USFDA approves sale of OTC hearing aids

The rules, which take effect in mid-October, apply to hearing aids for people with mild to moderate hearing loss. The aids will be available directly from stores or online without medical exams, a prescription or audiologist fitting adjustment.

White House National Economic Council director Brian Deese said the government estimated the rule will save consumers about $2,800 per pair of hearing aids and could help "tens of millions of Americans."

In 2017, Congress passed legislation requiring the FDA to create a category of over-the-counter hearing aids, but it was not fully implemented. In June 2021, President Joe Biden signed a broad competition executive order that instructed the Health and Human Services Department to "promote the wide availability of low-cost hearing aids," among directives aimed at a variety of industries.

Some Democrats like Representative Debbie Dingell would like Medicare, the government health insurance program for the elderly, to cover hearing aid costs.

The new category applies to hearing aids for adults with mild hearing loss.

The FDA's final rules for the sale of over-the-counter hearing aids lower the maximum sound output to reduce the risk to hearing from over-amplification of sound, revise the insertion depth limit in the ear canal, require user-adjustable volume control, performance specifications and device design requirements.

The Hearing Industries Association, representing hearing aid manufacturers, suppliers, distributors and hearing health professionals, says the new rule will "expand access to hearing aids among the estimated 38 million Americans who have perceived mild to moderate hearing loss."

Republican Senator Chuck Grassley said the final rule was "good news for consumers" and said the measure would "lower prices" and result in "more competition."