FDA approves over-the-counter sale of hearing aids

The Food and Drug Administration on Tuesday approved a move to make hearing aids available over the counter and without a prescription, according to a news release from the agency.

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The move allows any adult to purchase a hearing aid directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.

According to the FDA, a study has shown that around 30 million Americans experience hearing loss, but only about 1 in 5 will go to a doctor to get help.

Hearing aids are costly, with current prices ranging from about $2,000 to $4,000 a pair.

The new rule has some hoping competition for customers may lead to new products.

“This could fundamentally change technology,” Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health, told The New York Times. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”

According to the FDA, the agency reviewed more than 1,000 comments submitted about the new rule after it was proposed last year. The agency made a few changes that had been suggested, the release said.

The changes include lowering the maximum sound output of the devices and revising the depth limit devices can be inserted into the ear canal. Hearing aids also must have user-adjustable volume control.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Dr. Robert M. Califf.

“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” Califf said.

The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment.

The aids should be available over the counter by October.

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