in one ear as a condition for which users should seek medical
evaluation. FDA is declining to expand upon this labeling requirement
to include tinnitus in both ears since bilateral tinnitus often occurs
in the presence of any degree of hearing loss. As such, the warning
would be overly broad if it were to include bilateral tinnitus.

    (Comment 46) A few comments suggested modifying the proposed
language recommending users consult a hearing healthcare professional
if they remain concerned about their hearing or struggle to use the
device. The comments suggested that the labeling recommend users first
contact the manufacturer to allow them an opportunity to resolve any
issues.
    (Response) FDA is declining to implement this suggestion. The
statement notifies users that dissatisfaction with the compensation for
impaired hearing may call for the attention of a hearing healthcare
professional. Although FDA sees the potential benefit in users
consulting with manufacturers to resolve certain technical or use
questions, the purpose of the note is not to assist with device
troubleshooting. Manufacturers may, however, include a troubleshooting
section (or similar section) in the user instructions and provide
suggestions for when users should consult them for technical or use
issues that would not necessarily call for the involvement of a hearing
healthcare professional.
    (Comment 47) Some comments requested FDA require the labeling on
and/or inside the package of OTC hearing aids include information about
telecoils. Comments expressed concern that first-time hearing aid
purchasers will not be able to make informed decisions about telecoils
without an explanation of telecoil capabilities. Specific labeling
suggestions varied, but they included statements of whether the device
includes telecoils, explanations of what telecoils are, and the
benefits telecoils may provide.
    (Response) FDA is declining this suggestion because not all OTC
hearing aids will have telecoils, and existing requirements would
apply, for example for adequate directions for use (see section
502(f)(1) of the FD&C Act and Sec.  801.5). (See also the response to
Comment 94 about requiring telecoils.) Including the information about
the feature could be confusing to consumers when the device does not
include telecoils. Conversely, if a hearing aid includes telecoils,
information about them would be necessary to provide adequate
directions for use, so the information would have to appear in the
labeling (see section 502(f)(1) of the FD&C Act and Sec.  801.5).
    (Comment 48) Some comments requested that labeling for OTC hearing
aids include a questionnaire to assist consumers in deciding if OTC
hearing aids are appropriate for them. Comments recommended the
questionnaire to assist consumers in determining if they have a medical
condition that requires a visit to a hearing health care provider prior
to using OTC hearing aids.
    (Response) FDA will not be implementing this suggestion. The
labeling requirements we are finalizing, including information on Red
Flag conditions and symptoms of more significant hearing loss, are
sufficiently informative to provide reasonable assurance of safety and
effectiveness without the additional time and effort necessary to
complete a questionnaire and assess the results for purposes of
deciding whether an OTC hearing aid is appropriate.
    (Comment 49) A few comments expressed concern about the note
regarding what a hearing aid can do, which includes a statement that,
if a user has hearing loss in both ears, use of hearing aids for both
ears (bilateral hearing aids) may provide more benefit than just one
hearing aid. Comments suggested that this may discourage individuals
who wish to begin with only one hearing aid. Comments recommended
removing this paragraph from the note.
    (Response) FDA disagrees that this statement would deter
individuals from using one hearing aid. This statement does not suggest
that individuals must use two hearing aids in all cases. This statement
in the note simply conveys that two OTC hearing aids may provide more
benefit in the case of hearing loss in both ears. Moreover, should
individuals with hearing loss in both ears start with one OTC hearing
aid and desire more benefit, this information would be useful to help
them understand how to achieve greater benefit.
    (Comment 50) A few comments requested that the labeling include
guidance as to what to do when an eartip gets stuck in the ear canal.
    (Response) FDA infers that the information requested by comments is
meant to assist users in determining when to consult a healthcare
professional. FDA agrees that providing guidance to users on this issue
is important. We have updated the labeling to help users decide when to
seek medical help (see new Sec.  800.30(c)(2)(iii)(C)).
3. Outside Package Labeling and Purchasing Decisions
    (Comment 51) A few comments recommended a statement for individuals
with ability limitations, such as a developmental disability, similar
to statements directing people under the age of 18 to seek examination
and evaluation by hearing healthcare professionals. Commenters implied
that, just as with individuals under 18, individuals with ability
limitations may not have the same ability to determine their hearing
loss or the presence of more serious medical issues; therefore,
evaluation by a licensed professional would be necessary.
    (Response) FDA is declining to implement this suggestion. The
statements addressed to those under age 18 concern hearing healthcare
needs that are specific to younger people, such as speech and learning
difficulties. Additionally, as explained in the proposal, 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 (see 86 FR 58150 at 58158). The comments
provided no information to support that adults with ability limitations
face similar risks to those younger than 18.
    Further, we have revised the labeling with more user-friendly terms
throughout. We believe the information required in the labeling,
including statements identifying Red Flag conditions and advising users
to consult with a hearing healthcare professional if they continue to
struggle with or remain concerned about their hearing, are appropriate
for adults with perceived mild-to-moderate hearing impairment. We do
not agree that revising the labeling or limiting purchases for certain
adults in the manner suggested by the comments is necessary to provide
reasonable assurance of safety and effectiveness of OTC hearing aids.
    (Comment 52) A comment requested that FDA standardize the names of
hearing aid features so that interested people could compare products
more easily. In that vein, multiple comments suggested that FDA develop
a rating system to compare features. The commenter expressed that
information should be accessible to lay users and that relying on a
regulatory guidance document, should FDA issue one in the future, to
convey such information is unlikely to assist most consumers, who are
not experts in hearing aid technology. Similar comments desired a
rating system for device performance in certain conditions, for
example, live concerts.
    (Response) FDA agrees that interested people should have sufficient
information to compare products as easily as possible, and we have made
various revisions in this final rule to

improve the usefulness of the required labeling for laypeople. We are
also finalizing a requirement for a conspicuous mark identifying the
hearing aid as OTC that we expect will help purchasers and others
distinguish product categories (see Additional Revision 2 in section
III.D.3). Further, FDA's website describes common hearing aid
technologies and features to help orient consumers with the technology
and terminology, available at: https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids. However, we are not making additional
revisions in the final rule to standardize the names of device
features.
    We note that a number of regulatory requirements will nevertheless
assist consumers to compare devices and features. For example, the
applicable classification regulation for a device specifies the name of
the device type (so is standardized in that way), and the principal
display panel on the package of an OTC device must display a statement
of identity that includes the common name of the device, in bold
typeface (see Sec.  801.61). Further, the labeling must include
adequate directions for use that allow a layperson to use the device
safely and for its intended purpose(s) (see Sec.  801.5). And for OTC
hearing aids, we proposed and are finalizing a requirement under new
Sec.  800.30(c)(4) that the labeling include certain technical
specifications. Purchasers interested in the electroacoustic
performance could use this information to compare across devices.
    We acknowledge that manufacturers may use proprietary names for
device features, even when other manufacturers offer a similar feature
under a different name (perhaps also proprietary). However, FDA expects
that hearing aid technology will continue to evolve and that device
features will similarly evolve, including the specific capabilities.
Precisely identifying, describing, and naming those features and ways
to compare them by regulation, even for the present, is neither
practical nor necessary. Further, individuals may have different
preferences as to which features are more valuable in a hearing aid.
For similar reasons, a rating system is neither practical nor
necessary. Even with additional standardization of terminology, the
import of each feature may still not be apparent to purchasers, and
similarly, rating systems may not reflect (rate highly) the features of
a device that a given purchaser would value. Thus, finalizing
regulatory requirements for such a system of comparison is not likely
to communicate useful information to purchasers and may hinder
innovation by codifying current characteristics of device features.
    To communicate useful information, we expect that manufacturers
will describe their devices' features in ways that best appeal to the
intended users, and the labeling of a hearing aid will have to be
available to prospective users prior to purchase (see new Sec. Sec.
800.30(c)(2) and 801.422(c)(2)). Moreover, the labeling of a device
must not be false or misleading in any particular (see 21 U.S.C.
352(a)(1)). These requirements will help ensure that purchasers have
accurate information about a hearing aid and its features in a way that
allows them to compare these devices.
    As for ratings for device performance in certain conditions, given
the subjective nature of user preferences, developing a useful rating
system is impracticable. We expect that purchasers will have access to
a wealth of opinions from other purchasers, product testers or
reviewers, and consumer information organizations. This will allow
purchasers to find ratings that reflect their interests more than any
possible criteria standardized by regulation. For example, a purchaser
may prefer OTC hearing aids that users rate highly for use in a
restaurant. Additionally, user preferences may change in the future, so
any rating system may become quickly outdated.
    Regarding device performance more generally, as we explained in the
proposal, we are establishing electroacoustic performance requirements
for high-fidelity amplification (see 86 FR 58150 at 58163). A hearing
aid must meet these requirements to be available OTC, but the device
need not outperform them. By extension, a device need not perform
better than a high-fidelity level of amplification. Establishing a
rating system for compliant devices, that is, for those that would
already have high fidelity, would incorrectly imply some devices are
substandard. We are not finalizing requirements for describing how well
a device performs beyond the electroacoustic performance specifications
in the labeling, the performance itself being required to meet a
standard for high fidelity.
    (Comment 53) A few comments recommended that information about
whether a battery was included, and what type of battery is required,
be included on the labeling. Comments recommended the inclusion of this
information so that consumers can purchase the necessary batteries at
the same time as the OTC hearing aid and adequately compare OTC hearing
aids.
    (Response) We agree that it is important for manufacturers to
include information about the type, as well as the number, of
batteries, and whether batteries are included because this is
information consumers will need to use the hearing aid. Therefore, FDA
is revising the final rule to require this information on the labeling
outside the package of the hearing aid so that consumers are aware of
the battery requirements prior to, or at the time of, purchase.
    (Comment 54) A few comments recommended including a description of
any smartphone compatibility requirements to operate the hearing aid on
the outside package labeling. Comments argued this would allow
consumers to determine if they have the necessary device and
programming to operate the hearing aid prior to purchase.
    (Response) FDA agrees with the comments that this information is
important for consumers to know when comparing OTC hearing aids at the
retailer. Similar to the battery information discussed above,
information on the control platform is necessary for use of the hearing
aid. Therefore, FDA is revising the final rule to require that the
outside package labeling indicate whether a mobile device or other non-
included control platform is required, such as a smartphone, a remote
sold separately, or a personal computer. The labeling also will have to
indicate the type of control platform and how the hearing aid connects
to the control platform, for example, via Bluetooth and/or USB-C.
    (Comment 55) A few comments suggested that the rule require a list
of other basic features of each OTC hearing aid (for example, mobile
operating system, volume controls, feedback, telecoil, or accessories)
on the outside package. Comments expressed concern that, without a list
of features, consumers may have difficulty comparing different OTC
hearing aids and make an informed decision.
    (Response) FDA is declining to implement this suggestion in its
entirety. The packaging provides limited space for required labeling,
and while we have adopted some such suggestions--see the responses to
Comment 53, about batteries, and Comment 54, about smartphone
compatibility--we have not determined that the other information is
necessary on the outside package labeling to provide reasonable
assurance of safety and effectiveness. Additionally, we are finalizing
the requirements as proposed

that the inside package labeling, among other requirements, provide
illustration(s) of the OTC hearing aid that indicates operating
controls, user adjustments, and the battery compartment (see Sec.
800.30(c)(2)(iv)), provide information on the function of all controls
intended for user adjustment (see Sec.  800.30(c)(2)(v)), and describe
any accessory that accompanies the OTC hearing aid (see Sec.
800.30(c)(2)(vi)). As the inside package labeling must be made
available prior to purchase (see Sec.  800.30(c)(2)), consumers will be
able to access this information prior to purchase. Further, as
discussed in the response to Comment 26, any OTC hearing aid must have
labeling that bears adequate directions for use that allow a lay user
to use the device safely and for its intended purposes (see Sec.
801.5). In cases where necessary for adequate directions for use,
information on other features not specified in Sec.  800.30(c) will
have to appear in the labeling, and prospective users will have access
to the labeling prior to purchase.
    (Comment 56) Some comments expressed concerns for device labeling
that states an OTC hearing aid is ``FDA approved,'' ``FDA cleared,'' or
otherwise endorsed by the FDA. The comments asserted that such labeling
indicates that: FDA has inspected an OTC device for quality and/or
compliance with applicable legal requirements, that FDA has approved
the device for use by the individual purchaser, and/or that FDA favors
the device over others without such labeling. The comments argued that
such indications are misleading for purchasers.
    (Response) FDA does not endorse particular devices and
representations of such in labeling can be false or misleading. The
determination of whether ``FDA cleared,'' ``FDA approved,'' or similar
language on a device's labeling suggests FDA endorsement of the device
or is otherwise false or misleading is made on a case-by-case basis.
    Clearance of a device indicates that FDA has determined the device
to be substantially equivalent to a class I or II device. It does not
in any way denote official approval of a device or in any way imply
that the device is in compliance with any other pertinent sections of
the FD&C Act (see 41 FR 37458 at 37462, September 3, 1976). Likewise, a
grant of a De Novo classification request under 21 CFR 860.260(a)(1) or
compliance with registration and listing requirements under part 807
does not denote official approval or imply compliance with other
pertinent device requirements. Any representation that creates an
impression of official approval of a device due to complying with
requirements for premarket notification or registration is misleading
and constitutes misbranding (see Sec. Sec.  807.97 and 807.39,
respectively).
    The labeling of a device may be false or misleading for other
reasons too. For example, if a statement in the labeling creates an
impression that FDA officially favors one classified device over
another, it would likely be false or misleading. Or, if the labeling
uses FDA's logo, creating an impression that FDA has endorsed the
product, it would likely be false or misleading.\8\ A device would be
deemed to be misbranded under section 502(a)(1) of the FD&C Act if its
labeling included such false or misleading statements. The FD&C Act
prohibits doing or causing certain acts with respect to a misbranded
device (see, e.g., 21 U.S.C. 331(a)-(c), (k)).
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    \8\ FDA's logo is not for use on private sector materials,
including device packaging. For more information, you may wish to
review FDA's logo policy, available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy.
---------------------------------------------------------------------------

