Millions of people in the United States will be able to buy hearing aids without a prescription starting this fall, the Food and Drug Administration (FDA) announced Tuesday.
The new regulation seeks to cut red tape by creating a new class of hearing aids that
do not require a medical exam, prescription or other special evaluations.
The devices will be sold online or in pharmacies and stores.
They are intended for adults with mild to moderate hearing problems.
The FDA estimates that nearly 30 million people could benefit from hearing aids, but only one-fifth of hearing-impaired people currently use them.
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"This measure is an important milestone in making hearing aids more affordable and accessible," Health Secretary Xavier Becerra told reporters Tuesday.
The FDA first proposed the rule last year and it will go into effect in mid-October.
It comes after years of pressure from medical experts and consumer advocates to make these devices cheaper and more widely available.
Cost is now a big hurdle.
They can cost
more than $5,000
between the hearing aid and fitting services.
Insurance coverage is limited and Medicare doesn't pay for hearing aids, only diagnostic tests.
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"The requirement to go to a specialist was not only a burden and an inconvenience to many, it created a competitive barrier to entry," says Brian Deese, White House economic adviser.
Deese estimated that citizens could
save up to $2,800.
But FDA officials warned that the savings will depend on manufacturers launching products and their price.
"It's very hard to predict exactly what we're going to see and when," said Jeffrey Shuren, the FDA's chief of medical devices.
He added that they expect increased competition with new manufacturers, and new products from existing manufacturers.
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The new over-the-counter status will not apply to devices for more severe hearing loss, which will remain prescription.
Consumer electronics companies have been making lower-cost “personal sound amplification” devices for years, but they don't undergo FDA review and can't be marketed as hearing aids.
The new rule makes it explicit that these devices are not alternatives to those approved by the FDA.