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Until the FDA updates its draft guidance regarding hearing aids, previous draft guidance is in effect.
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