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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4043 Introduced in Senate (IS)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Delivering Over-the-Counter Hearing 
Aids Now Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) More than 38,000,000 individuals in the United States 
        experience some degree of hearing loss.
            (2) Difficulty hearing is reported by half of individuals 
        75 years and older, and nearly 1 in 3 individuals between the 
        ages of 65 and 75.
            (3) Individuals with hearing loss are at a greater risk of 
        developing Alzheimer's disease and Alzheimer's disease related 
        dementia.
            (4) Individuals in the United States with hearing loss are 
        more likely to experience feelings of loneliness and isolation, 
        which have been exacerbated by the COVID-19 pandemic.
            (5) Despite the prevalence of hearing loss, only 1 in 5 
        individuals who could benefit from a hearing aid use one.
            (6) The high cost of hearing aids, which are not generally 
        covered by private health insurance plans or under traditional 
        Medicare, makes them prohibitively expensive for many 
        individuals in the United States and limits access.
            (7) The provisions addressing the regulation of over-the-
        counter hearing aids were enacted in 2017 as part of the FDA 
        Reauthorization Act of 2017 (Public Law 115-52), which removes 
        outdated regulations blocking consumer access to affordable 
        hearing aids and allows certain types of hearing aids to be 
        made available over-the-counter to individuals in the United 
        States with mild to moderate hearing loss.
            (8) The law required the Food and Drug Administration to 
        issue implementing regulations not later than 3 years following 
        the date of enactment of the FDA Reauthorization Act of 2017 
        (Public Law 115-52), but the Food and Drug Administration did 
        not issue a proposed rulemaking for more than 4 years.
            (9) The law further required the Food and Drug 
        Administration to issue a final rule not later than 180 days 
        following the end of the public comment period for the proposed 
        rule. The public comment period closed on January 18, 2022.

SEC. 3. INSTRUCTION TO ISSUE FINAL RULE.

    Not later than 30 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue a final rule 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 described in section 709(b) of the FDA 
Reauthorization Act of 2017 (Public Law 115-52).
                                 <all>
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