    (Comment 57) A comment requested clarification on the applicability
of prescription labeling requirements under new Sec.  801.422 to the
implantable components of a bone-conduction hearing aid. The comment
argued that applying the labeling requirements to the implantable
components is unnecessary because a surgeon has already decided to
implant specific components, and the labeling under new Sec.  801.422
is neither necessary nor helpful for the surgeon or the hearing aid
user. In contrast, the non-implantable components of a bone-conduction
hearing aid, such as the sound processor, are often marketed separately
and not necessarily through a physician.
    (Response) FDA agrees that the labeling requirements under Sec.
801.422 are not necessary for reasonable assurance of safety and
effectiveness with respect to the implantable components of a bone-
conduction hearing aid. We have modified the classification regulation
to clarify that the labeling requirements for prescription hearing aids
apply only to the non-implantable components of a bone-conduction
hearing aid. In cases where the implantable components are not sold or
distributed with the non-implantable components, the implantable
components need not bear the labeling under new Sec.  801.422.
    (Comment 58) One comment requested that FDA strike Sec.
801.422(c)(1)(ii)(A). The comment stated that the decision to offer
trial rentals or purchase options is a trade issue and does not relate
to the safety or effectiveness of the device.
    (Response) FDA has decided to retain Sec.  801.422(c)(1)(ii)(A) (in
the final rule, this information is in Sec.  801.422(c)(1)(i)(C)). FDA
notes that Sec.  801.422(c)(1)(ii)(A) does not require offering a
trial-rental or purchase-option program. Instead, this provision just
requires that the outside package labeling for a prescription hearing
aid include information advising prospective users to inquire about the
availability of a trial-rental or purchase-option program.
    FDA also notes that Sec.  801.422(c)(1)(ii)(A) is substantially
identical to what was already required to be included in the user
instructional brochure for a hearing aid under former Sec.
801.420(c)(3). In other words, the information required under Sec.
801.422(c)(1)(ii)(A) is not new and has been required to be in hearing
aid labeling for many years. The only differences between Sec. Sec.
801.420(c)(3) and 801.422(c)(1)(ii)(A) are: Sec.  801.422(c)(1)(ii)(A)
applies only to prescription hearing aids, Sec.  801.422(c)(1)(ii)(A)
requires that the information be provided on the outside package
labeling for a prescription hearing aid, and the required statement
under Sec.  801.422(c)(1)(ii)(A) uses language that is easier to
understand.
    FDA continues to believe that this labeling requirement is
necessary to provide reasonable assurance of safety and effectiveness
of prescription hearing aids. When FDA included the requirement in
former Sec.  801.420(c)(3) to provide information in the user
instructional brochure advising prospective users to inquire about the
availability of a trial-rental or purchase-option program, FDA
acknowledged the difficulty of determining in advance whether an
individual will benefit from a hearing aid, and we noted that voluntary
trial-rental or purchase-option programs for prospective hearing aid
users were available (42 FR 9286 at 9289).
    FDA believed that trial-rental or purchase-option programs, which
provide prospective hearing aid users the opportunity to wear the
selected hearing aid so that the user can make an informed judgment on
whether a benefit is obtained from the use of the hearing aid, were
important to the welfare of the hearing impaired and therefore,
required that the user instructional brochure contain information
advising prospective users to inquire about the availability of such
program (42 FR 9286 at 9289). FDA explained that this information would
help assure that the

selected hearing aid would be beneficial and would encourage hearing
aid use among those prospective users who lack the motivation to try a
hearing aid because of the fear that they will spend a great deal of
money with no guarantee of benefit (42 FR 9286 at 9289). FDA believes
that the reasons for requiring this information in labeling continue to
apply for prescription hearing aids, which are typically sold through
licensed hearing aid dispensers, many of whom offer such programs.
    (Additional Revision 2) In response to various concerns evident in
the comments, we are including in this final rule a requirement that
the principal display panel of the outside package labeling of an OTC
hearing aid bear the conspicuous marks, ``OTC'' and ``hearing aid.''
FDA intends these marks to clarify for purchasers and others, including
retailers and State agencies, whether a product is a hearing aid
(regulated as a device), and whether it is available OTC. (See also the
response to Comment 18 discussing hearing aid terminology.) However,
these marks do not in any way denote official approval of the device,
and any representation that creates an impression of official approval
because of complying with these marking requirements or with the OTC
Hearing Aid Controls would be considered false or misleading and
constitute misbranding. (See also the response to Comment 56 regarding
other false or misleading statements.) The marking is necessary for
reasonable assurance of safety and effectiveness of OTC hearing aids
because it provides assurances that non-OTC hearing aids or non-devices
will not be confused for OTC hearing aids.
    The marks must have the same prominence as required under Sec.
801.61(c) for the device's statement of identity, and a manufacturer
may satisfy this new marking requirement if the statement of the
device's common name includes both ``OTC'' and ``hearing aid.'' For
example, a manufacturer may label its product as a ``Self-Fitting OTC
Hearing Aid'' (assuming the device's common name is ``self-fitting
hearing aid''). Such a device would meet this new marking requirement
as well as the requirement for the common name in the statement of
identity. Alternatively, the manufacturer may, for example, label its
product without including the marks in the common name of the device,
perhaps by placing ``OTC'' in a corner of the principal display panel
with the required prominence (assuming the device's common name
includes ``hearing aid''). Formatting the marks, for example, by
outlining them with a box, would be permissible provided the formatting
does not cause the marks to lack the required prominence (see 21 CFR
801.15(a)(6)).
4. Labeling Inside the Package and Technical Matters
    (Comment 59) A few comments requested that the frequency response
and ANSI S3.22 specifications of OTC hearing aids be included in the
user manual.
    (Response) FDA infers this request is to assist in selecting an OTC
hearing aid with optimal performance. We are not requiring the
requested information in OTC hearing aid labeling because, as we
explained in the proposal, this information is highly technical and
generally not useful to the lay user (see 86 FR 58150 at 58163).
However, we are finalizing the proposed requirement that OTC hearing
aid labeling include key electroacoustic performance specifications
that are more likely to assist prospective lay users in comparing and
selecting the devices, including the values for maximum output, full-on
gain, total harmonic distortion, self-generated noise, latency, and
upper and lower cutoff frequencies for the acoustic bandwidth.
    (Comment 60) A few comments expressed concern that requiring
summaries of clinical studies conducted by or for the manufacturer on
the inside labeling is not practical. Comments suggested that providing
a link to an online library of the clinical studies and a summary of
each study on the manufacturer's website would suffice.
    (Response) FDA disagrees that providing summaries of clinical
studies in the labeling inside the package is impractical. While we
understand that fully appreciating the outcomes of a study can entail a
lengthy technical document, presenting the most important findings
regarding the performance of the OTC hearing aid, in a user-friendly
format, need not take significant space in the labeling. We are
finalizing the requirement as proposed.
    (Comment 61) A few comments requested that the labeling include
information on how the OTC hearing aid can be fixed or repaired.
Comments requested that the information include whether a local hearing
healthcare professional can repair the device or if it needs to be sent
to the manufacturer. Comments argued this would allow prospective users
to make an informed decision when purchasing their devices.
    (Response) FDA agrees that manufacturers should provide users with
information on how to have their hearing aid repaired because this
information may be difficult for users to obtain on their own. The
inside package labeling requirements now include information on how and
where to obtain repair service or replacements, with at least one
specific address where the user can go or send the OTC hearing aid to
obtain such repair service or replacements.
    (Comment 62) A few comments expressed concern that estimating the
expected battery life will be difficult for manufacturers due to
inconsistencies between batteries and use conditions. Comments proposed
removing this requirement from the labeling inside the package.
    (Response) FDA recognizes that battery performance can vary but
will retain this requirement in the final rule because this information
will help prospective purchasers determine whether a hearing aid will
be suitable for their circumstances. Recognizing that performance can
vary from device to device, we did not propose, and are not requiring,
a specific method of estimating the battery life. However,
manufacturers may want to review Clause 4.7 (Battery Life) of ANSI/CTA-
2051:2017, which currently provides an acceptable method to estimate
the battery life (Ref. 8).
    (Comment 63) A comment proposed a requirement for OTC hearing aid
labeling to include information about the transport methods for
configuration information and other data to and from the OTC hearing
aid with all points along the supply chain.
    (Response) FDA is not adopting this proposal because such
information is focused on the electronic transfer of non-diagnostic
data and is not generally necessary for reasonable assurance of safety
and effectiveness of all OTC hearing aids. We note, however, that
should States establish or continue in effect requirements to disclose
such information, and the requirements are not specifically applicable
to hearing products, section 709(b)(4) of FDARA likely would not
preempt them. However, FDA is not opining on whether such disclosure
requirements likely would or would not be preempted under section
521(a) of the FD&C Act. (See also the response to Comment 115
concerning the collection of personal information as part of a sale of
an OTC hearing aid.)
    (Comment 64) A comment requested that FDA require labeling that
specifies the latency of any wireless streaming technologies the OTC
hearing aid uses.
    (Response) In certain circumstances, latency information in the
labeling may be necessary under existing requirements. For example, if
the information is necessary to provide adequate directions for use or
necessary

