[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Proposed Rules]
[Pages 58150-58191]
[FR Doc No: 2021-22473]

Vol. 86

Wednesday,

No. 200

October 20, 2021

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, 808, and 874

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

Regulatory Requirements for Hearing Aid Devices and Personal Sound
Amplification Products: Draft Guidance for Industry and Food and Drug
Administration Staff; Availability; Notice

Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 /
Proposed Rules

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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, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
proposing to establish a regulatory category for over-the-counter (OTC)
hearing aids and to make related amendments to update the regulatory
framework for hearing aids. Specifically, we propose to define OTC
hearing aids and establish applicable requirements; amend existing
rules for consistency with a 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
would become obsolete as a result of changes to the hearing aid
requirements. This action, if finalized, would more clearly define
prescription hearing aids; however, it would not change the
classification of existing device types. 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: Submit either electronic or written comments on the proposed
rule by January 18, 2022. Submit written comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 by November 19, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 18, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 18, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0555 for ``Establishing Over-the-Counter Hearing Aids.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 (PRA) to the Office of Management and
Budget (OMB) at https://www.reginfo.gov/public/do/PRAMain. Find this
particular information collection by selecting ``Currently under
Review--Open for Public Comments'' or by using the search function. The
title of this proposed collection is ``Medical Device Labeling
Regulations.''

FOR FURTHER INFORMATION CONTACT: 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

Executive Summary
    Purpose of the Proposed Rule
    Summary of the Major Provisions of the Proposed Rule
    Legal Authority
    Costs and Benefits
Table of Abbreviations and Acronyms Commonly Used in This Document
I. Background
    A. Need for the Regulation
    B. Current Regulatory Framework for Hearing Aids
    C. History of This Rulemaking
    D. Incorporation by Reference
II. Legal Authority
III. Description of the Proposed Rule
    A. Scope (Proposed Sec.  800.30(a))
    B. Definitions (Proposed Sec. Sec.  800.30(b) and 801.422(b))
    C. Labeling (Proposed Sec.  800.30(c))
    D. Output Limits (Proposed Sec.  800.30(d))
    E. Other Requirements (Proposed Sec.  800.30(e) and (f))
    F. Condition for Sale (Proposed Sec.  800.30(g))
    G. Preemption Provisions (Proposed Sec.  800.30(h))
    H. Proposed Repeal of Conditions for Sale and Modifications for
Prescription Labeling (Sec. Sec.  801.420, 801.421, 801.422)
    I. Proposed Amendments to Previous Exemption Decisions (Part
808)
    J. Other Proposed Amendments
IV. Findings Regarding Premarket Notification
V. Proposed Effective and Compliance Dates
    A. Effective Date
    B. Compliance Date for Hearing Aids Not Legally Offered for Sale
Prior to the Effective Date
    C. Compliance Date for Hearing Aids Legally Offered for Sale
Prior to the Effective Date
VI. Preliminary Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

Executive Summary

Purpose of the Proposed 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 proposing rules to address some of these concerns.
    Moreover, the FDA Reauthorization Act of 2017 (FDARA) directs FDA
to establish a category of OTC hearing aids through rulemaking, and
FDARA sets forth various requirements for OTC hearing aids, including
preemption provisions. In addition to protecting and promoting the
public health, we have developed these proposed rules to establish the
OTC category and implement the requirements of FDARA.

Summary of the Major Provisions of the Proposed Rule

    FDA is proposing to establish a regulatory category for OTC hearing
aids to improve access to hearing aid technology for Americans. OTC
hearing aids will be intended to address perceived mild to moderate
hearing loss in people age 18 or older. Alongside the OTC category, we
are proposing multiple related changes to the overall regulatory
framework for hearing aids to harmonize existing rules with the
eventual OTC category. We believe the proposals 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 proposing
general controls for OTC hearing aids consistent with FDARA. Moreover,
because the FD&C Act specifies that OTC hearing aids are those that use
the same fundamental scientific technology as air-conduction hearing
aids, we would realign the existing classification regulations for
hearing aids by sound conduction technology. However, the realignment
would not affect the device class or premarket notification exemption
status of any existing device. On the effective date of the final rule,
we would realign current product codes to correspond with the revised
regulations for consistency but would not otherwise change the codes.
    This rulemaking also affects other existing regulations that apply
to hearing aids. FDA has established device restrictions for hearing
aids that include labeling requirements as well as conditions for sale.
We are proposing to remove these device restrictions for hearing aids,
and establish a new regulation for prescription hearing aid labeling.
Further, FDA has 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 proposing to
remove the regulations codifying these decisions and establish other
regulations clarifying some of the effects of statutory preemption
under FDARA.

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.
    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
proposing 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.

Costs and Benefits

    This proposed rule to establish OTC hearing aids and align other
regulations, if finalized, would generate potential cost savings for
consumers with perceived mild to moderate hearing loss who wish to buy
lower cost hearing aids not bundled with professional services and not
requiring professional advice, fitting, adjustment, or maintenance but
who are currently unable to buy such products online because of State
regulations or because they do not shop online. The proposed rule, if
finalized,

would also generate costs for hearing aid manufacturers for changing
labeling of existing hearing aids as well as for reading the rule and
revising internal standard operating procedures in response to the
rule. 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.

   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.
ASA................................  Acoustical Society of America.
CFR................................  Code of Federal Regulations.
CTA................................  Consumer Technology Association.
dB.................................  Decibel.
dBA................................  A-weighted decibel.
EA.................................  Environmental assessment.
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.
GMPs...............................  Good manufacturing practices.
Hz.................................  Hertz.
ISO................................  International Organization for
                                      Standardization.
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.
PCAST..............................  President's Council of Advisors on
                                      Science and Technology.
PRIA...............................  Preliminary Regulatory Impact
                                      Analysis.
PSAP...............................  Personal sound amplification
                                      product.
Pub. L.............................  Public Law.
QS.................................  Quality System.
SPL................................  Sound pressure level.
U.S.C..............................  United States Code.
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I. Background

    FDA is proposing to define and establish general controls for an
OTC category of hearing aids. We intend these proposals to provide for
reasonable assurance of safety and effectiveness for these devices and
improve access to and foster innovation in hearing aid technology for
Americans, thereby promoting and protecting the public health. We would
make various other revisions, as described in this document, to align
existing regulations with statutory requirements and the new OTC
category.

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 (Ref. 3a and 3b). 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. 4). In addition, stakeholders have cited Federal
regulations that require specific labeling and conditions for sale,
initially implemented in the late 1970s, as barriers to access (e.g.,
Refs. 5 to 7). This document proposes a number of changes to the
regulatory framework for hearing aids to remove or reduce barriers to
certain air-conduction hearing aids for perceived mild to moderate
hearing impairment--a type of impairment often associated with aging--
that have the potential to be of great benefit to the public health.
    These proposals follow the enactment of FDARA, which included
provisions directing FDA to establish regulatory requirements for a new
category of OTC hearing aids and amended the FD&C Act to add section
520(q) (21 U.S.C. 360j(q); see Pub. L. 115-52). Section 520(q)(1) of
the FD&C Act defines OTC hearing aids, in part, as devices available
over-the-counter, without the supervision,

prescription, or other order, involvement, or intervention of a
licensed person, to consumers through in-person transactions, by mail,
or online. Section 520(q)(2) of the FD&C Act requires that such devices
be subject to the regulations FDA issues for them in accordance with
section 709(b) of FDARA.
    Section 709(b) of FDARA requires that FDA establish a category of
OTC hearing aids that includes, among other elements, requirements to
provide reasonable assurances of the safety and effectiveness of these
devices. We also make multiple proposals to prevent the sale of OTC
hearing aids to or for people younger than age 18. This document does
not, however, propose to create or classify a new device type.\1\
Further, this document does not propose to exempt additional devices
from the premarket notification requirements under section 510(k) of
the FD&C Act, commonly referred to as ``a 510(k)'' (21 U.S.C. 360(k)).
Section IV of this document discusses our findings regarding premarket
notification in more detail.
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    \1\ ``Device type'' as used in this document has the same
meaning as ``generic type of device'' in 21 CFR 860.3(i) (a
``generic type of device'' means ``a grouping of devices that do not
differ significantly in purpose, design, materials, energy source,
function, or any other feature related to safety and effectiveness,
and for which similar regulatory controls are sufficient to provide
reasonable assurance of safety and effectiveness'').
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    We are simultaneously proposing related changes to the regulatory
framework that currently applies to all hearing aids, as they are
defined in Sec.  801.420 (21 CFR 801.420), in light of the new OTC
category and to ensure consistency across rules pertaining to hearing
aids (see Sec.  801.420(a)(1)). Detailed information about each
proposal appears in section III.

B. Current Regulatory Framework for Hearing Aids

    Hearing aids, as defined in Sec.  801.420(a)(1), are currently
restricted class I and class II devices of multiple types. A summary of
the current regulatory framework for these devices appears in table 1.

                                                    Table 1--Summary of Current Regulatory Framework
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 Classification regulation, 21 CFR
              section                       874.3300                874.3305                874.3315               874.3325               874.3950
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Device Restrictions................  Restricted............  Restricted............  Restricted...........  Restricted...........  Restricted.
Class I, 510(k) exempt \1\.........  Air-conduction
                                      (``legacy'').
Class II, 510(k) exempt \1\........  ......................  Wireless air-
                                                              conduction.
Class II...........................  Bone-conduction.......  ......................  Tympanic membrane      Self-fitting air-      Transcutaneous air-
                                                                                contact hearing aid.   conduction.            conduction hearing
                                                                                aid system.
Product codes......................  ESD, LXB, MAH, LRB,     OSM...................  PLK..................  QDD..................  NIX.
                                      LDG.
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\1\ 510(k) exemptions are subject to the limitations in 21 CFR 874.9.

