Bose wins FDA green light for direct-to-consumer hearing aid

The agency said it is working on proposing regulations for a new category of over-the-counter hearing aids, expected in 2020. (Wikimedia Commons)

The FDA has cleared a direct-to-consumer hearing aid, developed by speaker manufacturer Bose, potentially opening the door for other consumer-focused electronics companies.

The de novo clearance makes it the first hearing aid authorized by the agency that allows users to fit, program and control the device on their own, without help from a healthcare provider. The Bose Hearing Aid is a wireless amplifier placed in the ear canal that can be adjusted by the user through a smartphone app.

In its review, the FDA evaluated clinical study data from 125 patients that showed outcomes with self-fitting of the Bose Hearing Aid were mostly comparable to professional fittings of the same device, between the amount of amplification selected, speech-in-noise testing and overall benefits.

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In addition, when participants self-fit the hearing aid, they reported generally preferring their settings over professionally selected settings.

The agency describes hearing loss as a significant public health issue in an aging population and estimates that about 37.5 million adults have at least some trouble hearing.

Though users may fit the hearing aid on their own, the Framingham, Massachusetts-based Bose must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser, the FDA said.

The agency said it is working on proposing regulations that would allow for a new legal category of over-the-counter hearing aids, required by the latest reauthorization of the FDA’s user fee agreements passed last year.

“The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health.

RELATED: Hearing-aid giant William Demant may make OTC devices if U.S. demand takes off

Bernstein’s Lisa Bedell Clive wrote in a note to investors that the Bose device may first be launched online, like how Walmart’s website sells FDA-approved hearing aids 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,” Clive wrote. “It will be interesting to see if this is the first of a number of new entrants. For instance, we know Samsung has looked at hearing aids in the past.”

Following the news of Bose's approval, the stocks of some of the largest international hearing aid manufacturers—Sonova, William Demant and GN Store Nord—each dropped about 10%.

Editor's note: A previous version of this story and its headline referred to the Bose device as an "over-the-counter" hearing aid, and was not correct. While the FDA has determined the product can be used safely and effectively without the involvement of a hearing care professional, certain legal restrictions prevent it from being sold as an over-the counter device, including state laws and requirements.

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