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Over-the-Counter Hearing Aids

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Approximately 38 million American adults have reported
some hearing loss, and an estimated 29 million U.S. adults could benefit
from using hearing aids, according to the National Institute on Deafness
and Other Communication Disorders. Historically, hearing aids have been
available only through a licensed professional and are often not covered
by health insurance, causing them to be unaffordable for many consumers.
In August 2022, FDA began allowing over-the-counter sales of certain
hearing aids. Our report describes what OTC hearing aids are, FDA’s
rulemaking process for creating the new OTC category for hearing aids,
FDA’s and other federal agencies’ oversight of OTC hearing aids,
existing research on the effect of OTC hearing aids on access to hearing
loss treatment, and key issues relating to OTC hearing aids.

Related GAO Work: GAO-24-106854. Over-the-Counter Hearing Aids:
Information on the New Medical Device Category
Date: Jun 06, 2024
Runtime: 00:02:00
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