Mon, 11 Dec 2023

Over-the-counter hearing aids approved for sale by US agency

Robert Besser
19 Aug 2022, 13:47 GMT+10

WASHINGTON D.C.: The U.S. Food and Drug Administration has approved the sale of over-the-counter hearing aids for people with mild to moderate hearing loss, which will take effect in October.

The move will enable millions of Americans to purchase hearing aids without first seeing an audiologist, potentially saving thousands of dollars.

The hearing aids will be available directly from stores or online without medical exams, a prescription or audiologist fitting adjustment.

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

Legislation passed by Congress in 2017 requiring the Food and Drug Administration to create a category of over-the-counter hearing aids, but this was not fully carried out.

Among a range of directives aimed at various industries, in June 2021 President Joe Biden signed a broad competition executive order instructing the Health and Human Services Department to "promote the wide availability of low-cost hearing aids."

Some Democrats, including Representative Debbie Dingell, have called for hearing aid costs to be covered by Medicare, the government health insurance program for the elderly.

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

The final rule was "good news for consumers" and would "lower prices" and result in "more competition," said Republican Senator Chuck Grassley, as quoted by Reuters.

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