Over-the-counter hearing aids could bring lower prices and a burst of innovation

Much will ride on new designs that make the devices fashionable

Chelle Wyatt holds her hearing aid Friday, April 15, 2022, in Salt Lake City.Rick Bowmer/Associated Press

Millions of Americans struggling with hearing loss may be out of excuses when newly approved over-the-counter sales of hearing aids start on Oct. 17. The cost of the devices will drop dramatically, and they should be easily accessible at pharmacies and electronics stores.

But one formidable barrier remains to be overcome: vanity.

“Some people feel that as soon as they put that hearing aid in their ear, they’re associated with being old,” said Barbara Kelley, executive director of the Hearing Loss Association of America.

Older adults, of course, suffer the most hearing loss. But many have been stragglers in embracing hearing aids. That could change if the market, projected to triple by the end of the decade, draws design innovators that bring the “cool factor” to a product long conspicuous for its dangling wires and bulbous plugs clamped behind the ears.

“I’m hopeful that we’re going to see breakthroughs in technology and innovation,” said Dr. Meaghan Reed, director of clinical audiology at Mass Eye and Ear in Boston. “If I am wearing something that looks more like a Bluetooth ear phone or an Apple Air Pod, that’s going to remove the stigma of age... that some people associate with hearing aids.”

Hip new designs won’t come right away. When stores begin stocking hearing aids for the first time, thanks to a Food and Drug Administration ruling last month to allow retail sales, the big change will be price.

Most people currently pay between $2,000 and $3,000 for medical-grade devices prescribed by specialist physicians called audiologists, a price tag that typically includes multiple office visits for screenings, fittings, and adjustments. Starting in mid-October, the cost of consumer hearing aids purchased in stores or online, with self-operated volume controls, is expected to range from $300 to $500.

That could entice legions of hearing-challenged but budget-conscious adults who now “bluff their way through conversations” at the dinner table or a workplace conference room, Kelley said.

US officials estimate as many as 80 percent of the roughly 30 million Americans with mild to moderate hearing loss go untreated even though they could benefit from the most common type of hearing aids, known as air-conduction devices. (The new FDA rule applies to those hearing aids but not to cochlear implants, which require a surgical procedure and are typically prescribed for patients with more severe hearing loss.)

Closer to home, the number of Massachusetts residents who are deaf or suffer some form of hearing loss is estimated at more than 1.4 million, roughly 20 percent of the state’s population, according to the Massachusetts Commission for the Deaf and Hard of Hearing.

Northborough resident Beth Wilson, 61, a retired engineer, has worn medically prescribed hearing aids for most of her life, upgrading every four years to new models that better amplify sounds, cancel ambient noise, and adjust to her changing environment whether she’s in a car, on the golf course, in a crowded restaurant, or on a ski slope.

The quality of the devices has improved over the years, Wilson said, but she thinks the rollout of over-the-counter sales could fast-track progress — and appeal to millions of people who, unlike her, have avoided hearing aids until now because of the price or the perceived hassle.

“Any time you develop ubiquitous applications of technology, you open the door for innovation,” Wilson said. “This will address the problem of people who have moderate hearing loss and could benefit from a hearing aid. But they find it daunting to go to a doctor, get a referral to an audiologist, go get a screening, get fitted with the device. And then there’s the sticker shock: My hearing aid cost me $3,000.”

There’s also a growing belief that treating hearing loss early may support cognitive health. Audiologists cite recent studies that have found adults with hearing loss are at greater risk for developing Alzheimer’s and other dementia. Researchers are looking into whether the social isolation seen in many with hearing loss leads to atrophy of brain functions.

“It may not be a cause and effect,” Kelley said. “But if people withdraw because of their hearing loss, that’s certainly not a good thing.”

The anticipated cost savings are especially important to retirees on fixed incomes because Medicare, the federal health insurance program for Americans ages 65 and over, doesn’t pay for hearing aids. (Some supplemental private Medicare plans do.)

While a push for Medicare coverage of the devices made it into the Build Back Better bill, an earlier version of the Democrats’ spending plan, it was cut from the climate and health bill that President Biden signed into law in August.

Retail sales could also be an attractive option for people with hearing loss who live in rural areas where medical specialists are few and far between. Audiologists at Mass Eye and Ear and elsewhere in the Boston area commonly treat patients coming from Western Massachusetts, New Hampshire, and Maine.

Technology analysts expect gangbuster growth in hearing aid sales. The US market, fueled by the FDA ruling, is projected to increase at an annual rate of more than 7 percent, to $10.8 billion by 2030, according to The Insight Partners, a research firm. The ruling “aims to stimulate competition” among device makers as “consumers [are] exposed to devices that are less expensive,” wrote research analyst Akshay Malunjkar.

In anticipation of the Oct. 17 launch, technology developers have been preparing to introduce retail products, including upgrades of personal sound amplification devices that are already sold over-the-counter but aren’t cleared for the hearing impaired. As one example, Malunjkar cited the development of sound control hearing aids by Framingham-based Bose Corp. The company in July said it will partner with Lexie Hearing of DeKalb, Ill., to market a consumer hearing aid powered by Bose, renowned for its speakers.

People with hearing loss will have to become smart consumers and scan the labels of retail hearing aids for, among other ,features, return policies that some manufacturers may offer but aren’t required by the FDA.

Health care professionals also anticipate that many with mild or moderate hearing loss may initially buy aids over-the-counter but eventually consult audiologists for hearing evaluations.

“My hope is this is going to improve the accessibility of hearing health care overall,” said Reed at Mass Eye and Ear. “It’s our responsibility as hearing health professionals to promote the services we provide and [advise] when an individual should seek more medical intervention.”