1. Hearing Aid Classifications
    Hearing aids are class I and class II wearable sound-amplifying
devices intended to compensate for impaired hearing. They currently
fall under five classification regulations (the following references
are to sections in Title 21 of the CFR):
    a. Hearing aid (Sec.  874.3300 (21 CFR 874.3300)). This device type
includes air-conduction (class I, 510(k) exempt, subject to the
limitations of exemption in Sec.  874.9) and bone-conduction (class II)
hearing aids. Class II bone-conduction hearing aids require a 510(k)
notification. These are all restricted devices.
    b. Wireless air-conduction hearing aid (Sec.  874.3305 (21 CFR
874.3305)). This device type is a hearing aid that incorporates
wireless technology in its programming or use, for example, controls
over Bluetooth. These devices are class II restricted, subject to the
special controls that have been issued for these devices, and 510(k)
exempt, subject to the limitations of exemption in Sec.  874.9.
    c. Tympanic membrane contact hearing aid (Sec.  874.3315 (21 CFR
874.3315)). This device type is a prescription device that compensates
for impaired hearing. Amplified sound is transmitted by vibrating the
tympanic membrane through a transducer that is in direct contact with
the tympanic membrane. These devices are class II restricted, subject
to the special controls that have been issued for these devices, and
require a 510(k) notification.
    d. Self-fitting air-conduction hearing aids (Sec.  874.3325 (21 CFR
874.3325)). This device type is a hearing aid that incorporates
technology, including software, that allows users to program their
hearing aids. This technology integrates user input with a self-fitting
strategy and enables users to independently derive and customize their
hearing aid fittings and settings. These devices are class II
restricted, subject to the special controls that have been issued for
these devices, and require a 510(k) notification.
    e. Transcutaneous air conduction hearing aid system (Sec.  874.3950
(21 CFR 874.3950)). This device type consists of an air-conduction
hearing aid attached to a surgically fitted tube system, which is
placed through soft tissue between the post auricular region and the
outer ear canal. These devices are class II restricted, subject to the
special controls that have been issued for these devices, and require a
510(k) notification.
    Devices of these types may be either prescription (for example,
devices for insertion deep in the ear canal) or non-prescription
devices (which include the majority of air-conduction hearing aids).\2\
For the purposes of this rulemaking, we refer to non-wireless, non-
self-fitting, air-conduction hearing aids as ``legacy hearing aids,''
which means all air-conduction hearing aids currently within Sec.
874.3300 but not air-conduction hearing aids currently within
Sec. Sec.  874.3305, 874.3325, or 874.3950.
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    \2\ We use the term ``non-prescription'' because the FD&C Act,
as amended by FDARA, defines OTC hearing aids and requires FDA to
undertake rulemaking to establish the OTC category. As such, no
hearing aid is yet OTC within the meaning of section 520(q) of the
FD&C Act. We use ``non-prescription'' to avoid confusing the
intended uses of current devices with devices that would eventually
meet the OTC Hearing Aid Controls.

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2. Hearing Aid Restrictions
    Hearing aids are currently subject to a set of restrictions on
sale, distribution, and use, established in accordance with section
520(e) of the FD&C Act. We will refer to those as ``Hearing Aid
Restrictions,'' and they include requirements for professional and
patient labeling, as a well as conditions for sale (see Sec. Sec.
801.420 and 801.421 (21 CFR 801.420 and 801.421, respectively)). All
legacy hearing aids, wireless air-conduction hearing aids, and self-
fitting hearing aids (as well as other device types) fall within a
separate, broader definition of hearing aids in Sec.  801.420(a)(1),
and therefore are currently subject to these restrictions.
    Among other requirements, Sec.  801.420 specifies that the User
Instructional Brochure labeling for hearing aids contain a warning
statement for hearing aid dispensers that prompts them to advise
prospective purchasers to consult with a physician if any of the listed
medical conditions are present (see Sec.  801.420(c)(2)). We will refer
to these medical conditions as ``red flag'' conditions in this
proposal. The rule further prescribes a notice to prospective users and
an additional statement about hearing loss in children (see Sec.
801.420(c)(3)). It also requires the disclosure of technical data
useful in selecting, fitting, and checking the performance of hearing
aids (see Sec.  801.420(c)(4)).
    Currently, Sec.  801.421 specifies a number of conditions for sale
for hearing aids. Such conditions include that a prospective user must
present to the dispenser a signed statement of medical evaluation from
a physician prior to sale (see Sec.  801.421(a)(1)). However, a
prospective user who is 18 years of age or older may waive the medical
evaluation requirement by signing a statement with a prescribed
advisement (see Sec.  801.421(a)(2)). A dispenser must provide an
opportunity for the prospective user to review the User Instructional
Brochure prior to signing a waiver and the sale of a hearing aid (see
Sec.  801.421(b)). Manufacturers and distributors must provide
sufficient copies of User Instructional Brochures to dispensers, and
upon written request, to prospective users; dispensers must similarly
provide the brochures (or the name and address of a manufacturer or
distributor to obtain a brochure) to prospective users upon request
(see Sec.  801.421(c)). Dispensers generally must retain a copy of a
medical evaluation statement or signed waiver for 3 years (see Sec.
801.421(d)).
    However, we announced in a guidance entitled ``Conditions for Sale
for Air-Conduction Hearing Aids'' that we do not intend to enforce the
medical evaluation, waiver, or recordkeeping requirements of Sec.
801.421 with respect to prospective purchasers who are 18 or older
(Ref. 8).
    In addition to other applicable misbranding and adulteration
provisions in sections 501 and 502 of the FD&C Act (21 U.S.C. 351 and
21 U.S.C. 352, respectively), hearing aids are currently subject to
misbranding provisions for restricted devices under section 502(q) and
(r) of the FD&C Act. Section 704(a) of the FD&C Act (21 U.S.C. 374(a))
authorizes FDA to inspect, among other things, certain records relating
to restricted devices.
3. State Requirements for Hearing Aids
    Under certain circumstances, State requirements apply to hearing
aids notwithstanding Federal requirements. In general, FDA's regulation
of hearing aids preempts State law, meaning that a State or a political
subdivision (e.g., a city) may not establish or continue in effect its
own requirement if that requirement is ``different from, or in addition
to,'' a requirement under the FD&C Act (see section 521(a) (21 U.S.C.
360k(a))). Many States have established requirements equivalent to
Sec.  801.420 or Sec.  801.421 (i.e., not ``different from, or in
addition to'' those regulations), which are not preempted by these
Federal requirements.
    However, for other State requirements, FDA has granted and denied
exemptions from preemption under section 521(b) of the FD&C Act for
some States that have applied. FDA responds to applications for such
exemptions by regulation, codified in subpart C of part 808 (21 CFR
part 808). Most of these regulations relate to hearing aids, and in
some of these regulations, FDA has granted exemptions--meaning those
States' requirements apply instead of, or in addition to, FDA's
requirements--for:
     Specifying the physician expertise needed to examine
prospective purchasers who are younger than 18 years of age;
     Advising purchasers when to seek medical attention based
on ``red flag'' conditions;
     Providing purchasers with certain information and
disclosures on receipts and other documentation;
     Recordkeeping requirements in addition to the Hearing Aid
Restrictions; and
     Providing written notice of a money-back guarantee where a
State court held the State requirement was preempted.
    And FDA has denied exemptions--meaning the States could not
establish or continue in effect requirements--for:
     Removing the waiver option for prospective purchasers who
are 18 years of age or older;
     Lowering the age at which a waiver of medical examination
prior to purchase was available;
     Changing the expertise for examinations, when conducted,
for people 18 years of age and older;
     Prohibiting certain marketing claims about improving
hearing; and
     Adopting different device testing standards.
    FDARA added a separate Federal preemption provision for State and
local laws, regulations, orders, or other requirements (for brevity, we
will refer to ``State or local requirements'' in this rulemaking)
specifically related to hearing products (FDARA section 709(b)(4)).\3\
That provision may affect the applicability of State or local
requirements for OTC hearing aids. Section III.G discusses the OTC
hearing aid preemption provisions and the effects of this rulemaking.
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    \3\ Additionally, FDARA section 709(b)(5) addresses the effect
of section 709 on certain private remedies.
---------------------------------------------------------------------------

4. Hearing Products Not Regulated as Hearing Aids
    FDA does not consider personal sound amplification products (PSAPs)
to be ``devices'' within the meaning of section 201(h) of the FD&C Act
(21 U.S.C. 321(h)) when they are not intended to aid a person with, or
compensate for, impaired hearing and do not otherwise meet the device
definition. Such PSAPs are not subject to medical device regulations,
nor would the proposed requirements of this rulemaking apply to such
PSAPs.\4\ Note that the name of a product on its own would not
ordinarily demonstrate intended use. Thus, merely calling a product
something besides ``hearing aid'' would 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.
---------------------------------------------------------------------------

    \4\ Section 520(q)(1)(B) of the FD&C Act also specifically
excludes from the definition of OTC hearing aids products intended
to amplify sound for nonhearing impaired consumers in situations
including hunting and bird watching.
---------------------------------------------------------------------------

C. History of This Rulemaking

    Although this proposal is the first step in this rulemaking, FDA
has taken other steps to initiate an update of the regulatory framework
for hearing aids.

Prior to the enactment of FDARA, FDA had considered means to improve
access to hearing aids. For example, we considered a report on the
public health implications of hearing loss in adults that made
recommendations to improve affordability and accessibility of hearing
aids and to foster innovative hearing aid technology. The October 2015
report by the President's Council of Advisors on Science and Technology
(PCAST) recommended, among other actions, that, ``FDA should approve
[a] class of hearing aids for over-the-counter (OTC) sale, without the
requirement for consultation with a credentialed dispenser'' (Ref. 7).
In addition, the report concluded, among other things, that the Federal
requirement for a medical examination, or a written waiver of such
examination, ``provides little patient benefit, while acting as a
barrier to access for the millions of Americans needing hearing
assistance'' (Ref. 7).
    Similarly, FDA, other Federal Agencies, and a consumer advocacy
group co-sponsored a study entitled ``Hearing Health Care for Adults:
Priorities for Improving Access and Affordability'' through the
National Academies of Sciences, Engineering, and Medicine (NASEM). The
resulting NASEM report, published on June 2, 2016, similarly recommends
that FDA create a new category of OTC ``wearable hearing devices''
(using a term distinct from ``hearing aids'') and also that FDA remove
the medical evaluation requirement for adults for hearing aids (Ref.
6). After a review of the literature and relevant clinical databases
from the U.S. Department of Defense and the U.S. Department of Veterans
Affairs, NASEM concluded that the health risk of missed diagnosis of
treatable causes of hearing loss in adults is low, and ``[the]
regulation [requiring a medical examination or waiver] provides no
clinically meaningful benefit, and the waiver presents a barrier to
access with no substantial enhancement of patient safety.''
    Both PCAST and NASEM provided recommendations regarding FDA Quality
System requirements (which set forth requirements for good
manufacturing practices or GMPs) for the proposed category of OTC
hearing aids. PCAST stated the following:

    FDA should exempt this class of hearing aids from QSR regulation
in its present form and substitute compliance with standards for
product quality and recordkeeping appropriate for the consumer-
electronics industry, developed by an appropriate third-party
organization and approved by FDA. Similar actions should be taken
with respect to diagnostic hearing tests used to dispense and fit
Class I hearing aids.

