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FDA Allows Over-the-Counter Hearing Aids
September 9, 2022

FDA Allows Over-the-Counter Hearing Aids

New FDA OTC Hearing Aids

The FDA recently issued a final rule establishing a new category of over-the-counter hearing aids, giving people with perceived mild to moderate hearing impairment the ability to purchase hearing aids directly from traditional retail stores or online retailers without the need for a medical exam, prescription or fitting adjustment by an audiologist. The rule also works to assure the safety and effectiveness of OTC hearing aids and encourage innovation and competition in the hearing aid technology marketplace.

The new OTC hearing aids are expected to be considerably less expensive than traditional hearing aids, will not require professional fitting, and some will likely offer controls or other integration with smartphones. This is great news for people with Medicare, especially since Traditional Medicare offers no hearing aid coverage. Some Medicare Advantage plans offer hearing aid coverage that is generally limited.

According to the National Institutes of Health, hearing loss affects approximately 33% of people aged 65-74 and nearly 50% of people older than 75 in the U.S. Left untreated, hearing loss can lead to reduced quality of life, depression and cognitive decline. Access to affordable hearing aids is incredibly important.

To learn more about the new FDA rule, visit

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