Over-the-Counter Hearing Aid Act of 2017
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in senate (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The FDA must update and finalize its draft guidance on hearing products.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.
What just happenedMar 21, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Who’s behind it
- Introduced in SenateMar 21, 2017
- Mar 21, 2017IntroReferral
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health, Education, Labor, and Pensions Committee - Mar 21, 2017IntroReferral10000
Introduced in Senate