    However, NASEM recommended that these devices ``[b]e subject to
quality system regulation (QSR) requirements, but be considered for
exemption from certain QSR requirements as determined by FDA to be
appropriate for this category.''
    We held a public workshop on April 21, 2016, entitled
``Streamlining Regulations for Good Manufacturing Practices (GMPs) for
Hearing Aids,'' (announced at 81 FR 784; see Ref. 9 for materials). FDA
requested comments on several topics relating to hearing healthcare
technology and improved access, including the appropriate level of GMP
regulation (Quality System requirements) to ensure the safety and
effectiveness of air-conduction hearing aid devices in consideration of
the PCAST report recommendations.
    FDA received hundreds of comments to the docket for this workshop
prior to the (extended) deadline of June 30, 2016. In addition, 2
keynote speakers (from PCAST and NASEM), 12 invited speakers, and 24
public speakers offered comments or presentations at the workshop.
Workshop speakers and submitters of docket comments were generally:
Healthcare professionals (or healthcare professional organizations),
members of industry, patients or consumers, academics, consensus
standards developers, and science organizations.
    Comments from this workshop ranged generally from strong opposition
to strong support for the PCAST recommendations. Other comments were
more nuanced. To summarize very broadly, all parties agreed that some
combination of regulatory requirements and flexibility in compliance
would provide reasonable assurance of safety and effectiveness. The
differences in opinion lie in the preferred approach and its
implementation to achieve these common goals. For example, some
preferred amending the QS regulation and relying on inspections while
others preferred allowing voluntary conformity to a consensus standard
potentially relying on third-party certification.
    In another effort to address the current regulatory framework, FDA
also issued a guidance document, as noted above, related to the
conditions for sale for air-conduction hearing aids. In that document,
we announced our intent to reexamine and modify Sec.  801.421 based on
the PCAST and NASEM recommendations, as well as from other
stakeholders, taking into consideration and addressing their
recommendations as appropriate before adopting regulations for OTC
hearing aids. The docket no. FDA-2016-D-3466 included commentary that
expressed support for the creation of a ``basic'' category of hearing
aids such as OTC hearing aids and provided recommendations for measures
to support safe and effective use. We also received multiple telephone
calls expressing similar interest in reducing regulatory burdens and
questioning how the issuance of the guidance affected States'
requirements.
    In developing this proposed rule, we considered the input and
questions we have received on the guidance, as well as the comments
from the April 2016 public workshop and the recommendations from PCAST
and NASEM.

D. Incorporation by Reference

    FDA is proposing to incorporate by reference the Method and tables
for clause 4.1 of ANSI/CTA-2051, ``Personal Sound Amplification
Performance Criteria,'' dated January 2017, from the American National
Standards Institute, 1889 L Street NW, 11th floor, Washington, DC
20036; https://www.ansi.org,<PHONE_NUMBER>. You may download the
standard from the web at https://webstore.ansi.org/standards/ansi/cta20512017ansi. The Method and tables for clause 4.1 describe how to
measure frequency response and include technical data for adaptations
for different circumstances. The Method and tables would provide a
standardized way to quantify frequency response for OTC hearing aids
and meet the related proposed requirements (see section III.E.1).
    FDA is also proposing to incorporate by reference ANSI/ASA S3.22-
2014, ``Specification of Hearing Aid Characteristics,'' dated November
2014, from the American National Standards Institute, 1889 L Street NW,
11th floor, Washington, DC 20036; https://www.ansi.org,<PHONE_NUMBER>.
ANSI/ASA S3.22-2014 describes tolerances and test methods used for
certain measurements of hearing aid performance. The application of
ANSI/ASA S3.22-2014 provides professional hearing aid fitters with
standardized technical information to help them select the correct
hearing aid and ensure optimal fit and performance for hearing aid
users (see section III.H.2).

II. 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, 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.
    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). 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 proposals in this rulemaking would be for the
efficient enforcement of the FD&C Act because, if finalized, they will
provide standards for the legal marketing of safe and effective hearing
aid devices.
    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)).
    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.

III. Description of the Proposed Rule

    We are proposing multiple related actions in this rulemaking:
     Add to part 800, subpart B (21 CFR part 800, subpart B),
definitions and other rules for OTC hearing aids;
     Remove Sec.  801.420 and repeal Sec.  801.421;
     Add to part 801, subpart H (21 CFR part 801, subpart H),
Sec.  801.422, labeling requirements for prescription hearing aids;
     Amend part 874, subpart D (21 CFR part 874, subpart D), in
multiple places to update classification regulations for hearing aids
and align hearing aid types by sound-conduction technology; and
     Amend part 808, subparts A and C (21 CFR part 808,
subparts A and C), by updating the Scope and removing most of the
current regulations codifying previous decisions for exemption from
Federal preemption for certain States.
    If this action is finalized, all non-OTC hearing aids will be
prescription devices and would be subject to the labeling requirements
in new Sec.  801.422 as well as those in the existing Sec.  801.109,
but they would no longer be restricted devices. Note that a prescriber
is any practitioner licensed by the law of the State in which the
practitioner practices to use, or order the use of, the device. When
the prescriber of a hearing aid need not be a physician, the labeling
of a prescription hearing aid will describe other prescribers, for
example, audiologists (see Sec.  801.109(b)(1)).
    We believe the proposed actions will, in combination, promote and
protect the public health by, among other things, providing reasonable
assurance of safety and effectiveness of OTC and prescription hearing
aids. These actions would also help minimize the complexity of the
applicable regulations, if finalized, through organization. We are
proposing to add the OTC Hearing Aid Controls to 21 CFR part 800,
subpart B, entitled ``Requirements for Specific Medical Devices,''
which would make them easy to locate. Labeling requirements for
prescription devices would remain in part 801, Labeling, subpart H,
``Special Requirements for Specific Devices.'' Table 2 outlines the
proposed hearing aid rules. Section III.I summarizes the proposed
revisions to part 808.

              Table 2--Outline of Proposed Hearing Aid Rule
------------------------------------------------------------------------
      800.30            801.422           874.3301          874.3305
------------------------------------------------------------------------
 Over-the-counter     Prescription
   hearing aid        hearing aid      Bone-conduction   Air-conduction
   controls \1\       labeling \1\       hearing aid       hearing aid
------------------------------------------------------------------------
(a) Scope.         (a) Scope.         (a)               (a)
                                       Identification.   Identification.
(b) Definitions.   (b) Definitions.   (b)               (b)
                                       Classification.   Classification.

(c) Labeling.      (c) Labeling.      Product codes
                                       LXB, MAH.         Legacy.

 Package.           Package.                             Wireless.
                                          Self-
 Labeling Inside    Labeling Inside                      Fitting.
 the Package.       the Package.
                                        Product codes
 Labeling on the    Labeling on the                      ESD, OSM, QDD,
 Device.            Device.
                                         LRB, and LDG.
 Technical          Technical
 Specifications.    Specifications.

                    Misbranding.
(d) Output         (d) Incorporation
 Limits.            by Reference.
(e)
 Electroacoustic
 Performance.

 Distortion
 Control.
  Self-
 generated Noise.

 Latency.

 Bandwidth.

 Smoothness.
(f) Design
 Requirements.

 Insertion Depth.

 Atraumatic
 Materials.
  Proper
 Fit.
  Tools,
 Tests, or
 Software.
(g) Condition for
 Sale.
(h) Effect on
 State Law.
(i) Incorporation
 by Reference.
------------------------------------------------------------------------
\1\ These requirements would apply in addition to all other applicable
  requirements, including applicable labeling requirements in parts 801
  and 830 (21 CFR parts 801 and 830). For example, for prescription
  devices, the labeling requirements in Sec.   801.109 would continue to
  apply in addition to new Sec.   801.422.

A. Scope (Proposed Sec.  800.30(a))

    The regulation would clarify which devices are subject to the OTC
Hearing Aid Controls. Among other changes, FDARA amended the FD&C Act
to define the term ``over-the-counter hearing aid,'' and section 709 of
FDARA directs FDA to establish certain requirements for labeling,
output limits, conditions for sale, and other requirements that provide
reasonable assurances of the safety and effectiveness of OTC hearing
aids. We propose to call this set of requirements ``Over-the-Counter
Hearing Aid Controls'' and add Sec.  800.30 to establish the OTC
category of hearing aids and their requirements.
    The scope, proposed paragraph (a), would specify the devices to
which the regulation would apply, assisting with the determination of
applicable requirements. This provision clarifies that a hearing aid is
either in the prescription or OTC category and that, regardless of
category, special controls found in the applicable classification
regulation and other requirements in the FD&C Act apply.

B. Definitions (Proposed Sec. Sec.  800.30(b) and 801.422(b))

    FDA proposes to include the definition of an OTC hearing aid,
consistent with the definition in section 520(q)(1) of the FD&C Act,
and the definitions of other terms integral to understanding Sec.
800.30. In several cases, we are proposing parallel definitions
(sometimes slightly modified) under the proposed requirements for
prescription hearing aid labeling in Sec.  801.422.
    Defining hearing aids. FDARA authorizes controls for devices that,
among other characteristics, use the same fundamental scientific
technology as air-conduction hearing aids under Sec. Sec.  874.3300 or
874.3305. Section 520(q)(1)(A)(i) of the FD&C Act does not specifically
refer to Sec.  874.3325 because, at the time of FDARA's enactment, FDA
had not classified that device type. However, we consider self-fitting
hearing aids currently classified under Sec.  874.3325 to be eligible
for regulation as OTC hearing aids.
    We consider them as such because, although self-fitting hearing
aids under Sec.  874.3325 differ from hearing aids under Sec. Sec.
874.3300 and 874.3305 in that they incorporate technology, including
software, that allows users to program their hearing aids, self-fitting
hearing aids use the same air-conduction technology as hearing aids
under Sec. Sec.  874.3300 and 874.3305. Self-fitting hearing aids also
meet the other elements of the OTC hearing aid definition in section
520(q)(1)(A) of the FD&C Act. For example, self-fitting hearing aids,
through tools, tests, or software, allow the user to control the
hearing aid and customize it to the user's hearing needs (see section
520(q)(1)(A)(iii) of the FD&C Act).
    The proposed definitions of ``hearing aid'' (which is the current
definition), ``air-conduction hearing aid,'' ``over-the-counter hearing
aid,'' and ``prescription hearing aid'' help to delineate the different
device categories.\5\ As stated in section 520(q)(1)(B) of the FD&C
Act, the definition of ``over-the-counter hearing aid'' does not
include PSAPs. Similarly, the definition of ``hearing aid'' more
generally excludes PSAPs that are not intended to aid with or
compensate for impaired hearing. The proposed definition of
``prescription hearing aid'' in proposed Sec.  801.422 is the same as
that in the OTC Hearing Aid Controls except that the definition for
prescription devices would cross-reference the OTC Hearing Aid
Controls, proposed Sec.  800.30.
---------------------------------------------------------------------------

    \5\ Although some have suggested the use of a different name for
OTC hearing aids, for example, a ``wearable,'' we are proposing to
continue referring to them as hearing aids to maintain consistency
with the device type classifications and section 520(q) of the FD&C
Act.
---------------------------------------------------------------------------

    Defining licensed persons. In that vein, OTC hearing aids will be
available without the supervision, prescription, or other order,
involvement, or intervention of a licensed person (section
520(q)(1)(A)(v) of the FD&C Act). A definition of ``licensed person''
would help delineate that a patient or consumer of OTC hearing aids
will not need to consult an audiologist, a physician, or other licensed
person prior to or after purchasing an OTC

hearing aid. The proposed definition of ``licensed person'' also
clarifies that FDA interprets ``licensed person'' to include businesses
consistent with the broad definition of ``person'' in section 201(e) of
the FD&C Act. For example, OTC hearing aids may be available for sale
from businesses that are not specially licensed to distribute OTC
hearing aids.\6\
---------------------------------------------------------------------------

