II 

117TH CONGRESS 

2D SESSION S. 4043 

To instruct the Secretary of Health and Human Services to issue regulations 

regarding over-the-counter hearing aids. 

IN THE SENATE OF THE UNITED STATES 

APRIL 7, 2022 

Ms. WARREN (for herself, Mr. GRASSLEY, Ms. HASSAN, and Mrs. BLACKBURN) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To instruct the Secretary of Health and Human Services 

to issue regulations regarding 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 ‘‘Delivering Over-the5 Counter Hearing Aids Now Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) More than 38,000,000 individuals in the 

9 United States experience some degree of hearing 

10 loss. 


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•S 4043 IS

1 (2) Difficulty hearing is reported by half of in2 dividuals 75 years and older, and nearly 1 in 3 indi3 viduals between the ages of 65 and 75. 

4 (3) Individuals with hearing loss are at a great5 er risk of developing Alzheimer’s disease and Alz6 heimer’s disease related dementia. 

7 (4) Individuals in the United States with hear8 ing loss are more likely to experience feelings of 

9 loneliness and isolation, which have been exacerbated 

10 by the COVID–19 pandemic. 

11 (5) Despite the prevalence of hearing loss, only 

12 1 in 5 individuals who could benefit from a hearing 

13 aid use one. 

14 (6) The high cost of hearing aids, which are not 

15 generally covered by private health insurance plans 

16 or under traditional Medicare, makes them prohibi17 tively expensive for many individuals in the United 

18 States and limits access. 

19 (7) The provisions addressing the regulation of 

20 over-the-counter hearing aids were enacted in 2017 

21 as part of the FDA Reauthorization Act of 2017 

22 (Public Law 115–52), which removes outdated regu23 lations blocking consumer access to affordable hear24 ing aids and allows certain types of hearing aids to 

25 be made available over-the-counter to individuals in 


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1 the United States with mild to moderate hearing 

2 loss. 

3 (8) The law required the Food and Drug Ad4 ministration to issue implementing regulations not 

5 later than 3 years following the date of enactment 

6 of the FDA Reauthorization Act of 2017 (Public 

7 Law 115–52), but the Food and Drug Administra8 tion did not issue a proposed rulemaking for more 

9 than 4 years. 

10 (9) The law further required the Food and 

11 Drug Administration to issue a final rule not later 

12 than 180 days following the end of the public com13 ment period for the proposed rule. The public com14 ment period closed on January 18, 2022. 

15 SEC. 3. INSTRUCTION TO ISSUE FINAL RULE. 

16 Not later than 30 days after the date of enactment 

17 of this Act, the Secretary of Health and Human Services 

18 shall issue a final rule to establish a category of over-the19 counter hearing aids, as defined in subsection (q) of sec20 tion 520 of the Federal Food, Drug, and Cosmetic Act 

21 (21 U.S.C. 360j), as described in section 709(b) of the 

22 FDA Reauthorization Act of 2017 (Public Law 115–52). 

Æ 


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