for practitioners licensed by law to use the device safely and for its
intended purpose(s), then the latency information would have to appear
in the device labeling (see Sec. Sec.  801.5 and 801.109(c),
respectively).
    However, as a general matter for hearing aids that incorporate
wireless streaming technology, FDA has determined that stating the
streaming latency is not necessary to provide reasonable assurance of
safety and effectiveness. Additionally, a variety of factors can affect
wireless streaming latency, including nearby radio interference,
distance between the transmitter and receiver, and the presence of
materials that absorb certain radiofrequencies. As such, a standardized
wireless streaming latency value may not reflect a particular device's
design or the environment in which the user wears the hearing aid; and
thus, FDA is not adding a requirement to include wireless streaming
latency information for all OTC hearing aids in this rule. We note that
FDA is finalizing requirements for OTC hearing aid labeling to include
manufacturer contact information. If users or prospective users are
interested in the streaming latency specifically, they will be able to
contact the manufacturer.
    (Comment 65) A few comments requested a labeling requirement
describing the fitting range across different frequencies (500, 1000,
2000, and 4000 Hertz) to help consumers determine the suitability of
different OTC hearing aids to meet their needs.
    (Response) FDA understands that traditionally, hearing aids are
designed and marketed with a specific fitting range in mind, and
manufacturers may maintain this practice. However, OTC hearing aids are
intended to be available without the involvement of a licensed person
(see 21 U.S.C. 360j(q)(1)(A)(v)). As such, FDA is not using audiometry-
defined thresholds or ranges of hearing loss in the final rule.
Instead, FDA is using descriptions of common symptoms of mild to
moderate hearing impairment in the labeling. As such, describing the
fitting ranges across different frequency bands is not necessary for
reasonable assurance of safety and effectiveness of OTC hearing aids.
However, manufacturers may choose to include this information in device
labeling, and prospective users will have access to the manufacturer's
contact information prior to purchase should they desire to inquire
about the fitting ranges.
5. Adverse Event Reporting
    (Comment 66) The proposed labeling included instructions on
reporting adverse events through the MedWatch portal, https://www.fda.gov/Safety/Medwatch, or by phone, 1-800-FDA-1088. A few
comments requested that email and mailing options also be provided for
adverse event reporting. Comments further recommended that FDA provide
a receipt of the complaint to individuals.
    (Response) We are declining to include a mailing address in the
labeling because submissions by mail should be on a MedWatch form, for
example, the Consumer Voluntary Reporting Form (FDA 3500B), which
contains the address along with additional instructions. Reference to
just the address in hearing aid labeling may result in reports
submitted in an unexpected manner and format, potentially causing
confusion, incomplete reports, and significant delays in processing
them. However, in addition to reporting events through the MedWatch
portal and 1-800-FDA-1088, consumers can submit their adverse event
reporting form to FDA by fax or the mailing address according to the
instructions on the form. Submitters will receive a reply from FDA
after we receive their report. Email is not currently an alternative to
the MedWatch online submission system.
    (Comment 67) A few comments recommended that in addition to
labeling information on reporting adverse events to FDA, contact
information for manufacturers should be required so that manufacturers
are provided the opportunity to review adverse events. Comments implied
that providing manufacturers with awareness about adverse events and
opportunity to address them would be beneficial to consumers.
    (Response) To help facilitate communications between users and
manufacturers, FDA has added the manufacturer's email and mailing
address to the labeling requirements (see final Sec.
800.30(c)(1)(i)(E)). Should users wish to report adverse events to the
manufacturer, they may use this information to do so. Manufacturers may
also include instructions in the labeling, that do not conflict with
the labeling requirements, on how to directly report adverse events to
them.
    (Comment 68) FDA included in the proposed labeling examples of
adverse events to be reported to FDA: irritation of the ear canal or
outer ear skin, injury from the device (like cuts or scratches, or
burns from an overheated battery), pieces of the device getting lodged
in the ear canal, and sudden increased severity in hearing loss with
the device. Some commenters suggested limiting the list to more-serious
conditions to avoid the adverse reporting system being overwhelmed by
reports of minor adverse events. Commenters expressed concern that if
the labeling were finalized as proposed, more serious adverse events
may get lost in the volume of what the commenters see as minor.
Commenters recommended adverse event reporting be limited to
significant injury and/or death.
    (Response) FDA is declining to limit the examples of adverse
events, or the reporting of adverse events, to significant injury and/
or death. FDA is interested in receiving information on all adverse
events to have a better understanding of OTC hearing aid product safety
and performance. Additionally, under section 709(d) of FDARA, FDA is
required to submit a report to Congress ``analyzing any adverse events
related to over-the-counter hearing aids.'' FDA is prepared to review
adverse event reports and has experience in sorting through adverse
event reporting data to identify safety signals and trends.
    (Comment 69) Comments requested that users of prescription hearing
aids be able to report adverse events to FDA similar to how OTC hearing
aid users can report through the MedWatch portal at https://www.fda.gov/Safety/Medwatch, or by phone, 1-800-FDA-1088.
    (Response) We agree that prescription hearing aid users should also
report adverse events to FDA. We proposed and are finalizing the same
note for prescription hearing aids to notify users of how to report
adverse events to FDA.
6. Miscellaneous Labeling Considerations
    (Comment 70) Some comments recommended that restrictions on the use
of OTC hearing aids by individuals under the age of 18 be removed.
Comments expressed the need for cost effective hearing aids for
individuals under 18. Additionally, comments asserted that individuals
under 18 are increasingly suffering from hearing loss as a result of
exposure to loud sounds, which they argued is hearing loss that can be
addressed by OTC hearing aids.
    (Response) FDA is declining to allow the sale of OTC hearing aids
to individuals under the age of 18. This condition for sale is
consistent with section 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 aged 18 and older. The use of OTC hearing
aids

in people younger than 18 presents risks to health beyond those
typically associated with use in older people. While FDA appreciates
the need for cost effective hearing aids for individuals under the age
of 18, the sale of OTC hearing aids will be limited to individuals who
are age 18 and older.
    (Comment 71) A few comments expressed concern that the manufacturer
contact information that FDA proposed to include in the labeling of OTC
hearing aids is limiting because the only alternative to a website
address was a telephone number. Comments argued that many individuals
with hearing loss do not prefer to communicate using the telephone and
recommended the inclusion of the manufacturer's email and mailing
address on labeling to provide greater access to users.
    (Response) FDA agrees that providing additional ways for users to
communicate with manufacturers will allow for users to resolve issues
with their hearing aids more easily. The labeling requirements have
been updated to include the manufacturer's mailing address and email
address.
    (Comment 72) A few comments noted that hearing aids are physically
small and do not have room for a serial number on them. Comments
recommended that the serial number be located on an accompanying item,
such as on the storage case or registration card.
    (Response) FDA is declining to implement this suggestion.
Manufacturers have been complying with this long-standing requirement
for labeling under Sec.  801.420, which we are revising and renumbering
as Sec.  801.422, and marking the serial number on the device itself
(since 1977). Additionally, because accompanying items can be
misplaced, marking the device itself is essential to the utility of the
serial number.
    (Additional Revision 3) As noted in the response to Comment 8, we
are finalizing labeling requirements for hearing aid software. We
expect much of the labeling to be electronic in nature, for example,
the graphic and printed matter that appear on a download web page or in
electronic display ``cards'' or dialogs in the software's user
interface. As such, electronic labeling may have a transitory nature,
and we are specifying the occasion and persistence of presentation. For
example, we are requiring that the labeling present a warning against
use in people younger than 18. In this example, the electronic
labeling, perhaps appearing in a modal dialog, need not appear at all
times. Rather, we are requiring that the labeling present the warning
to the user prior to first use of the software and persist until the
user acknowledges it. We are further requiring that the software
provide access to all of its labeling for later review, for example,
through a Help menu selection.
    We intend the software device labeling requirements to correspond
with the labeling requirements we proposed for packaged hearing aids to
the greatest extent possible. As such, we are requiring that the
software device labeling present certain information prior to first use
or obtaining payment information for the software (not necessarily the
hearing aid or amplification platform), reflective of the nature of the
information we are requiring on the packaging, that is, information the
prospective user should know prior to purchase, if a purchase is
involved. Some labeling is required prior to first use, but it could
appear after purchase of the software, if a purchase is involved. Other
labeling is required to be accessible in the software, but it need not
be presented at any particular time.
    We recognize that some of the information required in the labeling
under final Sec.  800.30(c)(1) through (4) may not apply to software.
For example, specific instructions for cleaning and disinfection likely
would not apply to stand-alone software (see final Sec.
800.30(c)(2)(vii)(D)). As another example, an illustration of the
battery compartment likely would not apply (see final Sec.
800.30(c)(2)(iv)). To address this, we made it clear that certain
information is required to the extent applicable. Thus, in the first
example, the software device labeling need not include instructions for
cleaning and disinfection if that information is not applicable. In the
second example, the software device labeling must include an
illustration(s), but not necessarily of the battery compartment if not
applicable. Further, in that example, a video would be an adaptation of
and suffice for an illustration(s). Although software may not have a
principal display panel like a packaged hearing aid, a software-loading
or Home screen could serve a similar function to provide the
information required under Sec.  800.30(c)(1)(iii).
    We have also included requirements for the software device labeling
to disclose compatibility requirements as well as any fees or payments.
Disclosure of compatibility requirements is necessary for reasonable
assurance of safety and effectiveness because this information
describes some of the necessary conditions under which the software
device will be usable and thus safe and effective. The disclosures of
any fees or payments are similarly necessary because they describe
necessary conditions under which the software or additional features
will start, continue, and/or cease to operate safely and effectively.
    The software labeling requirements we are finalizing under new
Sec.  800.30(c)(5) are in addition to any other applicable requirement,
including special controls. For example, 21 CFR 801.50, regarding
labeling requirements for stand-alone software, would still apply to
the software when appropriate under that regulation. As another
example, the general requirements for adequate directions for use (see
section 502(f)(1) of the FD&C Act and Sec.  801.5) would also apply,
unless the software device is exempt under Sec.  801.109.
    We are adding similar software device labeling requirements in
Sec.  801.422.

E. Output Limits (Sec.  800.30(d))

    Generally, comments on the output limits for OTC hearing aids
either agreed that FDA's proposed limits were appropriate or comments
proposed lower limits. Several comments recommended output limits that
depend on device design, for example volume control, compression, or a
limit on gain. FDA received many comments on this subject, some of
which included references to published scientific literature, consensus
standards, stakeholder position papers, and public health guidelines.
For the following reasons, we are finalizing lower output limits than
we proposed--111 and 117 dB SPL, which are multiples of 3-dB reductions
from the proposal--but we are not including a separate gain limit.
1. Finalizing Lower Output Limits
    After further considering the potential risk of worsening users'
hearing impairments as discussed below, as well as the literature
submitted to us in the comments (e.g., Refs. 10 and 11), we have
decided to finalize lower output limits than we proposed. We are
retaining the conditional structure of the output limits, with the
higher output permitted for devices with activated input-controlled
compression. (See the response to Comment 87 about requiring a user-
adjustable volume control for all OTC hearing aids.) We are also
retaining the limits expressed as Output Sound Pressure Level 90
(OSPL90) values rather than A-weighted values as suggested by some
comments. OSPL90 values are more common expressions of hearing aid
outputs, and they are consistent with the consensus standards we are
adopting, which refer to OSPL90 values.

    Comments suggested a variety of lower limits, but we are adopting a
general limit of 111 dB SPL, which is sufficient to mitigate the
greater risk potential from both acute high-output-levels and
cumulative exposure that we identified after further consideration. We
are correspondingly finalizing the higher conditional limit of 117 dB
SPL for devices with activated input-controlled compression.
    Many commenters suggested an output limit of 110 dB SPL and
considered this output limit sufficient to address even moderate
impairment, as each commenter defined the term ``moderate.'' However,
as discussed further below, we have applied an equal-energy principle
and used a 3-dB exchange rate in revising the general output limit to
111 dB SPL. We do not believe that an output limit of 110 dB SPL would
provide any meaningful difference with regard to safety.
    The output limits that we are finalizing balance safety and
effectiveness without unduly sacrificing either. We are not adopting
the even lower limits suggested in some comments because these lower
limits would reduce device effectiveness for people with perceived mild
to moderate hearing impairment to such a degree that the limits would
exclude some intended users from obtaining sufficient benefit of OTC
hearing aids. At the same time, progressively lower output limits yield
diminishing returns in terms of safety. Thus, lowering the output limit
even further as suggested in some comments would begin excluding
intended users without achieving meaningful improvements in safety for
them. As a result, lowering the output limits even further as suggested
in some comments would not provide reasonable assurance of
effectiveness for people with perceived mild to moderate hearing
impairment, and thus would not be ``appropriate'' for OTC hearing aids
per section 709(b)(2)(B) of FDARA.
    The reduction in effectiveness and benefit would result primarily
because, with even lower output limits, the hearing aid would no longer
have a sufficient dynamic range (``headroom'') for high-fidelity
amplification. The hearing aid could then apply compression and/or
other output limiting measures more often or to a greater degree,
resulting in perceptibly lower-fidelity (less effective) amplification.
In such circumstances, OTC hearing aids would have significantly
reduced effectiveness for the intended users, sometimes even in
normally non-hazardous environments. This reduction in effectiveness
would be increasingly noticeable for intended users as the device
output is reduced.
    By way of comparison, a comment urging FDA to adopt an output limit
of 102 dB SPL also urged FDA to limit the intended users of OTC hearing
aids to people with mild impairment rather than mild to moderate
impairment. As we explain in the response to Comment 10, we are not so
limiting the OTC category, and an output limit that low would not
provide reasonable assurance of safety and effectiveness in addressing
perceived mild to moderate hearing impairment. As provided in section
520(q)(1)(A)(ii) of the FD&C Act, OTC hearing aids are ``intended to be
used by adults age 18 and older to compensate for perceived mild to
moderate hearing impairment.''
    Moreover, many comments urging FDA to adopt lower limits than the
ones we are finalizing referred to material that stated output levels
in root mean square (RMS) terms. The limits we are finalizing are
expressed differently--expressed in terms of maximum peak values
(implicit in the measurement of OSPL90 values). To derive a peak value
based on an RMS level, one would increase the RMS level by an amount
that represents the ``crest factor'' of the output. Thus, except in one
circumstance that is not applicable to the materials submitted to us,
RMS values are lower than peak values for the purposes of considering
the sound output of hearing aids, and comparisons between RMS and peak
values need to take this difference into account.\9\
---------------------------------------------------------------------------