    \6\ See section III.G, discussing the codification of the
preemption provision, section 709(b)(4) of FDARA.
---------------------------------------------------------------------------

    FDA does not interpret section 520(q)(1)(A)(v) of the FD&C Act or
section 709(b) of FDARA as preempting a State's ability to establish or
continue in effect generally applicable State business or professional
licensing requirements. In general, such requirements would not be
``specifically related to hearing products,'' so they are not subject
to section 709(b)(4) of FDARA. If a person purports to be a licensed
professional or business, then a State could regulate the person as
such. Thus, for example, a person identifying as an ``audiologist''
would be subject to State professional or facility licensure
requirements because an audiologist is a licensed professional.
    However, unlike identifying as an ``audiologist,'' some
descriptions for professions do not on their own imply licensure in
relation to OTC hearing aids. Section 709(b)(4) of FDARA lists certain
activities that may be undertaken with respect to OTC hearing aids
without the supervision, prescription, or other order, involvement or
intervention of a licensed person. FDARA specifically lists the
servicing, marketing, sale, dispensing, use, customer support, or
distribution of OTC hearing aids. (For convenience, we will refer to
these activities collectively as ``commercial activity'' in this
document.) Thus, a person representing as a marketer, seller,
dispenser, distributor, or customer support representative (or an
equivalent description) of OTC hearing aids would not be a ``licensed
person'' for the purposes of Sec.  800.30 solely for that reason. Nor
could a State require such persons to undertake special licensing or
equivalent activities. In contrast, a person voluntarily identifying,
for example, as a ``licensed dispenser'' (i.e., not just a
``dispenser'') would be subject to corresponding State requirements for
such dispensers to the extent that the State requirements do not
restrict or interfere with commercial activity involving OTC hearing
aids (see section 709(b)(4) of FDARA).
    The proposed definition of ``licensed person'' specifies the
descriptions of profession, consistent with section 709(b)(4) of FDARA,
that would not, on their own, imply licensure relating to OTC hearing
aids. Section III.G of this document describes other preemption
scenarios in addition to licensed persons.
    Defining tools, tests, or software. Another element of the
definition of OTC hearing aids requires that users be able to control
or customize the devices through tools, tests, or software (see section
520(q)(1)(A)(iii) of the FD&C Act). We interpret this requirement to
refer to the ability for a layperson to perform such activities. As
such, the proposed definition of ``tools, tests, or software''
clarifies that OTC hearing aids are those devices that allow lay users
to control the device and customize it, such as the device's output, to
meet their individual hearing needs.
    Other definitions. The proposed definition of ``used hearing aid''
in both the OTC and prescription device provisions clarifies which
hearing aids would be subject to certain proposed labeling requirements
for used or rebuilt hearing aids. The proposed definitions are the same
for OTC and prescription hearing aids, and they are derived from the
current definition in Sec.  801.420 except that we have revised the
wording for clarity.
    The proposal for prescription hearing aid labeling in Sec.  801.422
retains the definition for ``dispenser'' that is currently applicable
to all hearing aids. However, we propose to revise the wording to
clarify that the definition applies only for purposes of prescription
hearing aid labeling and propose other clarifying revisions to track
the definition of ``person'' in section 201(e) of the FD&C Act more
closely. We believe the definition will continue to be useful because
the proposed requirements for prescription hearing aids refer to the
dispenser.
    FDA welcomes comments on the definitions pertinent to the
regulation of OTC hearing aids (as well as any other portion of this
proposal). In particular, we seek comments on the clarity of the
definitions and ways to improve the definitions to encourage and
support the broad availability of safe and effective devices.

C. Labeling (Proposed Sec.  800.30(c))

    We are proposing labeling requirements to provide consumers with
essential information for the safe and effective use of OTC hearing
aids. Section 709(b)(2)(C) of FDARA specifically directs FDA to
include, among appropriate labeling requirements, a conspicuous
statement that the device is only intended for adults age 18 and older,
information on how consumers may report adverse events, information on
any contraindications, conditions, or symptoms of medically treatable
causes of hearing loss, and advisements to consult promptly with a
licensed healthcare practitioner. In addition, section 709(b)(2)(A) of
FDARA directs FDA to establish requirements that provide reasonable
assurances of the safety and effectiveness of OTC hearing aids, and we
intend the proposed labeling requirements to do so.
    In considering which statements to require, we note the important
role of information in supporting broader use of OTC hearing aids. As
part of the 2016 FDA hearing aid workshop, the Hearing Loss Association
of America presentation stressed the importance of clear labeling to
inform consumers so that the consumer ``is empowered and knows what
they're buying and knows the limitations and what's possible'' (Refs. 9
and 10). FDA agrees, and we have proposed labeling requirements to
empower consumers.
    Further the proposed conspicuous statement that OTC hearing aids
are intended for people age 18 years and older is necessary because the
use of OTC hearing aids in people younger than 18 presents risks to
health beyond those typically associated with use in older people.
Whereas hearing loss in older adults is most commonly related to noise
exposure and aging, the etiology (causes) of hearing loss in younger
people is varied and may result from conditions that warrant prompt
diagnosis to avoid serious risks to health. These conditions may not be
readily apparent and can include, but are not limited to:
     Congenital malformations (present since birth) of the
external, middle, or inner ear;
     Infections, for example, otitis media (an inflammation of
the middle ear) or congenital infections;
     Genetic causes, including hereditary syndromes that can
involve cardiac, ophthalmic, renal, neurologic, and other organ systems
(that is, syndromes that can involve the heart, eyes, kidneys, nerves,
and other organs); or
     Certain exposures, for example, lead poisoning,
hyperbilirubinemia (a buildup of a metabolic byproduct, bilirubin, in
the blood), and drug ototoxicity (a toxic effect on the ear or its
nerves).
    The use of a hearing aid to treat hearing loss related to these
conditions, without a medical evaluation, may delay diagnosis and
treatment of the

underlying condition. Further, prompt diagnosis is critical because,
left untreated, these conditions may worsen, with potentially lifelong,
adverse health effects. Because the use of OTC hearing aids in people
younger than 18 presents risks to health beyond those typically
associated with use in older people, the proposed conspicuous
statements are appropriate and provide reasonable assurance of safety
and effectiveness of OTC hearing aids.
    The proposed labeling provisions include requirements for labeling
on the package and inside the package, along with requirements for
labeling on the device itself. These requirements would apply in
addition to all other applicable labeling requirements in, for example,
parts 801 and 830. In any of the labeling, manufacturers could continue
to include additional truthful, non-misleading information provided it
does not conflict with other requirements (such as those mentioned
above).
    In proposing where to place labeling statements--on the package or
inside the package--we have considered when users, prospective users,
and others should become aware of information (before or after
purchase). We have also considered the limited space available on the
packaging as well as simplicity of format.
    FDA welcomes your comments on the proposed labeling requirements,
including the placement or conspicuousness of statements, as well as
whether the statements are clear and understandable. For example, in
reviewing the proposals, did you find important information quickly?
Did you find the information clear and easy to understand? We are
particularly interested in your feedback about phrasing or formatting
to convey information to people who are anticipated users, or more
generally, who are not hearing health professionals. A rationale or
evidence would make your feedback more useful. For example, if a
proposed statement is unclear, telling us why is generally more helpful
than saying only that you find the statement to be unclear.
1. Package Labeling
    We are proposing that the outside of the package include
information that consumers would need to know prior to purchasing the
device, such as who is a candidate for the device, how to determine if
you are a candidate, and when to seek professional help before trying
the device. We believe this information empowers consumers and answers
threshold questions about the suitability of purchasing an OTC hearing
aid for their hearing needs. This proposal would also emphasize who the
intended user is, to reduce the likelihood that people younger than 18
would purchase or use an OTC hearing aid.
    To summarize, the proposed statements on the package describe:
     A conspicuous warning that the device is not for users
younger than 18 years old;
     The symptoms of perceived mild-to-moderate hearing loss;
     Considerations for seeking a consultation with a hearing
healthcare professional; and
     Red flag conditions: Warnings to consumers regarding signs
and symptoms that should prompt a consultation with a licensed
physician (preferably an ear specialist).
    However, we are not proposing to require other information on the
package, for example, mobile operating system compatibility or whether
the package contains the necessary batteries. Further, we are proposing
language that accurately conveys information to readers without relying
on specialized knowledge (i.e., for laypeople). We welcome your
comments on whether to require other information on the package
labeling and whether you had any difficulty understanding the
information (and if so, your suggestions for improvements).
    a. Symptoms suggesting perceived mild to moderate hearing loss.
Prospective users may not know their definitive degree, configuration,
or etiology of hearing loss. That is, they may not know the exact
nature or cause, so commenters for the public meeting discussed various
ways to communicate the signs of perceived mild to moderate hearing
loss and reasons to seek medical evaluation. They generally agreed that
such information should appear on the outside of the package. We agree
with this sentiment and are proposing that the information be readily
apparent prior to purchase to help people to determine whether an OTC
hearing aid may benefit them.
    To that end, we are proposing four scenarios that a person may
recognize (symptoms) that suggest perceived mild to moderate hearing
loss. We have selected these scenarios because they commonly present
difficulties to people with perceived mild to moderate hearing loss and
are situations in which users are likely to benefit from the use of OTC
hearing aids. We have also based the selection on stakeholder input
from the public workshops. Although people with normal hearing may
sometimes experience these scenarios, people with perceived mild to
moderate hearing loss will experience them more frequently, if not
regularly. We have phrased the information to emphasize that the device
is intended for people who are 18 or older, and the phrasing avoids
medical and technical terms while describing everyday situations.
    b. Considerations for seeking consultation with a hearing
healthcare professional. However, because a prospective user may have
hearing impairment beyond, or different from, perceived mild to
moderate hearing loss, we are proposing a statement to assist people in
evaluating the potential for increased benefit from an OTC hearing aid.
We believe this information is important, and have titled it as such,
and appropriate for users and prospective users who are not familiar
with hearing aids.
    c. ``Red flag'' conditions. In that vein, we are proposing to
continue to require a statement advising users and prospective users to
seek medical care if they exhibit any one of a number of conditions. We
are not modifying the list of conditions from its present form except
for phrasing and formatting changes to improve readability, as well as
a change to the time periods (from 90 days to 6 months). We intend the
change to the time periods to encourage consumers to consider a longer
personal history, which may help them to identify the conditions
without the involvement of a licensed person. The list includes
reliable indicators of the possibility of an underlying medical
condition that a hearing aid cannot treat. For example, fluid, pus, or
blood coming out of the ear may indicate an active infection, as could
sudden, quickly worsening, or fluctuating hearing loss. An examination
by a physician, preferably an ear specialist, would determine whether
such an underlying condition is present and treatable, potentially
halting or reversing hearing loss.
    d. Other information. We are also proposing to require that the
outside package include a web address and telephone number for
consumers to access a digital copy or request a paper copy of all
labeling, including the labeling inside the package, for that OTC
hearing aid. A website could provide easy access to the more
comprehensive information found in the labeling inside the package and
could allow the use of other media to convey information.
    FDA is proposing to require that this labeling be available online
or be able to be requested by phone prior to purchase to facilitate
product familiarity to make a purchasing decision. We believe having
the information found inside the package will help prospective users

