US SB670 | 2017-2018 | 115th Congress

Status

Spectrum: Bipartisan Bill
Status: Introduced on March 21 2017 - 25% progression, died in committee
Action: 2017-03-21 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

Summary

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 The FDA must update and finalize its draft guidance on hearing products.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.

Tracking Information

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Title

Over-the-Counter Hearing Aid Act of 2017

Sponsors


History

DateChamberAction
2017-03-21SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Same As/Similar To

HB1652 (Same As) 2017-03-24 - Referred to the Subcommittee on Health.
SB934 (Related) 2017-05-11 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 76.
HB2430 (Related) 2017-08-18 - Became Public Law No: 115-52. (TXT | PDF)

Subjects


US Congress State Sources


Bill Comments

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