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S 670 115th Congress Senate Health Administrative law and regulatory procedures Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Hearing, speech, and vision care Marketing and advertising

Over-the-Counter Hearing Aid Act of 2017

Introduced: March 21, 2017 Introduced by: Warren, Elizabeth Democratic · Massachusetts See on congress.gov
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 21, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 21, 2017
Introduced in Senate
 Plain-English summary Congressional Research Service

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The FDA must update and finalize its draft guidance on hearing products.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

What's happening now March 21, 2017

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Committees of jurisdiction 1
 Cosponsors 3
All 3 Democratic 1 Republican 2