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Hearing aids without a prescription or an exam? The FDA takes big step toward making that happen.

Kim M. Smith, president of the Utah Association of the Deaf, brushes her hair away from her hearing aid in a photo last year. (Isaac Hale/AP)

A long-awaited Food and Drug Administration proposal would allow millions of consumers to buy over-the-counter hearing aids in stores or online without a prescription or medical exam.

The agency’s move Tuesday to make hearing devices more accessible and affordable for millions of patients with mild to moderate hearing loss is the first step in a process that could make them available to consumers as soon as next fall. The agency’s proposal — coming more than four years after Congress ordered it to craft regulations for over-the-counter devices — would create a new category of hearing aids and supersede state-level regulations that require patients to go through physicians or audiologists to get prescriptions and fittings.

“Over the years, our number one call, email [and] letter is from people who can’t afford hearing aids, or they don’t have access to an audiologist or hearing aid specialist,” said Barbara Kelley, executive director of the Hearing Loss Association of America.

Currently, hearing aids cost an average of more than $5,000 per pair and are not typically covered by traditional Medicare or other insurers, while advocates argue that over-the-counter models could be a fraction of that cost.

For older adults who are most likely to experience hearing loss and many of whom live on fixed incomes, the price tag can be a significant barrier. And patients living in poorer or rural communities may struggle to find an audiologist. A study published in Social Science and Medicine in 2019 found that the counties with the largest numbers of older adults with hearing loss often had fewer available audiologists, in part because the doctors tend to practice in younger, wealthier urban areas.

Although about 38 million adults in the United States report hearing loss, few have tried the devices. Among adults over 70 with hearing loss, only one in three have ever worn one, according to data collected in the National Health Interview Survey.

“More than 30 million people suffer from some sort of hearing loss, and hearing is so vital to what we do, your ability to communicate with others is a huge part of your quality of life,” said Vinay Rathi, a physician at Massachusetts Eye and Ear. “We’re really denying people that sort of basic right, which is the ability to communicate with others, because of issues related to cost and access to audiologists.”

Dariana Noyola, of Lynn, Mass., learned the hard way what hearing loss could mean. She was a senior in high school when she lost half of her hearing because of chronic ear infections, and went through nearly four months of doctor visits and screenings before she was able to get hearing aids. While struggling to hear the people around her, she was trying to keep up with classes and interview for a full scholarship at Regis College in Weston, Mass.

“I was going insane, feeling like I was drowning, being misunderstood constantly,” said Noyola, now 19.

Noyola eventually got her hearing aids and her scholarship. But she says if she could have bought hearing aids without the doctors’ visits, it would have saved her time, money and a lot of anxiety. “That’s what the hope is … for hearing aids to be sold in CVS and pharmacies,” she said.

The FDA said on Tuesday that its new rule aims to spark innovation and increase competition by lowering barriers for new companies to enter the market. Simultaneously, it plans to regulate the new category of devices to ensure they are safe and effective.

The proposal follows more than five years of federal efforts to remove obstacles between patients and over-the-counter hearing aids. In 2015, the President’s Council of Advisors on Science and Technology under Barack Obama recommended that the FDA create a new category of “basic” hearing aids that could be purchased without a prescription or a doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which gave the FDA three years to enact the new rules.

The FDA missed that 2020 deadline, but President Biden renewed pressure in July when he signed an executive order that set a November deadline for a new proposed rule from the federal agency.

“Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra said in a statement on Tuesday. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”

Some opposition to over-the-counter sales has come from the manufacturers who dominate the existing market.

Brandon Sawalich, CEO of Starkey, one of the five major hearing aid manufacturers, said the company welcomes the FDA’s proposal but cautioned that over-the-counter hearing aids will not be a panacea for all hearing health issues. He said he worries that bad actors might sell subpar devices and dupe consumers seeking high-quality hearing aids.

“My only concern with all of this … it’s the reputation of hearing aids,” Sawalich said. “It’s the confusion … that this could bring to [hearing aids and] the role of the hearing professional.”

Although it took years for the FDA to act, some companies — including Bose, which sells a pair of hearing aids for about $850 — have already began selling cheaper devices. Bose obtained special clearance from the FDA to market its product as a hearing aid in 2018, but some other companies have labeled sound-amplification products as hearing aids in defiance of the existing regulations to market them to people with hearing loss.

The FDA declined to set a timeline for finalizing and publishing the new rule, but officials said that enacting it quickly was a top priority. After the 90-day public comment period ends, the agency said it anticipates enacting the finalized rule within 60 days and will give companies that already have hearing aid-like devices on the market 180 days to come into compliance.

“I give real credit to Secretary Becerra and the Biden administration, finally, to get this moving — and that means that lower-cost aids should be on the market by early next year,” said Sen. Elizabeth Warren (D-Mass.), who sponsored the Over-the-Counter Hearing Aid Act. “They’ll be available everywhere in the same way that people can buy glasses at the drugstore.”