choose a safe and effective device without the involvement of a
licensed person. As proposed, this information would be available
without the need for consumers to register for access, for example, by
registering for a website member login.
    Further, a download page could include, but would not be required
to include, additional resources, for example, video explanations or
tutorials to aid prospective users in selecting and using a device, as
well as a mechanism for reporting complaints or adverse events. Since
such additional resources would not be required under this proposal,
accessing such resources could entail, for example, registering as a
website member.
    Please note that we are not proposing to require the distribution
of paper copies for all OTC hearing aids because an analogous provision
in the Hearing Aid Restrictions yielded little benefit--very few people
requested a review of the paper copy--while adding to the regulatory
burden. We are seeking comment on these proposed requirements (and any
other portion of this proposed rule) regarding equitable access to the
information and/or OTC hearing aids.
    We are also proposing to require that the manufacturer disclose its
return policy or, if none, state that it does not accept returns. Such
a requirement would be appropriate, because prospective users of OTC
hearing aids may be unsure whether an OTC hearing aid will meet their
hearing needs. If an OTC hearing aid does not meet a user's hearing
needs, the user may leave the device in the ``dresser drawer.'' (This
is a common description of the phenomenon of relegating the device to
disuse--putting it away, never to use it again--and foregoing the
potential benefit of a more-satisfactory device). Thus, a statement of
the return policy would be appropriate because, without the services of
a licensed person, some users may be more dependent on the
manufacturer's return policy (as opposed to the licensed person's) to
avoid leaving an OTC hearing aid in the dresser drawer. A statement of
the return policy would provide appropriate information to prospective
users to help them determine the suitability of options given
individual circumstances and preferences such as budget and willingness
to try multiple OTC hearing aids. Additionally, consistent with the
existing hearing aid requirement in Sec.  801.420(c)(5), we are
proposing that, when an OTC hearing aid is used or rebuilt, the outside
package declare that fact. These requirements would advance the public
health by facilitating the purchase of devices that meet users' hearing
needs.
    We are not proposing to require that manufacturers accept returns
under these proposed Federal regulations. However, we likely would not
consider a generally applicable State or local requirement to accept
returns (i.e., the requirement applies to any product) as a requirement
specifically related to hearing products. Further, we believe that a
State or local requirement for retailers (persons who sell to end
users) to accept returned OTC hearing aids would likely promote--rather
than restrict or interfere with--commercial activity involving the
devices by reducing the financial risk to purchasers. As such,
generally, State or local requirements for returns would continue to
apply provided they do not conflict with the final rule based on this
rulemaking. We are seeking comment on whether such a State or local
requirement would promote, rather than restrict or interfere with,
commercial activities involving OTC hearing aids.
    Participants at the June 9, 2017, NASEM public workshop generally
agreed with the importance and utility of requiring certain information
on the package. Participants discussed potential labeling requirements
such as these for OTC hearing aids (see Ref. 11). Numerous participants
focused on the signs and symptoms of consumers who have mild-to-
moderate hearing loss and might potentially benefit from OTC hearing
aids. Specifically, participants expressed concerns that consumers
would need information to help decide whether to purchase the products
and/or whether to seek professional services. The proposed requirements
in this document have taken these comments into account.
2. Labeling Inside the Package
    We are proposing to require that manufacturers place labeling
inside of the package with the information that consumers will need
after purchasing an OTC hearing aid for its safe and effective use. The
proposed content of this labeling includes:
     Warnings, cautions, and notes, including a conspicuous
statement warning against the use of the OTC hearing aid in people
younger than 18 years old as well as a warning regarding ``red flag''
medical conditions to prompt consumers to consult with a licensed
physician and a note about how to report adverse events to FDA;
     Illustration(s) of and information about the controls,
user adjustments, and the battery compartment;
     A description of any accessory that accompanies the OTC
hearing aid;
     Adequate directions for use, consistent with Sec.  801.5
(21 CFR 801.5), including but not limited to information on sizing and
inserting the eartip as well as the tools, tests, or software that
allow the user to control and customize the OTC hearing aid to the
user's hearing needs (e.g., to self-select, self-fit, and self-check
the performance of the device);
     Technical specifications to allow users, prospective
users, and others to evaluate and compare the performance of OTC
hearing aids;
     Description of commonly occurring, avoidable events that
could adversely affect or damage the OTC hearing aid;
     Identification of known physiological side effects
associated with using the OTC hearing aid that may warrant consultation
with a physician, including but not limited to skin irritation and
accelerated build-up of ear wax (cerumen accumulation);
     Information on repair services; and
     If clinical or non-clinical studies were conducted by or
for the manufacturer to support the performance of the OTC hearing aid,
a summary of all such studies.
    We believe these labeling requirements for OTC hearing aids will
help provide reasonable assurance of safe and effective use of OTC
hearing aids for consumers with perceived mild-to-moderate hearing
loss. We intend the proposed labeling requirements to provide lay
consumers with adequate information, in particular, to ensure that
those purchasing OTC hearing aids know when to seek professional
intervention, how to use the device safely and effectively, and where
and how to obtain additional information or assistance. The 2016 NASEM
report supports FDA's proposal in that it similarly recommends that OTC
hearing aids ``[i]nclude thorough consumer labeling, including
information on:
     Frequency gain characteristics;
     adequate directions for use;
     communication challenges for which it may be helpful to
seek professional consultation; and
     medical situations, symptoms, or signs for which to
consult with a physician'' (Ref. 6).
    We agree that thorough consumer labeling will assist users,
potential users, and others with selecting, fitting, and wearing OTC
hearing aids. Even so, the proposed requirements in this rulemaking are
not intended as a substitute for other FDA regulations. Thus, for
example, if adequate directions for use were to require additional
information beyond that proposed in this rulemaking, manufacturers
would need to include

that additional information (see Sec.  801.5 regarding adequate
directions for use).
    As for the NASEM report's recommendations for OTC hearing aids
regarding information about communication challenges and medical
indicators, we agree that such information will help provide reasonable
assurance of safety and effectiveness, and we have included that
information, as well as the full-on gain value in our proposed labeling
requirements. (Gain is a measure of amplification, and its full-on
value is its maximum. We provide an explanation of gain in section
III.D.2.)
    We are not proposing to require additional technical information in
the labeling for OTC hearing aids other than those in proposed Sec.
800.30(c)(4); however, the labeling may optionally include such
information if desirable. For example, technical information similar to
what is currently required for all hearing aids may be useful in
assisting audiologists offering services to users (see Sec.
801.420(c)(4)). Multiple stakeholders voiced a similar view during the
2016 FDA workshop (Refs. 9, 10, and 12). Some added that scientific or
technical information (in addition to the information we are proposing
to require for OTC hearing aids) may be meaningful for consumers to
make their decisions, especially if they are familiar with the
technology. Although such additional information may be desirable for
some consumers, FDA does not believe it is necessary to assist
consumers in their selection.
    FDA intends to issue at a later date a separate comprehensive
guidance document that discusses, in part, labeling information and
communicating that information with the goals of increasing
transparency and choice to consumers. In accordance with 21 CFR 10.115,
we will announce the availability of the draft of that guidance
separately from this rulemaking, and the announcement will include
information for submitting comments about that guidance, which will be
separate and distinct from comments for this rulemaking. We do not
intend to consider comments submitted to the docket for this rulemaking
unless they pertain to the proposals in this document.
3. Labeling on the Device Itself
    We are proposing to require that the labeling on the device itself
include the serial number and symbol(s) for proper battery insertion
orientation when applicable. If the device has been used or rebuilt, a
tag indicating such would have to be physically attached to the device
in addition to the statement on the outside of the package.

D. Output Limits (Proposed Sec.  800.30(d))

    FDA is proposing a maximum acoustic output limit requirement for an
OTC hearing aid to provide reasonable assurance of safety and
effectiveness. Section 709(b)(2)(B) of FDARA directs FDA to establish
or adopt output limits appropriate for OTC hearing aids. A high output
can be unsafe and further impair hearing. However, too low an output
reduces device effectiveness and can lead to poor device performance,
including clipping and distortion. In turn, poor performance would
reduce consumer satisfaction and use of the devices. We believe that
the proposed output limits balance the above considerations for these
devices, so the limits are therefore appropriate for OTC hearing aids.
1. Overview of Proposed Output Limits
    We propose a maximum OSPL90 output level of 115 dB sound pressure
level (SPL) as a general rule to balance consumer safety with device
performance.\7\ However, we would permit a limit of 120 dB SPL for an
OTC hearing aid that implements input-controlled compression and a
user-adjustable device volume control (i.e., volume adjustment). This
is because a user-adjustable volume control allows the user to reduce
the output below the maximum, in effect, further reducing the device's
limit. Input-controlled compression is an automatic function that
dynamically reduces the output of frequency ranges based on the input.
Both of these design features thus reduce the likelihood that a user
will experience high acoustic outputs, at the device's limit, at any
given moment. Relatedly, we are proposing that the device labeling
state the value of the maximum OSPL90 level (see section III.C.1).
---------------------------------------------------------------------------

    \7\ OSPL90 is an abbreviation for the sound output as measured
in a standardized way. ANSI/ASA S3.22-2014 defines it as the SPL
developed in the specified 2-cm\3\ earphone coupler when the input
SPL is 90 dB with the gain control of the hearing aid full-on. To
simplify, this describes a way to simulate amplifying a sound into
the ear canal, providing a standardized measurement for the
amplified output.
---------------------------------------------------------------------------

