FDA finalizes rule to sell hearing aids over the counter

President Biden on Tuesday hailed a final rule from the Food and Drug Administration that will make hearing aids available without a prescription, a move that is expected to slash costs for consumers.

Mr. Biden last year pushed for a new category of store-based hearing aids that don’t require a medical exam or fitting from a specialist. He said nearly 40 million Americans have hearing loss but often cannot afford the devices.

“As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” Mr. Biden said.

He said the change could deliver as much as $3,000 in savings for families seeking a pair of hearing aids.

The move implements the Over-the-Counter Hearing Aid Act, which was passed by Congress as part of an FDA reauthorization bill during the Trump administration in 2017.

Mr. Biden in 2021 demanded a timeline for action as part of a sweeping executive order designed to kick-start competition in a variety of industries.

“It’s the latest action we are taking to make our economy more competitive and less concentrated. When too few companies dominate, American consumers pay higher costs,” Mr. Biden said Tuesday. “We’re finally building an economy that works for working families.”

One in 3 Americans aged 65 to 75 and half of those over 75 have trouble hearing, but hearing aids often are not covered by private insurance or Medicare.

Sens. Charles E. Grassley, Iowa Republican, and Elizabeth Warren, Massachusetts Democrat, have been vocal champions of over-the-counter sales, underscoring bipartisan support for the idea.

Officials have said people with deformities in the ear or pain and discomfort may need to seek specialized help instead of heading straight to the store to fix mild hearing loss.





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