The Food and Drug Administration has established a new category of over-the-counter hearing aids that don’t require oversight by audiologists for purchase, according to a final rule announced Tuesday.

OTC hearing aids may become available in traditional retail and drug stores as early as mid-October, when the rule takes effect, the agency stated.

The new regulation applies to certain air-conduction hearing aids intended for people 18 years of age and older with “perceived mild to moderate hearing impairment.” Other hearing aids, such as those for severe hearing impairment or intended for younger users, will remain prescription devices. The new rule also supplants competing state regulations, the FDA noted.

The hearing aid rule has been in the works since Congress passed bipartisan legislation on the matter in 2017. Officials expect it to result in expanded device access and to lower prices by encouraging competition among device makers.

Who benefits

Whether the regulatory change will benefit nursing home residents remains unclear. A 2019 study found that people who are dually eligible for Medicare and Medicaid are 41% less likely to use hearing care services and twice as likely to report having trouble hearing with their devices when compared to high-income Medicare beneficiaries. 

OTC sales may further separate the purchase of hearing aids from payment for supportive services that optimize use of the devices, the study’s authors noted at the time. Nursing homes may need to expand their offerings to include an audiologist’s or hearing specialist’s care, they suggested, to keep residents’ hearing aids from ending up in a drawer.

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