FDA Law about OTC Hearing aids

131 STAT. 1066 PUBLIC LAW 115–52—AUG. 18, 2017

SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.
(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further
amended by adding at the end the following:
‘‘(q) REGULATION OF OVER-THE-COUNTER HEARING AIDS.—
‘‘(1) DEFINITION.—
Review.
Determination.
Applicability.

‘‘(A) IN GENERAL.—In this subsection, the term ‘overthe-
counter hearing aid’ means a device that—
‘‘(i) uses the same fundamental scientific technology
as air conduction hearing aids (as defined in
section 874.3300 of title 21, Code of Federal Regulations)
(or any successor regulation) or wireless air
conduction hearing aids (as defined in section 874.3305
of title 21, Code of Federal Regulations) (or any successor
regulation);
‘‘(ii) is intended to be used by adults age 18 and
older to compensate for perceived mild to moderate
hearing impairment;
‘‘(iii) through tools, tests, or software, allows the
user to control the over-the-counter hearing aid and
customize it to the user’s hearing needs;
‘‘(iv) may—
‘‘(I) use wireless technology; or
‘‘(II) include tests for self-assessment of
hearing loss; and
‘‘(v) is available over-the-counter, without the
supervision, prescription, or other order, involvement,
or intervention of a licensed person, to consumers
through in-person transactions, by mail, or online.
‘‘(B) EXCEPTION.—Such term does not include a personal
sound amplification product intended to amplify
sound for nonhearing impaired consumers in situations
including hunting and bird-watching.
‘‘(2) REGULATION.—An over-the-counter hearing aid shall
be subject to the regulations promulgated in accordance with
section 709(b) of the FDA Reauthorization Act of 2017 and
shall be exempt from sections 801.420 and 801.421 of title
21, Code of Federal Regulations (or any successor regulations).’’.
(b) REGULATIONS TO ESTABLISH CATEGORY.—
(1) IN GENERAL.—The Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’), not
later than 3 years after the date of enactment of this Act,
shall promulgate proposed regulations to establish a category
of over-the-counter hearing aids, as defined in subsection (q)
of section 520 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j) as amended by subsection (a), and, not later
than 180 days after the date on which the public comment
period on the proposed regulations closes, shall issue such
final regulations.
(2) REQUIREMENTS.—In promulgating the regulations under
paragraph (1), the Secretary shall—
(A) include requirements that provide reasonable
assurances of the safety and effectiveness of over-thecounter
hearing aids;
(B) include requirements that establish or adopt output
limits appropriate for over-the-counter hearing aids;
(C) include requirements for appropriate labeling of
over-the-counter hearing aids, including requirements that
such labeling include a conspicuous statement that the
device is only intended for adults age 18 and older, information
on how consumers may report adverse events, information
on any contraindications, conditions, or symptoms of
medically treatable causes of hearing loss, and advisements
to consult promptly with a licensed health care practitioner;
and
(D) describe the requirements under which the sale
of over-the-counter hearing aids is permitted, without the
supervision, prescription, or other order, involvement, or
intervention of a licensed person, to consumers through
in-person transactions, by mail, or online.
(3) PREMARKET NOTIFICATION.—The Secretary shall make
findings under section 510(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(m)) to determine whether overthe-
counter hearing aids (as defined in section 520(q) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) require a report under section
510(k) to provide reasonable assurance of safety and effectiveness.
(4) EFFECT ON STATE LAW.—No State or local government
shall establish or continue in effect any law, regulation, order,
or other requirement specifically related to hearing products
that would restrict or interfere with the servicing, marketing,
sale, dispensing, use, customer support, or distribution of overthe-
counter hearing aids (as defined in section 520(q) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) through in-person transactions, by
mail, or online, that is different from, in addition to, or otherwise
not identical to, the regulations promulgated under this
subsection, including any State or local requirement for the
supervision, prescription, or other order, involvement, or intervention
of a licensed person for consumers to access overthe-
counter hearing aids.
(5) NO EFFECT ON PRIVATE REMEDIES.—Nothing in this
section shall be construed to modify or otherwise affect the
ability of any person to exercise a private right of action under
any State or Federal product liability, tort, warranty, contract,
or consumer protection law.
(c) NEW GUIDANCE ISSUED.—Not later than the date on which
final regulations are issued under subsection (b), the Secretary
shall update and finalize the draft guidance of the Department
of Health and Human Services entitled ‘‘Regulatory Requirements
for Hearing Aid Devices and Personal Sound Amplification Products’’,
issued on November 7, 2013. Such updated and finalized
guidance shall clarify which products, on the basis of claims or
other marketing, advertising, or labeling material, meet the definition
of a device in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) and which products meet the definition
of a personal sound amplification product, as set forth in such
guidance.
(d) REPORT.—Not later than 2 years after the date on which
the final regulations described in subsection (b)(1) are issued, the
Secretary of Health and Human Services shall submit to Congress
a report analyzing any adverse events relating to over-the-counter
hearing aids (as defined in subsection (q)(1) of section 520 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)).