    \9\ For square wave signals, the peak and RMS values would be
the same (a 0-dB difference). However, for the purposes of
describing hearing aid performance, a crest factor would be an
important element for considering limits as RMS values, for example,
to ensure a limit expressed as an RMS value allowed for effective
amplification of speech. Crest factors for speech are often 12-17
dB, with 15 dB being a value frequently cited in comments.
---------------------------------------------------------------------------

    As noted, we are also finalizing a lower limit for OTC hearing aids
with input-controlled compression activated. This value, 117 dB SPL, is
intended to maximize the available headroom for OTC hearing aids while
still providing reasonable assurance of safety and effectiveness. As we
explained in the proposal, input-controlled compression is an automatic
function that dynamically reduces the device's output and helps prevent
the device from continuously performing at its output limit (see 86 FR
58150 at 58161-58162). In these ways, the use of input-controlled
compression adequately addresses the safety concerns that the increased
output can raise. We explain our reasons for finalizing lower output
limits in more detail below.
    We wish to emphasize that, in finalizing lower output limits, we do
not intend to reduce the number of intended users for whom the use of
OTC hearing aids is safe and effective (in comparison to the proposed
limits). Rather, we are lowering final limits to allow sufficient
headroom for the same intended users, albeit less headroom than we
proposed. As stated above, the output limits that we are finalizing are
intended to balance safety and effectiveness without unduly sacrificing
either.
    In response to comments, we are also revising the final regulation
to permit the use of alternative acoustic couplers when a 2-cubic
centimeter (cm\3\) coupler is not compatible with the device design.
See the response to Comment 81 for more on this topic.
    Additionally, we are slightly modifying the phrasing of the
regulation to clarify that the device may reach the higher limit only
while the input-controlled compression is activated. For example, if a
user were to deactivate the feature, the device must not exceed the
general output limit of 111 dB SPL while the feature is deactivated.
2. Considerations for Appropriateness of Output Limits
    In deciding to finalize lower output limits, FDA is primarily
considering output limits that will provide reasonable assurance of
safety and effectiveness and are ``appropriate'' for OTC hearing aids
as section 709(b)(2)(B) of FDARA uses the term. To determine such
limits, we are balancing considerations of safety and effectiveness for
all intended users of these devices to both protect and promote the
public health. As we explained in the proposed rule, too high of an
output can be unsafe (see 86 FR 58150 at 58161). However, too low of an
output reduces device effectiveness and can lead to poor device
performance, and ultimately, can reduce satisfaction and use (see 86 FR
58150 at 58161).
    Many comments described the communication needs of hearing aid
users and how those interests relate to the output limits and the
purposes of establishing the OTC category of hearing aids. FDA agrees
that those interests are relevant to safety and effectiveness as well
as what would be appropriate. However, balancing the various
considerations related to safety and effectiveness is complex and
involves the application of scientific judgment. Thus, while FDA agrees
with the many thoughtful comments that several factors, discussed
further in this section, affect the determination of appropriate output
limits, we do not always agree

with the determination reached by commenters.
    One of the purposes of this rulemaking is to address a widespread
public health need stemming from relatively low adoption and use of
hearing aids by people who could benefit from them. More specifically,
an underlying goal of this rulemaking is broadening access to these
devices, without the involvement of a licensed person, to compensate
for perceived mild to moderate hearing impairment in adults. (See the
responses to Comments 10-12 for more about the scope of this
rulemaking.) FDA is mindful of the need to establish or adopt output
limits that would provide sufficient amplification to meet the user's
listening needs and thereby bolster user satisfaction, adoption, and
use. Moreover, OTC hearing aids need a sufficient output, maximizing
the available dynamic range (the headroom), to meet the hearing needs
of the breadth of the intended population of adults with perceived mild
to moderate hearing impairment. Therefore, the output limits must not
be too low.
    The appropriateness of output limits for OTC hearing aids should
also account for circumstances in which users must determine for
themselves when amplification may be excessive and then potentially
take action to mitigate or avoid the situation, without the involvement
of a licensed person for training or intervention. We are aware that
some users of hearing aids who have perceived mild to moderate
impairment may have difficulties with such tasks. For example, they may
have reduced dexterity or may have difficulty judging their listening
environments. Thus, we are also mindful of the need to establish or
adopt output limits that provide for reasonable assurance of safety and
effectiveness for such users and others. Therefore, the output limits
must not be too high. (See also the response to Comment 100 regarding
the use of consensus standards.)
    FDA has considered quantitative information to inform our
consideration of safety and effectiveness. In the proposed rule, we
referred to a national workplace safety guideline, ``Occupational Noise
Exposure,'' developed by the National Institute for Occupational Safety
and Health (NIOSH) (see 86 FR 58150 at 58161-62) (Ref. 9). That
guideline, which we will refer to as NIOSH-98, defines, among other
subjects, hazardous levels of sound exposure in relation to the
duration of exposure. It uses as its basis 85 dBA (A-weighted decibels)
over 8 hours (as in, a generic workday) as the maximum non-hazardous
exposure level (see paragraph 1.1 of NIOSH-98). Roughly speaking, the
difference between A-weighted decibels and decibels of sound pressure
level, for present purposes, is about 5 dB. As such, 120 dB SPL, or
about 115 dBA, of exposure over 28 seconds would be equivalent to a
full workday's allowable exposure for purposes of occupational safety
(see table 1-1 of NIOSH-98). To address different levels of exposure
besides 85 dBA, NIOSH-98 uses a 3-dB exchange rate (or equal-energy
rule), meaning that the allowable time before the exposure is
considered hazardous halves for every 3-dB increase (see paragraph
1.1.2 of NIOSH-98). In other words, for louder exposures, NIOSH-98
indicates less allowable time than 8 hours and vice versa for lower
exposures.
    We have applied an equal-energy principle and used a 3-dB exchange
rate as a basis for revising the output limits. This interval, rather
than another amount, more clearly reflects our consideration of non-
hazardous outputs and the differing output levels. Thus, 117 dB SPL,
which is 3 dB less than proposed, represents half the output power of
the proposal or twice the time to achieve the same cumulative exposure
(when the hearing aid is outputting at the limit). This translates to a
lower risk of impairment from using OTC hearing aids. However, half the
allowable power does not mean the output will sound ``half as loud.''
As such, not only does 117 dB SPL translate to a lower risk, it also
does not unduly sacrifice effectiveness.
    For the purpose of illustration, you might think of a person as
having a ``budget'' of allowable sound exposure from a hearing aid to
avoid further hearing impairment. The rate at which the person goes
through the budget depends on the output level, and higher outputs
(which have higher power) will use up the budget faster than lower
outputs. In other words, because outputs at 117 dB SPL are half the
power of those at 120 dB SPL, 117 dB SPL will use up the sound budget
more slowly. If a hearing aid user encounters a sound at 117 dB SPL
while using hearing aids, the user will thus have more of the budget
left over to continue wearing the hearing aid for the rest of the day
(without over-exposure) than if the loud sound were at 120 dB SPL.
Note, however, that this analogy is merely an illustration of some
concepts of cumulative exposure. Hearing healthcare professionals use
more technical and precise concepts to describe the effects of sound
exposure on hearing abilities.
    FDA notes that nothing in this rulemaking is intended to interpret
the application of NIOSH-98 for purposes of occupational exposure.
Rather, we are considering the effects of cumulative and ongoing
exposure in relation to equivalent peak output levels for the purposes
of this rulemaking. Conversely, we wish to clarify that referring to
NIOSH-98 does not mean that hearing aids should offer an output
comparable to occupational noise exposure. (The sound output of a
hearing aid is unlikely to reach its output limit regularly.)
Nonetheless, NIOSH-98 provides a well-reasoned quantitative approach to
the effects of sound exposure on people's hearing.
    While many comments agreed that FDA's proposed output limits
provided an adequate safety margin, other comments disagreed and called
our attention to scenarios in which sound exposure at a relatively high
level might be followed by continuing exposure at a relatively modest
level. In certain circumstances, the equal-energy principle would imply
that the relatively modest exposure could nevertheless be hazardous. In
the proposed rule, we used the 3-dB exchange rate to compare the
presumable reaction times between 120 dB SPL and 115 dB SPL, explaining
that the latter offers about triple the time, an additional 61 seconds
(approximately), given the 5-dB difference (see 86 FR 58150 at 58161).
This does not imply that a continuous sound output of 115 dB SPL is
safe for an extended period of use of an OTC hearing aid. This also
does not imply that the user has approximately 89 seconds to intervene
(for example, to remove the OTC hearing aid). Experiencing these output
levels for long-enough periods of time could place the user at greater
risk for further hearing impairment even though the user might judge
the follow-on exposures to be modest or normal.
    We acknowledge that the statement in ANSI/CTA-2051:2017 that 115
dBA (about 120 dB SPL) is an acceptable listening level for up to 30
seconds might imply that repeated exposures to 115 dBA (about 120 dB
SPL) over the course of a day's use of a hearing aid are necessarily
acceptable as long as the exposures are shorter than 30 seconds. (Note
that a day's use of a hearing aid may be longer or shorter than the
generic 8-hour workday that NIOSH-98 uses.) Further, we recognize that
referring to the full time as a safety margin did not adequately
account for exposure to other sounds throughout the day because using
the entire 28-second interval would equate to a day's worth of
allowable cumulative exposure. The

28-second interval assumes no other sound exposure during that 8-hour
timeframe rather than continuing use (and exposure) at a low-enough
level. In consideration of the comments, especially those calling our
attention to possible scenarios leading to excess cumulative exposure,
we have determined we should reduce the risks of cumulative exposure
and do so by finalizing lower output limits than proposed.
    Nevertheless, FDA does not expect OTC hearing aids to perform at or
near their maximum output capabilities for extended periods of time
during the day, if at all. As such, neither our reference to NIOSH-98
nor to ANSI/CTA-2051:2017 should be read to imply that constant outputs
at or near 115 dB SPL (about 110 dBA) are necessarily safe. Instead,
the limits we are finalizing are meant to be high enough to allow
sufficient headroom for high-fidelity amplification for people with
perceived mild to moderate hearing impairment, including amplification
of occasional peaks necessary to reproduce certain kinds of higher
intensity, but infrequent, sounds (see 86 FR 58150 at 58161-62).\10\
However, a device's design or software may have sufficient headroom
without reaching the maximum allowable output. We intend these output
limits to facilitate wide adoption of hearing aids and design
flexibility without being unnecessarily prescriptive.
---------------------------------------------------------------------------

    \10\ The maximum output for a person with greater hearing
impairment is likely to be higher than for a person with less
impairment; however, this general rule is subject to considerable
individual variability.
---------------------------------------------------------------------------

