One of the threads shared by two of FierceMedTech’s biggest stories of last year was the moment when traditionally consumer-focused tech companies—like Apple with its ECG-equipped smartwatch—were officially recognized as new players in the healthcare space.
Enter Bose, with its direct-to-consumer hearing aid. Not only is it the first FDA-authorized device that allows users to fit, program and control its settings without a doctor, but its de novo clearance opens a new path for companies—almost any company—to develop similar products of their own.
The largest international hearing aid manufacturers were caught in Bose's wake, too, with shares in Sonova, William Demant and GN Store Nord each dropping about 10% on news of the FDA’s green light.
Placed in the ear canal and personalized wirelessly through a smartphone app, Bose's hearing aid passed a clinical test to show that users really could make adjustments themselves. The 125-patient trial showed that outcomes with the self-fitted amplifier were mostly comparable to professional fittings of the same device.
Participants also reported a preference for their personal settings—between the amount of amplification selected, and speech-in-noise levels—compared to professional configurations.
However, the Bose product isn't a true “over-the-counter” hearing aid. Certain state laws may require hearing aids to be purchased from licensed dispensers, the FDA says. The agency is working on regulations to create a new legal category for OTC hearing aids.
Besides that, the device itself isn’t available yet—nor does the company have a release date to share, Bose told FierceMedTech.
But when the product is launched, Bose may begin by selling its hearing aid online, according to industry analysts, similar to how Walmart sells FDA-approved hearing aids on its website without an audiologist but not in-store.
“In our view, how big of a threat the OTC channel will be to traditional hearing aid companies in part depends on the entrance of consumer electronics players, with their strong brands and significant marketing muscle,” Bernstein's Lisa Bedell Clive wrote in an investor note. Samsung has considered hearing aids before, Clive pointed out. Now that Bose has broken the ground, she wrote, “it will be interesting to see if this is the first of a number of new entrants."