FDA Approves Marketing of Self-Fitting Hearing Aid

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The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid.  According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review pathway, is the first approved hearing aid that can be self-fit and adjusted by a user.

Malvina Eydelman, M.D., the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA’s Center for Devices and Radiologic Health commented:

“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.”

According to the press release, clinical studies found the self-fitting Bose Hearing Aid to yield comparable outcomes relative to those found using a professional fitting.   The press release also reported that users generally preferred self-adjusted settings over those selected by a professional.

In a statement made to TechCrunch, Joanne Berhiaume, a spokesperson for Bose, stated:

“Now, the De Novo grant by the FDA validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible and great sounding solutions to the millions of people who could benefit from hearing aids but don’t use them.”

Lindsay Laddaran
Lindsay A. Laddaran is an associate in our Orange County Office. Lindsay earned her J.D. from Georgetown University Law center, where she served as an executive editor of the Food and Drug law Journal. She received her B.S. degree in Biomedical Engineering at Washington University in St. Louis. Lindsay worked as a summer associate in 2016 and joined the firm in 2017.
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