    We have proposed output limits to prevent injuries from exposure to
loud sounds when amplified by OTC hearing aids while still allowing a
sufficient dynamic range of outputs, called ``headroom,'' to provide
effective amplification for users with perceived mild to moderate
hearing loss. A device without sufficient headroom (when the output
limit is too low) would not be as effective as a device with a higher
output. However, a device with too high an output limit could further
worsen hearing impairment.
2. Data and Stakeholder Perspectives on the Proposed Output Limit
    We base the proposed limits on physiological data and stakeholder
input, some of which appear in Clause 4.3 of ANSI/CTA-2051, a voluntary
consensus standard (Ref. 13). Note that, although ANSI/CTA-2051 is a
consensus standard for PSAPs, we believe that this standard is also
relevant for OTC hearing aids, which provide personal sound
amplification, albeit for purposes of aiding with or compensating for
impaired hearing. The standard's basis for the output limit is a
national workplace safety guideline, Occupational Noise Exposure, from
the National Institute for Occupational Safety and Health (NIOSH) (Ref.
14). NIOSH developed this standard, which we will refer to as NIOSH-98,
to define permissible exposure time depending on the intensity of the
sound.
    In general, the relationship between the loudness (SPL) and the
time before damage to hearing is inversely related: The louder the
sound, the shorter the time before hearing damage. Above about 85 dBA
(A-weighted decibels), the exposure time is cut in half for every 3 dB
increase in sound level (Ref. 14).\8\ Thus, the difference between
recommended exposure times for 115 dB SPL and 120 dB SPL is
approximately 61 seconds, where 115 dB SPL provides approximately
triple the permissible exposure time than 120 dB SPL (see the next
section for a more detailed explanation of the ``3-dB exchange rate'').
---------------------------------------------------------------------------

    \8\ Weighting sound levels means that different frequency ranges
have different values (weights) added or subtracted to them, so for
example, lower frequencies may receive more weight than higher
frequencies for the purpose of expressing the sound level. Different
sets of weighting values have different purposes. A-weighting tries
to account for the fact that the human ear is less sensitive to
lower frequencies, which generally do not sound as loud to people as
higher frequencies at the same SPL. Therefore, A-weighted decibels
can be useful to express how a listener might perceive a sound level
when considering the ear's variable sensitivity to different
frequencies. This weighting method is common but is not the only one
that accounts for human hearing perception. C-weighting is another.
---------------------------------------------------------------------------

    Appendix A of ANSI/CTA-2051 describes this tradeoff between output
level and exposure time, providing a rationale for a maximum OSPL90
output limit of 120 dB based on NIOSH-98. For the purposes of that
standard, NIOSH found that 115 dBA SPL is acceptable for up to about 30
seconds. ANSI/CTA-2051 explains that this allows the user sufficient
time to turn off or remove the hearing aid before the exposure becomes

unacceptably dangerous to hearing ability. ANSI/CTA-2051 observes that
sound levels of desirable, ``real-life sonic events'' can approach the
NIOSH-98 level, for example, a live symphony in which a user would want
to experience ``occasional peaks'' undistorted. However, a lower output
limit would not allow enough headroom for a faithful reproduction of
such peaks and would lead to output clipping or distortion. Thus, a
limit that allows desirable peaks, but sufficient time to react to
undesirably loud sounds, would be ideal. As ANSI/CTA-2051 explains, 115
dBA is equivalent to an OSPL90 value of approximately 120 dB SPL with
an allowance of 28 seconds to react.
    FDA agrees that an OTC hearing aid should provide sufficient
headroom to amplify relatively loud sounds such as those in a symphony,
yet the device should not have an output so high that the user does not
have time to act before sustaining injury. Further, the output should
not be consistently at a limit of 120 dB SPL, accomplished through the
inclusion of input-controlled compression and user-adjustable volume
control.
    In addition to considering the ANSI/CTA and NIOSH standards
supporting the proposed limits, we considered stakeholder input. On
June 9, 2017, NASEM held a public workshop meeting where participants
discussed, among other topics, a 120-dB SPL maximum output limit for an
OTC hearing aid (see Ref. 11). Numerous speakers commented that an
OSPL90 output limit somewhat lower than 120 dB SPL for OTC devices
would likely still provide sufficient amplification and headroom for
individuals with perceived mild to moderate hearing loss while
providing a safety margin in terms of sound-intensity exposure.
    Additional comments during the NASEM workshop raised the importance
of input-controlled compression and the inclusion of a user-adjustable
volume control in order to help reduce overamplification. Each of those
features can limit the device's output by dynamically reducing device
gain as the input level increases, thus increasing the safety profile
of a device: The user generally would not be listening at louder output
levels as often as would occur without these features.
    FDA has also reviewed numerous public comments on the risk of harm
from excessive output, stemming from our 2016 public workshop,
Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids (see
Refs. 9, 15, and 16). We agree that excessive amplification from OTC
hearing aids could pose a risk to individuals' health and thus are
proposing that the maximum output (OSPL90) of OTC hearing aids not
exceed a certain value, depending on device design features, that would
provide users enough time to react to loud sounds to prevent injuries.
    Some stakeholders have suggested inclusion of gain limits for OTC
hearing aids. Gain is a measurement based on the ratio between the
output and the input or, to simplify further, how much the device
amplifies (or reduces) the input. A gain limit would further reduce the
maximum device output because the device would sometimes reach the gain
limit, providing no further amplification, before it reached the output
limit. We are proposing not to limit the device gain because we believe
that the proposed maximum output limit (together with the other
proposed requirements) will provide reasonable assurance of safety and
effectiveness without limiting the device gain also.
    Moreover, a gain limit may unduly constrain the design of effective
devices. Appropriate gain characteristics can depend on the
implementation of the amplification circuit design (e.g., linear
amplification versus wide dynamic range compression). Thus, appropriate
gain settings for one device may not be appropriate for another device
of a different design. We believe that allowing flexibility in the gain
settings will help maximize the effectiveness of the particular circuit
design a manufacturer implements for a device to address perceived mild
to moderate hearing loss. In light of this, and since a maximum output
limit would also in effect limit gain, we do not believe a separate,
additional gain limit is necessary to provide reasonable assurance of
safety and effectiveness. We also note that the NASEM report does not
recommend any limit on gain for OTC devices, only on maximum output
(Ref. 6).
3. The Proposed Output Limit Requirements Help Provide Reasonable
Assurance of Safety and Effectiveness
    In further consideration of user-adjustable volume controls and
input-controlled compression, we believe that these two design features
together will sufficiently mitigate the risk of a higher maximum output
limit (from 115 dB SPL up to and including 120 dB SPL) by reducing the
likelihood that the user will experience excessive sound levels for
periods long enough to sustain damage to hearing (Ref. 14). Input-
controlled compression such as wide dynamic range compression is also
associated with hearing performance benefits in realistic environments
that have varying levels of sound intensity for persons with mild-to-
moderate sensorineural hearing loss (see, e.g., Refs. 17 to 21). That
is, besides reducing the device's effective output limit, input-
controlled compression also generally helps users hear better in daily
situations.
    In reaching this proposal on output limits, we note that hearing
aids, including OTC hearing aids, are intended to be worn during all
waking hours in a wide variety of listening environments and
situations. Thus, user comfort is relevant to safety and effectiveness,
and input-controlled compression and user-adjustable volume control
increase comfort by dynamically adjusting gain and keeping outputs
lower. This contributes to effectiveness and user satisfaction because
users are generally more willing to wear a comfortable device
consistently, maximizing the benefits of the device and the impact on
public health.
    We are not proposing to require input-controlled compression and a
user-adjustable volume control for all OTC hearing aids, however. Thus,
devices that do not have both of these features (which, in effect,
reduce the device's output limit) would have to respect a 115 dB SPL
limit, which would more than triple the safe exposure time compared to
a 120 dB SPL limit (Ref. 14).\9\ Users would have ample time to take
appropriate action to mitigate unacceptably high sound levels, for
example, by adjusting the volume (if the device has a user-adjustable
volume control), turning the device off, removing the device from the
ear, or moving out of the loud environment. As noted above, the device
labeling would also be required to include a reminder to consumers
that, if they are in a loud listening environment that warrants hearing
protection, they should remove their hearing aid(s) and use hearing
protection.
---------------------------------------------------------------------------

    \9\ Based on the 3-dB exchange rate--above 85 dB SPL, the time
halves for each 3-dB increase--of Clause 1.1.1 of NIOSH-98, which is
used by ANSI/CTA-2051, exposure to 115 dB SPL is 2(\5/
3\) or 3.17 times the ANSI/CTA-2051 recommended exposure
limit of 28 seconds for 120 dB SPL, equaling approximately 89
seconds.
---------------------------------------------------------------------------

    To summarize, we believe that a 115 dB SPL output limit would help
provide reasonable assurance of safety and effectiveness for the
intended population. However, we acknowledge that 120 dB SPL could have
additional effectiveness potential in certain circumstances, for
example, when listening to a symphony by a live orchestra (Ref. 13). As
discussed above, we believe that achieving that potential would be safe
only if the device also

includes input-controlled compression and a user-adjustable volume
control. Overall, we believe this device-design contingent proposal for
output limits helps provide reasonable assurance of safety and
effectiveness of OTC hearing aids while providing ample design space
for innovation.

E. Other Requirements (Proposed Sec.  800.30(e) and (f))

    Although certain labeling and output limits are necessary for
reasonable assurance of safety and effectiveness of OTC hearing aids,
these requirements alone are not sufficient to do so. FDA is therefore
proposing that the devices must meet certain performance and design
requirements in order to help provide reasonable assurance of safety
and effectiveness, pursuant to section 709(b)(2)(A) of FDARA.
1. Electroacoustic Performance Requirements To Help Provide a
Reasonable Assurance of Safety and Effectiveness
    We are proposing to establish electroacoustic performance
requirements to help ensure that the output of an OTC hearing aid
safely and effectively compensates for perceived mild to moderate
hearing loss in people age 18 and older. Electroacoustic performance
describes how well a hearing aid converts an electrical signal, either
digital or analog, into a sound (acoustic energy) or vice versa.
Currently, hearing aid labeling must include technical data for certain
performance characteristics gathered according to the test methods
specified in ANSI/ASA S3.22-2003 (see Sec.  801.420(c)(4)). We do not
believe, however, that the data that conform to ANSI/ASA S3.22 are
adequate for consumers to select their own hearing aid without the
supervision, involvement, or intervention of a licensed person (among
other reservations).
    This is because ANSI/ASA S3.22 does not specify any minimum
performance requirements. Instead, it specifies tolerances, which are
acceptable ranges of deviation from manufacturer-stated specifications.
The manufacturer, not a standard, determines how the hearing aid
performs. As a result, achieving optimal hearing aid performance
currently depends in part on interpreting the technical data supplied
by the manufacturer for selection and adjustment. The interpretation of
this information is highly technical, so the information is useful to a
professional but generally not the lay user.
    For OTC hearing aids, we believe that the devices must meet certain
electroacoustic performance specifications so that any OTC hearing aid
would perform safely and effectively for perceived mild to moderate
hearing loss after the user customizes the device for individual needs.
To that end, we are proposing to use several applicable specifications
for device performance from ANSI/CTA-2051 for OTC hearing aids. A
device that met these performance specifications would safely and
effectively reproduce sounds without the need for professional
involvement.
    Specifically, an OTC hearing aid should provide amplification with
high fidelity so that the user can accurately perceive daily social and
environmental sounds. High-fidelity (accurate) output means that the
device reproduces the input frequencies clearly, without distortion and
without undue frequency shaping. We believe such an OTC hearing aid
will have certain performance characteristics to achieve fidelity: The
OTC hearing aid would have sufficiently low distortion, would not
introduce excessive self-generated noise or time delays between input
and output, and would provide a sufficient frequency response bandwidth
and smoothness. An OTC hearing aid would have to achieve these, after
customization to the individual's hearing needs, without the
intervention of a licensed professional; that is, by design.
    We have reviewed ANSI/CTA-2051:2017, which includes specifications
for electroacoustic performance, and we believe that performance
requirements based primarily on its Category 1 specifications would
help provide reasonable assurance of safety and effectiveness of OTC
hearing aids.\10\ These specifications relate to the device's
processing of the input sound (the sounds detected by the device) to
generate the output sound (the amplified sound that the device produces
to assist the user). To summarize, FDA believes that the specifications
that would help provide reasonable assurance of safety and
effectiveness, as well as set an objective baseline for device
performance, are:
---------------------------------------------------------------------------

