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Medical Devices / Submissions and Approvals

FDA Clears Bose’s Hearing Aid for Marketing

Oct. 11, 2018

The FDA granted marketing authorization to the Bose Hearing Aid for patients 18 and older with mild to moderate hearing loss.

Patients can adjust the hearing aid using a mobile application on their phone. The wireless device is the first hearing aid that can be programmed and controlled by patients without any interaction with a health care provider.

The FDA cleared the device under the De Novo premarket review pathway based on data from clinical studies of 125 patients that showed self-fitting by patients was comparable to fittings by professionals.

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