    Some comments recommended that FDA adopt a requirement for
dosimetry, in essence applying similar principles as those described in
NIOSH-98. That is, they suggested that FDA require that OTC hearing
aids be able to measure the weekly sound exposure from the use of the
device. Instead of limiting peak output, the devices could then limit
exposure to a safe cumulative dose. While this approach may be one way
to limit exposure, insufficient scientific data exist regarding
cumulative exposure with the use of hearing aids by people with
perceived mild to moderate hearing impairment. Moreover, as we noted
above, this rulemaking and NIOSH-98 contemplate very different
contexts, so the quantitative information cannot be directly applied to
determining cumulative output limits appropriate for OTC hearing aids.
In sum, FDA believes that establishing a dosimetry-based limit for
regulatory purposes would be scientifically premature at this time.
    Indeed, quantitative analyses of safe maximum output limits are
generally difficult to apply because the data do not necessarily
reflect regulatory considerations. For example, they do not fully
reflect the intended users, specifically users with perceived mild to
moderate hearing impairment, or other considerations for reasonable
assurance of safety and effectiveness of OTC hearing aids. Some sources
use audiometric threshold-based analyses to quantitatively predict safe
maximum output limits (e.g., Ref. 10). However, such analyses use
criteria that FDA is not adopting as they have the effect of excluding
some people for whom OTC hearing aids would be appropriate. Other
references use threshold-based analyses for the maximum output for a
hearing aid that is programmed using existing professional fitting
formulas, applied to a database of audiograms (e.g., Ref. 11). These
results, however, do not fully reflect the intended users of OTC
hearing aids, and interpreting the results often involves the
application of criteria that FDA is not adopting, for example, the
choice and application of threshold-based hearing loss categories.
    In either case, these findings are limited for identifying
appropriate output limits for OTC hearing aids because this rulemaking
is intended to address perceived, not audiometrically quantified,
impairment. (See also the response to Comment 24 regarding measurements
of hearing loss and incorporating numerical thresholds into this
rulemaking.) Moreover, different commenters interpreted the same
references differently, demonstrating that even quantitative analyses
leave much to interpretation. Well-reasoned, scientific views still
exhibited significant diversity. The analyses are instructive, and we
have updated our risk assessment based in part on them, but they cannot
definitively settle the regulatory questions of this rulemaking. Hence,
although we are finalizing lower output limits based on the available
information, we are establishing the limits at 111 and 117 dB SPL
(peak, not RMS, values) rather than the even lower levels found or
suggested in some of the references submitted to us.
    Other comments recommended FDA adopt international standards
developed jointly by the WHO and the International Telecommunication
Union (ITU). These comments identified ITU-T H.870 (2018), ``Guidelines
for safe listening devices/systems,'' and ITU-T H.871 (2019), ``Safe
listening guidelines for personal sound amplifiers.'' However, the
guidelines refer to a WHO-derived standard value for the cumulative
sound exposure for non-hearing-impaired adults. In other words, they
use a dosimetry-based method, which we do not believe is a suitable
basis to establish an appropriate limit, as explained above.
    The guidelines do equate this to an output value of 80 dBA for 40
hours per week. However, the rationale underlying the guidelines relies
on WHO thresholds and citations to literature that, as explained, FDA
is not adopting and does not consider definitive (see the response to
Comment 24 about the WHO hearing loss thresholds). Further, as even
ITU-T H.871 (2019) explains, Ref. 10 can be read to suggest 90 dB SPL
RMS as the maximum sound output for persons with normal hearing (see
Appendix II of ITU-T H.871 (2019)). Such maximum sound output
recommendations for normal-hearing listeners cannot be used to derive
maximum output limits for a hearing aid to compensate for perceived
mild to moderate hearing impairment. Thus, FDA is declining to adopt
this cumulative exposure limit or the equivalent peak output value.
    The lack of sufficient data to establish regulatory limits based on
dosimetry does not, however, mean that dosimetry is not a useful
feature. Manufacturers that wish to include dosimetry-based features in
OTC hearing aids may do so.
    Ultimately, as stated previously the output limits that we are
finalizing reflect a balancing of safety and effectiveness. By lowering
the output limit 3 dB SPL from the proposed rule, these output limits
result in a meaningfully lower risk to the intended users, without
unduly sacrificing effectiveness.
3. Applying Analyses to Real-World Use of Hearing Aids
    As we explain in the responses to Comments 11 and 24, the
perception of hearing impairment is conceptually integral to
establishing the OTC category of hearing aids, and the application of
audiometric thresholds to make regulatory decisions is inconsistent
with how the hearing loss categories themselves were formulated.
Moreover, audiometric threshold ranges or databases of audiograms do
not necessarily reflect the needs and wants of the intended users of
OTC hearing aids in a precise way. As such, while quantitative analyses
provide useful information, including data on exposure versus stability
of hearing impairment, the conclusions have inherent limitations that
militate against adopting them wholesale for the regulatory purposes of
this rulemaking.
    FDA also considered how hearing health care providers fit hearing
aids in

a clinical environment. Ordinarily, a fitting algorithm determines the
necessary amplification, including the effective output limit of the
device for a given user. The provider would then make further,
iterative adjustments in consultation with the hearing aid user. These
processes effectively guarantee that the device's output will rarely
reach the device's maximum capability, if ever.
    However, OTC hearing aids may not have features that prevent the
user from continuous access to the device's maximum output. Some
comments conveyed concerns that users, without the aid of professional
judgment, would want to use unnecessarily high amplification on a
continual basis; they would tend to prefer higher outputs than a
hearing healthcare professional would set. In a worst-case example, the
volume control and other features could cause maximum device
amplification in a loud environment, and the user does not take action
to mitigate the effects. In such a worst-case scenario, the user could
suffer further impairment. Although these comments used anecdotes or
more general concerns based on professional experience to support their
views, we recognize that hearing healthcare providers sometimes
recommend lower outputs than hearing aid users might initially prefer.
Thus, while we would expect that a device would seldom perform at its
maximum, much less continuously, even when set at the applicable output
limit, that possibility is greater than for professionally fit devices,
for which the audiologist or hearing instrument specialist has, in
effect, limited the output. In further consideration of the differences
between professionally fit and user-customizable devices, we find
additional indications that the safety margin of the proposed output
limits is lower than we initially believed regarding the risks of
cumulative exposure.
    Several comments suggested that FDA also reconsider users' ability
to react to loud situations in which continued use of an OTC hearing
aid could present significantly increased risks of injury should the
user not remove the hearing aids or reduce the output. Some comments
observed that users of OTC hearing aids are likely to have
characteristics not shared by the general population. For example, OTC
hearing aid users may be more likely to have reduced dexterity or
experience cognitive difficulties. Such characteristics can hinder
adjusting a device in sufficient time, especially if the controls are
physically small or require navigation (as in opening a software
application on a smartphone to navigate to the correct control
interface).
    Other comments noted that, while obviously-loud sounds pose risks
of further hearing impairment, continuous exposure to lower intensities
can pose such risks over a sufficiently long period of device use.
Under the proposed limits, overexposure is possible in scenarios where
the device is set to its maximum (providing the maximum gain), yet the
amplified output does not discomfit the user enough to mitigate the
exposure. Such a scenario would entail an increased risk of impairment
to residual hearing from use of an OTC hearing aid.
    The ability for users to act to protect themselves was an important
factor in our proposed output limits (see 86 FR 58150 at 58162), and it
remains so for this final rule. FDA recognizes that some OTC hearing
aid users may need more time or assistance to react to noticeable
overexposure than an average member of the general population. The
required design and electroacoustic performance features for OTC
hearing aids will significantly reduce such risks for the intended
users. For example, a user-adjustable volume control will allow a user
to set and maintain the device's output below the maximum. However,
after considering the diversity of scientific comments, we are
persuaded that our proposal did not adequately account for cumulative
exposure to lower-intensity sounds during daily use over an extended
period of time--on account of users' ability or desire to intervene as
well as the other factors, explained above, that might increase
cumulative exposure and the resulting risks. Since a dosimetry-based
limit is impractical as discussed above, we are lowering the allowable
maximum output to address considerations of cumulative exposure.
4. Declining To Include Gain Limit
    Multiple comments, many of which urged FDA to establish or adopt a
lower output limit, recommended that FDA also adopt a gain limit. These
comments contended that a gain limit would improve device safety by
further reducing the risks of over-amplification, primarily due to the
device reaching its gain limit and providing no further amplification
before it reached its output limit (see 86 FR 58150 at 58162). In
effect, a gain limit would lower the output limit.
    FDA acknowledges that a gain limit may play a role in the
management of risks from overamplification. However, a gain limit
reduces the ability to adequately amplify soft sound inputs in some
cases, which can lead to decreased device effectiveness and user
satisfaction. Moreover, the appropriate gain for a given device will
depend on device design and features. Imposing a gain limit may
constrain device design and innovation, which could have an undesirable
effect on device benefit for intended users.
    In addition to preserving flexibility in device design, FDA is not
requiring a gain limit in order to maximize access to these devices for
the full range of intended users with perceived mild to moderate
hearing impairment. Intended users of these devices are a heterogenous
population with a range of hearing and communication difficulties and
needs. By not requiring a gain limit, the broadest range of intended
users will have access to effective devices. This flexibility empowers
users to customize their hearing aids to their needs, listening
preferences, and communication goals, and it allows for a wider range
of options should users' needs, preferences, and goals change over
time.
    FDA is establishing requirements to provide reasonable assurance of
safety and effectiveness of OTC hearing aids for the intended user
population, and further reducing the device's output by establishing a
gain limit is not necessary for such reasonable assurance. Indeed, a
gain limit in this case may detract from such reasonable assurance by
broadly reducing the available amplification for the user and limiting
the range of intended users of the device. Because the appropriate
output limits we are finalizing will sufficiently limit device output,
we are not finalizing a gain limit that would further reduce the
output. (See also the response to Comment 78, describing how frequency
response smoothness helps prevent under- and overamplification of
frequency bands, in effect, a more-focused reduction than a gain
limit.) This also allows manufacturers the flexibility to design their
devices to balance the required output limits with the amplification
needs of the intended user population.

F. Other Device Requirements (Sec.  800.30(e) and (f))

    Several comments shared a concern for an influx of unsafe or
ineffective devices to the marketplace, for example, devices that do
not satisfy the requirements of the OTC Hearing Aid Controls because of
lax enforcement and/or manufacturers or sellers evading regulatory
controls necessary for reasonable assurance of safety and effectiveness
of OTC hearing aids. Such comments tended to focus on the risks to
health of violative or non-conforming products, for example, impairment
of