    \10\ Note that the consensus standard includes a maximum
acoustic output as a Category 1 specification; however, we are
proposing a different maximum output level rather than the consensus
standard's (see section III.D). Additionally, we are proposing a
latency limit, which the standard includes as a Category 2
specification.
---------------------------------------------------------------------------

     Distortion control limits;
     Self-generated noise limits;
     Latency limit;
     Frequency response bandwidth; and
     Frequency response smoothness limits.
    We believe that the above listed electroacoustic requirements would
ensure that an OTC hearing aid can accurately reproduce daily speech
and other environmental sounds without the need for professional
involvement. We believe that this performance level is requisite for
the device to meet the needs of people with perceived mild to moderate
hearing loss. Likewise, the performance requirements would help ensure
that undesirable effects (such as distortion) do not impair safety and
effectiveness.
    ANSI/CTA-2051 is, to FDA's knowledge, the first voluntary consensus
standard to describe performance characteristics for hearing amplifiers
(as opposed to standardized test methods and tolerances). Upon
reviewing the voluntary consensus standard, and in consideration of
related presentations during FDA's 2016 hearing aid workshop, we
believe that the rationale and methodology of the standard are sound,
and we believe that adhering to the specifications in this standard
would yield high-fidelity OTC hearing aids. However, we are proposing
to establish as requirements the subset of those specifications that we
believe would help provide reasonable assurance of safety and
effectiveness in conjunction with the other proposals in this
rulemaking.
    Whether to require such electroacoustic performance specifications
for OTC hearing aids, and the specific values, were topics of
discussion during the June 9, 2017, NASEM public workshop (Ref. 11).
Additionally, public presentations of amplification measurements at
FDA's hearing aid workshop showed performance differences and
suitability in terms of frequency response bandwidth and smoothness
across devices that presenters considered (Refs. 9, 15, 16, 22). After
seeing such information, several participants opined that the Category
1 limits of ANSI/CTA-2051, together with the device latency limits (a
Category 2 limit in ANSI/CTA-2051), would collectively help ensure
safety and effectiveness of an OTC hearing aid with respect to its
electroacoustic performance.
    In addition to the performance aspects of the voluntary consensus
standard, we recognize that aligning FDA regulations with a voluntary
consensus standard may reduce administrative burdens while encouraging
and facilitating greater availability of safe and effective OTC hearing
aids. Note that we are not proposing to apply the electroacoustic
performance requirements to

prescription hearing aids, nor are we proposing to establish
requirements for OTC hearing aids that mirror the technical data
requirements under current Sec.  801.420(c)(4). We expect that the
involvement of a licensed professional for prescription hearing aids
will help provide for reasonable assurance of safety and effectiveness
for those devices. Similarly, although the technical data in current
Sec.  801.420(c)(4) will assist licensed professionals to select and
fit a prescription hearing aid, we do not believe that the technical
data are generally helpful for lay users of OTC hearing aids that meet
electroacoustic performance requirements.
    a. Distortion control limits. Distortion control limits describe
how faithfully an OTC hearing aid reproduces a given frequency or range
of frequencies at a given sound pressure level. An OTC hearing aid that
produces less perceptible total harmonic distortion, plus hearing-aid-
originated noise (i.e., total harmonic distortion plus noise), will
deliver a higher-fidelity sound to the user, meaning that the user will
be able to perceive sounds more accurately or clearly than a device
with higher perceptible total harmonic distortion plus noise. Total
harmonic distortion plus noise can depend on both the input and output
sound pressure levels and the corresponding (level-dependent) gain
settings of the device if applicable. We believe that the proposed
allowable levels of total harmonic distortion plus noise, when measured
as proposed at the specified sound pressure levels, will help ensure
accurate or clear amplification for the user of an OTC hearing aid.
    b. Self-generated noise level limit. The self-generated noise level
limit describes the maximum sound pressure level of noise that the OTC
hearing aid may produce, where ``self-generated noise'' means sounds
that are present in the output but not the input. Excessive self-
generated noise can obscure or overwhelm softer output sounds,
preventing the user from hearing such sounds. Excessive self-generated
noise may also distract or annoy users. Appropriately limiting self-
generated noise will therefore help users to hear softer output sounds
as well as improve their experience by avoiding the production of
perceptible noise or sounds that are not input sounds. We believe that
the proposed rule will appropriately limit self-generated noise.
    c. Latency limit. The latency limit describes how quickly an OTC
hearing aid produces the output sound relative to the input sound. A
shorter latency interval means that the device takes less time to
produce the output, and when short enough, the user will not perceive a
delay. A perceived delay is generally most noticeable when the device
amplifies the user's own voice, causing an effect much like an echo
that can be disorienting, distracting, or annoying. We believe that the
proposed latency limit will help to avoid perceptible output delays
that would reduce the benefit from an OTC hearing aid.
    d. Frequency response bandwidth. The frequency response bandwidth
of an OTC hearing aid is the range of frequencies that the device can
reproduce for the user to hear. Cutoff frequencies, both lower and
upper, are the limits of the bandwidth. The device would generally not
sufficiently amplify signals with frequencies outside of these limits,
meaning, below the lower cutoff or above the upper cutoff. A wider
bandwidth means that the device can amplify a broader range of sound
frequencies for users to hear. A bandwidth that is too narrow,
especially if the upper cutoff is too low, will result in insufficient
amplification of critical high-frequency sounds, including but not
limited to speech sounds such as /s/,/z/,/t/, and/sh/. We believe that
the proposed required frequency bandwidth, 250 Hz to 5 kHz, will ensure
amplification of daily speech or other environmental sounds because
almost all such sounds typically fall between these proposed lower and
upper cutoff frequencies.
    e. Frequency response smoothness limit. The frequency response
smoothness limit describes how uniformly the OTC hearing aid amplifies
different frequencies over its bandwidth. A uniform frequency response
when graphed would correspond to a smooth and relatively uniform curve,
which is the ``smoothness'' described by this limit. To describe this
requirement, we divide the frequency range into multiple, narrower
ranges called one-third octave bands. Any given peak in a one-third
octave band would have to remain below a set level compared to
neighboring bands, two bands above and two bands below, based on the
averages. Meeting this requirement for frequency response smoothness
means that the amplification performance is consistent across
frequencies for users.
    If a device does not amplify sounds uniformly across frequencies,
the user would potentially perceive differences in intensity for
different frequencies, reducing the audio fidelity and consequently the
user's hearing perception. This may include a perceptibly altered
speech quality (such as undue changes in the tone or timbre of the
intended sound), which may be distracting or annoying. In addition,
device output that is relatively excessive at lower frequencies
(compared to higher frequencies) poses an increased risk for damaging a
user's hearing at lower frequencies. This is because the typical user
has more residual hearing (i.e., better hearing thresholds) at lower
frequencies, consistent with a typical sloping hearing loss, the kind
of hearing loss associated with aging. We believe that the proposed
frequency response smoothness limit will ensure consistent performance
across frequency ranges and thereby help to provide reasonable
assurance of device safety and effectiveness.
    f. Performance test methods. For each of these proposed
electroacoustic requirements, we are specifying performance test
methods, including input and output sound pressure levels when
appropriate. We are proposing specific performance test methods because
different test methods could yield different results for the same
metric of device performance. Thus, specifying test methods helps
establish a common baseline to benchmark performance for any given
device. Additionally, a common baseline would allow prospective users
and others to compare electroacoustic performance across devices.
Facilitating comparison shopping may also promote users' satisfaction
with the OTC hearing aids that they decide to purchase.
2. Design Requirements To Ensure Proper Physical Fit and Prevent User
Injury
    We are proposing that the design of an OTC hearing aid must meet
certain requirements for safety and effectiveness:
     Maximum insertion depth;
     Eartip made from atraumatic materials;
     Proper physical fit; and
     Tools, tests, or software allowing the lay user to control
the device and customize it to the user's hearing needs.
    The above listed requirements seek to balance effective fit and
safe fit of an OTC hearing aid, accomplished by users themselves,
without professional assistance. An OTC hearing aid eartip (the part of
the OTC hearing aid that contacts and fits into the user's ear) must
fit the user so the device performs optimally, but an OTC hearing aid
must not damage the ear, including the ear canal and eardrum (tympanic
membrane).
    The device could damage the ear by scratching (abrading) the skin
around the eartip parts, puncturing the eardrum, or exacerbating
hearing loss if

