II 

115TH CONGRESS 

1ST SESSION S. 670 

To provide for the regulation of over-the-counter hearing aids. 

IN THE SENATE OF THE UNITED STATES 

MARCH 21, 2017 

Ms. WARREN (for herself, Mr. GRASSLEY, Ms. HASSAN, and Mr. ISAKSON) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for the regulation of over-the-counter hearing 

aids. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Over-the-Counter 

5 Hearing Aid Act of 2017’’. 

6 SEC. 2. REGULATION OF OVER-THE-COUNTER HEARING 

7 AIDS. 

8 (a) IN GENERAL.—Section 520 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by 

10 adding at the end the following: 


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1 ‘‘(p) REGULATION OF OVER-THE-COUNTER HEARING

2 AIDS.— 

3 ‘‘(1) DEFINITION.—In this subsection, the term 

4 ‘over-the-counter hearing aid’ means a device— 

5 ‘‘(A) that uses the same fundamental sci6 entific technology as air conduction hearing 

7 aids (as defined in section 874.3300 of title 21, 

8 Code of Federal Regulations) (or any successor 

9 regulation) or wireless air conduction hearing 

10 aids (as defined in section 874.3305 of title 21, 

11 Code of Federal Regulations) (or any successor 

12 regulation); 

13 ‘‘(B) that is intended to be used by adults 

14 over the age of 18 to compensate for perceived 

15 mild to moderate hearing impairment; 

16 ‘‘(C) that, through tools, tests, or software, 

17 allows the user to control the over-the-counter 

18 hearing aid and customize it to the user’s hear19 ing needs; 

20 ‘‘(D) that may— 

21 ‘‘(i) use wireless technology; or 

22 ‘‘(ii) include tests for self-assessment 

23 of hearing loss; and 

24 ‘‘(E) that is available over-the-counter, 

25 without the supervision, prescription, or other 


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1 order, involvement, or intervention of a licensed 

2 person, to consumers through in-person trans3 actions, by mail, or online. 

4 ‘‘(2) REGULATION.—An over-the-counter hear5 ing aid shall be subject to the regulations promul6 gated in accordance with section 2(b) of the Over7 the-Counter Hearing Aid Act of 2017 and shall be 

8 exempt from sections 801.420 and 801.421 of title 

9 21, Code of Federal Regulations (or any successor 

10 regulations).’’. 

11 (b) REGULATIONS TO ESTABLISH CATEGORY.— 

12 (1) IN GENERAL.—The Secretary of Health and 

13 Human Services (referred to in this section as the 

14 ‘‘Secretary’’), not later than 3 years after the date 

15 of enactment of this Act, shall promulgate proposed 

16 regulations to establish a category of over-the17 counter hearing aids, as defined in subsection (p) of 

18 section 520 of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 360j) as amended by sub20 section (a), and, not later than 180 days after the 

21 date on which the public comment period on the pro22 posed regulations closes, shall issue such final regu23 lations. 

24 (2) REQUIREMENTS.—In promulgating the reg25 ulations under paragraph (1), the Secretary shall— 


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1 (A) include requirements that provide rea2 sonable assurances of the safety and efficacy of 

3 over-the-counter hearing aids; 

4 (B) include requirements that establish or 

5 adopt output limits appropriate for over-the6 counter hearing aids; 

7 (C) include requirements for appropriate 

8 labeling of the over-the-counter hearing aid, in9 cluding how consumers may report adverse 

10 events, any conditions or contraindications, and 

11 any advisements to consult promptly with a li12 censed physician; and 

13 (D) describe the requirements under which 

14 the sale of over-the-counter hearing aids is per15 mitted, without the supervision, prescription, or 

16 other order, involvement, or intervention of a li17 censed person, to consumers through in-person 

18 transactions, by mail, or online. 

19 (3) PREMARKET NOTIFICATION.—The Sec20 retary shall make findings under section 510(m) of 

21 the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 360(m)) to determine whether over-the23 counter hearing aids (as defined in section 520(p) of 

24 the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 360j), as amended by subsection (a)) require 


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1 a report under section 510(k) to provide reasonable 

2 assurance of safety and effectiveness. 

3 (4) EFFECT ON STATE LAW.—No State or local 

4 government shall establish or continue in effect any 

5 law, regulation, order, or other requirement specifi6 cally applicable to hearing products that would re7 strict or interfere with the servicing, marketing, sale, 

8 dispensing, use, customer support, or distribution of 

9 over-the-counter hearing aids (as defined in section 

10 520(p) of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 360j), as amended by subsection (a)) 

12 through in-person transactions, by mail, or online, 

13 that is different from, in addition to, or otherwise 

14 not identical to, the regulations promulgated under 

15 this subsection, including any State or local require16 ment for the supervision, prescription, or other 

17 order, involvement, or intervention of a licensed per18 son for consumers to access over-the-counter hearing 

19 aids. 

20 (c) NEW GUIDANCE ISSUED.—Not later than the 

21 date on which final regulations are issued under sub22 section (b), the Secretary shall update and finalize the 

23 draft guidance of the Department of Health and Human 

24 Services entitled, ‘‘Regulatory Requirements for Hearing 

25 Aid Devices and Personal Sound Amplification Products’’, 


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1 issued on November 7, 2013. Such updated and finalized 

2 guidance shall clarify which products, on the basis of 

3 claims or other marketing, advertising, or labeling mate4 rial, meet the definition of a device in section 201 of the 

5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 

6 and which products meet the definition of a personal 

7 sound amplification product, as set forth in such guidance. 

Æ 


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