remaining hearing from excessive device output, injury stemming from
inferior manufacturing practices, or ineffective treatment resulting
from the possible difficulty of distinguishing an OTC hearing aid from
consumer electronics not intended to compensate for hearing loss.
    To provide reasonable assurance of safety and effectiveness of OTC
hearing aids, and thereby avoid an influx of unsafe or ineffective
devices, we are establishing requirements for, among other things, the
design and performance of OTC hearing aids. At the same time, the
requirements will not unnecessarily constrain device design or burden
manufacturing, which could hinder innovation or impede adoption and use
of the devices. Further, compliance with regulatory controls is a
concern for all devices, and FDA monitors the marketplace and conducts
regular inspections and other postmarket surveillance as part of
maintaining reasonable assurance of safety and effectiveness.
1. Electroacoustic Performance
    (Comment 73) Some comments urged FDA to adopt the same
electroacoustic performance requirements for prescription hearing aids
as those for OTC hearing aids.
    (Response) While FDA agrees that prescription hearing aids should
provide high-fidelity amplification for users, we do not agree that
prescription hearing aids should be subject to the same electroacoustic
performance requirements as OTC hearing aids. The requirements for OTC
hearing aids will provide reasonable assurance of safety and
effectiveness without the involvement of a licensed person, such as an
audiologist or hearing instrument specialist, to adjust the device
output and ensure it performs adequately. However, the requirements we
are finalizing for prescription hearing aids presume the involvement of
a licensed person: As prescription devices, they may only be sold to or
on the prescription or other order of a practitioner licensed by law to
use or order the use of the devices (see Sec.  801.109(a)(2)).
    The labeling requirements we are finalizing for prescription
hearing aids include technical specifications that an audiologist or
hearing instrument specialist can use to select and adjust the hearing
aid (see 86 FR 58150 at 58164). These requirements are virtually
identical to the long-standing labeling requirements for hearing aids
in former Sec.  801.420(c)(4) upon which professionals rely.
Additionally, we are finalizing a new requirement to state the latency
of the prescription hearing aid, measured with a method that is
accurate and repeatable to within 1.5 ms. This information will be
particularly useful for fitters given evolving hearing aid designs and
sound processing capabilities. However, we are not also establishing a
latency performance limit for prescription hearing aids. The
aforementioned information and the involvement of a licensed person
will provide reasonable assurance of safety and effectiveness of
prescription hearing aids without the additional performance
requirements necessary for OTC hearing aids.
    (Comment 74) A comment recommended that the requirements for an OTC
hearing aid sold by a licensed person be no different than those for
sale by a non-licensed person, and that the final rule should clearly
state that preemption would apply to this situation.
    (Response) To the extent that this comment recommends that the
requirements for the OTC hearing aid itself be no different when sold
by a licensed person, versus a non-licensed person, FDA agrees with the
comment. The requirements for OTC hearing aids themselves (output
limits, electroacoustic performance, labeling, etc.) that we are
finalizing apply equally to those sold by licensed and non-licensed
persons. To the extent that this comment recommends that State
regulation of the activities associated with the sale of OTC hearing
aids, for example, via licensing requirements, be preempted, we have
addressed that request along with similar comments in the Preemption
sections III.H and VIII.
    (Comment 75) A comment suggested that prescription hearing aids
have the same output limit as OTC hearing aids.
    (Response) FDA does not agree that prescription hearing aids should
have the same output limit as OTC hearing aids because people with a
more severe degree of hearing loss than perceived moderate impairment
may need additional gain, and therefore would need a higher output,
potentially above limits appropriate for OTC hearing aids. We recognize
that people with more severe hearing impairment can still suffer
further impairment of their remaining hearing, so the device output
must not be too high for them. We are finalizing a requirement, as
proposed, that labeling warn dispensers to exercise special care when
selecting and fitting a hearing aid with an output that exceeds 132 dB
SPL. This warning is nearly the same as the required warning statement
in former Sec.  801.420(c)(2). Nevertheless, the output necessary to
compensate for more severe hearing impairment safely and effectively,
though subject to individual variability, will generally be higher than
would be permissible for OTC hearing aids.
    (Comment 76) Comments suggested that FDA require input-controlled
compression for all OTC hearing aids to help significantly reduce the
risk that users could worsen their hearing impairment by using an OTC
hearing aid.
    (Response) FDA agrees that input-controlled compression can provide
multiple benefits for OTC hearing aid users. For example, this feature
allows the device to adapt the output dynamically, based on the
listening environment. This can reduce the user interaction necessary
to adjust the device for different situations. Some users find the
feature improves the hearing aid's comfort, contributing to their
satisfaction and encouraging continued use. This in turn can help
accomplish this rule's purposes of promoting wider adoption and use.
However, some users find the feature annoying or distracting, reducing
their satisfaction and discouraging them from using their hearing aids.
Moreover, the feature is not necessary for reasonable assurance of
safety or effectiveness (when the device does not exceed an output of
111 dB SPL). For these reasons, FDA is not requiring input-controlled
compression for all OTC hearing aids. (See also the response to Comment
77 about including noise-cancelling technology.)
    (Comment 77) A comment suggested requiring that OTC hearing aids
include noise-cancelling technology to prevent a loss of benefit from
using the devices in noisy environments.
    (Response) FDA agrees that noise-cancelling technology can help
hearing aid users in certain situations. For example, the feature can
help improve the clarity of voices by reducing the volume of only
background noise. This can reduce the user interaction necessary to
adjust the device for different situations. However, the feature is not
generally necessary for reasonable assurance of safety or effectiveness
because air-conduction hearing aids can still provide adequate
amplification to achieve effectiveness without the feature, so FDA is
not requiring noise-cancelling technology for all OTC hearing aids.
(See also the response to Comment 76 about including input-controlled
compression.)
    (Comment 78) Comments requested that FDA remove the frequency
response smoothness requirements so, these comments asserted, OTC
hearing aids would accommodate all kinds of

perceived mild to moderate hearing impairment, not just individuals
with typical age-related, sloping hearing impairment.
    (Response) Although FDA agrees that OTC hearing aids should be safe
and effective for the breadth of the intended user population with
perceived mild to moderate hearing impairments, we are not removing the
frequency response smoothness requirements for OTC hearing aids. As we
explained in the proposed rule, a smooth frequency response will ensure
that an OTC hearing aid does not under- or overamplify certain sounds
(see 86 FR 58150 at 58164). A device that does not have a smooth
frequency response can, for example, perceptibly distort speech quality
(see 86 FR 58150 at 58164).
    Moreover, the proposed frequency response smoothness requirements
do not limit device output to compensating only for typical age-
related, gradually sloping hearing impairment. More specifically, the
frequency response smoothness describes the flatness of the output when
the device is set to provide constant gain as a function of frequency,
that is, when the device is not set to provide frequency shaping. The
idea is that the flatter the response when the device is not set to
provide frequency shaping, the more consistently the device will
achieve any intended frequency shaping to accommodate the user's
customization, for example, to compensate for a sloping hearing loss.
    This is similar to how a loudspeaker's frequency response is later
adjusted by an equalizer, which shapes the input signal. In short,
frequency response smoothness does not prevent the device from
appropriately amplifying lower frequencies. Instead, it helps prevent
under- and overamplification at any frequency band that could result
from a device that does not appropriately shape the output. We are
finalizing the smoothness requirements as proposed.
    (Comment 79) Some comments proposed that OTC hearing aids have
cutoff limits: if the output were to exceed certain thresholds for a
long-enough time, the device would reduce or stop amplification, even
if the device never exceeded the allowable output limit.
    (Response) FDA agrees that an OTC hearing aid user could experience
over-amplification even if the device does not exceed the allowable
output limit. As we explain in section V.E of this document, we have
considered this possibility further and are correspondingly finalizing
output limits lower than we proposed. We also explain in that section
that insufficient data exist to establish regulatory limits for
exposure over time based on dosimetry. As with implementing dosimetry-
based features, manufacturers may establish cutoff limits for their
devices, but FDA is not requiring such features for OTC hearing aids.
    (Comment 80) A comment requested that FDA allow greater latency for
OTC hearing aids, suggesting 25 milliseconds (ms). The comment argued
that this delay would still not be perceptible to the user. Other
comments requested that FDA address latency for wireless streaming
technologies, such as Bluetooth, and other hearing aid designs.
    (Response) FDA does not agree that allowing greater latency will be
imperceptible. One comment cited for support material that showed four
out of nine people perceived a delay of 25 ms. (Two out of nine
perceived it at 15 ms.) This does not suggest that allowing greater
latency will be equally imperceptible, though such a small sample may
not have yielded generalizable results. Regardless, human hearing
perception can be sensitive to differences longer than 15 ms, depending
on frequencies and conditions, and signal processors for hearing aids
can reliably achieve latencies shorter than 15 ms. Given these
considerations, we do not agree that greater latency will be
imperceptible or that a limit of 15 ms unduly constrains device design.
FDA is not revising the latency limit for OTC hearing aids.
    Regarding wireless streaming technologies, the latency limit we are
finalizing is an electroacoustic performance metric that describes how
quickly an OTC hearing aid must produce the output sound relative to
the input sound, that is, the acoustic input (see 86 FR 58150 at
58164). It does not describe the time necessary for an OTC hearing aid
to receive and process a wireless signal after transmission, which can
often exceed 15 ms, even under ideal conditions. In contrast to
electroacoustic performance, FDA has not determined that a wireless
transmission latency limit is generally necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids because air-
conduction hearing aids compensate for impaired hearing primarily by
detecting sounds with on-board microphones. As such, wireless streaming
latency does not generally raise the same perceptual concerns as
electroacoustic latency. Therefore, we are not establishing a wireless
transmission latency limit. (See also the response to Comment 64
regarding labeling for wireless streaming latency.) However, there may
be circumstances where, based on the device's design, wireless
streaming latency does raise the same perceptual concerns as
electroacoustic latency. In such circumstances, manufacturers will
likely need to consider wireless transmission latency for devices that
incorporate such technology.
    As for different device designs regarding acoustic transmission,
the latency limit applies. For example, ``open-fit'' devices that allow
some incoming sound to bypass the hearing aid would also need to
respect the latency limit. Moreover, the latency limit is a performance
baseline. Manufacturers may design devices with lower latency should
they want to improve electroacoustic performance.
    (Comment 81) Some comments suggested that FDA permit different
acoustic couplers than proposed for the electroacoustic performance
testing requirements. These comments argued that standard 2-cm\3\
couplers would not be the most appropriate for some device designs, and
performance measurements would more accurately reflect device
capabilities if more suitable couplers were permitted.
    (Response) FDA agrees that 2-cm\3\ couplers may not be compatible
with some device designs. We are revising the final regulations to
permit use of alternative acoustic couplers that are compatible with
the device. The manufacturer would have to document how use of the
alternative approach is scientifically valid and technically
equivalent.
    (Comment 82) A comment requested that FDA prescribe the method to
test latency beyond requiring that measurements be accurate and
repeatable to within 1.5 ms.
    (Response) Although FDA is finalizing standardized test methods to
ensure other electroacoustic specifications are comparable across
devices, the comparability of latency is less sensitive to the specific
method. Latency is a measurement of time, so essentially any
scientifically suitable and accurate timing method will produce a
result that is comparable to other suitable and accurate methods, even
though the methods may differ in the specifics. As such, we are
specifying how accurate the timing must be but allowing flexibility for
the specific method. Nevertheless, clause 4.8 of ANSI/CTA-2051:2017
suggests two different methods, either of which is acceptable provided
the testing equipment is sufficiently accurate and precise.
    (Comment 83) A comment observed that FDA considered the
electroacoustic performance requirements in ANSI/

CTA-2051:2017, including the self-generated noise limit. However, FDA
did not specify A-weighted measurements for the self-generated noise
limit in the proposed regulation as the standard does. The comment
suggested FDA specify A weighting consistent with the standard.
    (Response) FDA agrees that A weighting is more consistent with the
standard. We are revising the self-generated noise limit in the final
regulation to refer to A-weighted decibels.
2. Design Requirements To Ensure Proper Physical Fit and Prevent User
Injury
    (Comment 84) Several comments urged FDA to hold OTC hearing aids to
the same hardware standards as prescription hearing aids. Some of these
comments focused on Quality System requirements (see Comment 95 and our
response). Others focused on equivalent electroacoustic performance.
    (Response) FDA agrees that OTC and prescription hearing aids should
both be held to standards appropriate for medical devices. However, we
are not applying all of the same specific rules to both because OTC and
prescription hearing aids differ in important respects, for example,
the intended uses.
    Some of the same rules will apply to both. As we explain in the
response to Comment 95, OTC hearing aids will be subject to quality
management system requirements that are appropriate for medical
devices. The same will be true for prescription hearing aids. Thus,
both OTC and prescription hearing aid manufacturers will need to comply
with the same Quality System requirements under part 820, even if their
individual implementations differ in the details. (See also the
response to Comment 96 about a risk-based approach to quality
management systems.)
    However, some of the requirements will differ, such as those for
device performance. We explain in the responses to Comments 73 and 75
that OTC and prescription hearing aids have different intended uses,
and therefore, they must satisfy different performance needs. Thus,
having reasonable assurance of safety and effectiveness of both
categories of hearing aids entails different specific requirements for
each category.
    (Comment 85) Some comments proposed requiring that eartips for OTC
hearing aids be made of ``medical grade'' materials to prevent
irritation or damage from the components of the device in contact with
the ear canal.
    (Response) FDA agrees that contact with substances can cause
adverse tissue reactions like skin irritation; however, the design
requirements that we are finalizing for OTC hearing aids, along with
existing requirements and policies, are sufficient to address the kinds
of materials used.
    The design requirements that we are finalizing for OTC hearing aids
include a requirement that the material for the eartip be atraumatic,
which is the same as proposed. As explained in the proposal, atraumatic
materials are those that prevent injuries to the skin and bone, and 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 (86 FR 58150 at 58165). In evaluating the material for the
eartip to determine whether it meets this requirement, manufacturers
may wish to review FDA's guidance, ``Use of International Standard ISO
10993-1, `Biological evaluation of medical devices--Part 1: Evaluation
and testing within a risk management process,' '' issued September 4,
2020, which describes FDA's approach to biocompatibility evaluation of
medical devices, including considerations and recommendations for
manufacturers.\11\
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    \11\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.
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    As described in the aforementioned guidance, OTC hearing aids
(depending on the specific device) would likely be a surface device in
contact with intact skin. As such, manufacturers should consider the
specific biological effects of cytotoxicity (toxic effects on cells),
sensitization (becoming more sensitive to materials over time), and
irritation or intracutaneous reactivity (a reaction within the layers
of the skin). The use of certain common materials in surface devices
contacting intact skin may help manufacturers to pursue least-
burdensome methods for evaluating biocompatibility.
    Additionally, as we explain in the responses to Comments 95, 96,
and 97, OTC hearing aids will be subject to the Quality System
requirements, which will also help provide for reasonable assurance of
safety and effectiveness.
    (Comment 86) Several comments suggested requiring that OTC hearing
aids use non-proprietary designs and/or open-platform technology
because, in the commenters' views, proprietary designs or closed
platforms would limit the compatibility of accessories, availability of
replacement parts, or possibility of modifications to the devices.
    Other, similar comments proposed that OTC hearing aids have a
standard user interface or support a standard application programming
interface (API) to allow users to access and modify device settings,
perhaps through third-party software, when the manufacturer has not
exposed the desired settings to user control. Some comments identified
a standard API (or some other standard protocol) as a way to enable
device interaction with other electronics of the user's choosing, for
example, a smartphone from a different manufacturer.
    (Response) While some OTC hearing aid users may desire such
features, we do not currently consider them necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids generally.
Hearing aids that incorporate proprietary designs and interfaces can be
safe and effective, without interaction with third-party products.
Manufacturers may implement open features, but we are not requiring
them.
    (Comment 87) Several comments suggested that all OTC hearing aids
have a user-adjustable volume control because the feature would be
integral to device safety regardless of its output limit. A comment
suggested that all hearing aids should have a volume control built into
the device itself, separate from a software controller (as in, a
``slider'' in a smartphone application, for example).
    (Response) FDA agrees that a user-adjustable volume control should
be a design feature of all OTC hearing aids, and we are finalizing such
a requirement under new Sec.  800.30(f)(5). However, although FDA
understands that a physical (that is, built into the device itself)
volume control could provide ready access for some users to adjust the
volume, we are declining to adopt this suggestion.
    While some users may find a physical volume control useful, several
comments that FDA received observed that many users of OTC hearing aids
may have limited dexterity, which would in turn limit the usefulness of
a hardware controller, for example, a small dial or push buttons on the
device. Similarly, we received comments emphasizing hearing aid users'
desire for a discreet device, including both its form and its
operation. A user interface, perhaps implemented on a remote control or
a mobile device, will allow design flexibility for manufacturers to
develop and market smaller hearing aids, and adjusting the volume
through such an interface may feel more discreet for many users than
reaching up to the

