F.D.A. Moves to Make Some Hearing Aids Available Without a Prescription

[JMAC]

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NYT
Published Oct. 19, 2021
Updated Oct. 20, 2021, 11:05 a.m. ET

"Current regulations, which are more than 40 years old, allow only licensed providers to prescribe and sell the devices, which can cost nearly $5,000 a pair, and require multiple visits for fitting, testing and adjustments."

"The rule, which has not yet been finalized, is the culmination of a years long push to make the medical devices available to more Americans."
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My italics:

"In 2015, a scientific advisory committee to President Barack Obama issued a report recommending that the F.D.A. create a new category of basic, over-the-counter hearing aids to help encourage innovation and drive down costs.

Two years later, Congress passed the Over-the-Counter Hearing Aid Act. Under the legislation, the F.D.A. was supposed to issue draft regulations for nonprescription hearing aids by August 2020, but the agency missed the deadline."

"The pandemic may have set the agency back, Dr. Lin said, but developing the rule was also a challenging task. “It’s a tall order for the F.D.A. to completely develop a completely new regulatory class that no other country in the world is doing,” he said."


https://www.nytimes.com/2021/10/19/h...50_diversified



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