The vital medical devices could be inexpensive and available over the counter. But efforts have stalled under the F.D.A.
By now, we were supposed to be swiftly approaching the day when we could walk into a CVS or Walgreens, a Best Buy or Walmart, and walk out with a pair of quality, affordable hearing aids approved by the Food and Drug Administration.
Hearing aids, a widely needed but dauntingly expensive investment, cost on average $4,700 a pair. (Most people need two.) So in 2017, Congress passed legislation allowing the devices to be sold directly to consumers, without a prescription from an audiologist. The next step was for the F.D.A. to issue draft regulations to establish safety and effectiveness benchmarks for these over-the-counter devices.
Its deadline: August 2020. A public comment period would follow, and then — right about now — the agency would be preparing its final rule, to take effect in May 2021. So by next summer, people with what is known as “perceived mild to moderate hearing loss” might need to spend only one-quarter of today’s price or less, maybe far less. And then we could have turned down the TV volume and stopped making dinner reservations for 5:30 p.m., when restaurants are mostly empty and conversations are still audible.
“These regulations are going to help a lot of people,” said Dr. Vinay Rathi, an otolaryngologist at Massachusetts Eye and Ear. “There could be great potential for innovation.”
So, where are the new rules? This long-sought alternative to the current state of hearing aid services has been delayed, perhaps one more victim of the pandemic.
Of course, the agency has other crucial matters to address just now. Although the office charged with hearing aid regulations is not the one assessing Covid-19 vaccines, an F.D.A. spokesman said via email that it was dealing with “an unprecedented volume of emergency use authorizations” for diagnostics, ventilators and personal protective equipment.
Nevertheless, “issuing the proposed rule remains a priority and we are working expeditiously to do so,” the spokesman added, providing no timetable for when that might happen.
It’s a major undertaking. The F.D.A. has never established such requirements for hearing aids, because ever since it last issued regulations, in 1977, only state-licensed providers have been allowed to prescribe and sell them — and have been presumed able to safeguard wearers. Providers and manufacturers have also kept prices high by combining testing, fitting and sales into one costly package, a practice the new law was designed to disrupt.
No other country has regulated over-the-counter hearing aids, according to Dr. Frank Lin, an otolaryngologist and director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University. “We’ll be the first,” he said. “There are no performance requirements. There’s no precedent.”
But, Dr. Rathi said, “it’s not like the F.D.A. put everything else on hold.” He pointed to an array of regulations issued last month by the agency, including guidance on cross-labeling oncology medications and rules on impurities in animal drugs. “They’re still going about a lot of their regular business.”
Recently he and a colleague wrote an editorial in The New England Journal of Medicine that questioned the delay, under a pointed title, “Deafening Silence from the F.D.A.”
Senator Elizabeth Warren, Democrat of Massachusetts and Senator Chuck Grassley, Republican of Iowa, who were among the sponsors of the bipartisan 2017 law, wrote to the F.D.A. commissioner last month urging action. They noted that “despite the pandemic, hearing loss continues to be a problem for millions of Americans.” In fact, masks and distancing create greater hearing difficulties.
One-quarter of Americans in their 60s and nearly two-thirds of those over 70 have hearing loss. Its damaging consequences can include social isolation, an increased risk of falls and much higher rates of dementia.
Yet a recent analysis of federal data shows that despite modest increases, in 2018 only about 18.5 percent of Medicare beneficiaries over 70 owned and used hearing aids.
Usage was lower among women than men and far lower among Black beneficiaries than white ones; the proportion of low-income seniors using hearing aids actually declined to 10.8 percent in 2018 from 12.4 percent in 2011.
Stigma explains some of that aversion. Hearing aids can feel like “constant reminders of aging,” said Kevin Franck, director of audiology at Massachusetts Eye and Ear and an author of the New England Journal editorial. “We have people who come in who want to hide them.”
The inconvenience of multiple visits to an audiologist or technician for testing, fitting and adjustment probably also plays a role.
But expense constitutes a formidable barrier. Traditional Medicare covers testing but not hardware or other services. (It does cover cochlear implants, for those whose hearing loss grows too severe for hearing aids.) Many Medicare Advantage plans provide some hearing coverage, but beneficiaries still wind up paying 79 percent of the cost out of pocket.
“It’s the No. 1 question we get,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “‘I can’t afford hearing aids and Medicare doesn’t cover them. What do I do?’”
Advocates plan to keep lobbying Congress for Medicare coverage for hearing services and aids, included in the expansive bill H.R.3 that passed the House of Representatives last year but never came to a Senate vote.
In the meantime, over-the-counter devices retailing for several hundred dollars could make hearing aids broadly more affordable, for people or — one day, perhaps — for Medicare.
They could also solve another consumer problem, Dr. Lin added. Manufacturers can legally sell PSAPs — personal sound-amplification products that resemble hearing aids — as long as they don’t advertise them as a remedy for hearing loss. Their quality varies drastically.
The Hopkins team has been testing whether trained community health workers could help low-income seniors improve their hearing. (A pilot study indicates they can.) Their research protocol uses an effective PSAP from Sound World Solutions that retails for about $700 a pair.
But, Dr. Lin said, “most of what you see out there — ‘$50 miracle device!’ — is complete garbage. People can’t tell which to trust.”
Once federal requirements are set for over-the-counter hearing aids, however, manufacturers of quality PSAPs can apply for approval. “All the other PSAPs will go by the wayside,” Dr. Lin said. If their labels say they’re not approved by the F.D.A., “nobody will buy them, and they shouldn’t.”
Eyeing a vast and underserved market, consumer electronics companies (said to include Apple and Samsung) are standing by, along with start-ups. “There’s a lot of venture capital funding for hearing technology, once the barriers come down,” Dr. Rathi said.
Bose acted early, receiving F.D.A. clearance in 2018 for its Hearphone, which the buyer could tune with a smartphone app. But without the new rule, state restrictions would have prevented national sales, so Bose didn’t market it.
The company is working on a new over-the-counter product, however. “We’re cautiously optimistic that 2021 will be the year,” said Brian Maguire, director of the Bose Hear group.
Once the F.D.A. acts and companies and retailers ramp up, expect new products and advertisements to pop up in stores and online. “We’ll have a bit of a Wild West period,” Ms. Kelley said. “People are going to be confused. They’re going to need a lot of information.”
At that point, audiologists will no longer serve as exclusive gatekeepers to hearing aids. But they can still render important services: testing, education and counseling, adjusting devices — even if clients bought them elsewhere.
“Wearing something comfortably in your ear all day, day after day, is a challenge,” Dr. Franck said. “You want it customized. If you hear echoes or feedback, audiologists know a lot about those issues.”
But the country has only about 18,000 audiologists, Ms. Kelley pointed out. Particularly in rural areas, people with hearing loss might need to drive hours to find one.
But a supermarket? A big box store? A pharmacy? A website? Almost everyone can get to one of those.
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