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  • Writer's pictureNancy Griffin

FDA Clears Path for Hearing Aids to Be Sold Over the Counter

Updated: Aug 23, 2022

One in three adults over 70 with hearing loss has ever used a hearing aid. The agency’s action opens the door to cheaper, more accessible devices without a prescription or medical exam.

The Food and Drug Administration decided on Tuesday to allow hearing aids to be sold over the counter without a prescription to adults. The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans from buying the devices. According to the National Institute of Deafness and Other Communication Disorders, nearly 25 percent of those aged 65 to 74 and 50 percent of those who are 75 and older have disabling hearing loss. Among adults aged 70 and older with hearing loss who could benefit from hearing aids, fewer than one in three (30 percent) has ever used them. Even fewer adults aged 20 to 69 (approximately 16 percent) who could benefit from wearing hearing aids have ever used them.

The New York Times reports the FDA cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. Costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 or more.

Age is the strongest predictor of hearing loss among adults aged 20 to 69, with the greatest amount of hearing loss in the 60 to 69 age group. Older people with untreated hearing loss suffer from cognitive decline, anxiety and depression and social isolation. Hearing loss also presents a financial burden for senior living communities as care costs per patient rise.

The FDA’s final rule takes effect in 60 days. People with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October, without being required to see a doctor for an exam to get a prescription.

The hearing aid change eliminates the requirement to see an audiologist for a hearing examination and fitting, a process not often covered by insurance. The new rule should bring significant innovation for hearing aids. Dr. Robert Califf, the F.D.A. commissioner, said in a news briefing that move is meant to “unleash the power of American industry” in a way that could have global influence. “This is a tremendous worldwide problem where I think American ingenuity can make a huge difference.”

Califf said in a briefing that the agency is working with manufacturers to ensure new devices meet the agency’s performance criteria. Consumers will be helped by labeling requirements, and health guidelines were also developed, including a list of hearing loss symptoms that should prompt a consultation with a specialist.

“The idea that the FDA is finally enacting legislation passed five years ago is exciting because it solves a public health problem through market-shaping strategy,” said Lin. “The FDA got the regulations right in the sense there is a clear path for companies like Apple, Samsung and Bose to enter the hearing aid market. There’s increasingly a convergence between consumer electronic and health care devices. Apple’s a perfect example: An Apple Watch can monitor atrial fibrillation—so is it consumer tech or a health device? The new regulations allow convergence to happen on a much faster scale.”


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