FDA grants de novo nod for Bose self-fitted hearing aid

The FDA today said it granted de novo clearance to a self-fitted hearing aid made by Bose Corp. for adults with mild to moderate hearing loss.

The Bose Hearing Aid is designed to allow the patient to fit, program and control the hearing aid without help from a healthcare provider, the first such device on the U.S. market, according to the FDA’s Center for Devices & Radiological Health.

The device uses air conduction by amplifying the signal from microphones into earphones. Patients use a mobile app to control and adjust the device on the fly.

“Hearing loss is a significant public health issue, especially as individuals age,” Dr. Malvina Eydelman, director of CDRH’s ophthalmic & ear, nose & throat devices division, said in prepared remarks. “Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

The federal safety watchdog said it considered data from studies involving 125 patients that showed comparable outcomes to professionally fitted Bose devices and that patients preferred the self-selected settings over the professionally fitted settings.

Although, like all hearing aids sold in the U.S., a prescription is required for the Bose device, the FDA said it’s putting together a proposal for a new category of over-the-counter devices.

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