United States · Bill · S
S. 9 (114th)
Over-the-Counter Hearing Aid Act of 2016
Introduced
1 December 2016
Last action
—
Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
—
Subjects
Discovery layer
Source updated
12 August 2025
Summary
Over-the-Counter Hearing Aid Act of 2016 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 provide reasonable assurances of safety and efficacy and 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 for over-the-counter hearing aids that are not identical to FDA requirements. Until the FDA updates its draft guidance regarding hearing aids, previous draft guidance is in effect.
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Votes
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Versions
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate · EN · 1 December 2016
Introduced in Senate (PDF)
Introduced in Senate · EN · 1 December 2016
Introduced in Senate
summary · EN · 1 December 2016
Sponsors
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Related records
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Sources
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- Official source: https://www.congress.gov/bill/114th-congress/senate-bill/9
- Open data entity: https://api.congress.gov/v3/bill/114/s/9