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    \11\ We refer to hearing products more generally, not just OTC
hearing aids. We wish to make clear that a State or locality may not
establish requirements for hearing products if those requirements
would restrict or interfere with commercial activity involving OTC
hearing aids. However, we do not interpret section 709 of FDARA as
preempting requirements that apply only to prescription hearing aids
(provided they do not restrict or interfere with commercial activity
involving OTC hearing aids) but such requirements could be preempted
under section 521 of the FD&C Act.
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    a. Example 1. For example, any given pharmacy may be subject to
certain State licensing requirements that apply regardless of whether
the pharmacy sells OTC hearing aids; it would not be exempt from such
licensing requirements merely because it sells OTC hearing aids.
Similarly, a requirement to include terms of sale or return on the
receipt that applied also to the sales of other (non-hearing) products
would not be preempted.
    b. Example 2. In contrast, requirements that attach on account of
the sale of hearing products (or would not attach but for the sale of
hearing products), would not be ``generally applicable.'' For example,
a requirement that any place of business must obtain a license or
certification to sell OTC hearing aids would be a requirement
specifically related to hearing products. In addition, it would serve
to restrict or interfere with commercial activity involving OTC hearing
aids and would be different from, in addition to, or not otherwise
identical to, the regulations issued under section 709(b) of FDARA.
Therefore, it would be preempted.
    A requirement may attach on account of the sale of hearing products
in a more indirect manner as well, and if it was in effect different
from, in addition to, or not otherwise identical to the terms of the
statute or Federal regulations, and if it restricted or interfered with
commercial activity involving OTC hearing aids, it would be preempted.
That is, a State or local requirement may appear on its face to be
generally applicable, but if in practice it was specifically related to
hearing products and would restrict or interfere with commercial
activity involving OTC hearing aids, the State or local requirement
would be preempted.
    c. Example 3. A requirement that a retailer may only sell OTC
hearing aids when it has an audiologist on premises would require the
involvement of a licensed person in at least some cases. This
requirement would restrict or interfere with commercial activity
involving OTC hearing aids, including by requiring the involvement of a
licensed person, and would be preempted.
    d. Example 4. Similarly, a requirement that sellers advise
purchasers of any hearing aids, whether prescription or OTC, of
specific medical information not required in the OTC Hearing Aid
Controls would be preempted with respect to the sale of OTC hearing
aids. Although the requirement attaches on account of the sale of
hearing aids more generally (not just OTC devices), it is
``specifically related to hearing products'' and would operate as a
condition of sale that is different from, in addition to, or otherwise
not identical to those proposed in this rulemaking. The requirement
would also restrict or interfere with commercial activity involving OTC
hearing aids. Therefore, the requirement would be preempted as applied
to the sale of OTC hearing aids.
    e. Example 5. A professional or ethical requirement that deemed a
sale to be professional malpractice if the dispenser permitted the sale
of any hearing aid without consultation would be preempted under FDARA.
It specifically relates to hearing products and by requiring
consultation prior to the sale of an OTC hearing aid, it would restrict
or interfere with commercial activity involving OTC hearing aids even
though the requirement on its face applies only to the dispenser (who
must meet licensing requirements).
    f. Example 6. A requirement that a seller maintain a statement of
medical examination, in connection with the sale of a hearing product,
would be preempted under FDARA because such a condition of sale would
restrict or interfere with commercial activity involving an OTC hearing
aid. Moreover, the requirement for a statement of medical evaluation
would restrict or interfere with commercial activity involving OTC
hearing aids by requiring the involvement of a licensed person during
the course of the commercial activity.
3. Requirements for Professionals and Establishments
    As with generally applicable requirements, we do not interpret
section 709 of FDARA as generally prohibiting the regulation of
professionals or establishments or exempting them from applicable
professional requirements, even in the case that the professional or
establishment only undertakes activities related to OTC hearing aids.
Thus, a person that purports to be a specially licensed professional or
establishment would be subject to applicable State and local
requirements. Such requirements may include periodic professional
examination or mandating the availability of testing equipment.
    FDA does, however, interpret section 709 of FDARA as preempting
certain kinds of professional or establishment requirements. To use one
specific example, many States have established definitions for hearing
aid fitters, dispensers, or other sellers and servicers. In some cases,
State or local requirements may deem an individual or establishment to
be a dispenser (or other defined term) by virtue of engaging in the
sale of or providing services for hearing aids. That status in turn
incurs legal obligations. As explained, we interpret section 709 of
FDARA as preempting such requirements to the extent that they would
require the involvement of a licensed person for consumers to access
OTC hearing aids or would otherwise restrict or interfere with
commercial activity involving (the servicing, marketing, sale,
dispensing, use, customer support, or distribution of) OTC hearing
aids.
    For the reasons explained in section III.B regarding the definition
of ``licensed person,'' we are specifying certain related terms that
would not on their own, as they relate to OTC hearing aids, indicate
professional or specialized obligations. For example, under the
proposed definition of ``licensed person,'' identifying as a

hearing aid ``dispenser'' would not imply licensure. Note that we would
consider a person identifying as a ``licensed dispenser'' to be subject
to State or local requirements applicable to licensed dispensers and
therefore considered a ``licensed person'' under section 709(b)(4) of
FDARA.
    The examples below focus only on the FDARA preemption provision
that applies to OTC hearing aids.
    a. Example 7. In contrast to identifying as a dispenser (without
using the word ``licensed''), as proposed, identifying as an
audiologist or hearing aid fitter, for example, may imply licensure,
depending on State and local requirements. Thus, a person who
advertises as an audiologist or hearing aid fitter--professional
services that may be provided, but cannot be required to be provided,
to sell OTC hearing aids--would be subject to State requirements that
apply to audiologists or hearing aid fitters. This would be true even
if such an audiologist or fitter only sold OTC hearing aids.
    b. Example 8. In contrast, a person who advertises as a hearing aid
dispenser or seller, and who only sells OTC hearing aids, cannot be
required to obtain specialized licenses to engage in commercial
activity involving OTC hearing aids.
    c. Example 9. As in Example 7, a person who only sells OTC hearing
aids but advertises as a licensed dispenser even though such licensing
is not required to sell OTC hearing aids--the person purports to be a
licensed person, not a ``dispenser'' more generally--would be subject
to State or local requirements that apply to licensed dispensers.
    We are proposing a preemption provision that speaks specifically to
professional requirements in order to clarify in the regulations that
the servicing, marketing, sale, dispensing, customer support, or
distribution of OTC hearing aids, on its own, does not obligate a
person to obtain specialized licenses, certificates, or any other State
or local sanction.

H. Proposed Repeal of Conditions for Sale and Modifications for
Prescription Labeling (Sec. Sec.  801.420, 801.421, 801.422)

    FDA is proposing to repeal the conditions for sale for hearing
aids, Sec.  801.421, because these would no longer be necessary.
Currently, those conditions apply to all hearing aids, but section
520(q)(2) of the FD&C Act specifies that OTC hearing aids will be
exempt from Sec. Sec.  801.420 and 801.421 or any successor
regulations. Instead of continuing to apply those conditions to non-OTC
hearing aids, FDA is proposing to repeal them. Additionally, FDA is
proposing to remove the current labeling requirements for hearing aids
in Sec.  801.420 and issue prescription labeling requirements under
Sec.  801.422, which would be in addition to the prescription labeling
requirements in Sec.  801.109.
    The repeal of Sec.  801.421 and the amendments to the labeling
requirements (amending the current labeling requirements, moving them
to a new section, and removing Sec.  801.420) would have further
regulatory implications. In proposing new Sec.  801.422, FDA is not
relying on its restricted device authority in section 520(e) of the
FD&C Act. Therefore, if this proposed rule is finalized, class I and
class II hearing aids would no longer be ``restricted devices'' under
section 520(e) of the FD&C Act. As such, certain Federal requirements
related to restricted devices would no longer apply to class I and
class II hearing aids. Further, the basis for some of FDA's exemption
decisions about preempted State requirements would change. The next
section of this document discusses those changes along with the
additional Federal preemption implications of FDARA and how we would
remove, update, or clarify those regulations. Repeal of the conditions
for sale would also obviate the need for the guidance entitled
``Conditions for Sale for Air-Conduction Hearing Aids''; if the repeal
of the conditions for sale is finalized, we would withdraw that
guidance (Ref. 8).
1. Repeal of Conditions for Sale Sec.  801.421
    As summarized in section I.C.2, the conditions for sale of hearing
aids under Sec.  801.421 require a statement of medical evaluation,
unless waived by a user 18 years of age or older; the availability of a
user instructional brochure and an opportunity to review it; and
records of the statements of medical evaluation or waiver. The
conditions also provide an exemption from the requirements in Sec.
801.421 for auditory trainers.
    In light of the fact that FDA is proposing to clarify that non-OTC
hearing aids would be prescription devices, such hearing aids would be
subject to State and local requirements for obtaining written or oral
authorization of a practitioner licensed by State law to administer the
use of the devices. For example, some States license audiologists to
administer the use of prescription hearing aids for an adult, so adults
could obtain a prescription for hearing aids from an audiologist in
those States. In the case of people younger than age 18, the proposed
prescription labeling statements described in the next section of this
document would in manner and form emphasize the importance of medical
evaluations. Because prescription hearing aids will require a written
or oral authorization from a practitioner licensed by law to administer
the device, and because we are proposing certain labeling requirements
in a certain manner and form, FDA is proposing to repeal the conditions
for sale (including the requirement for a medical evaluation and for
providing a user instructional brochure) because they would no longer
be necessary to provide reasonable assurance of safety and
effectiveness of prescription hearing aids. Thus, hearing aids that do
not meet the definition of, or the requirements for, OTC hearing aids
would all be prescription hearing aids, but they would no longer be
restricted devices. We expect that the application of prescription
requirements with the removal of device restrictions will not increase
the burden to obtain non-OTC hearing aids, and that the change will
promote consistency with other products, easing the burden on
purchasers. Specifically, hearing aids will be either prescription or
OTC; users and other interested people would not also need to inquire
whether a device is restricted.
    Additionally, repeal of the requirements discussed above would
obviate the need for the exemption for group auditory trainers, which
we are correspondingly proposing to repeal.
2. Revised Labeling for Prescription Hearing Aids
    We continue to believe that the labeling requirements are necessary
to provide reasonable assurance of safety and effectiveness of
prescription hearing aids. As such, we are proposing to retain most of
the required information currently in Sec.  801.420 in substance,
except as revised below, and place the proposed revised labeling
requirements that would be specific to prescription hearing aids in
Sec.  801.422, thereby removing Sec.  801.420. These proposed revisions
are to ensure that the wording is consistent with and similar to the
proposed labeling statements for OTC hearing aids when appropriate. In
particular, we are proposing to revise the labeling statements to be
more understandable and, when addressed to users and prospective users,
less technical.
    In general, as summarized in section II, a device's labeling must
bear adequate directions for use and certain adequate warnings in the
manner and form necessary to protect the user (see section 502(f) of
the FD&C Act). We

