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Hearing aids have been available for sale without a prescription in the US for more than a year. But the over-the-counter (OTC) devices, which were billed as more accessible and affordable than their prescription counterparts, have not exactly flown off store shelves—at least not yet.
Industry experts and audiologists attribute the relatively slow embrace of OTC hearing devices to three primary factors: price tags that can range from $90 to $5,000+, varied insurance coverage (if any), and a lack of competition between big-name tech companies. Still, it’s hard to gauge the exact demand for these OTC devices since “no organization is tracking sales,” the Hearing Industries Association (HIA) noted in a presentation last month.
Alicia Spoor, past president of the Academy of Doctors of Audiology, told Healthcare Brew that the OTC hearing aid market hasn’t seen a lot of new players after the FDA rule allowing nonprescription device sales took effect in October 2022. Instead, she said, it’s largely been dominated by legacy prescription hearing aid manufacturers with new OTC offerings alongside some smaller OTC brands.
More than 40 companies sell OTC devices, while 80+ have filed registrations or applications with the FDA, according to HIA.
“We haven’t seen that big push come in from a large player—like an Apple or a Samsung or Google—which in my personal opinion, is what needs to come in to actually help the OTCs have their own momentum and take off,” she said. “My opinion is that they’re just kind of playing it a little bit safe and letting some of those bugs come out.”
Spoor, a Baltimore and Washington, DC-area private practice audiologist, said she doesn’t expect any tech giants to enter the OTC hearing aid market for at least another couple years.
Beyond the lack of new competitors, accessibility and affordability concerns also plague the OTC hearing aid market, she said. The devices are less expensive than prescription hearing aids, which typically run about $4,000+ on average, but they can still cost hundreds of dollars and insurers may not fully cover the devices—whether they’re prescription or not.
“I think the technology is there. In 20 years, we’re going to look back on this and think, ‘Why did we wait so long?’” she said. “I hope we have [much better] access and affordability in the future.”
Meanwhile, Bill Brownie, interim CEO and COO of OTC device manufacturer Eargo, argued that some consumers are being priced out of the market because “many legacy manufacturers own hearing benefit managers that limit accessibility, consumer choice, and category innovation.”
“Most 2024 health insurance plans to date have made no changes to their hearing aid benefits, and some continue to exclude coverage of OTC hearing aids or add additional obstacles like pre-authorization requirements,” he said in a statement. “We remain committed to building a future where hearing care is transformative and accessible to all Americans who need it.”