Hearing-aid roadblocks

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 FDA 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. 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.

It’s a major undertaking. The FDA 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 meant 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, Rathi said, “it’s not like the FDA 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 FDA.”

Sens. Elizabeth Warren, D-Mass., and Charles E. Grassley, R-Iowa, who were among the sponsors of the bipartisan 2017 law, wrote to the FDA 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% of Medicare beneficiaries over 70 owned and used hearing aids.

Use 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% in 2018 from 12.4% 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 the formidable barrier. Traditional Medicare covers testing but not hardware or other services. (It does cover cochlear implants for people with severe hearing loss.) Many Medicare Advantage plans provide some hearing coverage, but beneficiaries still wind up paying 79% 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 HR 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, 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, 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,” Lin said. If their labels say they’re not approved by the FDA, “nobody will buy them, and they shouldn’t.”