.
    We also received a comment relating to the information collection
burden estimate. The comment expressed concern that, for a small
business, the ``cost for building a system from scratch'' and for
reading and understanding the rule, without a lawyer or a marketing
manager, is overly burdensome.
    Included in our estimate of 290 hours for ``Understanding and
implementing new regulatory requirements from hearing aids rule,'' is
an average of 5 hours each for an executive, a lawyer, and a marketing
manager to read and understand the rule. Therefore, we estimate 15
hours for reading and understanding the rule. We assume that a
manufacturer who does not employ a lawyer or marketing manager, would
take approximately the same amount of time to read and understand the
rule. This is consistent with the comment's statement that it took ``at
least 8 hours to read through and understand this rule.''
    While it is not clear what is meant by ``building a system from
scratch'' in this context, included in our estimate is time for
revising guidelines or standard operating procedures. We assume this
may take up to 25 hours for one executive, up to 100 hours for one
marketing manager, and up to 150 hours for one technical writer; a
total of 275 hours for revising guidelines or standard operating
procedures. Our estimate assumes that, as a standard business practice
and in compliance with the existing requirements, a company has
guidelines or standard operating procedures in place and that the
burden estimate represents only the time to revise existing
documentation to be consistent with the rulemaking. We believe this
estimate reflects an appropriate amount of time for understanding and
implementing the new regulatory requirements.
    Additionally, the comment expressed concern about the time to write
``the user instructional brochure from scratch.''
    We have included a 68-hour, one-time burden estimate for the
relabeling necessitated by the rulemaking. This estimate includes,
among other things, time for updating the user instructional brochure
and providing the required content online. Our recordkeeping burden
estimate of 1 hour for ``Labeling disclosures under Sec. Sec.
800.30(c)(2) and 801.422(c)(2); Hearing aids; electronic version of
user instructional brochure'' is an annual estimate, intended to
reflect the maintenance of records associated with the requirement in
Sec. Sec.  800.30(c)(2) and 801.422(c)(2) to make an electronic version
of a user instructional brochure available for download.
    We have not revised our burden estimate based on this comment.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

X. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or where there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain State requirements ``different from, or in
addition to, any requirement applicable under'' the FD&C Act that is
applicable to devices. (See section 521 of the FD&C Act; Medtronic v.
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, 552 U.S. 312
(2008).) Federal law also preempts State or local laws ``specifically
related to hearing products that would restrict or interfere with the
servicing, marketing, sale, dispensing, use, customer support, or
distribution of [OTC hearing aids] through in-person transactions, by
mail, or online, that [are] different from, in addition to, or
otherwise not identical to, the regulations promulgated under'' section

709(b) of FDARA (see section 709(b)(4) of FDARA).
    Section 521(b) of the FD&C Act provides that the Commissioner of
Food and Drugs may, upon application of a State or local government,
exempt a requirement from preemption, if the State or local requirement
for the device is more stringent than the requirement under the FD&C
Act, or if the requirement is necessitated by compelling local
conditions and compliance with it would not cause the device to be in
violation of a requirement under the FD&C Act. Following this process,
a State or local government may request an exemption from preemption
for those State or local requirements pertaining to hearing aid
products that are preempted by the Agency's final rule under section
521 of the FD&C Act. However, because FDARA does not provide a parallel
mechanism to exempt State or local requirements from its express
preemption provision, FDA is not considering exemptions under section
709(b)(4) of FDARA for OTC hearing aids.
    Thus, this final rule will create requirements that fall within the
scope of section 521 of the FD&C Act and/or section 709(b)(4) of FDARA.
It also amends Sec.  801.420 and repeals Sec.  801.421, and such
changes affect many of the decisions on applications for exemption from
preemption that were issued in relation to these two regulations under
section 521(b) of the FD&C Act, resulting in the removal of the
regulations codifying such decisions, as discussed further in section
V.I. above. The scope of preemption of this final rule is discussed in
more detail in sections III.G through I, above.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have a substantial direct effect on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive order and,
consequently, a tribal summary impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only with the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites