[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Rules and Regulations]
[Pages 50698-50762]
[FR Doc No: 2022-17230]

Vol. 87

Wednesday,

No. 158

August 17, 2022

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 800, 801, et al.

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-
Counter Hearing Aids; Final Rule

Federal Register / Vol. 87 , No. 158 / Wednesday, August 17, 2022 /
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 800, 801, 808, and 874

[Docket No. FDA-2021-N-0555]
RIN 0910-AI21

Medical Devices; Ear, Nose, and Throat Devices; Establishing
Over-the-Counter Hearing Aids

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
establishing a regulatory category for over-the-counter (OTC) hearing
aids and making related amendments to update the regulatory framework
for hearing aids. Specifically, we define OTC hearing aids and
establish applicable requirements; amend existing rules for consistency
with the new OTC category; repeal the conditions for sale applicable to
hearing aids; amend the existing labeling requirements for hearing
aids; and update regulations relating to decisions on applications for
exemption from Federal preemption that will become obsolete as a result
of changes to the hearing aid requirements. In creating a regulatory
category for OTC hearing aids and amending existing rules, we intend to
provide reasonable assurance of safety and effectiveness for these
devices as well as foster access to, and innovation in, hearing aid
technology, thereby protecting and promoting the public health.

DATES:
    Effective date: This rule is effective October 17, 2022.
    Compliance dates: For hearing aids that have been legally offered
for sale prior to October 17, 2022, including hearing aids that already
have a 510(k) clearance, compliance with the new or revised
requirements must be achieved by April 14, 2023. For hearing aids that
have not been offered for sale prior to October 17, 2022, or have been
offered for sale but are required to submit a new 510(k) due to changes
unrelated to this rule, 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
October 17, 2022.
    Incorporation by reference: The incorporation by reference of
certain material listed in this rule is approved by the Director of the
Federal Register as of October 17, 2022.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this final rule,
into the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT:
    With regard to the final rule: Srinivas Nandkumar, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].
    With regard to the information collection: Amber Sanford, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    Purpose of the Final Rule
    Summary of the Major Provisions of the Final Rule
    Legal Authority
    Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in this
Document
III. Background
    A. Need for the Regulation
    B. History of this Rulemaking and Public Participation
    C. Summary of Changes Between Proposed and Final Rules
    D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Responses
    A. Device Classification and Marketing
    B. Scope (Sec.  800.30(a))
    C. Definitions (Sec. Sec.  800.30(b) and 801.422(b))
    D. Labeling (Sec.  800.30(c))
    E. Output Limits (Sec.  800.30(d))
    F. Other Device Requirements (Sec.  800.30(e) and (f))
    G. Conditions for OTC Sale (Sec.  800.30(g))
    H. Preemption Provisions (Sec.  800.30(h))
    I. Repeal of Restrictions and Modifications for Prescription
Labeling (Sec. Sec.  801.420, 801.421, 801.422)
    J. Other Amendments
VI. Effective and Compliance Dates
    A. Effective Date
    B. Compliance Dates for Hearing Aids Not Legally Offered for
Sale Prior to the Effective Date
    C. Compliance Dates for Hearing Aids Legally Offered for Sale
Prior to the Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environment Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    Hearing loss affects an estimated 30 million people in the United
States and can have a significant impact on communication, social
participation, and overall health and quality of life. Despite the high
prevalence and public health impact of hearing loss, only about one-
fifth of people who could benefit from a hearing aid seek intervention.
Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as
old or debilitated, and value (perceived hearing benefit relative to
price). FDA is finalizing rules to address some of these concerns.
    Moreover, the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-
52) directs FDA to establish a category of OTC hearing aids through
rulemaking, and FDARA sets forth various requirements for OTC hearing
aids, including for reasonable assurance of safety and effectiveness,
as well as Federal preemption provisions. In addition to protecting and
promoting the public health, these rules establish the OTC category and
implement the requirements of FDARA.

B. Summary of the Major Provisions of the Final Rule

    FDA is establishing a regulatory category for OTC hearing aids to
improve access to hearing aid technology for Americans. OTC hearing
aids are intended to address perceived mild to moderate hearing loss in
people aged 18 or older. Along with the OTC category, we are finalizing
multiple related changes to the overall regulatory framework for
hearing aids to harmonize existing rules with the new OTC category. We
have determined that the requirements set forth in this rulemaking will
protect the public health by providing reasonable assurance of safety
and effectiveness for hearing aids, as well as promote the hearing
health of Americans by lowering barriers to access and fostering
innovation in hearing aid technology.
    Among other things, FDARA amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the
authorities to establish the OTC category of hearing aids among
provisions that are, by definition, general controls. We are finalizing
general controls for OTC hearing aids consistent with FDARA.

We are finalizing lower output limits than we proposed but have not
substantially changed the other electroacoustic performance
requirements for OTC hearing aids. We have simplified the phrasing
throughout the required labeling and have restated the maximum
insertion depth for OTC hearing aids in terms of a fixed measurement.
However, we are not realigning the air-conduction hearing aid
classification regulations as proposed.
    This rulemaking also affects other regulations that applied to
hearing aids. FDA had established device restrictions for hearing aids
that included labeling requirements as well as conditions for sale. We
are removing these device restrictions for hearing aids and
establishing a new regulation for prescription hearing aid labeling.
Further, FDA had by regulation granted or denied exemptions from
Federal preemption for State requirements pertaining to hearing aids.
The removal of the device restrictions on hearing aids, as well as
certain provisions of FDARA, impact most of these previous exemption
decisions, for example, by altering their scope. We are removing the
regulations codifying these decisions and establishing other
regulations clarifying some of the effects of statutory preemption
under FDARA.

C. Legal Authority

    The FD&C Act establishes a comprehensive system for the regulation
of devices intended for human use. Hearing aids are devices intended
for human use and so are subject to, among other requirements, the
device provisions of the FD&C Act. FDA has authority to establish
regulatory controls needed to provide reasonable assurance of safety
and effectiveness for these devices. As such, FDA is establishing
regulatory controls for OTC hearing aids and amending regulatory
controls for prescription hearing aids. Moreover, the FD&C Act directs
the establishment of an electronic radiation control program, and
hearing aids and personal sound amplification products (PSAPs) are
electronic products, subject to the electronic radiation control
requirements.
    Specific to OTC hearing aids, the FD&C Act and FDARA authorize
multiple controls, including authority for FDA to establish
requirements for device labeling, output limits, conditions for sale
and distribution, and other requirements that provide reasonable
assurance of safety and effectiveness of OTC hearing aids. FDARA
specifically directs FDA to establish a category of OTC hearing aids by
regulation that must include the aforementioned requirements.
    More generally, the FD&C Act further provides for labeling
requirements as general controls such that devices (and other medical
products) will not be misbranded. The FD&C Act also authorizes FDA to
issue regulations for the efficient enforcement of the FD&C Act. We are
establishing the following regulations pursuant to these authorities
and to fulfill the directive under FDARA.
    Additionally, both the FD&C Act and FDARA include preemption
provisions applicable to hearing aids.

D. Costs and Benefits

    This rule to establish OTC hearing aids and align other regulations
generates potential cost savings for consumers with perceived mild to
moderate hearing impairment who wish to buy lower cost hearing aids not
bundled with professional services and not requiring professional
advice, fitting, adjustment, or maintenance but who are currently
unable to buy such products online because of State regulations or
because they do not shop online. This rule also generates costs for
hearing aid manufacturers for changing labeling of existing hearing
aids as well as for reading the rule and revising internal standard
operating procedures in response to the rule. We estimate benefits of
between $6 million and $147 million per year based on 5th and 95th
percentile Monte Carlo results with a mean of $63 million per year. We
estimate annualized costs of between $1 million and $2 million per year
based on 5th and 95th percentile Monte Carlo results with a mean of $1
million per year. Combining benefits and costs, we used Monte Carlo
analysis to estimate annualized net benefits of between $5 million and
$145 million per year based on the 5th and 95th Monte Carlo percentile
results with a mean of $62 million per year at both 3 percent and 7
percent discount rates.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

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     Abbreviation/acronym                    What it means
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510(k).......................  A premarket notification for certain
                                devices.
ANSI.........................  American National Standards Institute.
APA..........................  Administrative Procedure Act.
ASA..........................  Acoustical Society of America.
ASHA.........................  American Speech-Language-Hearing
                                Association.
CDRH.........................  Center for Devices and Radiological
                                Health.
CFR..........................  Code of Federal Regulations.
cm\3\........................  Centimeter cubed (cubic centimeter).
CTA..........................  Consumer Technology Association.
dB...........................  Decibel.
dBA..........................  A-weighted decibel.
EA...........................  Environmental assessment.
ENT..........................  Ear-Nose-Throat.
FDA..........................  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FDARA........................  FDA Reauthorization Act of 2017.
FONSI........................  Finding of no significant impact.
FR...........................  Federal Register.
FRIA.........................  Final Regulatory Impact Analysis.
IQA..........................  Information Quality Act.
ISO..........................  International Organization for
                                Standardization.
ITU..........................  International Telecommunication Union.
mm...........................  Millimeter.
ms...........................  Millisecond.

MSW..........................  Municipal solid waste.
NASEM........................  National Academies of Sciences,
                                Engineering, and Medicine.
NIOSH........................  National Institute for Occupational
                                Safety and Health.
OMB..........................  Office of Management and Budget.
OSPL90.......................  Output sound pressure level with 90-dB
                                input.
OTC..........................  Over-the-counter.
PRA..........................  Paperwork Reduction Act of 1995.
PSAP.........................  Personal sound amplification product.
Pub. L.......................  Public Law.
RMS..........................  Root mean square.
SPL..........................  Sound pressure level.
U.S.C........................  United States Code.
WHO..........................  World Health Organization.
------------------------------------------------------------------------

III. Background

    FDA is defining and establishing general controls for an OTC
category of hearing aids. We intend these controls to provide for
reasonable assurance of safety and effectiveness for these devices,
thereby protecting the public health. We also intend these controls to
help improve access to and foster innovation in hearing aid technology
for Americans, thereby promoting the public health. We are making
various other revisions, as described in this document, to align
existing regulations with statutory requirements and the new OTC
category.
    For brevity, we will use the following terms as shorthand in this
document: ``Over-the-Counter Hearing Aid Controls'' for the general
controls for OTC hearing aids that we are finalizing under Sec.  800.30
(21 CFR 800.30).
    ``Commercial activity involving OTC hearing aids'' to refer to any
or all of the following activities: servicing, marketing, sale,
dispensing, use, customer support, or distribution of OTC hearing aids
through in-person transactions, by mail, or online.
    ``Customizable'' or ``customization,'' unless otherwise noted, to
refer to the elements of the statutory definition for OTC hearing aids
described in section 520(q)(1)(A)(iii) and (iv) of the FD&C Act (21
U.S.C. 360j(q)(1)(A)(iii) and (iv)). That is, for the purposes of this
document, a customizable hearing aid is one that, through tools, tests,
or software, allows the user to control the hearing aid and customize
it to the user's hearing needs. To do so, the hearing aid may use
wireless technology or include tests for self-assessment of hearing
loss. (See also the response to Comment 1 explaining customization in
more technical terms.)
    ``Involvement of a licensed person'' to refer to the supervision,
prescription, or other order, involvement, or intervention of a
licensed person.
    ``State or local requirement'' to refer to any State or local law,
regulation, order, or other requirement.

A. Need for the Regulation

    Hearing loss affects an estimated 30 million people in the United
States and can have a significant impact on communication, social
participation, and overall health and quality of life (Refs. 1 and 2).
Despite the high prevalence and public health impact of hearing loss,
only about one-fifth of people who could benefit from a hearing aid
seek intervention (Ref. 3). The use of hearing aids has been linked to,
among other health benefits, reductions in the incidence or severity of
cognitive decline, depression, and other health problems in older
adults (Refs. 2, 4, and 5). Additionally, benefits of hearing aid use
can include improved social participation and a better quality of life.
    Besides health benefits for individuals, more-widespread adoption
of hearing aids could have broader effects. By increasing social
participation, hearing aids could help to improve inclusion of
individuals in family, economic, civic, and religious life. Thus,
reducing barriers to hearing aid access might contribute to such
improvements. This could be particularly true for people of color,
rural Americans, low-income individuals, and others for whom barriers
to hearing aid access may be especially burdensome.
    Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as
old or debilitated, and value (perceived hearing benefit relative to
price) (Ref. 6). FDA is finalizing rules to address some of these
concerns.
    Moreover, section 709 of FDARA directs FDA to establish a category
of OTC hearing aids through rulemaking, and sets forth various
requirements for OTC hearing aids, including for reasonable assurance
of safety and effectiveness, as well as Federal preemption provisions.
In addition to protecting and promoting the public health, these rules
establish the OTC category and implement the requirements of FDARA.

B. History of This Rulemaking and Public Participation

    On October 20, 2021, in the Federal Register, FDA proposed multiple
regulatory changes, including proposing requirements for OTC hearing
aids, that would serve to provide reasonable assurance of safety and
effectiveness of hearing aids, address barriers to access to hearing
aids, and effectuate the requirements of section 709 of FDARA (86 FR
58150). Although the October 2021 proposal was the first step in this
rulemaking, the proposal followed other steps FDA had already taken to
initiate an update of the regulatory framework for hearing aids. Please
refer to the aforementioned issue of the Federal Register for further
details on the proposal and other steps taken by FDA.
    We received more than 1,000 comments on the proposed rule by the
close of the comment period, which was January 18, 2022. Commenters
included consumers, professionals, professional associations, hearing
aid manufacturers, public health organizations, public advocacy groups,
members of Congress, and State agencies. We describe and respond to the
comments in section V of this document. We have grouped similar
comments together under the same number, and in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments for purposes of our responses. The number
assigned to each comment or comment topic is purely for organizational
purposes and does not signify the comment's value or importance or the
order in which we received comments.

C. Summary of Changes Between Proposed and Final Rules

    In response to comments, we have made (and declined) a number of
changes for the final rule. The following summarizes the outcomes that
may be of greatest interest to readers:
    Output limits. We are finalizing lower output limits than we
proposed. The general limit will be 111 decibels of sound pressure
level (dB SPL), with 117 dB SPL allowable for devices while input-
controlled compression is activated.
    Gain limit. We did not propose, and are not finalizing, a separate
gain limit.
    Design requirements. We have revised the allowable insertion depth.
The most medial (innermost) component of an OTC hearing aid must be
reasonably expected to remain at least 10 millimeters (mm) from the
tympanic membrane (eardrum). We are also requiring that all OTC hearing
aids have a user-adjustable volume control.
    Labeling. We have improved phrasing throughout the labeling to make
it more understandable for hearing aid users (non-experts).
    Conditions for sale. We are not requiring age verification for the
sale of OTC hearing aids. Prescription hearing aid sales will be
subject to the requirements in Sec.  801.109 (21 CFR 801.109),
including that they be sold only to or on the prescription or other
order of a practitioner licensed by law to use or order the use of
(prescribe) the devices (which is as proposed).
    Scope and definitions. Perceived mild to moderate hearing
impairment remains the scope of the intended use of OTC hearing aids,
and we are declining to require measurements of hearing loss to
establish prospective users' qualification to purchase OTC hearing
aids.
    OTC category and self-fitting air-conduction hearing aid
classification. We are not requiring that OTC hearing aids be self-
fitting devices, and we have provided clarification on the difference
between customization and fitting.
    Quality System requirements. OTC hearing aids will be subject to
the requirements under part 820 (21 CFR part 820), which describes a
quality management system appropriate for medical devices.
    We explain those decisions and others, as well as provide our
thinking on other topics in the sections that follow.

D. Incorporation by Reference

    FDA is incorporating by reference ANSI/CTA-2051, ``Personal Sound
Amplification Performance Criteria,'' dated January 2017, which was
approved by the Office of the Federal Register. You may obtain a copy
from the Consumer Technology Association (CTA), 1919 S. Eads St.,
Arlington, VA 22202; https://www.cta.tech,<PHONE_NUMBER>. Among other
things, it describes how to measure frequency response and includes
technical data for adaptations for different circumstances and provides
a standardized way to quantify frequency response for OTC hearing aids
and to meet the related electroacoustic performance requirements.
    FDA is also incorporating by reference ANSI/ASA S3.22-2014 (R2020),
``Specification of Hearing Aid Characteristics,'' dated June 5, 2020,
which was approved by the Office of the Federal Register. You may
obtain a copy from the Acoustical Society of America (ASA), 1305 Walt
Whitman Road, Suite 300, Melville, NY 11747 Telephone: 1 (631) 390-
0215, Fax: 1<PHONE_NUMBER>, Email: [email protected] or
the American National Standards Institute (ANSI), 1889 L Street NW,
11th Floor, Washington, DC 20036; https://www.ansi.org,<PHONE_NUMBER>.
ANSI/ASA S3.22-2014 (R2020) describes tolerances and test methods used
for certain measurements of hearing aid performance. The application of
ANSI/ASA S3.22-2014 (R2020) provides professional hearing instrument
specialists with standardized technical information to help them select
the correct hearing aid and ensure optimal fit and performance for
hearing aid users.

IV. Legal Authority

    The FD&C Act establishes a comprehensive system for the regulation
of devices, as defined in section 201(h) of the FD&C Act (21 U.S.C.
321(h)), intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) defines three classes of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three classes of devices are class I (general
controls), class II (special controls), and class III (premarket
approval) (see 21 U.S.C. 360c). Hearing aids are devices intended for
human use and are subject to the FD&C Act. Currently, air-conduction
hearing aids are generally either class I or class II devices.
    The FD&C Act also directs the establishment of an electronic
product radiation control program under section 532(a) to protect the
public health and safety (see 21 U.S.C. 360ii(a)), and requires, among
other things, that manufacturers of electronic products provide
notification of certain defects (see 21 U.S.C. 360ll). Section
531(1)(B) of the FD&C Act defines electronic product radiation as,
among other phenomena, any sonic, infrasonic, or ultrasonic wave
emitted from an electronic product as the result of the operation of an
electronic circuit (see 21 U.S.C. 360hh(1)(B)). In turn, any
manufactured or assembled product which, when in operation, contains or
acts as part of an electronic circuit and emits (or in the absence of
effective shielding or other controls would emit) electronic product
radiation would be an electronic product (see 21 U.S.C. 360hh(2)(A)).
As such, hearing aids and PSAPs emit electronic product radiation and
are electronic products, meaning they are subject to the electronic
product radiation control requirements.
    FDARA amended the FD&C Act to apply requirements specific to
certain hearing aids and defined the term ``over-the-counter hearing
aid'' (see 21 U.S.C. 360j(q)). We are issuing these requirements for
OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes
FDA to establish requirements for labeling, output limits, conditions
for sale and distribution of OTC hearing aids, and other requirements
that provide for reasonable assurance of safety and effectiveness of
these devices.
    In addition, the FD&C Act provides that a device is misbranded
unless, among other requirements, its labeling bears adequate
directions for use (see section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)). Consistent with section 502 of the FD&C Act, FDA has issued
regulations that exempt certain kinds of devices from the requirement
for adequate directions for use. Section 502(f)(2) further requires
adequate warnings against use of a device in those pathological
conditions, or by children, where use of the device may be dangerous to
health. The labeling must also bear adequate warnings against unsafe
dosage or methods or duration of administration or application (see
section 502(f)(2) of the FD&C Act). Such warnings must be in such
manner and form as are necessary for the protection of the users (see
section 502(f)(2) of the FD&C Act).
    A device is also misbranded if its labeling is false or misleading
in any particular (see section 502(a) of the FD&C Act). Section 201(n)
of the FD&C Act states that in determining whether labeling or
advertising is misleading, there shall be taken into account not only
representations made or suggested but also the extent to which labeling
or advertising fails to reveal material facts.
    Other misbranding provisions under the FD&C Act would apply as
well,

including section 502(c), which deems a device to be misbranded if any
word, statement, or other information required by or under authority of
the FD&C Act to appear on the label or labeling is not prominently
placed thereon with such conspicuousness and in such terms as to render
it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
    Additionally, section 701(a) of the FD&C Act authorizes FDA to
issue regulations for the efficient enforcement of the FD&C Act (21
U.S.C. 371(a)). The regulations established in this rulemaking are for
the efficient enforcement of the FD&C Act because they will provide
standards for the legal marketing of safe and effective hearing aids.
    Violations of any final rules from this rulemaking, once in effect,
would render the hearing aids adulterated and/or misbranded under
sections 501 and/or 502 of the FD&C Act, and subject to enforcement
action, for example, seizure (see section 304 of the FD&C Act (21
U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C.
332)), and criminal prosecution (see section 303 of the FD&C Act (21
U.S.C. 333)). Prohibited acts include, among others, introducing an
adulterated or misbranded device into interstate commerce (see section
301 of the FD&C Act (21 U.S.C. 331)). Sections 538 and 539 of the FD&C
Act additionally set forth prohibited acts and provisions for
enforcement for electronic product radiation control (see 21 U.S.C.
360oo and 360pp, respectively).
    Under section 521 of the FD&C Act, no State or political
subdivision of a State may establish or continue in effect with respect
to a device intended for human use any requirement that is different
from, or in addition to, any requirement applicable under the FD&C Act
to the device and that relates to the safety or effectiveness of the
device or to any other matter included in a requirement applicable to
the device under the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C
Act also provides that FDA may grant an exemption from preemption under
certain circumstances. Section 709(b) of FDARA also includes a
preemption provision with respect to requirements for OTC hearing aids.

V. Comments on the Proposed Rule and FDA's Responses

    In the proposed rule, FDA welcomed comments on all aspects of the
proposal, and we specifically requested comments on certain topics to
encourage more-targeted feedback. Such topics included:

    the clarity of the definitions and ways to improve them;
    labeling requirements;
    equitable access to hearing aids and information about them;
    whether State or local requirements for returns would promote or
restrict or interfere with commercial activities involving OTC
hearing aids;
    design requirements to limit insertion depth;
    proposals for modification of, or alternatives to, the current
applicable Quality System requirements for OTC hearing aids;
    conditions for sale of OTC hearing aids to prevent sale to or
for people younger than 18;
    the removal of regulations in 21 CFR part 808 (part 808)
regarding exemptions from Federal preemption for State and local
requirements respecting hearing aids;
    possible effects of the rule on small manufacturers;
    data concerning the environmental assessment and our proposal
for a finding of no significant impact (FONSI);
    topics related to the Paperwork Reduction Act of 1995 (PRA) and
associated estimates for recordkeeping burdens; and
    potential impacts on Indian Tribes from this rulemaking.

    As appropriate, we summarize such comments that we received, along
with other pertinent comments, and respond to them in the corresponding
subsections that follow. As we indicated in the proposal, we considered
only comments submitted to the docket for this rulemaking that were
timely and pertinent (see 86 FR 58150-58161).
    The vast majority of comments that we received supported rulemaking
to encourage wider adoption of safe and effective hearing aids for
people who could benefit from them. FDA agrees that rulemaking can
encourage wider adoption of such devices, and we expect this final rule
to do so. Many commenters conveyed enthusiasm for affordable hearing
aids and/or wider availability without the involvement of a licensed
person, telling us that they expect the difference to make hearing aids
accessible to them--in some cases, for the first time. Some comments
observed that hearing impairment often correlates with lower income,
suggesting that lower prices may be particularly helpful for people who
may want to use hearing aids and that OTC hearing aids could serve an
important role in achieving equitable health outcomes.
    Still, many commenters voiced both support and concern for the role
of licensed persons and the value of professional services for hearing
health. In finalizing this rule, FDA is not suggesting that licensed
persons or their professional services are unimportant or not valuable.
Indeed, we recommend consulting licensed persons in several
circumstances, including for the diagnosis of hearing impairment and in
the fitting and continued use of OTC hearing aids when consumers choose
to seek such services. Many commenters asserted that the professional
services are worth the cost. In that vein, one comment suggested that,
like providing alternative distribution channels, increasing the number
of audiologists and other hearing health care providers would also
improve accessibility. This final rule, however, focuses on subjects
within FDA's purview, establishing device requirements that provide
reasonable assurance of safety and effectiveness for OTC hearing aids
without the involvement of a licensed person, as directed by FDARA.
    As for specific provisions, the comments generally supported
establishing requirements for labeling, output (volume) limits,
electroacoustic performance requirements, and other design requirements
for OTC hearing aids. However, individual comments varied on the extent
to which they supported specific proposals or proffered alternatives.
Comments that provided a rationale and/or evidence generally lent more
insight for FDA's consideration.
    We acknowledge that some comments did not support this rulemaking,
many of them stating that hearing aids are medical devices and should
not be regulated as consumer electronics. We interpret such comments to
mean that OTC hearing aids should not have a relaxed standard for
safety or effectiveness, nor should OTC hearing aids be subject to less
stringent requirements for product quality than other medical devices.
We agree that OTC hearing aids must meet the same standard as other
devices for having reasonable assurance of safety and effectiveness,
consistent with the FD&C Act and section 709 of FDARA, and that OTC
hearing aids be subject to the quality system requirements applicable
to other devices. However, we note that different device types and
categories will raise different issues related to safety and
effectiveness. Thus, while devices must meet the same standard of
having reasonable assurance of safety and effectiveness, different
device types and categories can engender different regulatory
requirements to achieve the same standard. This final rule establishes
requirements specific to hearing aids and although the requirements for
OTC and prescription hearing aids are not the same, these requirements,
along with other applicable requirements under the FD&C Act, provide
for reasonable assurance of safety and effectiveness for

both categories of hearing aids (we note that in this document when we
describe the requirements in Sec.  800.30 (21 CFR 800.30) or Sec.
801.422 (21 CFR 801.422) as providing reasonable assurance of safety
and effectiveness, we mean in conjunction with other applicable
requirements under the FD&C Act).

A. Device Classification and Marketing

    We received several comments about the interplay among device
classification regulations, the OTC Hearing Aid Controls, and premarket
notification requirements. Generally, we agree that clarification on
such issues will help ensure that manufacturers identify and follow the
appropriate regulatory requirements for their devices.
    (Comment 1) Multiple comments requested clarification on the
difference between self-fitting hearing aids classified under Sec.
874.3325 (21 CFR 874.3325) and hearing aids that, through tools, tests,
or software allow users to control the hearing aids and customize them
to the users' hearing needs. Many such comments pointed out that the
clarification will help manufacturers determine the applicability of
premarket notification requirements and special controls.
    (Response) Under section 520(q)(1)(A) of the FD&C Act, an OTC
hearing aid must be controllable by the user and customizable to the
user's hearing needs. We interpret the requirement for customization to
hearing needs to mean that the device must allow the user to cause
frequency-dependent changes based on the user's preference. This is
because a single profile for gain versus frequency is unlikely to
accommodate the majority of hearing needs for perceived mild to
moderate impairment. For example, a flat gain profile across frequency
is unlikely to meet the hearing needs of users with sloping hearing
loss, the kind of impairment often associated with aging, as well as a
non-flat gain profile across frequency would. However, a flat gain
profile across frequency may be preferable for some people with a
different kind of hearing loss. In short, to have reasonable assurance
of safety and effectiveness of OTC hearing aids, the devices must offer
capabilities for a variety of perceived mild to moderate hearing
impairments, and customization is the method or process that allows the
user to match the device output to individual preference.
    We interpret the requirement for user control to mean that the user
can access or select the output characteristics most significant to the
user's hearing perception. For an OTC hearing aid, we consider these
characteristics to include the frequency-dependent output profile and
the output volume. The controls must allow the user to select the
output volume and profile according to preference. The user may control
the output profile, for example, with a physical toggle switch, a
selection through a software interface, or providing preferences for
software to select the optimal profile dynamically.
    FDA views customization as a more-general concept than self-
fitting. Fitting is a customization process that instills in the device
frequency-dependent settings for the specific user. A self-fitting
process instills frequency-dependent settings through the user
interacting with the device or an accessory to the device. Self-fitting
hearing aids incorporate technology, including software, that
integrates user input with a self-fitting strategy and enables users to
independently derive and customize their hearing aid fitting and
settings (see Sec.  874.3325(a)). A self-fitting strategy is a fitting
process, with the selected output profile intended to correspond to the
user's audiogram more closely than a hearing aid that is not fitted.
Many hearing aids that are customizable but not fitted have a limited
set of standardized output profiles, often called ``presets.''
    In considering whether a hearing aid is self-fitting, FDA takes
into account, among other things, the device's design and labeling. For
purposes of distinguishing fitting a hearing aid from selecting among
standardized output profiles, we focus on the determination and
configuration of device settings that would be appropriate for the
specific user, especially the frequency-dependent settings. (However,
this focus does not exclude other factors that would still be relevant
to determining intended use.) For example, a hearing aid outputting a
preset likely would not be self-fitting, but a hearing aid that allowed
the user to make frequency-dependent modifications to a preset to suit
the user's preferences likely would be self-fitting.
    FDA recognizes that, because a preset may approach a user's ideal
fitting, a device with several presets may be difficult to distinguish
from a self-fitting device. However, we note that devices with a small
number of presets, for example, three, are not ordinarily considered
self-fitting when the user chooses the profile. However, a hearing aid
with a greater number of profiles would more closely resemble a fitting
process, with the selected output profile intended to correspond to the
user's audiogram more closely, in which case the hearing aid likely
would be considered self-fitting. Similarly, toggling between a small
number of programs, for example, for noise reduction or scene
selection, would generally not indicate self-fitting, but setting or
adjusting compression knee points in frequency sub-bands, would tend to
indicate self-fitting. Moreover, FDA would likely consider a device
that includes self-fitting functionality to be self-fitting, regardless
of whether the individual user takes advantage of the functionality.
    In sum, customization need not entail self-fitting, though self-
fitting is a kind of customization. Whether a hearing aid is self-
fitting depends on its intended use, which may be shown by, among other
things, the device's design and labeling (see Sec.  801.4 (21 CFR
801.4)). Some limited feature sets would not ordinarily cause a device
to be a self-fitting hearing aid, while more advanced adjustment
capability, especially for frequency-dependent settings, would tend to
indicate that the device is a self-fitting hearing aid. FDA has made a
minor revision to the requirement to provide specific instructions for
use of tools, tests, or software to clarify that such instructions need
not always refer to self-fitting; such instructions must include
instructions for self-fitting only when the OTC hearing aid is a self-
fitting device (see final Sec.  800.30(c)(2)(vii)(B)).
    (Comment 2) Many comments urged FDA: to clarify that the definition
of OTC hearing aids under section 520(q)(1)(A) of the FD&C Act is
synonymous with the identification for self-fitting air-conduction
hearing aids under Sec.  874.3325(a); to declare that self-fitting
hearing aids are OTC devices; to declare that OTC hearing aids must be
self-fitting; and/or to require that OTC hearing aid labeling bear the
description ``self-fitting'' or a similar description.
    (Response) Although FDA expects that many OTC hearing aids will be
self-fitting, we do not agree with these comments. As explained in the
response to Comment 1, a hearing aid may be customizable in the manner
required under section 520(q)(1)(A)(iii) of the FD&C Act yet not be
intended to entail fitting. Thus, we are not requiring that OTC hearing
aids be self-fitting devices.
    By extension, we are not requiring in this final rule that OTC
hearing aids bear labeling that describes the devices as ``self-
fitting'' or a similar description. However, Sec.  801.61 (21 CFR
801.61) still applies, and this provision requires, among other things,
a statement of identity on the principal display panel of an OTC
device. (See also the responses to Comment 21, regarding other
considerations for self-fitting

capabilities of OTC hearing aids, and Comment 18, regarding identifying
and selling OTC hearing aids.)
    Moreover, FDA intends that any hearing aid that uses the same
fundamental scientific technology as those defined under Sec. Sec.
874.3300(a) (21 CFR 874.3300(a)), 874.3305 (21 CFR 874.3305), and
874.3325 (21 CFR 874.3325) qualify as an OTC hearing aid (provided it
satisfies all other applicable requirements). Some future hearing aid
device types may also meet the statutory definition (and satisfy all
other applicable requirements) to be available over the counter.
Requiring that OTC hearing aids be a currently classified air-
conduction hearing aid could have the effect of limiting the OTC
category to current technologies rather than allowing the category to
extend to new types of hearing aids.
    (Comment 3) Some comments requested clarification on what would
qualify as ``tools, tests, or software'' for the purposes of
controlling an OTC hearing aid and customizing it to the user's hearing
needs. Similar comments requested that FDA clarify which legacy and
wireless air-conduction hearing aids would satisfy the customization
requirement but not be a self-fitting hearing aid.
    (Response) FDA interprets the requirement for tools, tests, or
software broadly. We would, for example, consider a device that allows
the user to cycle through output profiles with a push-button selector
switch and to set the volume with a knob to meet the requirement.
Should such a hearing aid be sufficiently customizable, and should it
not incorporate wireless or self-fitting technology, then it would
presumably be an air-conduction (``legacy'') hearing aid classified
under Sec.  874.3300 and could be made available OTC. (See the response
to Comment 1 for more about distinguishing customization and fitting.)
    (Comment 4) Comments expressed concerns about the potential to
bypass premarket notification requirements and special controls if non-
self-fitting hearing aids could be later configured or modified, for
example, if the manufacturer ``unlocks'' self-fitting software or
provides the user with options for ``advanced settings'' or the like.
They urged FDA to finalize rules to prevent such an outcome.
    (Response) Existing requirements already address modifications to
devices, including hearing aids. Under Sec.  807.81(a)(3) (21 CFR
807.81(a)(3)), a 510(k) is required if the device is about to be
significantly changed or modified, namely, a major change or
modification in the intended use or other kind of change or
modification that could significantly affect the safety or
effectiveness of the device. For example, a change or modification that
causes a device to fall within a different classification regulation
would be considered significant. Additionally, as explained in the
response to Comment 1, aspects of the device's design and labeling can
demonstrate the device's intended use (see Sec.  801.4). If a wireless
air-conduction hearing aid later incorporates self-fitting technology
(for example, by downloading software) or such technology is later made
accessible to the user (for example, by ``unlocking'' after an
additional purchase), such a change would almost certainly demonstrate
that the modified device was a self-fitting air-conduction hearing aid
classified under Sec.  874.3325 (assuming it was not a new device
type). As such, it would be subject to the premarket notification
requirements and special controls that apply to self-fitting air-
conduction hearing aids.
    In sum, a change in intended use or other aspect can cause a change
in applicable requirements, and a device must comply with applicable
regulatory requirements. As such, if a manufacturer intends to unlock
or similarly upgrade its hearing aid with self-fitting technology such
that it would fall within the self-fitting air-conduction hearing aid
classification regulation, then prior to initial introduction into
interstate commerce of the device, the manufacturer must comply with
applicable requirements, including 510(k) requirements and compliance
with the special controls. (See also the response to Comment 6 about
the information a 510(k) should include.)
    (Comment 5) Several comments requested clarification on when
manufacturers of OTC hearing aids would need to submit a premarket
notification, also called a 510(k). Many of these comments urged FDA to
require 510(k)s for all OTC hearing aids.
    (Response) FDA's existing requirements and related policies for
submitting 510(k)s apply to hearing aids intended for OTC availability
and use. We are not imposing additional general requirements for
510(k)s.
    For manufacturers that have already legally introduced self-fitting
air-conduction hearing aids into interstate commerce, changes to their
devices to satisfy the OTC Hearing Aid Controls may require submission
of a 510(k). However, in certain situations FDA intends not to enforce
the requirement for a 510(k), as discussed in section VI on effective
and compliance dates.
    This policy also applies to non-self-fitting devices (wireless air-
conduction and legacy air-conduction hearing aids). However,
manufacturers of non-self-fitting devices may wish to consider the
implications of using a test for somebody besides the user to fit the
device. For devices intended for fitting based off of a user-supplied
audiogram, a requirement for the involvement of a licensed person to
produce the audiogram may cause the device not to be an OTC hearing aid
as defined in section 520(q)(1)(A) of the FD&C Act.
    Further, if a manufacturer or other non-licensed person obtains
hearing ability data to customize (or even fit) a hearing aid, the
manufacturer should consider whether the instrument used to obtain the
data is a diagnostic (or other) device. Using a hearing aid with a
diagnostic device may implicate changes to a hearing aid concerning the
compatibility or interoperability with other devices, including other
components or accessories, that could significantly affect the hearing
aid's risk profile, necessitating a 510(k).
    Notwithstanding these general principles, in each case,
manufacturers should evaluate any changes in light of FDA's guidance,
``Deciding When to Submit a 510(k) for a Change to an Existing
Device,'' issued October 25, 2017, which describes specific changes
that generally do or do not require premarket notification.\1\
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    \1\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
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    To illustrate: If a manufacturer of a wireless air-conduction
hearing aid updates device labeling and adds a user self-assessment
test intending the test to enable the user to independently customize
and derive the fitting and settings (the device is intended to entail
fitting), then FDA would anticipate the manufacturer would need to
submit a 510(k). FDA's guidance document lists several considerations
that would likely apply. In this example, the changes included:
    the directions for use, including the use and application of the
self-test to the device settings (see A4 of the aforementioned guidance
on deciding when to submit a 510(k), ``Could the change affect the
directions for use of the device?'');
    the control mechanism and/or operating principle (see B2 of the
same guidance, ``Is it a control mechanism, operating principle, or
energy type change?'');
    the device's design, specifically changes to its performance,
components

or accessories, and human factors of the interface (see B5 of the same
guidance, ``Is it any other change in design (e.g., dimensions,
performance specifications, wireless communication, components or
accessories, or the patient/user interface)?''); and
    those that significantly affect its use, potentially necessitating
clinical validation data (see B5.1 and B5.3 of the same guidance,
``Does the change significantly affect the use of the device?'' and
``Are clinical data necessary to evaluate safety or effectiveness for
purposes of design validation?'').
    Each of those changes in this example could require a 510(k),
depending on the specifics of the changes. In deciding whether to
submit a 510(k), manufacturers may want to review the guidance in its
entirety since the considerations for the example are not exhaustive
and may or may not be applicable, depending on the specific device.
Manufacturers may also want to review FDA's guidance, ``Deciding When
to Submit a 510(k) for a Software Change to an Existing Device,''
issued October 25, 2017.\2\
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    \2\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device.
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    Note that, although a wireless air-conduction hearing aid
classified under Sec.  874.3305, or a legacy air-conduction hearing aid
classified under Sec.  874.3300, is exempt from requirements for
premarket notification, some changes could exceed the limitations of
exemption under Sec.  874.9 (21 CFR 874.9), depending on the specifics.
    (Comment 6) Commenters requested clear guidance on the specific
information manufacturers would need to submit in a 510(k) to bring
devices to market quickly, avoiding unnecessary delays or unnecessarily
hindering innovation.
    (Response) In addition to the required information specified in the
510(k) procedures under 21 CFR part 807, subpart E, the specific
information that a manufacturer should submit will vary based on the
new device or specific changes made to an existing device. Therefore,
providing specific guidance for all manufacturers in this final rule is
not feasible. However, FDA's usual policies on the content and format
of 510(k)s apply to submissions for hearing aids, including for
modifications made to satisfy applicable special controls and the OTC
Hearing Aid Controls. Manufacturers may wish to review publicly
available information regarding the De Novo classification of self-
fitting air-conduction hearing aids. (See the response to Comment 5
regarding when to submit a 510(k).)
    In the case of OTC hearing aids, we anticipate that many
manufacturers that submit a 510(k) could avail themselves of the
Abbreviated 510(k) Program, as described in FDA's guidance of that
name, issued on September 13, 2019.\3\ Should a manufacturer
incorporate self-fitting (or other) technology into one of its existing
legacy or wireless devices and need to submit a 510(k), we would expect
that the manufacturer could leverage the similarity with exempt devices
as a least-burdensome way to obtain marketing authorization for the
device that is not exempt from premarket notification requirements.
Manufacturers of existing devices may not need to re-address questions,
for example, related to electromagnetic compatibility (EMC), provided
the manufacturer has not made changes that would affect EMC and require
a 510(k) under our usual policies. Further, summary reports describing
how the hearing aid complies with applicable special controls may be
especially useful in addressing clinical data that support the
effectiveness of the self-fitting strategy, usability testing, and
software verification, validation, and hazard analysis.
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    \3\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
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    Moreover, manufacturers that have decided to submit a 510(k),
whether traditional or abbreviated, may wish to review FDA's guidance,
``Format for Traditional and Abbreviated 510(k)s,'' issued on September
13, 2019.\4\ The guidance provides a general framework for the format
and content of a 510(k).
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    \4\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks.
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    (Comment 7) Commenters requested that FDA exempt certain kinds of
hearing aids, including self-fitting devices, from premarket
notification requirements. Some posited that FDA would accrue
sufficient experience with self-fitting air-conduction hearing aids to
evaluate the potential for 510(k) exemption 2 years after the effective
date of this final rule. Others requested that FDA explain how OTC
hearing aids will become 510(k)-exempt.
    (Response) FDA's usual policies for exempting devices from
premarket notification requirements apply to self-fitting air-
conduction hearing aids. Stakeholders may wish to review FDA's
guidance, ``Procedures for Class II Device Exemptions from Premarket
Notification,'' issued February 19, 1998.\5\ The guidance lists several
factors that FDA may consider for exemption, including:
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    \5\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.

    The history (if any) of false or misleading claims or of risks
associated with inherent characteristics of the device, such as
device design or materials (FDA considers the risks associated with
false or misleading claims, and the frequency, persistence, cause,
or seriousness of the inherent risks of the device);
    How characteristics of the device necessary for its safe and
effectiveness performance are well established;
    How changes in the device that could affect safety or
effectiveness will either be readily detectable or not materially
increase the risk of injury, incorrect diagnosis, or ineffective
treatment;
    How any changes to the device would not be likely to result in a
change in the device's classification; and
    The role of the limitations of exemption.

    Although the amount of time that has passed since the
classification of the device in question may affect how FDA views the
factors, for example, the history of false or misleading claims, the
amount of time since classification is not generally directly relevant.
That is, 2 years after the effective date of this final rule may or may
not afford sufficient experience and information to exempt all self-
fitting air-conduction hearing aids from premarket notification
requirements. We did not propose to exempt self-fitting air-conduction
hearing aids and are not doing so now (see 86 FR 58150 at 58171).

B. Scope (Sec.  800.30(a))

    We received several comments on which devices should be subject to
the OTC Hearing Aid Controls and, conversely, which devices should be
prescription. Sometimes these comments referred to definitions rather
than scope. In this section, we respond to comments on scope, including
comments where the suggested changes to the definitions affect the
scope. The next section of this document, specifically for definitions,
responds to comments that relate more directly to the clarity of terms
or the usefulness of different terms.
    (Comment 8) Comments requested clarification on the applicability
of the OTC Hearing Aid Controls in circumstances in which software
intended for compensation for hearing loss operates or adapts the
output of other hearing products such as earbuds or headphones.

    (Response) To date, FDA has not classified a device that adapts the
output of other hearing products, such as earbuds, to compensate for
perceived mild to moderate hearing impairment, including a device that
accomplishes this through software. Overall, FDA encourages innovation
of hearing products that are safe and effective and, to that end,
intends to consider developing guidance to provide clarification on the
applicability of laws and regulations implemented by FDA in
circumstances where software would operate or adapt the output of
hearing products to compensate for perceived mild to moderate hearing
impairment. However, considering that in such circumstances, the
software might be distributed separately from the hearing product, FDA
has added requirements in the OTC Hearing Aid Controls for software
device labeling. Similar requirements for software device labeling were
also added to Sec.  801.422. (See Additional Revision 3 in section
III.D.6 describing the labeling requirements for hearing aid
software.\6\) The software device labeling requirements take into
consideration certain aspects associated with software not distributed
with the hearing product, including that such software may not be
provided in a package.
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    \6\ We refer to ``additional revisions'' to indicate changes
that FDA has made in further consideration of comments and the
issues involved in this rulemaking, but that are additional to the
suggestions made explicitly in comments. We have numbered the
Additional Revisions in the order that they appear in this document,
which depends upon the subject of the revision--definitions, outside
package labeling, etc.--not the order in which the Additional
Revisions are cross-referenced in our responses to comments.
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    (Comment 9) A comment questioned whether a software interface for
professionals such as audiologists or hearing instrument specialists
would cause a hearing aid to be a prescription device if the
professional could adjust the output in excess of the applicable limit.
    (Response) If a manufacturer markets an OTC hearing aid that meets
the OTC hearing aid definition and complies with all applicable
requirements of the OTC Hearing Aid Controls--but also offers an
additional separate feature, a software interface for professionals
that allows only licensed persons to adjust the device output--FDA
likely would not consider the hearing aid to be a prescription device,
but the software interface for professionals would be a prescription
device and therefore must comply with Sec. Sec.  801.422 and 801.109.
(Note that a software interface for an air-conduction hearing aid,
which is the subject of this response, would be distinct from the
hypothetical hearing-aid software device, described in the response to
Comment 8, that operates or adapts the output of other hearing products
such as earbuds or headphones.)
    However, the intended use of a device can change after initial
introduction into interstate commerce (see Sec.  801.4). If a
manufacturer intends prescription uses of a device, the manufacturer
should consider how to ensure the device will satisfy all applicable
requirements, for example, prescription labeling requirements. Should a
manufacturer provide or allow users, and not just licensed persons,
ready access to an interface that allows the user to configure the
device to provide output in excess of that allowed for OTC hearing
aids, this would indicate the device is intended for users (not limited
to licensed persons) to set an excessively high output. FDA would be
more likely to determine that the intended use was not for perceived
mild to moderate hearing impairment. Additionally, such a device would
not meet the required output limits in the OTC Hearing Aid Controls.
Therefore, such a device would be considered a prescription hearing aid
and must meet applicable requirements, including those under Sec. Sec.
801.422 and 801.109; otherwise, it would be in violation of the FD&C
Act.
    (Comment 10) Some comments suggested that FDA limit the scope of
the OTC Hearing Aid Controls to devices intended only for people with
perceived mild, but not moderate, hearing impairment. Some of these
comments suggested that perceived moderate hearing impairment requires
the involvement of a licensed person for successful treatment, and as
such, hearing aids intended for perceived moderate hearing impairment
should not be available over the counter.
    (Response) FDA disagrees that the involvement of a licensed person
is necessary for hearing aids intended for perceived moderate hearing
impairment. We are retaining perceived moderate hearing impairment
within the scope of the OTC Hearing Aid Controls. The question of
whether the involvement of a licensed person would benefit an
individual's hearing healthcare is separate from whether the individual
would benefit from the use of an OTC hearing aid. In other
circumstances, the availability and use of OTC medical products to
treat an illness or impairment does not imply the illness or impairment
is not serious. Similarly, the availability and use of OTC medical
products does not negate the benefit of a licensed person's
involvement. FDA considers the use of OTC hearing aids, even when
intended for perceived moderate hearing impairment, to be such a set of
circumstances.
    Further, by statute, OTC hearing aids include devices that are
intended to compensate for perceived moderate hearing impairment, and
such devices are to be available to consumers over the counter without
the involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(ii)
and (v)). Section 709(b) of FDARA requires FDA to issue regulations
that include, among other requirements, provisions for reasonable
assurance of safety and effectiveness. This rule will provide
reasonable assurance of safety and effectiveness, without the
involvement of a licensed person, for OTC hearing aids, including for
hearing aids intended for perceived moderate hearing impairment.
    Thus, while the involvement of a licensed person may benefit people
with perceived hearing impairment, whether of a mild or moderate
degree, FDA does not agree that consumers must attempt to obtain such a
benefit prior to purchasing hearing aids over the counter. FDA is
maintaining perceived moderate hearing impairment within the scope of
the OTC Hearing Aid Controls.
    (Comment 11) Some comments objected to the inclusion of
``perceived'' when referring to the kind of hearing impairment for
which OTC hearing aids are intended. The commenters express concern
that a person's perception of hearing loss may be too subjective, and
that the use of OTC hearing aids should be based on more objective
measures. Some of the comments suggested that FDA require prospective
users to obtain audiograms, which are graphs or test results showing
the person's ability to hear different frequencies, from a licensed
person prior to purchasing an OTC hearing aid.
    Besides obtaining an audiogram, other comments suggested a more
general testing or examination requirement by a licensed person for
prospective users, prior to purchase. In this way, these commenters
suggested, OTC hearing aid users would have more certainty that OTC
hearing aids would appropriately compensate for their hearing
impairment, and/or the prospective user does not have an underlying,
medically treatable cause of hearing impairment, for example, one of
the ``red flag'' conditions. (A ``red flag'' condition is a sign or
symptom that should prompt a consultation with a doctor, preferably an
ear-nose-throat doctor.)
    (Response) FDA disagrees. We are retaining ``perceived'' in
reference to a

person's degree of hearing impairment and the intended use of OTC
hearing aids for legal and policy reasons. The term ``perceived'' is
used in section 520(q)(1)(A)(ii) of the FD&C Act to describe the
intended use for OTC hearing aids. Moreover, objective measurements of
hearing impairment are not necessary for reasonable assurance of safety
and effectiveness of OTC hearing aids.
    Relying on perceptions of hearing impairment is also appropriate
because the type and degree of impairment exist on a continuum, as does
a person's perception and experience of the impairment. A given degree
(quantification) of hearing impairment will not necessarily reflect
whether an OTC hearing aid is likely to benefit a specific individual.
We have therefore focused on communication and other perceptual
experiences (such as listening to music) in which an intended user is
likely to suspect or notice--that is, to perceive--hearing impairment.
FDA expects this approach based on perception to assist users and
prospective users better than an approach that does not.
    Additionally, while FDA agrees that an audiogram would provide a
prospective user with an objective measure of hearing impairment, we do
not agree that the scope of the OTC Hearing Aid Controls should include
only hearing aids for objectively measured impairments. Such a
limitation is counter to the objectives of section 709 of FDARA,
including making available hearing aids OTC, without the involvement of
a licensed person, to consumers through in-person transactions, by
mail, or online.
    We acknowledge that this places some onus on users and prospective
users. However, this is the case with respect to OTC availability of
many medical products, and we are establishing requirements that will
provide reasonable assurance of safety and effectiveness for such
availability of hearing aids. We also observe that, while an audiogram
might help a user or a licensed person tailor the hearing aid, or
initially select it, even a hearing health care provider would still
ask the user how the device sounds to the user. The user's perception
would help the hearing health care provider make further adjustments. A
person's desire to seek and use hearing aids depends more directly upon
that person's perception of their hearing impairment than the
definitive degree of impairment, and even a licensed person fitting and
adjusting the device would also account for the user's perception. (See
also the response to Comment 24 about defining hearing loss
numerically.)
    Further, FDA has included information in the labeling requirements
for OTC hearing aids intended to help users understand whether the
devices are suitable based on their perceptions, realistic expectations
for hearing aid use, and suggestions on when to obtain professional
assistance before and after purchase. Should prospective OTC hearing
aid users still feel uncertain about their perceptions of impairment,
notwithstanding the availability of the aforementioned information,
they may choose to obtain or undergo professional testing prior to
purchase.
    (Comment 12) Some commenters suggested that FDA require a
prescription for OTC hearing aids.
    (Response) FDA disagrees. Requiring a prescription to purchase an
OTC hearing aid would be contrary to the purposes of this rulemaking,
the definition of OTC hearing aids in the FD&C Act, and FDARA which
includes the mandate to establish requirements for hearing aids to be
available over the counter (see section 520(q)(1)(A)(v) of the FD&C Act
and section 709(b)(1) and (b)(2)(D) of FDARA). It also would negate the
probable health benefits created by wider availability of hearing aids,
as we described in the proposal (see 86 FR 58150 at 58152).
    (Comment 13) Multiple comments suggested FDA remove dispensing from
the list of commercial activities that FDA included in the definition
of ``licensed person.'' The definition listed commercial activities
involving OTC hearing aids for which a State or locality could not
require the involvement of a licensed person. For example, a State
could not require a person representing as a dispenser of OTC hearing
aids to undertake special licensing or equivalent activities solely for
that reason.
    Such comments cited various reasons, for example, that State
regulatory regimes impose obligations on people representing as
dispensers, so referring to the term in the OTC Hearing Aid Controls
would create an inconsistency with State regulatory requirements. Other
comments pointed out that people expect dispensers to have licenses,
and FDA's regulations would be inconsistent with such expectations.
Still others cited the need for dispensers to acquire and/or
demonstrate qualifications prior to dispensing OTC hearing aids.
    Similar comments suggested that FDA instead refer to dispensers as
``sellers,'' ``vendors,'' ``merchants,'' or other such terms. These
terms, the comments assert, would distinguish salespeople from hearing
health care providers.
    (Response) FDA is not modifying the scope of the OTC Hearing Aid
Controls or the definition of ``licensed person'' to exclude dispensing
of OTC Hearing Aids. As we explained in the proposed rule, FDARA lists
certain activities that may be undertaken with respect to OTC hearing
aids for which a State or locality cannot require the involvement of a
licensed person (see 86 FR 58150 at 58158). One such activity that
FDARA explicitly lists is the dispensing of OTC hearing aids. This
means that, under Federal law, a State or locality cannot require a
dispenser of OTC hearing aids to undertake special licensing or
equivalent activities because that would in essence require the
involvement of a licensed person, contrary to section 709(b)(2)(D) of
FDARA and section 520(q)(1)(A)(v) of the FD&C Act.
    Additionally, in establishing the OTC category for hearing aids, we
have developed requirements to provide reasonable assurance of safety
and effectiveness for OTC hearing aids without the involvement of a
licensed person (see section 709(b)(2) of FDARA). Imposing special
licensing requirements or equivalent activities, therefore, is not
necessary to provide reasonable assurance of safety and effectiveness
of OTC hearing aids. Although not required, a purchaser of OTC hearing
aids can still seek the assistance of a licensed person when selecting
a hearing aid.
    Since a person may dispense OTC hearing aids without a specialized
license or the need to involve a licensed person, referring to
dispensers by another term such as ``vendor'' or ``seller'' is not
necessary to distinguish dispensing from activities requiring
specialized licensure or the involvement of a licensed person.
Moreover, we have previously defined dispensers as persons engaged in
the sale, lease, or rental of hearing aids (see prior Sec.
801.420(a)(3)). The regulations we are finalizing in this rulemaking
use essentially the same definition. In sum, using alternative titles
for dispensers may serve to confuse consumers by unnecessarily
establishing another term for a legally permissible activity as well as
incorrectly implying that FDA's interpretation of the term has changed.
    FDA recognizes that State and local requirements sometimes
incorporate the term ``dispenser,'' and multiple States impose
requirements on account of dispensing hearing aids. However, FDARA
section 709(b)(4), to summarize, provides that no State or local
government shall continue in effect certain State or local requirements
that are different from, in addition to, or otherwise not identical to
the

regulations issued under FDARA section 709(b). Thus, regardless of
whether a State or locality amends or otherwise updates its
requirements, it may not continue in effect the inconsistent
requirements prior to their amendment or repeal.
    As we explained in the proposal, despite the fact that licensure is
not required for dispensing OTC hearing aids, some persons may
voluntarily identify as a ``licensed dispenser,'' (see 86 FR 58150 at
58168). Although a State or locality could not require dispensers (or
other persons) to undertake special licensing solely on account of
commercial activity involving OTC hearing aids, a State or locality
could still establish licensure criteria that would apply to those
voluntarily identifying as licensed persons. In such a case, the
dispenser's identification as a licensed person would imply that the
dispenser complies with applicable State or local licensing
requirements, albeit voluntarily. (See also the responses to Comment
15, discussing other licensing considerations, and Comment 127,
discussing the involvement of a licensed person for prescription
hearing aids.)
    In sum, in light of Federal statutory and other requirements,
including those that provide reasonable assurance of safety and
effectiveness of OTC hearing aids, FDA is not narrowing the scope of
the OTC Hearing Aid Controls to exclude dispensing. This does not,
however, prevent dispensers of OTC hearing aids from voluntarily
subjecting themselves to State or local licensing requirements to
obtain a license (or its equivalent).
    (Comment 14) Comments suggested that OTC hearing aids be available
for all degrees of hearing impairment, including degrees greater than
moderate. Some of these comments further noted that Medicare does not
currently pay for or reimburse the cost of hearing aids. As such, the
comments asserted that OTC hearing aids should be usable as lower-cost
alternatives to prescription hearing aids for individuals with more-
profound impairments.
    (Response) For the reasons explained in the response to Comment 10,
FDA is establishing requirements for perceived mild to moderate hearing
impairment. Thus, the appropriate device output limit that we are
establishing would not extend to hearing impairment that would require
a greater output than that which is appropriate for perceived moderate
hearing impairment.
    However, devices of the same type may generally be intended either
for prescription or OTC use. For example, a manufacturer marketing an
OTC wireless hearing aid could also market another wireless hearing aid
with a higher output than that permitted for OTC hearing aids. This
higher output would render it a prescription device. As with other
products that have differing uses but share manufacturing similarities,
a hearing aid manufacturer may be able to realize economies of scale by
selling an OTC version and a prescription version of hearing aids that
fall within the same type, which in turn could lower the prices for
prescription hearing aids. (See also the response to Comment 17 about
limitations on FDA's authority to require reimbursement for devices.)
    (Comment 15) Some comments suggested FDA define which activities
involving hearing aids would require licensure.
    (Response) FDA does not generally determine which activities
involving medical products require licensure. However, section
709(b)(4) of FDARA lists several activities for which States or
localities may not require specialized licensure for, or the
involvement of a licensed person in, commercial activity involving OTC
hearing aids. These listed activities are the servicing, marketing,
sale, dispensing, use, customer support, or distribution of OTC hearing
aids through in-person transactions, by mail, or online. As we
explained in the proposal, we interpret the listed activities broadly,
so for example, the term ``sale'' would include leases or rentals (see
86 FR 58150 at 58165).
    States usually determine the requirements for licensure or the
involvement of licensed persons. States may still do so with respect to
hearing aids when not prohibited by section 709(b)(4) of FDARA (and
other applicable laws). Where section 709(b)(4) of FDARA does not list
an activity, when construing the terms broadly, a State may require
licensure for that activity as it relates to OTC hearing aids. We note
that the proposal provided a discussion and some examples (see 86 FR
58150 at 58167-58168). Thus, for example, a State may require a license
for a hearing aid fitter, because ``fitting'' is not listed among the
activities in section 709(b)(4) of FDARA, and we do not interpret any
of the listed activities to include fitting. A person could not be a
fitter in that State, even for OTC hearing aids, without a license.
However, the State could not require a hearing aid fitting prior to a
user purchasing an OTC hearing aid because that would restrict or
interfere with commercial activity involving OTC hearing aids. See the
response to Comment 13 for further explanation.
    Thus, a State may still establish criteria for licensing dispensers
should a person voluntarily decide to become a licensed dispenser of
OTC hearing aids. In other words, although a State cannot require a
license for dispensing OTC hearing aids, a State can establish what a
person must do to obtain, and claim to have, a license for dispensing
hearing aids. FDA expects that States may wish to continue in effect
licensing requirements to dispense prescription hearing aids, and we
expect that some hearing aid dispensers may wish to obtain a license in
the event they desire to advertise as ``licensed'' and/or to sell
prescription hearing aids in addition to OTC hearing aids.
    (Comment 16) Some comments urged FDA to limit the scope of OTC
availability as much as possible, at least in the beginning. These
comments conveyed concerns for the absence of a licensed person in
various roles, including education and counseling. One such comment
suggested that a more-limited scope would be easier to broaden later
than the reverse, limiting a broader scope.
    (Response) In the proposed rule, we explained that several barriers
likely impede people's access to hearing aids, including among others,
Federal and State regulatory requirements (see 86 FR 58150 at 58152,
58154). We are undertaking this rulemaking in part to remove or reduce
such barriers to access by establishing requirements that will provide
reasonable assurance of safety and effectiveness while encouraging
broad availability (see 86 FR 58150 at 58158). Moreover, we received a
wealth of thoughtful and nuanced comments about the scope of the OTC
Hearing Aid Controls, including this Comment, and we have determined
that a more-restrictive approach is not necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids. Considering
our purpose to broaden access and our determinations regarding
reasonable assurance of safety and effectiveness, we do not agree that
narrowing the scope of the OTC Hearing Aid Controls, with the intention
of considering a broader scope later, is currently an appropriate
strategy.
    (Comment 17) Some comments noted the role of health insurers,
including Medicare, in a person's ability to obtain hearing aids.
Comments suggested that FDA focus on payments or reimbursements for
hearing aids, potentially including financial incentives.
    (Response) FDA does not have authority to require payors to pay for
or reimburse the cost of hearing aids or to offer financial incentives
to obtain the

devices. However, we intend this rule, among other ends, to broaden
access to hearing aids by eliminating certain kinds of requirements
that likely add to the cost of accessing the devices. For example, we
are establishing rules to make OTC hearing aids available without the
involvement of a licensed person.

C. Definitions (Sec. Sec.  800.30(b) and 801.422(b))

    This section focuses on explaining the final definitions.
Generally, commenters sought clarity, and we have generally accepted or
declined suggestions with the goal of improving clarity of the
definitions.
    (Comment 18) Multiple comments proposed that FDA use another name
to identify OTC hearing aids. For example, some comments proposed
``over-the-counter hearing device,'' ``self-fit over-the-counter
hearing device,'' ``hearing amplifiers,'' and ``hearing devices.''
Generally, these commenters sought to avoid confusion with existing
devices for both consumers and State regulators. Otherwise, commenters
believed, consumers may be misled into believing that OTC hearing aids
are equivalent to prescription hearing aids with respect to
performance, safety, and effectiveness, and there may be regulatory
issues for State licensing boards. Other comments argued that the
availability of OTC devices through retailers such as grocery or
department stores would suggest that these devices are not hearing
aids, so referring to them as such would be inappropriate.
    By identifying OTC hearing aids in a different way, consumers,
regulators, and other stakeholders would, the comments argued, have a
clearer indication of devices subject to the new regulatory category.
Many such comments noted that the use of a term other than ``hearing
aid'' was recommended by the National Academies of Sciences,
Engineering, and Medicine (NASEM) in their report, ``Hearing Health
Care for Adults: Priorities for Improving Access and Affordability,''
and by the Hearing Care Associations in their Consensus Paper,
``Regulatory Recommendations for OTC Hearing Aids: Safety &
Effectiveness'' (Ref. 7).
    (Response) FDA will continue to use the term ``hearing aids'' to
refer to the OTC and prescription devices subject to this rulemaking
because the use of this term is appropriate. Hearing aids, whether OTC
or prescription, are wearable sound-amplifying devices intended to
compensate for impaired hearing. The term ``hearing aid'' describes
several device types reflected in various classification regulations.
Although OTC hearing aids use air-conduction technology, prescription
hearing aids may do so as well (for example, an air-conduction hearing
aid that provides a higher output than that specified in the OTC
Hearing Aid Controls would be prescription). Therefore, the use of the
term ``hearing aid'' is appropriate to reflect both OTC and
prescription devices that fall within the same device type (for
example, wireless air-conduction hearing aids under Sec.  874.3305).
Moreover, section 520(q)(1)(A) of the FD&C Act explicitly uses and
defines the term ``over-the-counter hearing aid[s],'' and section
709(b)(1) of FDARA requires the establishment of ``a category of over-
the-counter hearing aids.'' Thus, referring to the devices by a
different name would not only be inconsistent with the applicable
classification regulations and statutes, but also FDA expects that
doing so would cause confusion and uncertainty for consumers
considering purchasing an OTC hearing aid.
    Further, we expect this rulemaking to broaden the kinds of
retailers that sell OTC hearing aids, helping to increase the
availability of the devices. By extension, the availability of OTC
hearing aids (by that name) in grocery and department stores would help
fulfill one of the purposes of this final rule. Moreover, many
technologically similar products are available and go by several names,
including ``personal amplifier.'' Based on their intended use(s), some
of these may not be devices and/or meet applicable requirements for
devices, yet they may appear to some prospective purchasers to be
suitable alternatives to safe and effective devices.\7\ We expect that
consumers are familiar with the name ``hearing aid,'' and using that
name will better support broadened use of the devices. At the same
time, we expect that introducing yet another name for a similar
technology, albeit regulated as a device, would only serve to increase
confusion in the marketplace because prospective purchasers may think
that a hearing aid could be marketed under other names, including those
used for products that do not meet applicable device requirements.
Thus, we have determined that the best way to indicate whether the
device is subject to this rulemaking is to use the name ``hearing aid''
as used for the device types in the applicable classification
regulations, and the name that is established in the FD&C Act and
FDARA, OTC hearing aids.
---------------------------------------------------------------------------

    \7\ FDA is finalizing a guidance alongside this rulemaking to
help stakeholders distinguish hearing aids from PSAPs. To summarize,
a PSAP is an electronic product intended for non-hearing-impaired
people to amplify sounds in certain environments. A PSAP is not
intended to aid with or compensate for impaired hearing.
---------------------------------------------------------------------------

    To assist consumers further, as well as ease determining the
applicability of the OTC Hearing Aid Controls, we are modifying the
labeling and conditions for sale for OTC hearing aids. See Additional
Revisions 2 (section III.D.3) and 4 (section III.G), respectively, for
further explanation.
    Although the technical specifications are different for OTC hearing
aids and prescription hearing aids, as explained elsewhere in this
document, FDA believes the technical specifications for each category
are appropriate. Additionally, information on the technical
specifications is required to be provided in the device labeling. FDA
believes that OTC hearing aids that comply with Sec.  800.30 and other
applicable requirements (for example, Quality System requirements) will
have reasonable assurance of safety and effectiveness for people aged
18 and older with perceived mild to moderate hearing impairment.
    (Comment 19) A comment suggested that the definition of ``hearing
aid'' should include an explicit statement that PSAPs are not hearing
aids. The comment mentioned the draft guidance we are finalizing
concurrently with this final rule, ``Regulatory Requirements for
Hearing Aid Devices and Personal Sound Amplification Products,'' which
is published elsewhere in this issue of the Federal Register and is
also available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products, and characterized the draft of
the guidance as ``provid[ing] essential distinctions between [hearing
aids] and PSAPs.''
    (Response) FDA agrees that distinguishing between hearing aids
(devices) and PSAPs (non-devices) can be an important interest for
purchasers, manufacturers, and other stakeholders. We are finalizing
requirements for the principal display panel on the package of an OTC
hearing aid to bear the marks ``OTC'' and ``hearing aid'' (see
Additional Revision 2 in section III.D.3). We are also finalizing a
corresponding condition for sale that sellers may only make a hearing
aid available OTC when its package bears the requisite marks (see
Additional Revision 4 in section III.G). Moreover, we are finalizing
the aforementioned draft guidance document, intended to describe
hearing aids, PSAPs, their respective intended uses, and the regulatory
requirements that apply to both types of products.

    We are not, however, modifying the definition of ``hearing aid'' to
state that PSAPs are not hearing aids. As we explained in the proposed
rule, the name of a product on its own would not ordinarily demonstrate
intended use (86 FR 58150 at 58154). Thus, merely excluding PSAPs from
the definition of hearing aid does not remove a product from device
regulation under the FD&C Act if, for example, its labeling
demonstrated that the product was intended to compensate for hearing
loss. We think the actions we are taking will better assist
stakeholders to distinguish between products than modifying the
definition of ``hearing aid'' in the OTC Hearing Aid Controls.
    (Comment 20) Some comments suggested adding definitions to the
classification regulation for self-fitting hearing aids (Sec.
874.3325). For example, comments suggested FDA define ``programming the
hearing aid'' and ``self-fitting strategy.''
    (Response) FDA is not adding definitions for purposes of the self-
fitting air-conduction hearing aid classification at this time. In
considering possible definitions to add, including those suggested in
the comments, we sought to balance clarity with flexibility. The
phrasing of Sec.  874.3325(a) is intended to cover a range of
technologies, both present and future, without unduly constraining
innovation. For example, the regulation refers to a ``self-fitting
strategy,'' rather than a more prescriptive description. Under this
regulation, manufacturers could choose different strategies to achieve
self-fitting by the user while still being substantially equivalent to
other devices of the same type. After considering the comments, we have
decided not to constrain the classification further.
    However, we recognize that these commenters desired to clarify the
classification of different types of air-conduction hearing aids,
including the applicability of special controls and premarket
notification requirements. We have provided our thinking and
expectations in section V.A. of this document to address such concerns.
Further, FDA may issue guidance on this subject in the future following
our Good Guidance Practices and inviting additional comments (see 21
CFR 10.115).
    (Comment 21) Several comments requested that FDA define self-
fitting hearing aids in such a way as to clarify that the devices must
be manipulable by the general public. Many of these comments showed
concern about predatory business practices, through which manufacturers
might prevent users from customizing device output, because they did
not view self-fitting capability as clearly required for OTC hearing
aids.
    (Response) FDA agrees that OTC hearing aids must be somehow
manipulable by lay users; however, we are not adopting these
suggestions.
    As explained in the response to Comment 1, not all OTC hearing aids
are self-fitting devices classified under Sec.  874.3325. Thus, FDA
declines to define self-fitting hearing aids in the way suggested by
comments.
    Further, modifying the self-fitting hearing aid classification
regulation in the suggested way is not necessary. By definition, self-
fitting air-conduction hearing aids allow users to program their
hearing aids, and the devices integrate user input with a self-fitting
strategy and enable users to independently derive and customize their
hearing aid fitting and settings. Should users themselves be unable to
derive or customize the fitting and settings independently, or program
their hearing aids, FDA likely would not consider it a self-fitting
air-conduction hearing aid.
    More generally, section 520(q)(1)(A)(iii) the FD&C Act defines an
OTC hearing aid, in part, as a device that allows the user to control
the hearing aid and customize it to the user's hearing needs. Should
users of a hearing aid be unable to control and customize the device in
the manner required, the hearing aid would not be an OTC hearing aid as
defined in the FD&C Act or final Sec.  800.30, and thus, would be a
prescription device.
    FDA also notes that the FD&C Act, the OTC Hearing Aid Controls, and
the classification regulation for self-fitting air-conduction hearing
aids all refer to the ``user'' of the hearing aid. Referring to
manipulation by the general public may not accurately or adequately
represent the intended user(s) of a hearing aid because the intended
user(s) may differ in significant ways from the general population.
However, FDA agrees that manufacturers should generally assume that
users are laypeople (not experts) regarding OTC hearing aids, and we
are finalizing the definition of ``tools, tests, or software'' as
proposed. The definition specifically requires that a lay user be able
to control and customize an OTC hearing aid. Further, because OTC
hearing aids are not prescription devices (and are not otherwise exempt
from certain labeling requirements), the labeling must include adequate
directions for use, which are directions under which a layperson can
use the device safely and for its intended use(s) (see Sec.  801.5 (21
CFR 801.5)).
    (Comment 22) A comment suggested that FDA explicitly require that
users have control of the device output to customize the device to
their hearing needs. This comment argued the phrasing of the definition
for ``tools, tests, or software'' that FDA proposed is ambiguous,
potentially allowing manufacturers to restrict control of the device to
physical fit but not the sound output.
    (Response) As explained in the response to Comment 21, section
520(q)(1)(A)(iii) of the FD&C Act defines an OTC hearing aid as a
device that, through tools, tests, or software, allows the user to
control the hearing aid and customize it to the user's hearing needs.
In final Sec.  800.30(b), we define ``tools, tests, or software'' as
components that allow lay users to control the device and customize the
device sufficiently. As explained in the response to Comment 1, we
interpret the requirement for customization to hearing needs to mean
that the device must allow the user to cause frequency-dependent
changes based on the user's preference, and the requirement for user
control to mean that the user can access or select the output
characteristics most significant to the user's hearing perception.
These elements sufficiently describe the requisite controllability and
customization without unnecessarily constraining future technologies
that could be available OTC. We are not modifying the OTC Hearing Aid
Controls as suggested. However, as explained elsewhere in this
document, we added a user-adjustable volume control to the design
requirements for OTC hearing aids so users will be able to control this
aspect of the sound output.
    (Comment 23) Comments suggested that FDA include in the definition
of ``used hearing aid'' a stipulation that a bona fide hearing aid
evaluation extend through a trial period that might last as long as 90
days. That is, a device would not be considered a ``used hearing aid''
solely because a prospective purchaser wore it for an extended trial
period, without the presence of the dispenser or a hearing health
professional selected by the dispenser.
    (Response) FDA is not adopting this suggestion because purchasers
should be aware of use of the device outside of observation to ensure
appropriate operating conditions. This is because a device will be in
contact with the ultimate user's skin for extended periods, and the
device contains sensitive electronics. Without observation, a device
that a prospective

user is evaluating may be used in a way that would make the device
unsanitary for the ultimate user, or the device could have been
subjected to damaging conditions.
    However, we are revising the definitions and labeling requirements
to clarify labeling terms to convey information better. If a
manufacturer inspects and tests a used hearing aid, makes any necessary
modifications to the hearing aid to ensure it satisfies applicable
requirements to be available OTC, including for labeling,
electroacoustic performance, and design, and the manufacturer has
adequately reprocessed the hearing aid for the next user, then the
manufacturer may describe the device as ``rebuilt'' in the required
labeling rather than ``used.''
    (Comment 24) Multiple comments proposed that FDA define mild to
moderate hearing impairment in terms of objective criteria. For
example, these comments suggested that FDA adopt thresholds used by the
American Speech-Language-Hearing Association (ASHA) or the World Health
Organization (WHO) to categorize hearing impairment. Others suggested
more generally that labeling describe hearing impairment in detail so
that prospective OTC hearing aid users would ``understand exactly''
their degree of hearing impairment.
    (Response) FDA is declining to define hearing impairment for
purposes of the OTC Hearing Aid Controls in terms of objective
measurements because defining hearing impairment in such a way is
neither necessary for, nor consistent with, establishing an OTC
category of hearing aids.
    Inconsistency would arise because the requirements to establish the
OTC category focus on the hearing aid user's perception as well as
making devices available without the involvement of a licensed person.
Specifically, section 520(q)(1)(A)(ii) of the FD&C Act refers to
``perceived'' impairment in defining the intended use of OTC hearing
aids. As explained in the response to Comment 11, the subjective nature
of hearing impairment is integral to the regulatory category we must
establish for OTC hearing aids.
    Further, an objective definition based on measurement of hearing
impairment would imply the need to involve a licensed person, such as
an audiologist or hearing instrument specialist, to administer a test
or otherwise provide an exact understanding. However, OTC hearing aids
must be available without the involvement of a licensed person (see 21
U.S.C. 360j(q)(1)(A)(v)), and FDA has determined that an objective
measurement of hearing impairment is not necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids. Thus,
defining the degrees of impairment in objective terms, using one of
several available schemes for categorization, would be contrary to the
purposes of this final rule as well as unnecessary.
    We acknowledge that many licensed persons use audiometric
threshold-based hearing loss categories to describe hearing loss
severity, and this information may be useful to OTC hearing aid users
should they choose to seek it out. However, the perception of hearing
difficulties is on a continuum that is not confined to specific
audiometric threshold categories. For example, two people with the same
audiometric thresholds may have different subjective perceptions of,
and different personal preferences for addressing, the impairment. The
intended user population will have a broad range of perceptual
difficulties and communicative function because of the wide variability
and overlap in perception of hearing impairment within and across
hearing loss severity.
    The ASHA and WHO hearing loss categories each reflect a continuum
while providing high-level clinical guidance. These categories do not
represent discrete perceptual boundaries for the patient or for the
treating professional. Furthermore, these hearing loss categories were
not formulated to determine regulatory questions such as whether an
individual should have access to OTC hearing aids. We are declining to
adapt and apply such a scheme in that way.
    Nonetheless, we are establishing labeling requirements to help
consumers recognize perceived mild to moderate hearing impairment. See
the response to Comment 35 for more on this topic. Further, the
labeling encourages users and prospective users to seek professional
services in several circumstances, and people who wish to measure their
degree of hearing impairment objectively or definitively may still
obtain such measurements voluntarily.
    (Comment 25) One comment suggested that the definition of
``prescription hearing aid'' be revised to further state that these
devices are dispensed by a State-licensed professional.
    (Response) FDA declines to revise the definition of ``prescription
hearing aid'' as suggested because it is unnecessary. Prescription
hearing aids are prescription devices and as such, they are subject to
Sec.  801.109. Under Sec.  801.109(a), a prescription device is a
device that is: (1) either in the possession of a person, or his agents
or employees, regularly and lawfully engaged in the manufacture,
transportation, storage, or wholesale or retail distribution of such
device or in the possession of a practitioner, such as physicians,
dentists, and veterinarians, licensed by law to use or order the use of
such device and (2) is to be sold only to or on the prescription or
other order of such practitioner for use in the course of his
professional practice. Because prescription hearing aids are required
to be in the possession of persons lawfully engaged in the retail
distribution (or certain other activities) of such devices, and must be
sold only to or on the prescription or other order of a licensed
practitioner, the revision suggested in the comment is unnecessary.
    (Additional Revision 1) After further consideration, FDA is
modifying the definition of ``dispenser'' for the purposes of
prescription hearing aids under final Sec.  801.422(b). FDA proposed
that the term refer to any person engaged in the sale of prescription
hearing aids. However, we observed a potential for confusion based on
comments we received, because a person engaged in the sale of OTC
hearing aids would also be a dispenser. Thus, while the definition of
the term in Sec.  801.422(b) is for the purposes of prescription
hearing aid labeling, the definition as proposed may have appeared to
create an inconsistency with the use of the term outside of Sec.
801.422. To avoid the potential inconsistency and confusion, we are
removing ``prescription'' from the final definition of ``dispenser.''

D. Labeling (Sec.  800.30(c))

    FDA received many comments related to labeling for OTC hearing
aids. Most of these comments focused on ensuring the information would
be easy to understand for most people, that is, people who are not
professionals in a field related to hearing impairment. Commenters
suggested various means to improve the labeling, including different
phrasing, formatting, or positioning. Others provided general feedback
and emphasized Plain Language principles, and a need to avoid jargon or
overly technical phrasing, to help readers understand information in
the labeling. FDA agrees that Plain Language principles apply in the
case of labeling for hearing aid users, and that Plain Language will
help users to understand the information in the device labeling.

1. User-Friendly Labeling
    (Comment 26) Some comments expressed concern that FDA did not
validate the labeling of the OTC hearing aids. Many of these comments
are concerned that without labeling validation, a consumer's ability to
self-diagnose their hearing loss will be hindered. These comments
suggested that a requirement for manufacturers to validate labeling
will help to ensure that users can properly self-diagnose their hearing
loss.
    (Response) FDA is declining to adopt labeling validation
requirements for OTC hearing aids at this time. The labeling
requirements we are finalizing benefitted from extensive input from
many sources, including docket comments and public workshops, such as
the one convened by NASEM. Additionally, self-fitting air-conduction
hearings aids under Sec.  874.3325 are subject to a special control
requiring usability testing, which inherently includes testing the
directions for use by the user. Further, any device must have labeling
bearing adequate directions for use unless subject to an exemption (see
section 502(f)(1) of the FD&C Act and Sec.  801.5). This means that the
directions for use for an OTC hearing aid must allow a lay user to use
the device safely and for its intended purposes (see Sec.  801.5).
Given these requirements, and the extensive input we have received for
labeling, a requirement for additional validation is not needed for
reasonable assurance of safety and effectiveness.
    (Comment 27) Multiple comments proposed that labeling refer to an
``Ear-Nose-Throat Doctor,'' ``ENT,'' or similar terms instead of
referring to an ``ear specialist.'' These comments suggested that ``ear
specialist'' is not specific enough because it might imply somebody
besides a physician. For example, it could refer to an audiologist or a
hearing aid dispenser, neither of whom need be a physician. As such,
``ear specialist'' may confuse or inadvertently mislead hearing aid
users.
    (Response) FDA agrees that ``ear-nose-throat doctor'' and ``ENT''
are more descriptive and likely more common than ``ear specialist.'' We
have revised labeling throughout to adopt this suggestion when
referring to physicians.
    (Comment 28) A comment suggested that labeling refer to
``physicians'' rather than ``doctors'' because people who are not
physicians may be doctors, for example, people who hold Ph.D.s
(philosophical doctors) or chiropractors (some of whom are doctors of
chiropractic).
    (Response) We are not adopting this suggestion. We are adopting
suggestions to refer to ``ear-nose-throat doctors'' instead of ``ear
specialists'' to provide better guidance to people who may be
unfamiliar with hearing healthcare delivery (see the response to
Comment 27). However, we do not expect that people will seek the
assistance of philosophical doctors or chiropractors for their hearing
needs just because the labeling for OTC hearing aids refers to a
``doctor'' rather than a ``physician.'' Instead, we expect people who
seek the assistance of a doctor for their hearing needs will exercise
reasonable judgment in discerning which kind of doctor might help them
with their hearing needs, in the same way they might exercise
reasonable judgment to find appropriate providers when suggested by OTC
labeling for other health concerns.
    (Comment 29) A comment requested that ``doctor'' and ``physician''
in the labeling be revised to ``licensed healthcare practitioner.'' The
comment argued that use of ``licensed healthcare practitioner'' is
consistent with FDARA and would ensure that patients see qualified
individuals, yet not confuse and limit consumers about whom they can
consult.
    (Response) FDA is declining to replace all references to ``doctor''
or ``physician'' with ``licensed healthcare practitioner'' because
there are certain aspects of hearing care where it is warranted that a
patient consult a ``doctor.'' As discussed in the response to Comment
27, FDA is updating the term ``ear specialist'' to ``ear-nose-throat
doctor (ENT)'' to avoid confusion as to whom a consumer should consult.
Where FDA now uses the term ``ENT'' it is to clarify who is best
positioned for a patient to consult on a particular matter. For
example, an ENT would generally be the kind of provider who has the
necessary qualifications and expertise to conduct an examination for
the diagnosis of Red Flag conditions. We acknowledge, however, that not
all hearing healthcare providers need to be physicians and there are
many situations, such as consumers continuing to have difficulty
hearing even after beginning use of OTC hearing aids, where consulting
licensed healthcare providers would be necessary or appropriate.
    (Comment 30) A few comments recommended rewording the ``red flag''
condition warnings to present the issue first and then the solution.
Comments suggested the warning should be updated to read, ``[p]rior to
purchasing this device, if you have any of the following you should
promptly consult with a licensed physician, preferably, an Ear-Nose-
Throat (ENT) doctor.''
    (Response) FDA agrees that a different presentation would more
effectively communicate the warning. In response to comments proposing
rewording to increase readability, we have retitled the warning and
reordered the introduction in the manner suggested and adopted slightly
different phrasing that we think will be more user-friendly.
    (Comment 31) A comment expressed concern about the caution that
hearing aids are not hearing protection. Some comments argued that it
is impracticable for hearing aid users to take out their hearing aids
in situations where a loud sound is passing by. Comments recommended
the caution be updated to advise individuals to mute or turn off their
hearing aids when experiencing a loud sound and only recommend removal
of hearing aids if the hearing aid does not provide any hearing
protection.
    (Response) FDA is declining to implement this revision. FDA has
included information in the labeling requirements to help users have
realistic expectations when using hearing aids. This particular caution
is intended to assist users in the day-to-day use of their hearing aid
and to notify them that they should not rely on their hearing aid for
hearing protection. Additionally, the labeling includes a caution that
individuals should turn down the volume or remove the device if the
sound is uncomfortably loud or painful. These two cautions provide
appropriate guidance to help ensure safety when experiencing a loud
sound.
    (Comment 32) A few comments requested revisions to the note
regarding expectations about what a hearing aid can do to use more
positive framing. Comments argued that the note was more a notice of
what hearing aids cannot do, and a more positive framing would increase
readability and product desirability.
    (Response) FDA agrees that it is important for users to read and
understand the labeling easily, and we have updated the note to include
language about the benefits as well as limitations of OTC hearing aids.
The language was further updated to provide notice that users may need
to wait a few weeks to get used to their hearing aids.
    (Comment 33) A few comments requested that FDA require a minimum
font size so that consumers can read and understand the particulars of
each OTC hearing aid. Comments recommended requiring font sizes from
12-14 points.
    (Response) FDA is declining to implement this suggestion. This rule
applies to a large number of manufacturers and their various hearing
aids so FDA believes some flexibility is

warranted. Additionally, we do not believe a minimum font size is
necessary to ensure users can read and understand the labeling for OTC
hearing aids because there are requirements that address this. For
example, under section 502(c) of the FD&C Act, a device is misbranded
if any word, statement, or other information required by or under
authority of the FD&C Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness and in such terms
as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use (see 21
U.S.C. 352(c)). Given this and other requirements, and the need for
some flexibility as the rule applies to a variety of devices, FDA does
not believe a minimum font size is warranted.
    (Comment 34) A few comments recommended that the descriptions of
functions of the hearing aids include figures and videos alongside text
to provide additional clarity on how to use hearing aids.
    (Response) To help users after purchase, the inside labeling must
include, among other information, a description of accessories;
illustration(s) of the OTC hearing aid that indicates operating
controls, user adjustments, and battery compartment; adequate
directions for use; technical specifications; and a description of
commonly occurring, avoidable events that could adversely affect or
damage the OTC hearing aid. The labeling requirements will allow a lay
user to use the device safely and for its intended purposes (see Sec.
801.5). The additions suggested by comments are not necessary for
reasonable assurance of safety and effectiveness.
2. User Education
    (Comment 35) A comment suggested that device package labeling
describe hearing impairment in terms of common perceptual difficulties.
In specific, it proposed that labeling describe mild impairment as
having difficulty hearing soft-spoken people and young children.
According to the comment, people with mild impairment are often able to
hear loud or more-intense vowel sounds but may miss some of the softer
consonant sounds. Thus, they may have to ask people to speak up or
repeat themselves on occasion. The comment further stated that for
someone with typical hearing, this is comparable to placing a finger in
one's ears.
    The comment proposed that labeling describe moderate impairment as
having additional difficulty hearing vowel sounds in addition to
missing consonant sounds. According to the comment, this means that
when someone is speaking at a normal volume, a person with moderate
hearing impairment is unable to hear most of the speech sounds.
Accordingly, people with moderate hearing impairment often comment that
they hear sounds but cannot always understand speech.
    (Response) To help users determine whether they have perceived mild
to moderate hearing impairment, FDA has revised the package labeling
requirements by simplifying the language and making it less formal.
(See the response to Comment 41 for more about these revisions.)
However, while we agree that the suggested descriptions may also be
useful for prospective users, other factors impact determining the
labeling requirements. These factors include, for example, the limited
space available for the outside package labeling, as many comments
emphasized, and whether the information is necessary to provide
reasonable assurance of safety and effectiveness. The descriptions
suggested in the comment would add to the length of the material on the
outside packaging for OTC hearing aids. Additionally, the required
information under final Sec.  800.30(c)(1)(B) sufficiently helps to
provide reasonable assurance of safety and effectiveness, without the
addition of the suggested text, because it contains enough information
for someone to identify whether an OTC hearing aid may be intended for
their particular hearing impairment. Therefore, we are not revising
this final rule in the way suggested by the comment.
    However, as stated above, the additional information described in
the comment may still be useful so we intend to add similar information
to FDA's website, which has pages focused on hearing aids and hearing
loss. You can access the main web page at: https://www.fda.gov/medical-devices/consumer-products/hearing-aids. You may also wish to review
information from the National Institute on Deafness and Other
Communication Disorders. You can access their web pages at: https://www.nidcd.nih.gov/health/hearing-ear-infections-deafness. These
websites provide more information for people interested in learning
about hearing aids and hearing loss.
    (Comment 36) A few comments expressed concern that, without proper
warnings on the label, purchasers would not be informed on the
limitations of OTC hearing aids with regard to their degree of hearing
impairment.
    (Response) FDA agrees and is finalizing the clear statement that we
proposed, with an updated, more user-friendly list of common symptoms
of mild to moderate hearing impairment. We are also finalizing the
requirement, with similarly improved language, that the labeling
describe signs of more severe impairment.
    (Comment 37) A few comments expressed concern about the statement
that hearing aids will not restore normal hearing and that training and
counseling from a hearing healthcare professional may increase
satisfaction. Comments argued that these ideas are based upon current
limitations of hearing aids and recommended the statement be removed
because, they argued, future hearing aids may have the capability to
restore hearing to a normal level.
    (Response) FDA is declining to remove this statement. The note
informs consumers of the limitations and benefits they should expect
from an OTC hearing aid. Since many purchasers will be selecting and
using OTC hearing aids without the involvement of a licensed person,
FDA has included statements, including the one discussed above, to help
consumers have realistic expectations about OTC hearing aids. This
helps provide reasonable assurance of safety and effectiveness.
    (Comment 38) A few comments requested that labeling include a
warning of when to stop use of OTC hearings aids. The comments
expressed concerns that some hearing aid users may be unaware that they
should stop use of OTC hearing aids due to the onset of certain
conditions, for example, ear drainage, pain, and balance issues.
    (Response) FDA agrees that certain conditions should suggest that
users consult with a hearing healthcare provider, but we do not agree
that the onset of such conditions necessarily indicates the user should
stop using OTC hearing aids. FDA has revised the labeling to make it
more general so that it warns users to see a doctor, preferably an ear-
nose-throat doctor, if the user experiences any of the listed problems
before or after purchase.
    (Comment 39) A few comments recommended an additional warning on
the inside package labeling to alert individuals that there is
potential harm when wearing hearing aids for longer than recommended.
Comments proposed a warning to users to exercise special care in the
use of the device. It would warn against use of the hearing aid for
more than 12 hours a day, for example, and against use if the device
becomes uncomfortable, either due to the loudness of sound or the
physical fit of the device. Such proposed warnings sought to mitigate
the risk of further

impairment if the device was set to the maximum output level and worn
for periods of time exceeding these recommendations.
    (Response) FDA is declining to implement such suggestions. OTC
hearing aids are designed to be worn all waking hours in a variety of
listening environments and situations. The labeling required in this
rule provides reasonable assurance of safety and effectiveness,
including through notices that the hearing aid sound output should be
neither uncomfortable nor painful, and that the hearing aid should not
cause pain or discomfort when inserting or placing it.
    (Comment 40) A few comments expressed concern that the labeling
lacked reference to how a hearing healthcare professional can assist
and benefit a person purchasing an OTC hearing aid. Comments
recommended FDA develop labeling that includes guidance that, due to
their specialized knowledge, hearing healthcare professionals are
better at assisting in hearing tests and maximizing the benefits of a
hearing aid.
    (Response) FDA declines to make this addition to the labeling. This
rule includes requiring specific language to assist consumers in
determining whether an OTC hearing aid best meets their needs and when
to consult a licensed professional. As mandated by FDARA, this rule
establishes requirements to provide reasonable assurance of safety and
effectiveness of OTC hearing aids without the involvement of a licensed
person; therefore, while FDA agrees that licensed professionals provide
valuable services, FDA will not be incorporating further requirements
to include additional information about the benefit of licensed
professionals in the labeling.
    (Comment 41) FDA proposed that the outside package labeling include
a statement that the device may not be useful for more significant
hearing loss or complicated hearing needs. Some comments expressed
concern that the warning used ``significant hearing loss'' without
providing a definition of how to distinguish mild to moderate from
significant hearing loss. These comments suggested that FDA further
delineate mild to moderate from significant hearing loss, some of them
suggesting we use objective criteria rather than more-subjective
perceptual terms.
    (Response) The final labeling requirements include the signs
suggestive of both perceived mild to moderate hearing impairment and
more significant hearing impairment. FDA included this information to
assist consumers in determining whether OTC hearing aids can meet their
needs. We have improved the phrasing of this information to be more
understandable to inexperienced hearing aid users, including by
removing the phrases the comments characterized as not defined well
enough. However, as discussed in the response to Comment 24, FDA is
declining to define hearing impairment in terms of objective criteria
for the reasons explained in that response. We are continuing to
delineate the different degrees of severity with perceptual terms as we
believe this will be most useful to the intended users.
    (Comment 42) Comments expressed concern that the symptoms
suggesting perceived mild to moderate hearing impairment can also be
indications of more significant hearing loss.
    (Response) FDA infers these comments are concerned that consumers
may mistake their degree of hearing loss due to the commonality of
symptoms. FDA disagrees. FDA has specified some listening scenarios
that represent some of the most common perceptual difficulties a user
with perceived mild to moderate hearing impairment may experience.
Although these symptoms may apply to multiple types and degrees of
impairments, they are most common to perceived mild to moderate hearing
impairment and therefore helpful to prospective users of OTC hearing
aids. Further, FDA is also requiring that the symptoms commonly
experienced by individuals with more significant impairment, with a
recommendation to consult with a hearing healthcare professional, be
included on the outside package labeling. Although FDA is finalizing
more user-friendly language, we are declining to modify the symptoms
for perceived mild to moderate hearing impairment. We believe that this
information, along with the information required in the labeling to
assist people with more severe impairment, will help prospective users
determine whether an OTC hearing aid is a good choice for them.
    (Comment 43) A few comments suggested labeling requirements include
notice to individuals younger than 18 years old who are experiencing
hearing issues that they should visit a hearing healthcare provider
prior to using hearing aids due to complications that can cause
auditory impairment and developmental issues.
    (Response) FDA agrees with the concerns expressed by these comments
and believes the labeling requirements address these concerns. For
example, the labeling requirements in the proposed rule, which are
being finalized here, include language that individuals under the age
of 18 should consult with a doctor and refrain from using OTC hearing
aids. It emphasizes the possible need for medical testing and the
potential for hearing impairment in younger people to affect speech and
learning.
    (Comment 44) A few comments recommended that labeling include an
explanation on the differences between prescription hearing aids, OTC
hearing aids, and PSAPs to help consumers to select the appropriate
device.
    (Response) FDA is declining to require in the labeling an
explanation of the differences between OTC hearing aids, prescription
hearing aids, and PSAPs. Although this information may be helpful to
know, it is not necessary for reasonable assurance of safety and
effectiveness of OTC or prescription hearing aids. The labeling
requirements for OTC hearing aids include common symptoms of those with
mild to moderate hearing impairment and symptoms of more significant
hearing loss to help consumers decide whether an OTC hearing aid is a
good choice for them. Further, as discussed elsewhere in this document,
prescription hearing aids must be sold only to or on the prescription
or other order of a licensed practitioner (see Sec.  801.109).
Therefore, a licensed practitioner will be involved in determining
whether a prescription hearing aid is appropriate for an individual
with hearing impairment. Additionally, FDA is issuing a guidance with
this final rule that will provide additional clarification of the
differences between hearing aids and PSAPs. The notification of
availability for the guidance appears elsewhere in this issue of the
Federal Register.
    (Comment 45) A few comments requested that OTC hearing aid labeling
include a warning that people should not use OTC hearing aids if they
have tinnitus. Comments expressed concern that tinnitus can be an
indicator of serious medical conditions requiring proper management
from a hearing healthcare professional, and failure to seek immediate
treatment could cause further harm.
    (Response) In the labeling requirements, FDA has included tinnitus