have defined ``adequate directions for use,'' in part, as directions by
which a layperson can use the device safely and for the purposes for
which it is intended (see Sec.  801.5). However, we have exempted
prescription devices from the requirement for labeling to bear adequate
directions for use provided they meet certain conditions (see Sec.
801.109). For prescription devices, labeling must bear, among other
statements, information for use under which practitioners licensed by
law to administer the device can use it safely and for the purpose for
which it is intended (see Sec.  801.109(c)). In any case, the labeling
for a device must not be false or misleading in any particular (see
section 502(a)(1) of the FD&C Act). Labeling may be false or misleading
because, among other reasons, it fails to reveal facts material to its
use (see section 201(n) of the FD&C Act). Therefore, prescription
hearing aid labeling must include certain adequate warnings as well as
information for the licensed professional to use the device safely and
for the purpose for which it is intended, and the labeling must not
fail to reveal certain material facts.
    To determine whether those requirements are met, we consider the
sale, distribution, and use of prescription hearing aids. In the case
of prescription hearing aids, a prospective user would obtain one from
a practitioner licensed by law in that State. However, the professional
qualifications for fitters and other licensed practitioners, as well as
dispensers more generally, vary widely. Therefore, we are proposing to
require information for dispensers to ensure necessary warnings are
conveyed in an adequate manner and form for every device. The proposal
includes warnings: (1) Of possibilities for underlying pathological
conditions, (2) against use in people younger than 18 without a medical
evaluation, and (3) of injury potential from high output.
    We are further proposing to require the disclosure of certain
technical specifications, which is necessary to provide fitters and
dispensers information for the safe and effective use of the device.
This information is material to the use of the device, as this
information would be necessary for a hearing health professional to
select an appropriate device. Without this information, a hearing
health professional would be unable to determine a safe and effective
device for the user without unnecessarily increasing the risks to
health to the user. This provision includes a proposed requirement that
measurement of the specifications conforms to ANSI/ASA S3.22-2014,
``Specification of Hearing Aid Characteristics,'' to provide for
uniformity in testing and measurement, which in turn aids hearing
health professionals in selecting or fitting an appropriate
prescription hearing aid.
    The proposed user labeling requirements are also intended to
provide adequate warnings against use in certain pathological (``red
flag'') conditions, and by children, where the use would be dangerous
to health; as well as adequate warnings against unsafe dosage or
methods or duration of administration or application. We propose that
this manner and form are necessary for the protection of the users.
    Once a user obtains a prescription hearing aid, use of the device
occurs without direct supervision of a licensed professional, and
notably, such use is generally intended to occur over long periods each
day, every day. Therefore, in addition to the proposed information for
hearing health professionals summarized above, we are proposing
warnings and information specifically for users. We intend this
information to be more understandable for laypeople while communicating
warnings against use in certain pathological (``red flag'') conditions,
against use in children without a medical evaluation, and in a manner
and form that are necessary for the protection of the users.
    For the reasons explained above, we believe that the proposed
labeling requirements for prescription hearing aids are necessary to
provide reasonable assurance of safety and effectiveness. This proposal
also maximizes consistency with OTC hearing aid labeling to reduce the
burden on manufacturers that wish to offer both categories of hearing
aids. Although we are proposing the foregoing warnings and information
in manner and form as are necessary for the protection of users, the
specificity of this proposal would also encourage uniformity while
conveying essential information appropriate for the type of hearing
healthcare delivery. By minimizing burdens and fostering familiarity,
the specificity and consistency would also help promote availability
and use of prescription devices.
    To provide for clarity and efficient enforcement of the FD&C Act,
FDA is proposing to provide explicitly that a prescription hearing aid
that does not satisfy the labeling requirements of proposed Sec.
801.422, if finalized, would be misbranded under sections 201(n),
502(a), and 502(f) of the FD&C Act. Moreover, as explained, we believe
that the labeling statements as we propose to revise them are material
to and necessary for the safe and effective use of prescription hearing
aids. Thus, we believe that an explicit misbranding provision in the
prescription labeling requirements will provide for clarity as well as
the efficient enforcement of the FD&C Act.
    If we finalize the repeal of the conditions for sale under Sec.
801.421, we would correspondingly withdraw the guidance document
entitled ``Conditions for Sale for Air-Conduction Hearing Aids''
because that guidance announces our policy regarding certain provisions
of Sec.  801.421 and would cease to be relevant (Ref. 8).

I. Proposed Amendments to Previous Exemption Decisions (Part 808)

    A State or a political subdivision (e.g., a city) may not establish
or continue in effect its own requirement with respect to a device for
human use if that requirement is different from, or in addition to, a
requirement applicable under the FD&C Act to the device (see section
521(a) of the FD&C Act). Under section 521(b) of the FD&C Act, upon
application of a State or political subdivision of a State, FDA may, by
regulation, exempt from preemption a State or political subdivision
requirement applicable to a device if: (1) The requirement is more
stringent than a requirement under the FD&C Act that would be
applicable to the device if an exemption were not in effect or (2) the
requirement is required by compelling local conditions and compliance
with the requirement would not cause the device to be in violation of
the FD&C Act. FDA has granted some exemption requests and most, if not
all, of FDA's decisions to grant exemption from preemption were based
on the State or local requirement being more stringent.
    FDA's decisions on States' applications for exemption from Federal
preemption under section 521 of the FD&C Act are codified in
regulations under part 808, subpart C. The regulations codifying these
decisions include both granting and denial of exemption from
preemption. Therefore, ``exemption decisions'' as used in this document
include both types of decisions. Most of the applications for exemption
from Federal preemption related to State medical device requirements
that apply to hearing aids, as they existed at the time of the
exemption decisions, and that were different from or in addition to the
requirements in Sec. Sec.  801.420 and/or 801.421. Because FDARA
directs FDA to establish different requirements for some hearing aids
that are not subject to section 521(b) of the FD&C Act, many of the
current exemption decisions would not accurately reflect the regulatory

framework for hearing aids under FDARA and the FD&C Act as amended.
Moreover, if we finalize the changes we are proposing to the existing
requirements for hearing aids in Sec. Sec.  801.420 and 801.421, the
previous exemption decisions based on those requirements may no longer
apply.
1. Exemption Decisions Under Section 521(b) Are Affected by FDARA
(Proposed Sec.  808.1(g))
    As explained in section III.G of this document, and as indicated
above, some decisions on exemption from Federal preemption under
section 521(b) of the FD&C Act would no longer accurately reflect the
applicability of State requirements after the enactment of FDARA and
upon establishing the OTC category of hearing aids. To assist
stakeholders to understand the changes effected by FDARA, we are
proposing to codify how FDARA limits the scope of exemption decisions
under section 521(b) of the FD&C Act. We believe this proposal will
provide a concise reference for stakeholders to ascertain the changes
effected by FDARA.
    Note that we are not considering exemptions from section 709(b)(4)
of FDARA for State or local requirements. This is because FDARA does
not provide a parallel mechanism to exempt State or local requirements
regarding hearing products that would restrict or interfere with
commercial activity involving OTC hearing aids. We refer to preemption
under section 709(b)(4) simply to clarify how FDARA affects State and
local requirements.
2. Removal of Regulations Codifying Exemption Decisions Affected by
Amendments to Sec.  801.420 and Repeal of Sec.  801.421 if Finalized
    As explained above, FDA's exemption decisions are codified in
regulations under part 808, subpart C. These decisions were issued in
the 1980s and apply to the specific State provisions identified in the
regulations and the specific Federal requirements in effect at the
time. As mentioned above, most of the exemption decisions related to
State medical device requirements that apply to hearing aids and that
were different from or in addition to the requirements in Sec. Sec.
801.420 and/or 801.421. We are proposing to remove 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. We are proposing this
because the exemption decisions codified in those regulations may no
longer apply due to changes to the Federal hearing aid requirements as
proposed in this rulemaking and changes to the specific State
provisions we have identified in those regulations since the decisions
were made over 30 years ago.
    In particular, the repeal of the conditions for sale would
eliminate specific Federal requirements that preempt certain State or
local requirements. As such, whether we previously granted or denied
exemptions, the exemption decisions would no longer apply because the
State or local requirements that differed from, or were in addition to,
Sec.  801.421 would no longer be preempted. Therefore, we are proposing
to remove the State-specific regulations in part 808 codifying
exemption decisions pertaining to the conditions for sale for hearing
aids because those decisions would no longer be applicable if the
conditions for sale are repealed.
    Also, the proposed amendments to the hearing aid labeling
requirements may affect the exemption decisions relating to Sec.
801.420. Although the proposed Sec.  801.422 is similar to Sec.
801.420 in that it too would address labeling for hearing aids, the
labeling requirements are not identical to those in Sec.  801.420 and
include substantive changes. Moreover, 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. Thus, not only will the
Federal requirements change, but the State requirements that were the
subject of the exemption decisions may have changed too since the
decisions were made.
    Given that the exemption decisions were based on specific Federal
requirements and specific State requirements that existed at the time
of the decision, changes in either may affect those decisions such that
they are no longer applicable. Because the exemption decisions relating
to hearing aid labeling requirements may no longer be applicable, we
are proposing to remove the regulations codifying these decisions. We
specifically seek comments from the States regarding the proposed
removal of the regulations in part 808, subpart C, codifying these
exemption decisions. For example, if a State disagrees with the
proposed removal of the regulation(s) in part 808, subpart C, because
the State believes the exemption decision still applies, a statement
and explanation why in the comments may be helpful.
    We note that when Sec.  801.422 is finalized and in effect, no
State or political subdivision of a State may establish or continue in
effect with respect to prescription hearing aids, any requirement which
is different from, or in addition to, any requirement in Sec.  801.422
(see section 521(a) of the FD&C Act). However, a State or political
subdivision thereof may apply for an exemption from preemption by
following the process in part 808 for any requirement that is preempted
by Sec.  801.422 (see also section 521(b) of the FD&C Act).

J. Other Proposed Amendments

    FDA is proposing several amendments to provide for consistency,
including with the proposals in this rulemaking, if finalized, and to
improve clarity. We are proposing the following:
     To realign the hearing aid classification regulations by
sound conduction mode so that legacy air-conduction hearing aids,
wireless air-conduction hearing aids, and self-fitting air-conduction
hearing aids would be under one classification regulation; bone-
conduction hearing aids would be under a separate classification
regulation.
     To clarify that air-conduction hearing aids are subject to
Sec.  800.30 or Sec.  801.422, as applicable, and bone-conduction
hearing aids are subject to Sec.  801.422.
     To revise the special control currently in Sec.
874.3305(b)(1) for consistency with the special control currently in
Sec.  874.3325(b)(3). Although the proposed revision to Sec.
874.3305(b)(1) would require demonstration of electrical safety and
thermal safety, we believe that generally manufacturers of wireless
air-conduction hearing aids regulated under Sec.  874.3305 have been
evaluating these safety aspects for their devices and therefore, this
proposed revision would have little to no impact on these
manufacturers.
     To revise the special controls for wireless hearing aids
currently in Sec.  874.3305(b) and for self-fitting hearing aids
currently in Sec.  874.3325(b) to eliminate redundancy, for example,
removing special controls that would be addressed by the proposed
labeling requirements for both OTC and prescription hearing aids.
     To revise Sec. Sec.  874.3315 and 874.3950 to clarify that
these devices are subject to the prescription hearing aid labeling
requirements, including in proposed Sec.  801.422.
     To clarify that a tympanic membrane contact hearing aid
under Sec.  874.3315 is a wearable device for

purposes of prescription hearing aid labeling.
    We are also proposing non-substantive modifications to the
decisions regarding exemption from Federal preemption in part 808 to
assist stakeholders to understand the subject matter of the individual
exemption decisions.
1. Realignment of Hearing Aid Classification Regulations by Sound
Conduction Mode
    To increase clarity and to reduce administrative burdens associated
with interpreting regulations, we are proposing to separate the
classification regulations for bone-conduction and air-conduction
hearing aids. We believe this will increase clarity because air-
conduction devices are technologically more similar to each other than
they are to bone-conduction devices. In addition, section
520(q)(1)(A)(i) defines an OTC hearing aid as a device that, among
other criteria, uses the same fundamental scientific technology as air-
conduction hearing aids that are wearable devices. Therefore, bone-
conduction hearing aids do not fall within the scope of the OTC hearing
aid definition and moving them to a separate classification regulation
(proposed Sec.  874.3301) will help make that clear. Tympanic membrane
contact hearing aids also do not fall within the scope of the OTC
hearing aid definition because, among other reasons, they do not use
the same fundamental scientific technology as air-conduction hearing
aids, and as specified in Sec.  874.3315, they will continue to be
regulated as prescription devices.
    The proposed realignment of the air-conduction hearing aid types
would also locate all OTC hearing aids within the same classification
regulation; however, not all air-conduction hearing aids would be OTC
hearing aids. For example, high-output air-conduction devices would be
prescription. Further, transcutaneous air conduction hearing aid
systems entail surgical implantation of a tube to conduct sound, so we
do not consider them suitable for OTC availability; the devices will
continue to be regulated under Sec.  874.3950. The realignment will not
affect any device that does not use the same fundamental scientific
technology, such as cochlear implants (product code MCM) or implantable
middle ear hearing devices (product code MPV).
    In realigning the regulations by sound conduction mode, we are not
proposing to reclassify any device or change the exemption status under
section 510(m)(2) of the FD&C Act for premarket notification for any
device type (see 21 U.S.C. 360(m)(2)). For example, wireless air-
conduction hearing aids regulated under Sec.  874.3305 would continue
to be class II exempt, subject to the limitations of exemption in Sec.
874.9, and special controls would continue to apply to these devices in
addition to the general controls. (The proposed general controls under
Sec.  800.30 or Sec.  801.422, if finalized, would also apply.) As of
the effective date of the final rule, we would realign current product
codes to correspond with the revised regulation numbers for consistency
but would not otherwise change the codes. Also, we would change the
name of each classification regulation to reflect the sound conduction
mode.
    Note that the regulation for air-conduction hearing aids would
embody a split classification, where different devices under the
regulation would have different classifications and special controls
depending on the technology and design. As discussed above, we would
also amend the wireless hearing aid special controls to provide for
consistency with the special controls for self-fitting hearing aids,
and we would amend the special controls for wireless hearing aids and
self-fitting hearing aids to eliminate redundancy.
2. Non-Substantive Revisions to Exemption Decisions for Clarity and
Ease of Use
    In addition to the amendments in part 808 explained in section
III.I., we are proposing to amend the remaining State-specific
regulation in part 808 to include paragraph headings that would appear
in italics. Currently, the regulations do not include paragraph
headings and, as such, require stakeholders to look elsewhere to
understand the content of the State or local requirements as they were
at the time FDA made an exemption decision. The paragraph headings will
assist stakeholders by briefly describing the subject of the individual
exemption decisions, thereby providing additional information and
context for stakeholders.

IV. Findings Regarding Premarket Notification

    FDA may, in appropriate circumstances, exempt a class II device
from premarket notification requirements under section 510(m)(2) of the
FD&C Act. Section 709(b)(3) of FDARA directs FDA to make such findings,
that is, to determine whether OTC hearing aids require a report under
section 510(k) to provide reasonable assurance of safety and
effectiveness. As described in section I.B, legacy and wireless air-
conduction hearing aids are exempt from section 510(k) subject to the
limitations of exemption, and we are not proposing to alter the
exemption status of such devices.
    Self-fitting air-conduction hearing aids are not currently exempt.
FDA classified this device type in October 2019 (see 84 FR 57610), and
the Agency does not have sufficient information or experience with this
device type to exempt these devices from premarket notification.
Accordingly, FDA has determined that, at this time, reports under
section 510(k) continue to be necessary to provide reasonable assurance
of safety and effectiveness. We therefore do not propose to exempt them
at this time.

V. Proposed Effective and Compliance Dates

A. Effective Date

    FDA proposes that this rule, if finalized, be effective 60 days
after the publication of the final rule in the Federal Register. We
propose 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 21 CFR 807.81(a)(3), 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 the final rule.
If a person (e.g., manufacturer) markets such a device without
complying with the new or revised requirements or if applicable,
receiving 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.
    At present, legacy and wireless air-conduction hearing aids are
exempt from section 510(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.)
However, self-fitting air-conduction hearing aids are not exempt and,
therefore, are subject to premarket notification requirements. We
believe that modifications to hearing aids, including labeling changes,
to comply with the proposed OTC Hearing Aid Controls may exceed the
limitations of exemption, for example because the device was formerly
intended for use by healthcare professionals only. We believe that
labeling changes for such hearing aids to comply with the proposed
prescription hearing aid labeling requirements are less likely to
exceed the limitations of exemption.

VI. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed 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).
Based on our preliminary analysis, OMB's Office of Information and
Regulatory Affairs has determined that this proposed 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. We believe we can certify that the proposed rule will not
have a significant economic impact on a substantial number of small
entities. The estimated annualized cost over 10 years is $0.009 million
per firm, which is unlikely to represent more than 3 percent to 5
percent of the revenue of an affected manufacturer. However, we note
that some uncertainty exists as to these impacts, so we have chosen to
draft an initial regulatory flexibility analysis. We request comments
relating to the effect of this proposed rule on small manufacturers.
    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 $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    The proposed rule, if finalized, would define a new regulatory
category for OTC hearing aids and make corresponding changes to the
existing regulatory framework, including defining hearing aids not
meeting the proposed OTC requirements as prescription medical devices,
as well as providing new labeling requirements for both OTC and
prescription hearing aids. This proposed rule, if finalized, would
generate potential cost savings for consumers with perceived mild to
moderate hearing loss 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. The proposed rule, if finalized, would
also generate 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 3
summarizes our estimate of the annualized costs and the annualized
benefits of the proposed rule, if finalized.

                                     Table 3--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ------------------------------------------------
             Category                   Primary      Low estimate    High estimate                                      Period              Notes
                                       estimate                                      Year dollars    Discount rate      covered
                                                                                (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/            $63              $6            $147            2020               7              10
     year.                                      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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/              1               1               2            2020               7              10
     year.                                       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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized    ..............  ..............  ..............  ..............               7
     $millions/year.                                                                                3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:                                             ..............
                                   ---------------------------------------------------------------------------------------------------------------------

    Other Annualized Monetized      ..............  ..............  ..............  ..............               7
     $millions/year.                                                                                3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:                                             ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
analysis of economic impacts is available in the docket for this
proposed rule (Ref. 23) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental impact of
this proposed 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 if the proposed rule is finalized.
    The environmental assessment (EA) considers environmental impacts
related to additional waste to landfills at municipal solid waste (MSW)
facilities. The proposed action would 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 and
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 proposed action is not expected to have a significant
impact on MSW, landfill facilities, and the environment.
    The Agency has concluded that the proposed rule will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's finding of no significant
impact (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.
FDA invites comments and submission of data concerning the EA and
FONSI.

VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the PRA (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the annual 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.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Medical Device Labeling Regulations; OMB Control Number
0910-0485--Revision.
    Description: FDA is proposing to establish a regulatory category
and related rules for OTC hearing aids to improve access to hearing aid
technology for Americans. FDARA amended the FD&C Act by placing the
authorities to establish the OTC category of hearing aids among
provisions that are, by definition, general controls, which is what
these rules would be. Alongside the OTC category, we are proposing
multiple related changes to the overall regulatory framework for
hearing aids to harmonize existing rules with the eventual OTC category
while continuing to provide a reasonable assurance of safety and
effectiveness. We believe the proposals set forth in this rulemaking
will promote the hearing health of Americans by lowering barriers to
access and fostering innovation in hearing aid technology. The set of
general controls we are proposing, Over-the-Counter Hearing Aid
Controls, would apply to all hearing aids that meet the definition of
an OTC hearing aid under the FD&C Act, regardless of the device's
class. Among other provisions, the controls would include requirements
for labeling and device design, as well as a condition for sale to
prevent the sale and use of the devices by people younger than age 18.
We are also proposing to remove the labeling requirements in the
existing restrictions but establish a new regulation for labeling
specific to prescription hearing aids. The new prescription labeling
requirements would be similar to the current labeling requirements but
maintain consistency with the new labeling requirements for OTC hearing
aids (for example, so that ``red flag'' conditions, as revised, will be
the same). We are proposing to repeal the other existing restrictions,
i.e., the conditions of sale, because, if this rule is finalized as
proposed, the new labeling requirements for prescription hearing aids,
the requirement for a prescription, and other existing requirements
would provide reasonable assurance of safety and effectiveness.
    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 4--Estimated One-Time Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                    Average burden
                        Activity                             Number of      records per    Total annual         per         Total hours    Total capital
                                                           recordkeepers   recordkeeper       records      recordkeeping                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Understanding and implementing new regulatory                        105               1             105             284          29,820      $4,100,000
 requirements from hearing aids rule....................
Hearing aids relabeling; one-time burden................             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 5--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                      Activity; 21 CFR section                          Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed labeling disclosures under 800.30(c)(2) and 801.422(c)(2);             105                8              840                1              840
 Hearing aids; electronic version of user instructional brochure...
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.

                         Table 6--Estimated Annual Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Activity; 21 CFR Section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per 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 capital costs or 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 Preliminary Regulatory Impact Analysis (PRIA) for
this rulemaking (Ref. 23).
    Estimated One-Time Burden: OTC Hearing Aids proposed rule--one-time
burden (Recordkeeping): As noted in the PRIA for this proposed rule, we
estimate it will take 3 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 284 hours for each manufacturer.
    OTC Hearing Aids proposed rule--one-time relabeling burden (Third-
Party Disclosure):
    The proposed rule would necessitate the relabeling of all current
hearing aids (approximately 840). The labeling cost model used in the
PRIA suggests, based on a compliance period of 6 months, a one-time
estimated third-party disclosure burden for relabeling of about 68
hours per product.
    We request comments on these estimates.
    Estimated Annual Burden: Over-the-Counter Hearing Aid Controls--
Sec.  800.30 (Recordkeeping and Third-Party Disclosure): Proposed Sec.
800.30 sets forth labeling requirements for OTC hearing aids. Proposed
Sec.  800.30(c)(1) describes the warnings and other important
information that the outside package must bear. Additionally,
manufacturers must include on the outside package label a weblink to
all labeling and any additional resources, their return policy or lack
thereof, and, if the OTC hearing aid is used or rebuilt, they must
declare that fact.
    Proposed Sec.  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 regarding repair service; and, if applicable, a summary of
all clinical or non-clinical studies

conducted to support the performance of the OTC hearing aid.
    Proposed Sec.  800.30(c)(3) provides requirements for the labeling
on an OTC hearing aid itself, specifically, name of the manufacturer,
model name or number, serial number, and year of manufacture and if
applicable, information regarding the battery. Also, if the OTC hearing
aid is used or rebuilt, the manufacturer must physically attach a
removable tag to the hearing aid declaring that fact.
    We include no estimate for provisions under proposed Sec.
800.30(c)(1)(i)(A) through (D), (c)(2)(i)(A) and (B), and
(c)(2)(iii)(A) through (D) 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 PRIA for this proposed rule 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 proposed Sec. Sec.  800.30(c)(2) and
801.422(c)(2)).
    The proposed rule would necessitate the relabeling of all current
hearing aids (approximately 840) according to either the proposed 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 PRIA suggests an
annual estimated third-party disclosure burden of about 19 hours per
product.
    We request comments on these estimates and assumptions.
    Prescription Hearing Aid Labeling--Sec.  801.422 (Third-Party
Disclosure):
    Proposed Sec.  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 proposed Sec.  801.422(c)(1)(i)(A) and (B), (c)(2)(i)(A) through
(C), and (c)(2)(ii)(A) through (E) 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).
    Proposed Sec.  801.422(c)(1) provides the warnings that must be on
the outside package labeling and, if applicable, that the prescription
hearing aid is used or rebuilt.
    Proposed Sec.  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;
additional warnings; caution and notices for users; and additional
information that must be included in the user instructional brochure.
    Proposed Sec.  801.422(c)(3) provides the requirements for the
labeling on a prescription hearing aid itself, specifically, name of
the manufacturer, model name or number, serial number, and year of
manufacture; as well as 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.
    Proposed Sec.  800.422(c)(4) provides the technical specification
elements that must appear in the user instructional brochure or in
separate labeling that accompanies the device.
    The PRIA 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 proposed Sec. Sec.  800.30(c)(2) and
801.422(c)(2)).
    The proposed rule would necessitate the relabeling of all current
hearing aids (approximately 840) according to either the proposed 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 PRIA suggests an
annual estimated third-party disclosure burden of about 19 hours per
product.
    We request comments on these estimates and assumptions.
    To ensure that comments on information collection are received, OMB
recommends that written comments be submitted through https://www.reginfo.gov/public/do/PRAMain (see ADDRESSES). All comments should
be identified with the title of the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. These information
collection requirements will not be effective until FDA publishes a
final rule, OMB approves the information collection requirements, and
the rule goes into effect. FDA will announce OMB approval of these
requirements in the Federal Register.

IX. Federalism

    FDA has analyzed this proposed 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'' chapter V of 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, and if this rule becomes final, 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, if this proposed rule is made final, the final rule would
create requirements that fall within the scope of section 521 of the
FD&C Act and/or section 709(b)(4) of FDARA. If made final, it would
also amend Sec.  801.420 and repeal Sec.  801.421, and such changes
would 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
III.I. above. The scope of preemption of this proposed rule, if
finalized, is discussed in more detail in sections III.G through I,
above.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
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. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

XI. 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
are subject to change over time.

1. Lin, F., J. Niparko, and L. Ferruci, ``Hearing Loss Prevalence in
the United States.'' Archive of Internal Medicine, 171:1851-1853,
2011.
2. Dalton, D.S., ``The Impact of Hearing Loss on Quality of Life in
Older Adults.'' The Gerontologist, 43(5):661-668, 2005.
*3. NIH. Hearing Aids Fact Sheet. National Institute on Deafness and
Communication Disorders. 2010. Available at: https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing.
3a. Maharani, A., Dawes, P., et al., ``Longitudinal Relationship
Between Hearing Aid Use and Cognitive Function in Older Americans.''
Journal of the American Geriatrics Society, 66(6):1130-1136, 2018.
3b. Mahmoudi, E., Basu, T., et al., ``Can Hearing Aids Delay Time to
Diagnosis of Dementia, Depression, or Falls in Older Americans?''
Journal of the American Geriatrics Society, 67(11):2362-2369, 2019.
4. McCormack, A. and H. Fortnum, ``Why Do People Fitted With Hearing
Aids Not Wear Them?'' International Journal of Audiology, 52(5):360-
368, 2013.
*5. Gudmundsen, G., Citizen Petition, FDA-2003-P-0342. Received
August 11, 2003.
6. NASEM, ``Hearing Health Care for Adults: Priorities for Improving
Access and Affordability.'' Board on Health Sciences Policy,
Committee on Accessible and Affordable Hearing Health Care for
Adults; Blazer, D.G., S. Domnitz, and C.T. Liverman, Eds., 2016.
DOI: 10.17226/23446. Available at: https://www.nap.edu/catalog/23446/hearing-health-care-for-adults-priorities-for-improving-access-and.
*7. Executive Office of the President. ``Aging America & Hearing
Loss: Imperative of Improved Hearing Technologies.'' PCAST. 2015.
Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_letterreport_final.pdf.
*8. FDA, ``Immediately in Effect Guidance Document: Conditions for
Sale for Air-Conduction Hearing Aids.'' Guidance for Industry and
Food and Drug Administration Staff. December 12, 2016. Available at:
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm531995.pdf.
*9. FDA, ``Streamlining Good Manufacturing Practices (GMPs) for
Hearing Aids,'' public workshop. Silver Spring, MD; April 21, 2016.
Available at: https://wayback.archive-it.org/7993/20171114234227/https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480336.htm.
*10. Wallhagen, M., ``HLAA Response to Call for Comment.'' For
Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.
Silver Spring, MD; April 21, 2016. Available at: https://wayback.archive-it.org/7993/20171115155122/https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM497333.pdf.
11. NASEM, ``Over-The-Counter Hearing Devices Discussion: Safety and
Quality Requirements and Considerations Session.'' MP3, 1:15:39
(English). National Academies' Hearing Health Care Report: June 2017
Dissemination Meeting; Washington, DC, 2017.
*12. Lintz, J.S., ``FDA Testimony.'' For Streamlining Good
Manufacturing Practices (GMPs) for Hearing Aids. Silver Spring, MD;
April 21, 2016. Available at: https://wayback.archive-it.org/7993/20171114234227/https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM500626.pdf.
13. ANSI/CTA 2051: Personal Sound Amplification Performance Criteria
(voluntary consensus standard). 2017. Available at: https://webstore.ansi.org/standards/ansi/cta20512017ansi.
*14. NIOSH, Occupational Noise Exposure, publication number 98-126.
June 1998. Available at: https://www.cdc.gov/niosh/docs/98-126/pdfs/98-126.pdf.
*15. Killion, M.C., ``Presentation on the Work of the CTA PSAP
Standard Committee.'' For Streamlining Good Manufacturing Practices
(GMPs) for Hearing Aids. Silver Spring, MD; April 21, 2016.
Available at: https://wayback.archive-it.org/7993/20171115155142/https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM497364.pdf.
*16. Laureyns, M., ``The Potential Risk of Using PSAPs.'' For
Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.
Silver Spring, MD; April 21, 2016. Available at: https://wayback.archive-it.org/7993/20171115155108/https:/www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM497406.pdf.
17. Dillon, H., Hearing Aids. 2nd ed. New York, NY: Thieme
Publishers, 2012.
18. Kuk, F.K., ``Theoretical and Practical Considerations in
Compression Hearing Aids.'' Trends in Amplification, 1(1):5-39,
1996.
*19. Bose, ``Hearing Health and Technology Workshop,'' public
comment, P171200 #00140, to FTC. Received May 18, 2017. Available
at: https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00140.
20. Hearing Review, ``NASEM Committee Looks at Regulations for OTC
Hearing Devices.'' June 12, 2017. Available at: https://www.hearingreview.com/2017/06/nasem-committee-looks-regulations-otc-hearing-devices/.
21. Starkey Hearing Technologies, The Compression Handbook: An
Overview of the Characteristics and Applications of Compression
Amplification. 4th ed., 2017. Visit https://starkeypro.com/pdfs/The_Compression_Handbook.pdf.

22. Smith, C., L.A. Wilber, and K. Cavitt, ``PSAPs vs Hearing Aids:
An Electroacoustic Analysis of Performance and Fitting
Capabilities.'' Hearing Review, June 14, 2016, 2016. Available at:
https://www.hearingreview.com/2016/06/psaps-vs-hearing-aids-electroacoustic-analysis-performance-fitting-capabilities/.
*23. FDA, ``Preliminary Regulatory Impact Analysis; Initial
Regulatory Flexbility Analysis; Unfunded Mandates Reform Act
Analysis.'' 2019. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 800

    Administrative practice and procedure, Incorporation by reference,
Medical devices, Ophthalmic goods and services, Packaging and
containers, Reporting and recordkeeping requirements.

21 CFR Part 801

    Incorporation by reference, Labeling, Medical devices, Reporting
and recordkeeping requirements.

21 CFR Part 808

    Intergovernmental relations, Medical devices.

21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, we
propose that 21 CFR parts 800, 801, 808, and 874 be amended as follows:

PART 800--GENERAL

0
1. The authority citation for part 800 is revised to read as follows:

    Authority:  21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360j,
360k, 361, 362, 371.
    Section 800.30 also issued under Sec. 709, Pub. L. 115-52, 131
Stat. 1065-67.

0
2. Add Sec.  800.30 to subpart B to read as follows:

Sec.  800.30  Over-the-Counter Hearing Aid Controls.

    (a) Scope. This section specifies the requirements for over-the-
counter (OTC) air-conduction hearing aids. Air-conduction hearing aids
that satisfy the requirements in paragraphs (c) through (f) of this
section are considered ``available'' over the counter as section
520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the
term. Air-conduction hearing aids that do not meet the definition in
section 520(q) of the Federal Food, Drug, and Cosmetic Act and do not
satisfy the following requirements are prescription hearing aids.
Unless otherwise specified, the requirements in this section are in
addition to other applicable requirements, including but not limited to
special controls found in the applicable classification regulation.
    (b) Definitions for the purposes of this section. This section uses
the following definitions:
    Air-conduction hearing aid. An air-conduction hearing aid is a
hearing aid that conducts sound to the ear through the air.
    Hearing aid. A hearing aid is any wearable device designed for,
offered for the purpose of, or represented as aiding persons with or
compensating for, impaired hearing.
    Licensed person. A licensed person is a person as defined in
section 201(e) of the Federal Food, Drug, and Cosmetic Act that holds a
license or degree for the diagnosis, assessment, or treatment of
hearing loss; or that holds a license to sell or distribute hearing
aids. A person that must meet generally applicable licensing or
operating requirements such as annual health and safety inspections,
provided the generally applicable licensing or operating requirement is
consistent with this section and other applicable requirements under
the Federal Food, Drug, and Cosmetic Act, is not a ``licensed person''
solely for that reason. A person that represents as a marketer, seller,
dispenser, distributor, or customer support representative (or an
equivalent description) is not a ``licensed person'' solely by making
such representations.
    Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid
is an air-conduction hearing aid that does not require implantation or
other surgical intervention, and is intended for use by a person age 18
or older to compensate for perceived mild to moderate hearing
impairment. The device, through tools, tests, or software, allows the
user to control the hearing aid and customize it to the user's hearing
needs. The device may use wireless technology or may include tests for
self-assessment of hearing loss. The device is available over-the-
counter, without the supervision, prescription, or other order,
involvement, or intervention of a licensed person, to consumers through
in-person transactions, by mail, or online, provided that the device
satisfies the requirements in this section.
    Prescription hearing aid. A prescription hearing aid is a hearing
aid that is not an OTC hearing aid as defined in this section or a
hearing aid that does not satisfy the requirements in this section.
    Sale. Sale includes a lease, rental, or any other purchase or
exchange for value.
    Tools, tests, or software. Tools, tests, or software are components
of the device that, individually or in combination, allow a lay user to
control the device and customize it sufficiently, such as the device's
output, to meet the user's hearing needs.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it
for any period of time. However, a hearing aid shall not be ``used''
merely because a prospective user wore it as part of a bona fide
hearing aid evaluation to determine whether to select that particular
hearing aid for that prospective user. A hearing aid evaluation is
``bona fide'' if it was conducted in the presence of the dispenser or a
hearing health professional selected by the dispenser to assist the
prospective user in making a determination.
    (c) Labeling. An OTC hearing aid shall bear all of the following in
the labeling.
    (1) Outside package labeling. The outside package of an OTC hearing
aid shall bear all of the following:
    (i) Warnings and other important information. All of the following
shall appear on the outside package:
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TP20OC21.008

[GRAPHIC] [TIFF OMITTED] TP20OC21.009

    (ii) Statement of build condition. If the OTC hearing aid is used
or rebuilt, the outside package shall declare that fact. A sticker
under and visible through the outer wrapper will suffice to declare
such fact.
    (2) Labeling, inside the package. The manufacturer or distributor
of an OTC hearing aid shall include a user instructional brochure
inside the package and shall make an electronic version available for
download without site or customer registration and without requiring
purchase of any product or service. The user instructional brochure
shall include all of the following:
    (i) The following warnings, which shall appear in the following
order and prior to any content except the cover page:

[GRAPHIC] [TIFF OMITTED] TP20OC21.010

    (ii) Any additional warnings the manufacturer may include prior to
the caution and notices to users in paragraph (c)(2)(iii) of this
section.
    (iii) The following caution and notices for users, which shall
appear prior to any content except the cover page and the warnings
under paragraphs (c)(2)(i) and (ii) of this section:

[GRAPHIC] [TIFF OMITTED] TP20OC21.011

[GRAPHIC] [TIFF OMITTED] TP20OC21.012

    (iv) An illustration(s) of the OTC hearing aid that indicates
operating controls, user adjustments, and the battery compartment.
    (v) Information on the function of all controls intended for user
adjustment.
    (vi) A description of any accessory that accompanies the OTC
hearing aid, including but not limited to wax guards and accessories
for use with a computer, television, or telephone.
    (vii) Specific instructions for all of the following:
    (A) Instructions for sizing or inserting the eartip of the OTC
hearing aid to prevent insertion past the bony-cartilaginous junction
of the external auditory canal and damage to the tympanic membrane.
    (B) The tools, tests, or software that allow the user to control
the OTC hearing aid, including self-select, self-fit, and self-check
the performance of the OTC hearing aid, and customize it to the user's
hearing needs, including information about properly fitting eartips.
    (C) Use of the OTC hearing aid with any accompanying accessories.
    (D) Maintenance and care of the OTC hearing aid, including the
procedure to follow in washing the earmold, when replacing tubing on
those hearing aids that use tubing, and in storing the hearing aid when
it will not be used for an extended period of time.
    (E) If the battery is replaceable or rechargeable, how to replace
or recharge the battery, including a generic designation of replacement
batteries.
    (F) Expected battery life.
    (G) Any other information necessary for adequate directions for use
as defined in Sec.  801.5.
    (viii) Identification of any known physiological side effects
associated with the use of the OTC hearing aid that may warrant
consultation with a physician, including if applicable, skin irritation
and accelerated accumulation of cerumen (ear wax).
    (ix) The technical specifications required by paragraph (c)(4) of
this section.
    (x) A description of commonly occurring, avoidable events that
could adversely affect or damage the OTC hearing aid, including but not
limited to ear wax buildup, drops, immersion in water, or exposure to
excessive heat.
    (xi) If the hearing aid incorporates wireless technology in its
programming or use, appropriate warnings, instructions, and information
relating to electromagnetic compatibility and wireless technology and
human exposure to non-ionizing radiation.
    (xii) If the manufacturer provides a repair service or licenses or
certifies third-party repair services, information on how and where to
obtain repair service, including at least one specific address where
the user can go or send the OTC hearing aid to obtain such repair
service.
    (xiii) If clinical or non-clinical studies were conducted by or for
the manufacturer to support the performance of the OTC hearing aid, a
summary of all such studies.
    (3) Labeling on the device. The labeling on an OTC hearing aid
itself shall bear all of the following clearly and permanently, except
as provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the
positive terminal for battery insertion unless the battery's physical
design prevents inserting the battery in the reversed position.
    (iii) If the OTC hearing aid is used or rebuilt, the manufacturer
shall physically attach a removable tag to the hearing aid declaring
that fact.
    (4) Technical specifications. All of the following technical
specifications shall appear in the user instructional brochure that
accompanies the device. You may additionally include it on the outside
package.
    (i) The maximum output limit value (OSPL90).
    (ii) The full-on gain value, which is the gain with a 50 dB SPL
pure-tone input and volume set to full on.
    (iii) The total harmonic distortion value.
    (iv) The self-generated noise value.
    (v) The latency value.
    (vi) The upper and lower cutoff frequencies for bandwidth.
    (d) Output limits. The output limit for an OTC hearing aid shall be
the device maximum acoustic output sound pressure level (SPL) in a 2-
cubic centimeter (cm\3\) coupler when the device input is a 90 dB SPL
pure-tone, and the gain/volume control is full on. An OTC hearing aid
shall not exceed the following limits:
    (1) General output limit. An OTC hearing aid shall not exceed an
output limit of 115 dB SPL at any frequency except as provided in
paragraph (d)(2) of this section.
    (2) Output limit for a device with input-controlled compression and
user-adjustable volume control. An OTC hearing aid that includes input-
controlled compression and a user-adjustable volume control shall not
exceed an output limit of 120 dB SPL at any frequency.
    (e) Electroacoustic performance limits. An OTC hearing aid shall
perform within all of the following electroacoustic limits. Measure
each electroacoustic performance characteristic using a 2-cm\3\ coupler
where applicable.
    (1) Output distortion control limits. Test the output distortion of
the OTC hearing aid as follows to ensure that it does not exceed the
limit specified in paragraphs (e)(1)(i) through (iii) of this section.
    (i) The total harmonic distortion plus noise shall not exceed 5
percent for output levels within one of the following sets of levels,
depending on the test method:

