On October 28, the Federal Register published its final order on the Bose De Novo application for a self-fitting hearing aid, classifying the device as a Class II medical device (special controls) and preparing the way for other self-fitting hearing aids for similar special controls, unless the Agency should later determine otherwise.
Bose filed a De Novo application in May 2018 for its self-fitting Bose Hearing Aid, a user-fitted wireless air conduction hearing aid intended for mild-to-moderate hearing loss that can be adjusted through a mobile application without the assistance of a healthcare professional. By granting it De Novo status in October 2018, FDA allowed marketing of the first self-fit hearing device (although Bose has not released the device yet). It’s important to note that the self-fitting device is not part of—and should not be confused with—the upcoming new class of over-the-counter (OTC) hearing devices for which the FDA is expected to propose regulations this month.
Bose Receives FDA Class II Designation for Self-fitting Hearing Aid, Favorable ITC Ruling on Headphone Patent Infringement