The New York Times

Hearing Aids at the Mall? Congress Could Make it Happen

A few years hence, when you’ve finally tired of turning up the TV volume and making dinner reservations at 5:30 p.m. because any later and the place gets too loud, you may go shopping.

Perhaps you’ll head to a local boutique called The Hear Better Store, or maybe Didja Ear That? (Reader nominees for kitschy names invited.) Maybe you’ll opt for a big-box retailer or a kiosk at your local pharmacy.

If legislation now making its way through Congress succeeds, these places will all offer hearing aids. You’ll try out various models — they’ll all meet newly established federal requirements — to see what seems to work and feel best. Your choices might include products from big consumer electronics specialists like Apple, Samsung and Bose.

If you want assistance, you might pay an audiologist to provide customized services, like adjusting frequencies or amplification levels. But you won’t need to go through an audiologist-gatekeeper, as you do now, to buy hearing aids.

The best part of this over-the-counter scenario: Instead of spending an average of $1,500 to $2,000 per device (and nearly everyone needs two), you’ll find that the price has plummeted. You might pay $300 per ear, maybe even less.

So many people will be using these new over-the-counter hearing aids — along with the hordes wearing earbuds for other reasons — that you won’t feel self-conscious. You’ll blend right in.

That, at least, represents the future envisioned by supporters of the Over-the-Counter Hearing Aid Act of 2017, which would give the Food and Drug Administration three years to create a regulatory category for such devices and to establish standards for safety, effectiveness and labeling.

The approach seems to appeal to both conservatives (by deregulating an industry that currently restricts hearing aid sales to audiology practices) and to liberals (by extending an aspect of health care to many more people).

Just look at the odd-bedfellow sponsors: Senator Elizabeth Warren, Democrat of Massachusetts, and Senator Charles Grassley, Republican of Iowa. In the House, Representative Joseph Kennedy, Democrat of Massachusetts, and Representative Marsha Blackburn, Republican of Tennessee.

They’ve attached the hearing aid provision to a bill reauthorizing the F.D.A. to collect fees from drug and device manufacturers, which Congress must pass before its August recess to keep the agency functioning.

The bill won approval from the Senate Health, Education, Labor and Pensions committee last month and sailed through the House Energy and Commerce Committee on Wednesday.

“I don’t think we could have had this conversation 20 years ago, or even 10, because the technology wasn’t there,” said Barbara Kelley, executive director of the Hearing Loss Association of America.

In the last two years, though, both the President’s Council of Advisors on Science and Technology and a National Academy of Sciences report called for the F.D.A. to establish an over-the-counter category.

Decades back, when professionals had to manually adjust analogue hearing aids for each wearer, a process requiring repeated visits, it made sense to restrict sales to licensed audiologists, said Dr. Frank Lin, an otolaryngologist and epidemiologist at Johns Hopkins University.

Now, users can program digital devices themselves. If the legislation passes, consumers will find more choices over the counter, instead of being limited to products from the six manufacturers who produce nearly all hearing aids sold in the United States. And new players (including start-ups) will enter a market they’ve been excluded from.

“For any established consumer electronics company experienced with sound, this doesn’t have to be a substantial research and development effort,” Dr. Lin said.

Just in time. Mild to moderate hearing loss becomes nearly ubiquitous at older ages, affecting more than 60 percent of those in their 70s and nearly 80 percent of those over age 80. Yet only one older person in five currently wears hearing aids.

With Medicare coverage of hearing aids prohibited by law, cost represents a major reason. “The number one complaint we get in phone calls every day is, ‘I need help, I can’t afford hearing aids,’” Ms. Kelley said.

Can untrained consumers really choose devices that help them hear? Nobody could answer that question definitively until recently, when Indiana University researchers ran the first double-blind clinical trial.

Working with 154 participants aged 55 to 79 who had mild to moderate hearing loss but had never worn hearing aids, the researchers compared the experiences of those randomly assigned to full-bore audiology services and those making over-the-counter selections.

Audiologists fitted one group with a pair of high-quality behind-the-ear hearing aids (the ReSound Alera 9) that retailed for about $3,600 a pair at the time.

A second group, after watching a short instructional video, chose its own aids from three ReSound Alera 9s programmed to address the most common hearing loss patterns.

Audiologists fitted a placebo group with the same devices, programmed to provide no amplification.

After six weeks, with participants encouraged to work up to six to eight hours’ daily use, the investigators compared their responses to a questionnaire assessing the hearing aids’ benefits and their results on a sentence-repetition test.

The two non-placebo groups showed comparable, clinically significant improvement on both measures, said Larry Humes, distinguished professor of speech and hearing sciences and the lead author of the study, recently published in the American Journal of Audiology.

“It didn’t matter whether the audiologist fitted them or the consumer made his own choice,” Dr. Humes said. “They both were effective, and they didn’t differ.”

One disparity did crop up: When the researchers asked whether participants would consider buying their new hearing aids, more than 80 percent of the audiologist-fitted group said yes, and 55 percent of the self-selectors did (as did 36 percent of the placebo group).

Some consumers feel more comfortable with professional guidance, apparently. If the proposed law passes, they’ll retain that option.

Dr. Humes sees the results as good news, nonetheless. “O.T.C. is designed to meet the needs of the 80 percent who don’t get hearing aids,” he said. If half that group decides to buy them, “that’s a big improvement.”

More is at stake here than the ability to mingle at cocktail parties. Older adults with hearing loss report more falls, and more hospitalizations and periods of poor mental and physical health. Some experience an accelerated rate of cognitive decline.

Dr. Lin is beginning a five-year study, with $16 million from the National Institutes of Health, to determine whether treating hearing loss effectively could delay the onset of cognitive decline and dementia.

He points out that those who begin treatment early, before hearing loss has grown severe, have better results. More accessible and affordable hearing aids could encourage that.

That effort could still falter, of course. The stigma against hearing aids could prove stronger than we think, depressing sales and stalling the innovation that proponents predict.

Hearing aid makers and some audiologists’ groups want the bill to apply only to those with mild, not moderate, hearing loss.

With more complex problems, “do-it-yourself hearing care will not be as successful for you,” said Carole Rogin, president of the Hearing Industries Association.

Such efforts might dilute the bill. However the F.D.A. labels over-the-counter devices, anyone will be able to buy them.

And even if the bill passes both chambers as written, there’s been no word from the White House about whether the president will sign it. So it may be too early to fantasize about going to a store called Hear! Hear!

But enthusiasts like Dr. Lin think over-the-counter sales could do more to make hearing aids broadly affordable than even Medicare coverage would.

“It fundamentally moves the needle,” he said. “It allows for a diversity of options for a diversity of people.”


News & Media

Related Articles

Position 1

Lorem ipsum dolor sit amet, consectetuer adipiscing elit.

Position 2

Lorem ipsum dolor sit amet, consectetuer adipiscing elit.

Position 3

Lorem ipsum dolor sit amet, consectetuer adipiscing elit.