the device is too close to the eardrum. In particular, the skin that
lines the ear canal is especially thin and delicate. The lateral
(outer) third of the canal is composed of cartilage, and the medial
(inner) two-thirds, which ends at the ear drum, of bone. Each of these
parts of the ear is therefore quite sensitive and easily injured. To
provide reasonable assurance of safety and effectiveness, the design of
an OTC hearing aid must allow insertion and prolonged contact with
these sensitive areas while preventing injury to them. We believe the
above listed requirements would ensure proper physical fit for optimal
performance while avoiding injury to the user's ear canal skin, bony
inner ear canal, the eardrum, or other middle ear structures.
    a. Maximum insertion depth. We considered whether we could express
a design requirement for manufacturers for maximum insertion depth as a
given length. However, specific anatomical dimensions such as the
length of the cartilaginous and bony portions of the external auditory
canal and distance to the tympanic membrane can vary greatly among
adults. That is, the distance to the eardrum differs greatly from
person to person. A given length may be too long for one person
(potentially resulting in injury with device insertion or placement)
but too short for another (potentially impairing device performance by
too shallow of an insertion). In contrast, we believe that the bony-
cartilaginous junction is a readily identifiable and consistent
anatomical landmark that can serve as a design limit for manufacturers
of OTC hearing aids. That is, we believe a practical way to describe
the depth limit is to base it on the area of the ear canal
corresponding to where cartilage meets bone. However, we welcome
comments, particularly those with support from peer-reviewed sources,
about other design requirements (e.g., in terms of absolute length) to
limit the insertion depth and prevent damage to the tympanic membrane
or other injuries while also promoting device effectiveness.
    b. Construction from atraumatic materials. We are proposing that
the eartip be encased by atraumatic materials, that is, materials that
prevent injuries to the skin and bone, for example, because they are
very flexible. The use of atraumatic materials reduces the chance that
daily use or accidental contacts will cause damage to the delicate skin
or bone of the ear.
    c. Proper physical fit. We are proposing that the OTC hearing aid
have features that enable users to readily achieve a safe, customized,
acoustically favorable, and comfortable physical fit in the ear canal
and/or external ear. For example, the manufacturer may wish to provide
interchangeable eartips of varying sizes. However, we are not proposing
a specific design feature or strategy because such specificity may
constrain the design of an OTC hearing aid and impede design
innovations. This proposed requirement corresponds with the proposed
labeling requirements to describe how users may obtain such a fit,
including sizing or inserting the eartip to minimize the risk of
injury.
    d. Tools, tests, or software. We are proposing to codify the
requirement that an OTC hearing aid must include tools, tests, or
software through which a lay user can control the device and customize
it to the user's hearing needs. Examples of tools, tests, or software
include but are not limited to: A user-adjustable volume control, a
user-adjustable tone control, the ability for a user to change preset
listening programs manually, interactive software for self-selecting,
testing, and fitting, or a switch to enable or disable automatically
determined settings, such as acoustic environment sensing or noise
cancellation. An OTC hearing aid would need to include tools, tests, or
software, or some combination of those features, sufficient to
customize the device to meet the user's hearing needs.
3. QS Requirements
    We are soliciting further input on potential revisions to the
applicable QS requirements for OTC hearing aids. The input that we have
already received, while valuable, is sometimes contradictory and does
not fully address FDA's concerns for the quality of medical devices. As
described in section I.C, we received stakeholder input suggesting that
FDA reduce the provisions of the QS regulation applicable to the
devices as the provisions are overly burdensome. We also received input
that the current requirements are important and not unduly burdensome
(Ref. 9). While FDA wishes to minimize regulatory burdens, we must have
reasonable assurance of safety and effectiveness, which a quality
system helps to provide.
    In considering the range of feedback already received, we note that
the QS requirements are interdependent yet inherently flexible. This
scheme relies on each of the provisions working together. Further,
because hearing aids are medical devices, a quality system for medical
devices specifically, as opposed to a quality system for consumer
electronics more generally, is necessary to provide reasonable
assurance of safety and effectiveness. This is because medical device
quality systems address regulatory concerns regarding safety and
effectiveness that systems for consumer electronics do not.
    While the use of the quality system described in part 820 would be
more appropriate for OTC hearing aids and straightforward to implement
than another standard with various reservations, exceptions, and
modifications, FDA is open to considering alternatives to the existing
QS requirements. Any such changes would be proposed in a separate
rulemaking proceeding, and interested parties would have an opportunity
to comment during that rulemaking. However, we welcome proposals for
how the QS requirements could be modified, or an alternate approach
implemented, to ensure the quality of OTC hearing aids and provide a
reasonable assurance of safety and effectiveness.
    Finally, with regard to the QS requirements, FDA is undertaking
other separate efforts to minimize regulatory burdens for manufacturers
by proposing the harmonization of part 820 with an international
consensus standard.
    In light of the foregoing--including contradictory input already
received, the inherent flexibility of the QS requirements, the need for
a quality system suited to medical devices, and other changes that FDA
is proposing--we are seeking further input on potential modifications
to the QS requirements that would be applicable to OTC hearing aids to
inform future rulemaking.

F. Condition for Sale (Proposed Sec.  800.30(g))

    FDA is proposing to establish a condition for sale of OTC hearing
aids to prevent sale to people younger than 18, helping to provide
reasonable assurance of safety and effectiveness. We are proposing the
condition for sale pursuant to section 709(b)(2)(D) of FDARA, which
directs FDA to describe the requirements under which the sale of OTC
hearing aids is permitted, without the supervision, prescription, or
other order, involvement, or intervention of a licensed person, to
consumers through in-person transactions, by mail, or online. For the
purposes of this provision, we interpret ``sale'' broadly to include,
among other transactions, leases and rentals.
    The proposed condition for sale is consistent with 709(b)(2)(C) of
FDARA and section 520(q)(1)(A)(ii) of the FD&C Act, which establish
that OTC hearing aids are only intended for people age 18 and older. As
described above, the use of OTC hearing aids in people younger

than 18 presents risks to health beyond those typically associated with
use in older people. Accordingly, we are proposing to prohibit the sale
of an OTC hearing aid to or for a person younger than 18 years.
    FDA has considered whether other conditions for sale for OTC
hearing aids are necessary in addition to the proposed labeling that
includes conspicuous statements that OTC hearing aids are only intended
for people age 18 and older. This proposed condition for sale provides
a basis for comments on the subject.
    FDA also considered whether requirements on sellers to verify the
age of purchasers or, in the case of online or mail-order sales, the
age of the recipient, would promote the public health. However, mindful
that the current conditions for sale have been criticized as described
above, we believe that a requirement to obtain proof of age could make
hearing aids more difficult to obtain. For example, people with limited
means or mobility may not have a government-issued photographic
identification that shows their birthdate. Similarly, age verification
for online or mail-order sales could impede delivery of OTC hearing
aids or reduce the number of willing sellers, which could
disproportionately affect OTC hearing aid access in remote or rural
areas. Moreover, FDA does not expect high demand for OTC hearing aids
from or for people younger than 18. Thus, a requirement for age
verification could impose a barrier to access, particularly for
underserved populations, without a corresponding benefit to the public
health.
    FDA welcomes your comments on whether a prohibition of sales to or
for people younger than 18 years, without the need to verify age, would
best promote access to OTC hearing aids while protecting the hearing
health of people younger than 18 years. Alternatively, we welcome your
comments on what other conditions for sale may protect the hearing
health of people younger than 18 years. In the case of alternative
conditions for sale, FDA is particularly interested in conditions that
would not disproportionately burden underserved communities. FDA is
also interested in your comments on whether labeling, without the
prohibition on sales, adequately protects the health of people younger
than 18.
    We intend to minimize burdens and provide flexibility for sellers,
while also protecting the hearing health of people younger than 18,
helping to promote the public health by promoting the availability of
OTC hearing aids for people who are 18 and older.

G. Preemption Provisions (Proposed Sec.  800.30(h))

    FDA is proposing to codify the provisions regarding preemption and
private remedies under section 709(b)(4) and (5) of FDARA to assist
stakeholders in understanding the legal framework for OTC hearing aids.
These provisions are not codified in the FD&C Act, meaning they do not
appear under Title 21 of the U.S. Code, but apply nonetheless. We
believe that including these provisions in the Code of Federal
Regulations will assist our stakeholders, who may not be as familiar
with requirements that are not codified in the FD&C Act, such as these,
by consolidating applicable requirements in one location that is more
familiar.
    This may be particularly helpful because FDARA added to the
existing preemption framework for devices. In general, under section
521(a) of the FD&C Act, device requirements established by a State (or
a political subdivision) are preempted when the requirements are
different from, or in addition to, requirements applicable to the
device under the FD&C Act and which relate to the safety or
effectiveness of the device or to any other matter included in the
requirements applicable to the device. FDA may by regulation grant or
deny exemptions to this preemption in response to an application from a
State (or political subdivision) under certain conditions specified in
section 521(b) of the FD&C Act. Prior to the enactment of FDARA, FDA
issued regulations in response to such applications, most of them
relating to hearing aids, which are codified in part 808.
    However, section 709(b)(4) of FDARA established preemption specific
to OTC hearing aids that is different from the general rule for
preemption under section 521(a) of the FD&C Act. Although FDARA did not
explicitly address the existing exemptions from preemption related to
hearing aids, section 709(b)(4) of FDARA applies preemption to any
requirement of a State (or local government) specifically related to
hearing products, that would restrict or interfere with commercial
activity involving OTC hearing aids (which, as mentioned above, we will
use as shorthand in this document for the servicing, marketing, sale,
dispensing, use, customer support, or distribution of OTC hearing aids
through in-person transactions, by mail, or online), that is different
from, in addition to, or otherwise not identical to, FDA's regulations
issued under FDARA section 709(b). We are therefore proposing to amend
the scope of part 808 to reflect the additional preemption set by FDARA
(see section III.I.1).
1. FDARA Preempts State Regulation of OTC Hearing Aids
    Under FDARA section 709(b)(4), the OTC Hearing Aid Controls that
are the subject of this rulemaking, proposed Sec.  800.30, if
finalized, would preempt any State or local requirement specifically
related to hearing products that would restrict or interfere with
commercial activity involving OTC hearing aids, that is different from,
in addition to, or otherwise not identical to, the OTC Hearing Aid
Controls, including any State or local requirement for the supervision,
prescription, or other order, involvement, or intervention of a
licensed person for consumers to access OTC hearing aids.
    FDA interprets section 709(b)(4) of FDARA, including the terms
therein, as consistent with its purpose that State or local government
requirements specifically related to hearing products not restrict or
interfere with commercial activity involving OTC hearing aids. For
example, we interpret this provision as preempting State or local
requirements specifically related to hearing products that would
restrict or interfere with leases, consignments, or deliveries of OTC
hearing aids, though not explicitly mentioned in FDARA, because such
activities fall within the commercial activity involving OTC hearing
aids covered by the provision, in this example, within the marketing,
sale, dispensing, use, and/or distribution. Further, the FDARA
preemption provision applies to requirements specifically related to
hearing products generally, as opposed to devices or hearing aids more
specifically, where such requirements restrict or interfere with
commercial activity involving OTC hearing aids.
    As explained, we do not interpret section 709(b) of FDARA as
necessarily preempting State requirements regulating professional
services such as speech pathology, audiology, or fitting. A State
could, for example, continue to regulate such professional services
generally. However, to the extent State or local governments require
that purchasers of OTC hearing aids seek those services, such
requirements would be preempted by section 709(b)(4) of FDARA as
interfering with or restricting commercial activity involving OTC
hearing aids. The same would be true were a State, for example, to
require providers to undertake an activity, such as certification and
examination specific

to hearing aids, in order to sell OTC hearing aids.
2. Generally Applicable State and Local Requirements Are Not
Necessarily Preempted Under FDARA
    As noted in section III.B, FDA does not interpret FDARA to preempt
generally applicable requirements. By ``generally applicable,'' we mean
that the requirement relates to other products in addition to hearing
products, to services not specific to hearing products, or to unfair
trade practices in which the requirements are not limited to hearing
products.\11\ Requirements that apply to any place of business that
offers goods or services for sale would likely be generally applicable
and therefore not preempted (see also Sec.  808.1(d)(1)). Similarly,
requirements that apply to certain places of business may be generally
applicable provided the requirements do not attach on account of
selling, or other commercial activity involving, hearing products.
State or local requirements that make compliance with Federal
regulations enforceable by State or local authorities would also not
generally be preempted. The examples below focus only on the FDARA
preemption provision that applies to OTC hearing aids.