Over-The-Counter Hearing Aids

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The U.S. Food and Drug Administration (FDA) announced that by mid-October 2022, adults with mild to moderate hearing impairment will be able to buy hearing aids directly from stores, pharmacies and other retailers without a prescription or health care appointment (New York Times, August 22, 2022). That’s good news for the 30 million U.S. adults who could benefit from hearing aids but think they are too expensive or too much trouble. The process of getting prescription hearing aids can cost several thousand dollars, and Medicare and most insurance policies do not cover these costs. The over-the-counter hearing aids are likely to be much less expensive.

Hearing loss is associated with increased risk for dementia, depression, isolation from society, anxiety, falling and reduced mobility. Loss of hearing has many different causes, some as simple as ear wax buildup, or as serious as nerve damage or tumors.

The FDA’s rules for over-the-counter (OTC) hearing aids apply only for adults 18 years and older, with mild to moderate hearing loss. People with severe hearing loss, or with other ear symptoms such as pain, dizziness or ringing in the ears, will still be encouraged to use the traditional process for prescription hearing aids.

The OTC hearing aids will have user-adjustable volume controls and a low maximum sound output so they cannot accidently be turned up too loud. The FDA has not set rules for return or exchange of OTC hearing aids, but they do require manufacturers to state their return policies.