device to adjust it, perhaps needing additional effort to manipulate
physically small controls.
    This is consistent with the many comments we received urging that
we require the devices to have wireless controls. (See the response to
Comment 94 for further discussion on this topic.) For people who are
less inclined to use software, they may still purchase a device with a
physical volume control or, alternatively, they may still manually
limit the sound exposure by, for example, removing the device, covering
the microphone, or seeking a quieter environment.
    (Comment 88) A comment suggested that all OTC hearing aids have an
option for volume limitation and a parental volume control.
    (Response) FDA is not adopting these suggestions because the output
limits we are finalizing will provide reasonable assurance of safety
and effectiveness without requiring an additional feature that would
limit the output further. (See also section V.E.4 of this document
explaining why FDA is not establishing a separate gain limit.) However,
we are finalizing a requirement that all OTC hearing aids have a user-
adjustable volume control (see the response to Comment 87).
    A parental volume control is likewise not necessary for reasonable
assurance of safety and effectiveness, including cases in which the
caregiver is not the user's parent. Moreover, establishing a
requirement for ``parental control'' may imply that the devices are
intended for people younger than 18, which is not the case for OTC
hearing aids (see 21 U.S.C. 360j(q)(1)(A)(ii)).
    (Comment 89) A comment proposed that the user-adjustable volume
control must allow for at least 6 dB of potential adjustment to the
device output to ``ensure perceptual functionality.'' This amount, the
comment asserted, would help significantly reduce the risk that users
could worsen their hearing impairment by using an OTC hearing aid.
Other similar comments suggested that FDA specify the performance
requirements for the volume control in terms of the range.
    (Response) FDA is not requiring that a user-adjustable volume
control adjust the volume in 6-dB increments at a minimum, and FDA is
not specifying the range for the volume control.
    The comment proposing 6-dB increments asserted that a 3-dB change
in signal intensity is the average needed for users to perceive a
volume difference, thus a 6-dB increment would ensure that users
perceive it. However, FDA expects that users will manipulate the
control until they perceive not only a difference but a satisfactory
output volume, regardless of the size of the increment. Further, a 6-dB
minimum increment may force users to increase the volume more than
desired, providing unnecessarily high amplification while constraining
device design and performance. FDA does not agree that a minimum volume
adjustment increment of 6 dB will appreciably reduce risks or increase
effectiveness.
    As for the range over which the volume control must operate, a
specification is not necessary for reasonable assurance of safety or
effectiveness, and it may constrain device design unnecessarily. The
output of an OTC hearing aid may not exceed the applicable limit under
final Sec.  800.30(d) regardless of the performance of the volume
control, so establishing an upper limit would be redundant. As for a
lower limit, a specific minimum setting would generally depend on the
device design. Thus, for similar reasons to not requiring a minimum
increment, we are not requiring a minimum volume setting.
    (Comment 90) Comments suggested establishing an absolute limit on
the maximum insertion depth for OTC hearing aids. There was variability
in the range of recommended insertion depth limit ranging from 7.5 mm
to 21 mm, though the most frequent recommendation was 15 mm to 17 mm.
    (Response) FDA agrees that a fixed limit on the insertion depth of
an OTC hearing aid is a better measurement than the anatomical landmark
that we proposed (the bony cartilaginous junction). We are finalizing a
fixed insertion depth limit relative to the expected distance from the
eardrum (tympanic membrane). Note that a ``fixed insertion depth
limit'' means a limit that is a specific distance measurement rather
than a more relative description. This meaning is different from
describing a hearing aid as ``fixed length'' (or similar) in reference
to a hearing aid that does not change length. FDA did not propose and
is not finalizing a design requirement that hearing aids have a fixed
length.
    As we explained in the proposal, the length of the ear canal can
vary greatly among adults (see 86 FR 58150 at 58165). A fixed insertion
depth limit may be too deep for some individuals, potentially resulting
in injury. Comments noted that a hearing aid inserted too deeply in the
ear canal can cause increased sound pressure levels to be delivered to
the eardrum as well as push earwax deeper into the ear canal. However,
the same fixed depth limit may be too short for others, potentially
reducing device effectiveness. As comments recognized, the hearing aid
must be inserted deeply enough for it to stay in place despite jaw
movement, and deeper insertion also helps with reducing acoustic
feedback and improving gain (amplification). Moreover, deeper insertion
can help reduce the cosmetic impact of the hearing aid, that is, help
it to be less visible, which may reduce self-consciousness or
perceptions of stigma from wearing the device.
    Furthermore, we are not aware of any widely accepted method to
describe the measurement of the insertion depth of hearing aids. Ear
canal anatomy varies across individuals, and methods may not agree on
exactly where to start the measurement for various OTC hearing aid
designs. These factors may lead to significantly different measurements
of insertion depth for the same device.
    We proposed a limit based on an anatomical landmark, and several
comments characterized the proposal as insufficiently defined and
subject to significant variability across individuals. While
measurements relative to the individual's anatomy would be ideal, we
recognize it is not currently practical, considering the uncertainties
stemming from anatomical variability and insertion depth measurement.
    As such, following review of all relevant comments, we have
determined a limit defined by the distance of the innermost (that is,
most medial) component of the hearing aid relative to the eardrum. This
should be a generally understandable and consistently measurable way to
ensure safe design of the device with respect to placement in the ear
canal. Thus, we are limiting the insertion depth to a specific expected
distance (``setback'') from the eardrum (tympanic membrane): 10 mm from
the innermost component of the device to the eardrum. In establishing
this limit, we considered that its primary purpose is to minimize the
risk of injury to the tympanic membrane and the skin of the bony
portion of the ear canal. We believe that an OTC hearing aid designed
to have a 10-mm setback will minimize the risk of injury from inserting
the device too deeply while allowing for individual anatomic
variability, but without unduly limiting effectiveness.
    For adults, the average length of the ear canal has been estimated
to be 23-28 mm (Refs. 12 and 13). Using an average length of 25 mm,
manufacturers may generally assume that the maximum insertion depth of
a hearing aid designed with a setback of 10 mm

from the tympanic membrane would be approximately 15 mm. We acknowledge
that an OTC hearing aid design based on this setback limit may result
in an actual setback of somewhat less than 10 mm in users with shorter
than average ear canals. However, we believe that the limit is
conservative enough to ensure safety even in these cases. Some comments
pointed out that receiver-in-the-canal hearing aids can have insertion
depths of 20-21 mm. However, an audiologist or hearing instrument
specialist typically fits such a device. We do not currently consider
such insertion depths to be appropriate for OTC hearing aids.
    (Comment 91) Some comments proposed either encouraging or requiring
that OTC hearing aids use only instant-fit eartips or customized
eartips, fabricated based on non-invasive ear scans, to couple the
device to the ear canal. A few of these comments further suggested that
FDA require a licensed person to fabricate custom earmolds or ear
shells.
    (Response) FDA is not requiring the use of instant-fit eartips or
eartips fabricated based on non-invasive ear scans because currently
classified devices to create earmolds and ear shells are not intended
for the user of the OTC hearing aid. Instead, earmolds and ear shells
are intended for use by a hearing health professional because they
often require an impression-making procedure. As some comments noted,
improperly taking the impression can leave behind impression material
or injure the ear. Separately requiring instant-fit (or non-invasively
created) eartips is unnecessary for reasonable assurance of safety and
effectiveness of OTC hearing aids.
    However, a manufacturer may design an OTC hearing aid intended to
be compatible with custom earmolds or ear shells, that is, the use of
such is optional but not necessary. (A device intended to rely on
taking impressions would imply the need for a licensed person, hence
the device would not be ``available'' over the counter.) We do not wish
to preclude this possibility, nor do we wish to limit the kinds of
eartips in the future that may be safe and effective for users of OTC
hearing aids. Considering the current regulatory framework and a desire
to avoid unduly constraining design, we are not adopting this
suggestion.
    (Comment 92) A comment suggested that OTC hearing aids with
removable eartips must have a specific minimum amount of force to
remove the eartips from the device. The comment asserted this would
help prevent an eartip from falling off the device and lodging in the
ear canal.
    (Response) FDA is not requiring that eartips have a minimum force
to detach them from the device because determining a generally
applicable threshold would be impractical and unnecessary. The force
exerted on an eartip during normal removal or wear may vary depending
on the device design, materials, and the user's anatomy, among other
factors. Furthermore, any minimum force requirement would need to
ensure that the force was not so great as to hinder the ability of
users to change eartips, particularly for users who have limited
dexterity. However, we note that manufacturers of devices with
removable eartips should consider the risks of accidental separation of
an eartip within the canal and ensure their specific designs prevent
such adverse events. Although we are not establishing a threshold for
force that would apply to all OTC hearing aids, manufacturers should
incorporate robust device designs that help provide for safe and
effective hearing aids.
    (Comment 93) Comments suggested that FDA require a self-
administered hearing test to accompany OTC hearing aids because users
are not always able to determine whether their hearing loss is mild or
moderate.
    (Response) While a self-administered hearing test may be one way
for users to control OTC hearing aids and customize the devices to
their hearing needs, we are not requiring that self-administered
hearing tests accompany OTC hearing aids. In some cases, a test is not
necessary to achieve safe and effective amplification to compensate for
perceived mild to moderate hearing impairment. For example, a self-
fitting strategy could do so by guiding the user through a setup
process that is not a diagnostic hearing test. Further, users may wish
to obtain a hearing test by some other means, for example, by
voluntarily visiting an audiologist. The inclusion of a hearing test
with the device, in either case, would be unnecessary. Manufacturers
may decide to incorporate a validated diagnostic function as
appropriate for their device designs, but we do not agree that it
should be a requirement for all OTC hearing aids.
    (Comment 94) A comment suggested requiring that OTC hearing aids
integrate Bluetooth or telecoil technology so users can configure the
devices with their smartphones.
    (Response) While Bluetooth or other wireless technologies may be
desirable for some users of OTC hearing aids, we are not requiring such
functionality. We acknowledge that, by definition, a wireless hearing
aid will incorporate wireless technology in its programming or use, and
we would expect that, with current technologies, most OTC hearing aids
will incorporate wireless.
    However, we also expect that wireless technology will continue to
evolve, and specifying protocols or capabilities may unnecessarily
constrain design and hinder innovation. For example, telecoil
technology may currently be practical for relatively larger form factor
devices, but users may not desire the functionality or the size
necessary to incorporate a telecoil, for example, if preferring a
smaller device. Other methods of connectivity may also develop, and
such devices may be appropriate for OTC availability despite lacking
wireless technology. In sum, requiring such features could potentially
increase cost while hindering innovation and reducing adoption and use
of OTC hearing aids. (See also the response to Comment 87 about
requiring a physical control for volume adjustment.)
3. Quality System Requirements
    In the proposal, we sought input on the Quality System requirements
that would apply to OTC hearing aids but also explained that any
changes to the Quality System requirements would be proposed in a
separate rulemaking proceeding (86 FR 58150 at 58165). Below we
summarize the input that we received and respond to it.
    (Comment 95) Many comments supported FDA's proposal that all
applicable Quality System requirements under part 820 remain in force
for the manufacture of OTC hearing aids. Most of these comments
emphasized that hearing aids are medical devices and, as such, should
be subject to commensurate manufacturing requirements. Most such
comments also opined that the current requirements are not unduly
burdensome or unreasonably costly, and in fact, can aid device
development. For example, as one such comment stated, the application
of Quality System requirements helps manufacturers to identify risks
and problems early, helping to focus resources on the most promising
new ideas. Such requirements allow manufacturers to identify what works
well and effectively investigate what does not. The requirements
collectively help reduce costs and time to market.
    (Response) We have further considered the applicability of Quality
System requirements under part 820, and we are not modifying the
applicability of the requirements for

