H.R. 1652 · 115th Congress
Over-the-Counter Hearing Aid Act of 2017
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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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KennedySponsor14 cosponsors · 10 D, 4 R
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Blackburn
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Carter
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Bacon
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McGovern
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Norton
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Tsongas
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Dingell
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Peterson
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Clarke
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Shea-Porter
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Lofgren
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Buchanan
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Higgins
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Raskin2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids.
What it does: CRS summary · Introduced in House · Mar 21, 2017
Over-the-Counter Hearing Aid Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.
State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.
The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Over-the-Counter Hearing Aid Act of 2017
Latest action (Mar 24, 2017): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Mar 21, 2017
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.