    (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB
SPL; or
    (B) Using a 500-Hz one-third-octave pulsed-noise signal, measure at
67 dB SPL and 97 dB SPL.
    (ii) You must measure the total harmonic distortion using a 500-Hz
input tone with an analyzer that has a bandwidth at least as wide as
the frequency limits of the OTC hearing aid.
    (iii) You must measure the output distortion at the OTC hearing
aid's maximum volume and the input sound level to the OTC hearing aid
adjusted to produce the required outputs.
    (2) Self-generated noise level limits. Self-generated noise shall
not exceed 32 dB SPL. You must disable any methods that artificially
lower the apparent noise floor for the measurement. Such methods would
include but are not limited to auto-muting and downward expansion.
    (3) Latency. Latency shall not exceed 15 ms. You must measure the
latency with a method that is accurate and repeatable to within 1.5 ms.
    (4) Frequency response bandwidth. The lower cutoff frequency shall
extend to 250 Hz or below, and the upper cutoff frequency shall extend
to 5 kHz or greater. You must measure the frequency response bandwidth
as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017.
    (5) Frequency response smoothness. No single peak in the one-third-
octave frequency response shall exceed 12 dB relative to the average
levels of the one-third-octave bands, two-thirds octave above and below
the peak. You must measure the frequency response smoothness using
values for a diffuse field and the corrected one-third-octave frequency
insertion response as specified in the Method for clause 4.1 in ANSI/
CTA-2051:2017.
    (f) Design requirements. An OTC hearing aid must conform to all of
the following design requirements.
    (1) Insertion depth. The design of an OTC hearing aid shall limit
the insertion of the eartip to the bony-cartilaginous junction of the
external auditory canal and no deeper.
    (2) Use of atraumatic materials. The material for the eartip of an
OTC hearing aid shall be atraumatic.
    (3) Proper physical fit. The OTC hearing aid shall be designed to
enable consumers to readily achieve a safe, customized, acoustically
favorable, and comfortable physical fit in the ear canal and/or
external ear.
    (4) Tools, tests, or software. The OTC hearing aid shall, through
tools, tests, or software, permit a lay user to control the device and
customize it to the user's hearing needs.
    (g) Condition for sale of an OTC hearing aid. The sale of an OTC
hearing aid to or for a person younger than 18 years of age is
prohibited.
    (h) Effect on State law. Any State or local government requirement
for an OTC hearing aid is preempted to the following extent.
    (1) Preemption. No State or local government shall establish or
continue in effect any law, regulation, order, or other requirement
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 is different from, in addition
to, or otherwise not identical to, the regulations issued under section
709(b) of the FDA Reauthorization Act of 2017, including any State or
local requirement for the supervision, prescription, or other order,
involvement, or intervention of a licensed person for consumers to
access OTC hearing aids.
    (2) Professional requirements.--(A) General rule. The servicing,
marketing, sale, dispensing, customer support, or distribution of OTC
hearing aids, or an equivalent activity, whether through in-person
transactions, by mail, or online, shall not cause, require, or
otherwise obligate a person providing such services to obtain
specialized licensing, certification, or any other State or local
sanction unless such requirement is generally applicable to the sale of
any product or to all places of business regardless of whether they
sell OTC hearing aids. However, although a State or local government
may not require the order, involvement, or intervention of a licensed
person for consumers to access OTC hearing aids, a licensed person may
service, market, sell, dispense, provide customer support for, or
distribute OTC hearing aids.
    (B) Sale of OTC hearing aids is not an exemption. The servicing,
marketing, sale, dispensing, customer support, or distribution of OTC
hearing aids does not exempt a person from any State or local
government's professional or establishment requirements that are
consistent with this section.
    (C) Representations may create professional obligations. A person
shall not incur specialized obligations by representing as a servicer,
marketer, seller, dispenser, customer support representative, or
distributor (or an equivalent description) of OTC hearing aids.
However, a person representing as any other defined professional or
establishment, or as a State licensed dispenser, is subject to
applicable State and local requirements even if the person undertakes
commercial or professional activities only in relation to OTC hearing
aids.
    (3) Private remedies. This section does not 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.
    (i) Incorporation by reference. (A) The standard required in this
section is incorporated by reference into this section with the
approval of the Director of the Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. All approved material is available for inspection at
the Food and Drug Administration, Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, and is
available from the sources indicated below. It is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, email
[email protected] or go to https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (B) ANSI. The American National Standards Institute, 1889 L Street
NW, 11th floor, Washington, DC 20036, [email protected], https://www.ansi.org,<PHONE_NUMBER>.
    (1) ANSI/CTA-2051, ``Personal Sound Amplification Performance
Criteria,'' clause 4.1, dated January 2017.
    (2) [Reserved]
    (ii) [Reserved]

PART 801--LABELING

0
3. The authority citation for part 801 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j,
371, 374.

Sec.  801.420  [Removed]

0
4. Remove Sec.  801.420.

Sec.  801.421  [Removed]

0
5. Remove Sec.  801.421.
0
6. Add Sec.  801.422 to subpart H to read as follows:

Sec.  801.422  Prescription hearing aid labeling.

    (a) Scope. This section specifies the labeling requirements for
prescription hearing aids. Any hearing aid that does not satisfy the
requirements of Sec.  800.30 of this chapter shall be a prescription
device. Unless otherwise specified, the requirements in this section
are in addition to other applicable requirements, including but not
limited to special controls found in the

applicable classification regulation. This section does not apply to
group auditory trainers.
    (b) Definitions for the purposes of this section. This section uses
the following definitions:
    Dispenser. A dispenser is any person, as defined in section 201(e)
of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of
prescription hearing aids to any member of the consuming public or any
employee, agent, salesperson, and/or representative of such a person.
    Hearing aid. A hearing aid is any wearable device designed for,
offered for the purpose of, or represented as aiding persons with or
compensating for, impaired hearing.
    Prescription hearing aid. A prescription hearing aid is a hearing
aid that is not an over-the-counter (OTC) hearing aid as defined in
Sec.  800.30 of this chapter or a hearing aid that does not satisfy the
requirements in Sec.  800.30 of this chapter.
    Sale. Sale includes a lease, rental, or any other purchase or
exchange for value.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it
for any period of time. However, a hearing aid shall not be ``used''
merely because a prospective user wore it as part of a bona fide
hearing aid evaluation to determine whether to select that particular
hearing aid for that prospective user. A hearing aid evaluation is
``bona fide'' if it was conducted in the presence of the dispenser or a
hearing health professional selected by the dispenser to assist the
prospective user in making a determination.
    (c) Labeling. A prescription hearing aid shall bear all of the
following labeling.
    (1) Outside package labeling. The outside package of a prescription
hearing aid shall bear all of the following:
    (i) Warnings. All of the following shall appear on the outside
package:
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TP20OC21.013

    (B) Statement of build condition. If the prescription hearing aid
is used or rebuilt, the outside package shall declare that fact. A
sticker under and visible through the outer wrapper will suffice to
declare such fact.
    (2) Labeling, inside the package. The manufacturer or distributor
of a prescription hearing aid shall include a user instructional
brochure inside the package and shall make an electronic version
available for download without site or customer registration and
without requiring purchase of any product or service. The user
instructional brochure shall include all of the following:
    (i) The following warnings, which shall appear in the following
order and prior to any content except the cover page:

[GRAPHIC] [TIFF OMITTED] TP20OC21.014

[GRAPHIC] [TIFF OMITTED] TP20OC21.015

[GRAPHIC] [TIFF OMITTED] TP20OC21.016

BILLING CODE 4164-01-C
    (iii) An illustration(s) of the prescription hearing aid that
indicates operating controls, user adjustments, and the battery
compartment.

    (iv) Information on the function of all controls intended for user
adjustment.
    (v) A description of any accessory that accompanies the
prescription hearing aid, including but not limited to wax guards, and
accessories for use with a computer, television, or telephone.
    (vi) Specific instructions for all of the following:
    (A) Use of the prescription hearing aid with any accompanying
accessories.
    (B) Maintenance and care of the prescription hearing aid, including
the procedure to follow in washing the earmold, when replacing tubing
on those hearing aids that use tubing, and in storing the hearing aid
when it will not be used for an extended period of time.
    (C) If the battery is replaceable or rechargeable, how to replace
or recharge the battery, including a generic designation of replacement
batteries.
    (D) Expected battery life.
    (vii) Identification of any known physiological side effects
associated with the use of the prescription hearing aid that may
warrant consultation with a physician, including if applicable, skin
irritation and accelerated accumulation of cerumen (ear wax).
    (viii) The technical specifications required by paragraph (c)(4) of
this section unless such specifications appear in separate labeling
accompanying the prescription hearing aid.
    (ix) A description of commonly occurring, avoidable events that
could adversely affect or damage the prescription hearing aid,
including but not limited to ear wax buildup, drops, immersion in
water, or exposure to excessive heat.
    (x) If the hearing aid incorporates wireless technology in its
programming or use, appropriate warnings, instructions, and information
relating to electromagnetic compatibility and wireless technology and
human exposure to non-ionizing radiation.
    (xi) If the manufacturer provides a repair service or licenses or
certifies third-party repair services, information on how and where to
obtain repair service, including at least one specific address where
the user can go or send the prescription hearing aid to obtain such
repair service.
    (xii) If clinical or non-clinical studies were conducted by or for
the manufacturer to support the performance of the prescription hearing
aid, a summary of all such studies.
    (3) Labeling on the device. The labeling on a prescription hearing
aid itself shall bear all of the following clearly and permanently,
except as provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the
positive terminal for battery insertion unless the battery's physical
design prevents inserting the battery in the reversed position.
    (iii) If the prescription hearing aid is used or rebuilt, the
manufacturer shall physically attach a removable tag to the hearing aid
declaring that fact.
    (4) Technical specifications. Technical specifications useful in
selecting, fitting, and checking the performance of the prescription
hearing aid shall appear in the user instructional brochure or in
separate labeling that accompanies the device. You must determine the
technical specification values for the prescription hearing aid
labeling in accordance with the test procedures of the American
National Standard, ``Specification of Hearing Aid Characteristics,''
ANSI/ASA S3.22-2014. As a minimum, the user instructional brochure or
such other labeling shall include the appropriate values or information
for the following technical specification elements as these elements
are defined or used in such standard:
    (i) Saturation output curve (SSPL 90 curve).
    (ii) Frequency response curve.
    (iii) Average saturation output (HF-Average SSPL 90).
    (iv) Average full-on gain (HF-Average full-on gain).
    (v) Reference test gain.
    (vi) Frequency range.
    (vii) Total harmonic distortion.
    (viii) Equivalent input noise.
    (ix) Battery current drain.
    (x) Induction coil sensitivity (telephone coil aids only).
    (xi) Input-output curve (only for hearing aids with automatic gain
control).
    (xii) Attack and release times (only for hearing aids with
automatic gain control).
    (5) Misbranding. A prescription hearing aid that is not labeled as
required under this section and Sec.  801.109 of this chapter shall be
misbranded under sections 201(n), 502(a), and/or 502(f) of the Federal
Food, Drug, and Cosmetic Act.
    (d) Incorporation by reference. (1) The standard required in this
section is incorporated by reference into this section with the
approval of the Director of the Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. All approved material is available for inspection at
the Food and Drug Administration, Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, and is
available from the sources indicated below. It is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, email
[email protected] or go to https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.:
    (2) ANSI. The American National Standards Institute, 1889 L Street
NW, 11th Floor, Washington, DC 20036, [email protected], https://www.ansi.org,<PHONE_NUMBER>.
    (i) ANSI/ASA S3.22-2014, ``Specification of Hearing Aid
Characteristics,'' dated November 2014.
    (ii) [Reserved]

