Hearing aids are more affordable and perhaps more necessary than ever | ET REALITY


A year ago, the Food and Drug Administration announced new regulations allowing the sale of hearing aids without a prescription and setting standards for their safety and effectiveness.

That step, which was supposed to take three years but required five, heralded cheaper, high-quality hearing aids that people with mild to moderate hearing loss could buy online or at local pharmacies and big-box stores.

And how’s it going? It’s a mixed picture.

Manufacturers and retailers have gotten serious about making hearing aids more accessible and affordable. However, the OTC market remains confusing, if not downright chaotic, for the mostly elderly consumers the new regulations were intended to help.

Last year also saw renewed attention on the importance of treating hearing loss, which affects two thirds of people over 70 years old. Researchers at Johns Hopkins University published the first randomized clinical trial showing that hearing aids could help slow the rate of cognitive decline.

Some background: In 2020, the influential Lancet Commission on Dementia Prevention, Intervention and Care identified hearing loss as the potentially largest disease modifiable risk factor for dementia.

Previous studies have shown a link between hearing loss and cognitive decline, said Dr. Frank Lin, an otolaryngologist and epidemiologist at Johns Hopkins and lead author of the new research.

“What was left unanswered was: If we treat hearing loss, does it really reduce cognitive loss?” he said. He ACHIEVE study (for the assessment of aging and cognitive health in older people) showed that, at least for a particular group of older adults, this could be the case.

Of nearly 1,000 people ages 70 to 84 with untreated mild to moderate hearing loss, half received hearing evaluations from audiologists, were fitted with mid-priced hearing aids, and were counseled on how to use them for several months. 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 loss. But among older and less wealthy participants, hearing aids reduced the rate of cognitive decline by 48 percent, compared with the control group, a difference the researchers considered “clinically significant.”

This subset of participants had lower incomes and “were older, less educated, and had higher rates of diabetes and hypertension,” Dr. Lin said. Because those factors are also associated with dementia, “the people at highest risk really benefit the most,” he said.

In trying to slow cognitive decline, “with many other therapies and treatments, we learn that they can be too little, too late,” he added. ACHIEVE indicates that “they can still see the benefits later in life.” Another three years of follow-up should reveal any additional effects of hearing aid use in both groups.

The researchers also plan to publish findings on how hearing aid use affects brain atrophy, social isolation, depression and quality of life.

Some experts oppose emphasizing a connection between dementia and hearing loss“As if you planted a seed of dementia and the hearing aid prevented it from germinating,” said Dr. Jan Blustein, a medical researcher at New York University Grossman School of Medicine.

Because of the stigma of dementia, “people who would potentially receive treatment for hearing loss may be less likely to receive it,” Dr. Blustein said.

He added that allowing for greater social interaction, with its known beneficial effects on cognition and mental health, is reason enough to promote the use of hearing aids. Researchers at the University of Colorado also recently reported that consistent hearing aid use by older adults was associated with a lower risk of falls.

But acquiring quality over-the-counter hearing aids, as opposed to more expensive prescription devices through an audiology practice, can still be a challenge.

FDA reviews “self-fitting” hearing aids, the kind that users can customize with a smartphone app; has found eight brands that comply with the regulations since 2022. A small studio A study recently published in JAMA Otolaryngology found that patients given a commercially available self-fitting hearing aid in a clinical trial could, after six weeks, hear as well as patients who had been fitted with the same device by audiologists. .

But not everyone with hearing loss is comfortable with online sales and adjustments you can make yourself through apps. And devices that don’t adjust themselves and instead use preset controls don’t undergo any FDA review.

“It’s still Day 1 of the market opening,” said Barbara Kelley, executive director of the Hearing Loss Association of America, an advocacy and support group. “Prices are gone everywhere. “There is still confusion among consumers.”

To add to that uncertainty, some marketers have turned to misleading advertising; some claim their devices restore natural hearing, for example. No hearing aid can do that.

“There are bad actors,” said Kate Carr, president of the Hearing Industries Association, which represents major manufacturers. “A company advertised ‘CIA technology’.” In response, the FDA published a guide for consumers this year.

Still, progress. Over-the-counter self-adjusting devices that work well are now widely available for about $1,000 a pair; Prescription hearing aids purchased through audiologists cost several times as much.

Perhaps because older Americans are unaware or distrustful of new over-the-counter devices, or because they still consider price a barrier, initial sales appear modest. (Traditional Medicare does not cover hearing aids; Medicare Advantage plans that offer hearing benefits still leave Patients pay most of the costs..)

Lexie Hearing, a major manufacturer, sells self-fitting devices over the counter for $799 to $999 a pair online and in 14,000 stores nationwide. According to Seline van der Wat, chief operating officer, the company is on track to sell 90,000 pairs this year.

But Lexie, whose headphones are designed and manufactured by Bose, is encouraged by her findings that 94 percent of those buyers are first-time buyers.

“We can finally access a part of the market that was previously unpenetrated due to costs,” he said. The company projects sales of 260,000 pairs next year and one million annually in 2027.

Other device manufacturers and distributors are also increasing their offerings. Best Buy announced that 200 more of its stores began selling over-the-counter hearing aids this summer, and that number will reach 600 this fall. Global vision company EssilorLuxottica plans to introduce Headphones built into headphones for glasses. at the end of next year.

Several traditional manufacturers have also begun selling over-the-counter devices, sometimes partnering with better-known consumer companies to promote brand recognition: WS Audiology with Sony, Sonova with Sennheiser. Some experts expect Apple, Sanyo or other consumer electronics giants to enter this field.

To help guide buyers, HearAdvisor, a company founded by two audiologists and a hearing scientist, has built an independent acoustics laboratory in Rockford, Illinois, to evaluate and rate prescription and over-the-counter hearing aids for people with mild to moderate.

“We’re trying to be the Good Housekeeping seal of approval for hearing aids,” said co-founder Andy Sabin.

After testing about 50 devices to date, HearAdvisor awarded its “Expert Choice” award to 13. In general, over-the-counter devices that cost $1,000 or more work well, Dr. Sabin said, while those sold online today for less than $500 “are often junk.” In fact, some may reduce intelligibility.

Wirecutter, a division of The New York Times, has also evaluated hearing aids, and the Hearing Loss Association has planned a series of webinars called OTC 101. The first, on November 1, will feature the participation of FDA regulators.

The United States is the first country to develop a regulated market for over-the-counter hearing aids, and “technology companies and retailers are still experimenting,” Dr. Lin said. He predicts greater innovation and lower prices in the future.

For the moment, however, he said, “it’s still a work in progress.”

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