F.D.A. Clears Path for Over-the-Counter Hearing Aids

The Food and Drug Administration decided on Tuesday to allow hearing aids to be sold over the counter without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices.

The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans from buying the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people.

Under the F.D.A.’s new rule, 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 agency cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. 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.

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

The F.D.A.’s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details in the rule.

Dr. Robert Califf, the F.D.A. commissioner, said the move is meant to “unleash the power of American industry” in a way that could have global influence.

“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” Dr. Califf said during a news briefing. “This is a tremendous worldwide problem where I think American ingenuity can make a huge difference.”

The White House hailed the move as a signature accomplishment for President Biden, who was planning to sign the Inflation Reduction Act on Tuesday. That legislation includes other health measures, like caps on drug costs for Medicare beneficiaries, that are likely to be popular among midterm voters.

The hearing aid change eliminates the requirement to see an audiologist for a hearing examination and fitting, a process not often covered by insurance. Federal officials estimated a $2,800 savings on the cost of a pair of hearing aids. Brian Deese, White House director of the National Economic Council, said making the change was a “top priority” for the president.

“This is going to make a really concrete difference in the lives of millions of Americans,” Mr. Deese said.

Whether it will make a difference at the voting booth remains to be seen, said Jonathan Oberlander, a professor of health policy at the University of North Carolina. He termed the F.D.A.’s move a “consolation prize” of sorts, given the Democrats’ unsuccessful efforts to expand basic Medicare to cover vision, dental and hearing. The upside for the party, though, is that some of the hearing aids should be on store shelves by the time voting begins.

Hearing loss is associated with dementia, isolation and other health problems in older adults. Yet the barriers to getting hearing help have included costs that are not covered by Medicare. There is also stigma — such as appearing “old” — that comes with use.

April Shrum, 45, of Bremerton, Wash., has been willing to get hearing aids for years, but has been unable to get them covered by her insurance. She said she lost some hearing firing guns while training to deploy to Iraq about a decade ago. But her hearing loss never tested to a level that qualified her for coverage.

“I don’t have to have a prescription for it,” Ms. Shrum said, “which means I can buy them myself and it’s fantastic.”

Broader appreciation for the importance of keen hearing for adults is off-kilter: A recent survey found that people aged 50 to 80 were twice as likely to plan on taking their pet to the veterinarian in the coming year than to get their hearing checked.

“It breaks my heart a little bit,” said Sarah Sydlowski, associate chief improvement officer of the Cleveland Clinic’s Head and Neck…