U.S. FDA Okays Over-the-Counter Sale Of Hearing Aids

The FDA has cleared the way for hearing aids to be sold over the counter (OTC) without a prescription, a long-awaited wish of millions of Americans.

Photo Insert: FDA said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription, and specialty evaluations.

The agency issued a final rule that took years to complete and opens the door to cheaper, more accessible devices without a prescription or medical exam, the New York Times reported.

Reporting for the Associated Press (AP), Matthew Perrone wrote that OTC sales of hearing aids are expected this fall in the US and millions of Americans will be able to buy hearing aids under a long-awaited rule finalized Tuesday.

FDA said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription, and specialty evaluations. The devices will be sold online or OTC at pharmacies and retail stores.

The devices are intended for adults with mild to moderate hearing problems.

The FDA estimates that nearly 30 million adults could potentially benefit from hearing aids, but only about one-fifth of people with hearing problems use the devices currently.

“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Health and Human Services Secretary Xavier Becerra, told reporters Tuesday.

The FDA first proposed the rule last year and it will take effect in mid-October. The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.

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