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL
MEDICAL DEVICE REQUIREMENTS

0
7. The authority citation for part 808 is revised to read as follows:

    Authority: 21 U.S.C. 360j, 360k, 371.
    Section 808.1 also issued under Sec. 709, Pub. L. 115-52, 131
Stat. 1065-67.

PART 808--[AMENDED]

0
8. In part 808, remove the words ``the act'' and add in their place
``the Federal Food, Drug, and Cosmetic Act''.
0
9. In Sec.  808.1, add headings to paragraphs (a) through (f) and add
paragraph (g) to read as follows:

Sec.  808.1   Scope.

    (a) Introduction. * * *
    (b) General rule for State and local requirements respecting
devices. * * *
    (c) Exempting from preemption certain State or local requirements
respecting devices. * * *
    (d) Meaning of ``requirements applicable to a device.'' * * *
    (e) Determination of equivalence or difference of requirements
applicable to a device. * * *
    (f) Applicability of Federal requirements respecting devices. * * *
    (g) Exemptions not applicable to certain State or local government
requirements specifically related to hearing products. An exemption
under this part shall not apply to any State or local government law,
regulation, order, or other requirement specifically related to hearing
products, including any requirement for the supervision, prescription,
or other order, involvement, or intervention of a licensed person for
consumers to access over-the-counter hearing aids, that:
    (1) Would restrict or interfere with the servicing, marketing,
sale, dispensing, use, customer support, or distribution of

over-the-counter hearing aids, as defined under section 520(q) of the
Federal Food, Drug, and Cosmetic Act, through in-person transactions,
by mail, or online; and
    (2) Is different from, in addition to, or otherwise not identical
to, the regulations issued under section 709(b) of the FDA
Reauthorization Act of 2017.
0
10. Revise Sec.  808.3 to read as follows:

Sec.  808.3   Definitions.

    Compelling local conditions includes any factors, considerations,
or circumstances prevailing in, or characteristic of, the geographic
area or population of the State or political subdivision that justify
exemption from preemption.
    More stringent refers to a requirement of greater restrictiveness
or one that is expected to afford to those who may be exposed to a risk
of injury from a device a higher degree of protection than is afforded
by a requirement applicable to the device under the Federal Food, Drug,
and Cosmetic Act.
    Political subdivision or locality means any lawfully established
local governmental unit within a State which unit has the authority to
establish or continue in effect any requirement having the force and
effect of law with respect to a device intended for human use.
    State means any State or Territory of the United States, including
but not limited to, the District of Columbia and the Commonwealth of
Puerto Rico.
    Substantially identical to refers to the fact that a State or local
requirement does not significantly differ in effect from a Federal
requirement.

Sec.  808.53   [Removed and Reserved]

0
11. Remove and reserve Sec.  808.53.
0
12. Revise Sec.  808.55 to read as follows:

Sec.  808.55   California.

    The following California medical device requirements are preempted
under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and
FDA has denied them exemption from preemption:
    (a) Medical devices; general provisions. Sherman Food, Drug, and
Cosmetic Law, Division 21 of the California Health and Safety Code,
sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to
the extent that they apply to devices; and
    (b) Ophthalmic devices; quality standards. California Business and
Professions Code, section 2541.3 to the extent that it requires
adoption of the American National Standards Institute standards Z-80.1
and Z-80.2.

Sec. Sec.  808.57 through 808.101   [Removed and Reserved]

0
13. Remove and reserve Sec. Sec.  808.57 through 808.101.

PART 874--EAR, NOSE, AND THROAT DEVICES

0
14. The authority citation for part 874 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
15. Redesignate Sec.  874.3300 as Sec.  874.3301 and revise to read as
follows:

Sec.  874.3301   Bone-conduction hearing aid.

    (a) Identification. A bone-conduction hearing aid is a wearable
sound-amplifying device intended to compensate for impaired hearing and
that transmits sound to the inner ear through the skull. A bone-
conduction hearing aid is subject to the requirements in Sec.  801.422
of this chapter.
    (b) Classification. Class II.
0
16. Revise Sec.  874.3305 to read as follows:

Sec.  874.3305  Air-conduction hearing aid.

    (a) Identification. An air-conduction hearing aid is a wearable
sound-amplifying device intended to compensate for impaired hearing
that conducts sound to the ear through the air. An air-conduction
hearing aid may be wireless, self-fitting, or both. An air-conduction
hearing aid is subject to the requirements in Sec.  800.30 or Sec.
801.422 of this chapter, as applicable. Air-conduction hearing aid
generic types exclude the group hearing aid or group auditory trainer,
master hearing aid, and the tinnitus masker, regulated under Sec. Sec.
874.3320, 874.3330, and 874.3400, respectively.
    (b) Classification. (1) Legacy hearing aid. Class I for an air-
conduction hearing aid that is not a wireless or self-fitting device.
This hearing aid is exempt from premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec.  874.9.
    (2) Wireless hearing aid. Class II (special controls) for an air-
conduction hearing aid that incorporates wireless technology in its
programming or use. A wireless hearing aid may also be a self-fitting
hearing aid. A wireless hearing aid that is not a self-fitting hearing
aid is exempt from the premarket notification procedures in subpart E
of part 807 of this chapter subject to the limitations in Sec.  874.9.
The special controls for a wireless hearing aid are:
    (i) Performance data must demonstrate the electromagnetic
compatibility (EMC), electrical safety, and thermal safety of the
device;
    (ii) Performance testing must validate safety of exposure to non-
ionizing radiation; and
    (iii) Performance data must validate wireless technology functions.
    (3) Self-fitting hearing aid. Class II (special controls) for a
wireless air-conduction hearing aid that incorporates technology,
including software, that allows users to program their hearing aids.
This technology integrates user input with a self-fitting strategy and
enables users to independently derive and customize their hearing aid
fittings and settings. A self-fitting hearing aid is not exempt from
premarket notification procedures, notwithstanding the exemption in
paragraph (b)(2) of this section. The special controls for a self-
fitting hearing aid, in addition to the special controls for a wireless
hearing aid if the device incorporates wireless technology, are:
    (i) Clinical data must evaluate the effectiveness of the self-
fitting strategy;
    (ii) Electroacoustic parameters, including maximum output limits,
distortion levels, self-generated noise levels, latency, and frequency
response, must be specified and tested;
    (iii) Software verification, validation, and hazard analysis must
be performed; and
    (iv) Usability testing must demonstrate that users can correctly
use the device as intended under anticipated conditions of use.
0
17. In Sec.  874.3315, revise paragraph (a) to read as follows:

Sec.  874.3315  Tympanic membrane contact hearing aid.

    (a) Identification. A tympanic membrane contact hearing aid is a
prescription wearable device that compensates for impaired hearing.
Amplified sound is transmitted by vibrating the tympanic membrane
through a transducer that is in direct contact with the tympanic
membrane. A tympanic membrane contact hearing aid is subject to the
requirements in Sec.  801.422 of this chapter.
* * * * *

Sec.  874.3325   [Removed]

0
18. Remove Sec.  874.3325.
0
19. In Sec.  874.3950, add a sentence at the end of paragraph (a) to
read as follows:

Sec.  874.3950   Transcutaneous air conduction hearing aid system.

    (a) * * * A transcutaneous air conduction hearing aid system is
subject to the requirements in Sec.  801.422 of this chapter.
* * * * *

    Dated: October 8, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-22473 Filed 10-19-21; 8:45 am]
BILLING CODE 4164-01-P