I 
115TH CONGRESS 
1ST SESSION H. R. 1652 
To provide for the regulation of over-the-counter hearing aids. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 21, 2017 
Mr. KENNEDY (for himself, Mr. CARTER of Georgia, and Mrs. BLACKBURN) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To provide for the regulation of over-the-counter hearing 
aids. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Over-the-Counter 
Hearing Aid Act of 2017’’. 
SEC. 2. 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) is amended by 
adding at the end the following: 
VerDate Sep 11 2014 
02:14 Mar 22, 2017
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1652.IH
H1652
SSpencer on DSK4SPTVN1PROD with BILLS
HR 1652 IH
‘‘(p) REGULATION OF OVER-THE-COUNTER HEARING 
AIDS.— 
‘‘(1) DEFINITION.—In this subsection, the term 
‘over-the-counter hearing aid’ means a device— 
‘‘(A) that uses the same fundamental sci-
entific 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); 
‘‘(B) that is intended to be used by adults 
over the age of 18 to compensate for perceived 
mild to moderate hearing impairment; 
‘‘(C) that, through tools, tests, or software, 
allows the user to control the over-the-counter 
hearing aid and customize it to the user’s hear-
ing needs; 
‘‘(D) that may— 
‘‘(i) use wireless technology; or 
‘‘(ii) include tests for self-assessment 
of hearing loss; and 
‘‘(E) that is available over-the-counter, 
without the supervision, prescription, or other 
VerDate Sep 11 2014 
02:14 Mar 22, 2017
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1652.IH
H1652
SSpencer on DSK4SPTVN1PROD with BILLS
HR 1652 IH
order, involvement, or intervention of a licensed 
person, to consumers through in-person trans-
actions, by mail, or online. 
‘‘(2) REGULATION.—An over-the-counter hear-
ing aid shall be subject to the regulations promul-
gated in accordance with section 2(b) of the Over- 
the-Counter Hearing Aid 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 (p) of 
section 520 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j) as amended by sub-
section (a), and, not later than 180 days after the 
date on which the public comment period on the pro-
posed regulations closes, shall issue such final regu-
lations. 
(2) REQUIREMENTS.—In promulgating the reg-
ulations under paragraph (1), the Secretary shall— 
VerDate Sep 11 2014 
02:14 Mar 22, 2017
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H1652.IH
H1652
SSpencer on DSK4SPTVN1PROD with BILLS
HR 1652 IH
(A) include requirements that provide rea-
sonable assurances of the safety and efficacy of 
over-the-counter 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 the over-the-counter hearing aid, in-
cluding how consumers may report adverse 
events, any conditions or contraindications, and 
any advisements to consult promptly with a li-
censed physician; and 
(D) describe the requirements under which 
the sale of over-the-counter hearing aids is per-
mitted, without the supervision, prescription, or 
other order, involvement, or intervention of a li-
censed person, to consumers through in-person 
transactions, by mail, or online. 
(3) PREMARKET
NOTIFICATION.—The Sec-
retary shall make findings under section 510(m) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(m)) to determine whether over-the- 
counter hearing aids (as defined in section 520(p) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j), as amended by subsection (a)) require 
VerDate Sep 11 2014 
02:14 Mar 22, 2017
Jkt 069200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H1652.IH
H1652
SSpencer on DSK4SPTVN1PROD with BILLS
HR 1652 IH
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 specifi-
cally applicable to hearing products that would re-
strict or interfere with the servicing, marketing, sale, 
dispensing, use, customer support, or distribution of 
over-the-counter hearing aids (as defined in section 
520(p) 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 require-
ment for the supervision, prescription, or other 
order, involvement, or intervention of a licensed per-
son for consumers to access over-the-counter hearing 
aids. 
(c) NEW GUIDANCE ISSUED.—Not later than the 
date on which final regulations are issued under sub-
section (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’’, 
VerDate Sep 11 2014 
02:14 Mar 22, 2017
Jkt 069200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H1652.IH
H1652
SSpencer on DSK4SPTVN1PROD with BILLS
HR 1652 IH
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 mate-
rial, 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. 
Æ 
VerDate Sep 11 2014 
02:14 Mar 22, 2017
Jkt 069200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6301
E:\BILLS\H1652.IH
H1652
SSpencer on DSK4SPTVN1PROD with BILLS