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Medical Devices / Submissions and Approvals

FDA Clears Bose’s Hearing Aid for Marketing

Oct. 11, 2018
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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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