A year ago, the Food and Drug Administration announced new rules allowing the sale of over-the-counter hearing aids and setting standards for their safety and effectiveness.
That move—which was supposed to take three years, but actually took five years—represented affordable, high-quality hearing aids that people with mild to moderate hearing loss could purchase online or from local pharmacies and major stores.
so how’s it going? It’s a mixed picture.
Manufacturers and retailers have become serious about making hearing aids more accessible and affordable. Yet the OTC market remains confusing, if not downright chaotic, for most of the older consumers the new rules were intended to help.
The past year has also seen a renewed focus on the importance of treating hearing loss, which affects Two-thirds of people over 70 years of age, Researchers at Johns Hopkins University have published the first randomized clinical trial showing that hearing aids can help slow the pace of cognitive decline.
Some background: In 2020, the influential Lancet Commission on Dementia Prevention, Intervention and Care identified hearing loss as the single greatest potential impairment. Modifiable Risk Factors for Dementia,
Dr. Frank Lynn, an otolaryngologist and epidemiologist at Johns Hopkins and lead author of the new research, said previous studies had demonstrated an association between hearing loss and cognitive decline.
“What remained unanswered was, if we treat hearing loss, does it actually reduce cognitive impairment?” He said. get study (For Aging and Cognitive Health Assessment in the Elderly) showed that, at least for a particular group of older adults, this may be the case.
Of about 1,000 people ages 70 to 84 with untreated mild to moderate hearing loss, half received a hearing evaluation from an audiologist, were fitted with moderately priced hearing aids, and were allowed to use them for several months. Advice was given about. The control group participated in a health education program.
Over three years, the study found that hearing aid use had little effect on healthy volunteers at low risk of cognitive impairment. But among participants who were older and less affluent, the hearing aids reduced the rate of cognitive decline by 48 percent compared with the control group, a finding the researchers deemed “clinically meaningful.”
This subgroup of participants had lower income and “were older, less educated, had higher rates of diabetes and hypertension,” Dr. Lin said. Because such factors are also associated with dementia, “people at higher risk really have the most benefit,” he said.
In trying to slow cognitive decline, “as with many other treatments and therapies, we learn that they may be too little, too late,” he said. ACHIEVE indicates that “they may still see benefits later in life.” Another three years of follow-up will reveal any further effects of hearing-aid use on both groups.
The researchers also plan to publish findings about how hearing-aid use affects brain atrophy, social isolation, depression, and quality of life.
Some experts object to this emphasis Relationship between dementia and hearing loss“It’s as if it plants a dementia seed and hearing aids prevent it from germinating,” said Dr. Jan Bluestein, a medical researcher at the NYU Grossman School of Medicine.
Because of the stigma of dementia, “people who would otherwise seek treatment for hearing loss may be less likely to,” said Dr. Bluestein.
Enabling greater social interaction, along with its known beneficial effects on cognition and mental health, is reason enough to promote hearing-aid use, he said. Researchers at the University of Colorado also recently reported that frequent hearing aid use by older adults was associated with Less risk of falling.
But obtaining quality hearing aids over the counter, unlike more expensive prescription devices through an audiology practice, can still seem challenging.
FDA reviews “self-fitting” hearing aids, which users can customize with a smartphone app; It has found eight brands in compliance with the rules from 2022 small study A recent study published in JAMA Otolaryngology found that patients who were given commercially available, self-fitting hearing aids in a clinical trial heard just as well as patients fitted with the same device by an audiologist, after six weeks. Can.
But not everyone with hearing loss feels comfortable making adjustments themselves through online sales and apps. And devices that are not self-fitting, and instead use preset controls, do not undergo FDA review at all.
“It’s still the first day the market is open,” said Barbara Kelly, executive director of the Hearing Loss Association of America, an advocacy and support group. “The price points are all over. “There is still confusion among consumers.”
Adding to that uncertainty, some marketers have resorted to misleading advertising – for example, some claim that their devices restore natural hearing. No other hearing aid can do this.
“There are bad actors,” said Kate Carr, president of the Hearing Industries Association, which represents major manufacturers. “A company was advertising ‘CIA Technology’.” In response, the FDA published A guide for consumers this year.
Still, progress. Self-fitting OTC devices that perform well are now widely available for about $1,000 per pair; Prescription hearing aids purchased through an audiologist cost several times more.
Perhaps because older Americans are not aware of or distrust new over-the-counter devices, or because they still find price a barrier, initial sales appear modest. (Traditional Medicare does not cover hearing aids; Medicare Advantage plans that offer hearing benefits are still closed Patients are paying most of the costs,
Lexi Hearing, a leading manufacturer, sells self-fitting OTC devices for $799 to $999 per pair online and in 14,000 stores nationwide. According to Chief Operating Officer Celine van der Watt, the company is on track to sell 90,000 pairs this year.
But Lexi, whose hearing aids are designed and engineered by Bose, is encouraged by its findings that 94 percent of those buyers are first-time buyers.
“We are finally able to reach a part of the market that was previously unattainable due to cost,” he said. The company projects sales of 260,000 pairs next year and one million pairs per year in 2027.
Other equipment manufacturers and distributors are also acting quickly. Best Buy announced that 200 OTC hearing aids became available in most stores This summer, and that number will reach 600 this fall. Global Vision Company EssilorLuxotica plans to introduce glasses earpiece hearing aids At the end of next year.
Many traditional manufacturers have also begun to sell over-the-counter devices, sometimes in collaboration with better-known consumer companies to boost brand recognition: Sony with WS Audiology, Sennheiser with Sonova. Some experts expect Apple, Sanyo or other consumer-electronics giants to enter the field.
To help guide buyers, HearAdvisor – a company founded by two audiologists and a hearing scientist – has created an independent acoustics laboratory in Rockford, Illinois, which provides prescription and OTC hearing aids for people with mild to moderate loss. Evaluates and ranks both.
“We’re trying to be the Good Housekeeping seal of approval for hearing aids,” said co-founder Andy Sabin.
After testing nearly 50 devices to date, HereAdvisor gave 13 its “Expert Choice” award. In general, OTC devices costing $1,000 or more perform well, Dr. Sabin said, while those sold online today for less than $500 are often junk. , Some may actually reduce intelligibility.
Wirecutter, a division of The New York Times, has also evaluated hearing aids, and the Hearing Loss Association plans a series The webinar is called OTC 101, The first, on November 1, will be presented to FDA regulators.
The United States was the first country to develop a regulated OTC hearing aid market, and “technology companies and retailers are still experimenting,” Dr. Lin pointed out. He predicts increased innovation and lower prices in the future.
However, he added, “It’s still very much a work in progress.”