OTC hearing aids. The device quality system requirements are part of
the general controls for all devices that help provide for reasonable
assurance of safety and effectiveness. In the proposal, we explained
that we had previously received conflicting feedback on the
possibilities but that we believed a quality management system specific
to medical devices was appropriate (see 86 FR 58150 at 58165).
Moreover, we consider the Quality System requirements to be
interdependent yet inherently flexible (see 86 FR 58150 at 58165). We
continue to hold these views, and although we again received
conflicting comments, we agree that the requirements are not unduly
burdensome. (See also the response to Comment 96, explaining the risk-
based nature of the Quality System requirements and the revisions FDA
is proposing in a separate rulemaking.)
    (Comment 96) A comment proposed that the extent of Quality System
controls be based on the risks of device use and the complexity of the
device. It suggested that manufacturers be allowed to maintain a
Declaration of Conformity, along with supporting documentation, that
the manufacturer could provide to FDA upon request.
    (Response) As we explained in the proposed rule, the Quality System
requirements under part 820 are inherently flexible (see 86 FR 58150 at
58165). We have elsewhere explained that one of the purposes of the
flexibility is to allow manufacturers to develop and follow procedures
and processes that are appropriate to a given device and according to
the state of the art for designing and manufacturing that device (see
87 FR 10119 at 10121, February 23, 2022). Moreover, FDA is proposing to
harmonize part 820 with an international consensus standard,
International Organization for Standardization (ISO) 13485:2016,
``Medical devices--Quality management systems--Requirements for
regulatory purposes,'' that has an even more flexible approach to
quality based on risk management (see 87 FR 10119 at 10122). Thus,
although FDA agrees that Quality System controls should be based in
part on the risks of device use, we are not modifying this final rule
because the requirements are already flexible and risk-based, and we
are elsewhere proposing to harmonize the risk-based approach with a yet
more flexible international consensus standard.
    Regarding the use of Declarations of Conformity, section
514(c)(1)(A) of the FD&C Act provides that a person may submit a
Declaration of Conformity to an FDA-recognized consensus standard to
meet a requirement under the FD&C Act (see 21 U.S.C. 360d(c)(1)(A)). If
a person elects to use a Declaration of Conformity in such a way, the
person must provide a Declaration of Conformity certifying that the
device in question is in conformity with an FDA-recognized consensus
standard (see 21 U.S.C. 360d(c)(1)(B)). That is, Declarations of
Conformity appertain to devices themselves; to declare that a device is
in conformity to a standard for a quality management system is not
equivalent to declaring that the quality management system itself
conforms to the standard. For more information on using Declarations of
Conformity, you may wish to refer to FDA's guidance, ``Appropriate Use
of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices,'' issued September 14, 2018.\12\
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    \12\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
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    For systems, a certificate (or certification process) is an
analogous mechanism to document and declare conformity. However, in our
separate proposal regarding harmonization of Quality System
requirements with an international consensus standard, we stated that
FDA does not intend to exempt from FDA inspections manufacturers that
are certified as conforming to the standard (see 87 FR 10119 at 10128).
Further, FDA does not intend to develop a certification program or
issue such certificates (see 87 FR 10119 at 10128). As explained
elsewhere in this document, FDA does not view OTC hearing aids as a
unique case for purposes of Quality System requirements. As such, we
are declining to modify how manufacturers may use Declarations of
Conformity or to accept certifications in lieu of demonstrating
compliance under FDA's usual policies for the manufacture of OTC
hearing aids. Should FDA determine to follow a different general
approach to certifications for purposes of quality management, we will
announce such a determination in the final rule based on our proposal
to harmonize part 820 with ISO 13485:2016.
    (Comment 97) Multiple comments proposed that OTC hearing aids be
exempt from the Quality System requirements of part 820. Some of these
comments stated that the requirements of the Hearing Aid Restrictions,
Sec. Sec.  801.420 and 801.421, addressed safety concerns with
specialized labeling but that modern devices no longer raise these
concerns. As such, these commenters viewed the requirements under part
820 as unnecessary.
    (Response) FDA does not agree that specialized labeling for, or the
diminution of past risks of, hearing aids suggests that the OTC
category of hearing aids be exempt from Quality System requirements.
Rather, FDA expects that the establishment and continued application of
an appropriate Quality System would help reduce device risks and
support effectiveness, and are an important control to help provide for
reasonable assurance of safety and effectiveness. Further, an
appropriate Quality System serves different purposes than labeling, and
the two are not substitutes for each other. For example, a Quality
System includes production and process controls to ensure that a device
conforms to its specifications (see Sec.  820.70(a)). Labeling does not
serve this purpose and cannot substitute for production and process
controls. We note that the implementation of a Quality System entails
risk-based decision-making and that the system's appropriateness is
related to the device. The Quality System requirements are inherently
flexible, and comments we received agree that a Quality System that
complies with part 820 is not unduly burdensome.
4. Choice and Specification of Standards
    (Comment 98) Some comments suggested that FDA not specify the exact
editions of the standards we are incorporating by reference. In this
way, the commenters sought to simplify the process for keeping
regulations up to date with new editions of the standards, as the
respective organizations develop and publish them.
    (Response) While FDA appreciates the value in keeping regulations
in sync with consensus standards, we are not adopting this suggestion
as doing so would impermissibly allow the standards organizations to
change regulatory requirements without FDA going through notice-and-
comment rulemaking. In addition, we note that, under the incorporation
by reference regulations issued by the Office of the Federal Register,
incorporation by reference of a publication is limited to a specific
edition and ``future amendments or revisions of the publication are not
included'' (1 CFR 51.1(f)). Thus, under Federal regulations, we cannot
incorporate by reference a specific standard and all future editions of
that standard. By incorporating all or parts of a standard by
reference, we are referring to those parts exactly as they are in that
specific edition, at the time we finalize the rule.

    (Comment 99) Some comments observed that FDA proposed different
consensus standards for regulatory purposes for OTC and prescription
hearing aids, specifically ANSI/CTA-2051:2017 and ANSI/ASA S3.22-2014,
respectively. These comments raised concerns that the different
standards treat the same hearing aid performance aspects differently,
which could be confusing or create inconsistencies. They proposed that
FDA use only one standard for both OTC and prescription hearing aids.
    (Response) FDA does not agree that these standards treat the same
performance aspects differently. These standards are not incompatible
or divergent for purposes of regulating OTC and prescription hearing
aids. Rather, the standards serve different purposes, which is
appropriate for regulating different categories of hearing aids.
    As we explained in the proposal, ANSI/ASA S3.22-2014 specifies test
methods and measurement tolerances, not device performance (see 86 FR
58150 at 58163). For example, ANSI/ASA S3.22-2014 does not specify an
output limit. Instead, it describes to manufacturers one way to
determine the maximum output, using an OSPL90 curve over a specific
bandwidth, and the measurement tolerance for it, that the maximum
``shall not exceed that specified by the manufacturer plus 3 dB,'' (see
clause 6.2). ANSI/ASA S3.22-2014 does not help provide for safety and
effectiveness by establishing a baseline for performance but rather, in
effect, by defining common terms to describe device performance.
    ANSI/CTA-2051:2017 itself integrates use of those common terms. For
example, ANSI/CTA-2051:2017 relies on ANSI/ASA S3.22-2014 to describe
test methods by using OSPL90 curves. (However, we note that in one
place, the standard refers to ANSI/ASA S3.22-2009, rather than 2014, as
a normative reference.) In other words, one standard builds on the
other: ANSI/CTA-2051:2017 specifies how well an amplifier should
perform instead of leaving it solely to the manufacturer (as ANSI/ASA
S3.22-2014 does for hearing aids), but in either case, the
specifications are measured and tested based on ANSI/ASA S3.22-2014.
    (Comment 100) Some comments objected to the use of ANSI/CTA-
2051:2017 for purposes of regulating hearing aids on the basis that an
industry group developed the standard rather than a disinterested
organization. Other similar comments alternatively or additionally
objected that the standard was developed for consumer electronics but
not medical devices. In either case or both, these comments argued, the
use of the standard is not appropriate for the regulation of OTC
hearing aids.
    (Response) FDA acknowledges that, in some cases, standards
developed specifically for medical devices may be more appropriate for
regulatory purposes. For example, we are continuing to apply Quality
System requirements specific to manufacturing medical devices, as
opposed to a quality management system intended for other kinds of
manufacturers. We note that the comments questioning the use of ANSI/
CTA-2051:2017, as opposed to a standard specifically for medical
devices, generally did not question the test methods or performance
specifications specifically--the major exception being the device
output limit in clause 4.3, as discussed in the previous section. (Some
comments did question the performance specifications on grounds besides
being adopted from a consumer-technology standard. See, for example,
Comment 78 and the response.)
    Some of these comments suggested that FDA use ANSI/ASA S3.22-2014
instead because that standard applies specifically to hearing aids.
However, as explained in the response to Comment 99, the standards do
not serve the same purposes, so they are not substitutes for each
other. Additionally, as explained in response to Comment 99, although
ANSI/CTA-2051:2017 specifies how well an amplifier should perform
instead of leaving it solely to the manufacturer (as ANSI/ASA S3.22-
2014 does for hearing aids), in either case, the specifications are
measured and tested based on ANSI/ASA S3.22-2014. Although ANSI/CTA-
2051:2017 was intended for personal sound amplification more generally
than hearing aids, as discussed elsewhere in this document (see also
the discussion in 86 FR 58150 at 58163-64), the performance
specifications we are adopting based on that standard will provide
reasonable assurance of safety and effectiveness of OTC hearing aids.
We are therefore not replacing it with a different standard.
    (Comment 101) A comment stated that FDA violated the Information
Quality Act by not subjecting the ``CTA Standard'' to pre-dissemination
review requirements. This comment argued that FDA cannot therefore use
the ``CTA Standard'' in support of the output limits.
    (Response) Neither the Information Quality Act (IQA) nor any
information quality guidelines require FDA to engage in the pre-
dissemination review this comment said is required.
    The IQA, or Data Quality Act,\13\ required the Director of the
Office of Management and Budget (OMB) to issue ``guidelines . . . that
provide policy and procedural guidance to Federal agencies for ensuring
and maximizing the quality, objectivity, utility, and integrity of
information (including statistical information) disseminated by Federal
agencies.'' Under the IQA, the guidelines OMB issues must require each
covered Federal agency to issue guidelines concerning information
``disseminated by the agency,'' and to ``establish administrative
mechanisms allowing affected persons to seek and obtain correction of
information maintained and disseminated by the agency that does not