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.