The U.S. FDA approved the marketing of the first self-fitting hearing aid for people with mild to moderate hearing loss. The Bose Hearing Aid allows users to fit, adjust, and control the device without a hearing health professional. This nod came after the FDA reviewed the results of clinical studies that showed the device's self-fitting features to be comparable with professional fitting in terms of adjusting the amount of amplification, speech in noise testing, and overall performance.
"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," said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health in a press release. "The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care."
The Bose Hearing aid makes use of air conduction through sound vibrations that are captured in the device's microphones. It allows users to adjust the hearing aid through a mobile app, enabling them to control its features to suit real-time and real-world listening environments. Notably, the device comes with a label informing consumers when to consult a hearing health care professional.
Some states, however, may still require consumers to purchase these hearing aids from a licensed hearing aid dispenser. At present, the FDA is still drafting a set of regulations for over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017. These regulations are expected to be reviewed and finalized by 2020. (Read this cover story for more on OTC hearing aids and the FDA regulations.)
The Bose Hearing Aid was reviewed under the FDA's De Novo premarket regulatory pathway for new and low-to-moderate risk products for which there are no prior legally marketed device.