The FDA granted a De Novo classification for the Bose Hearing Aid on October 5, 2018. The De Novo program allows manufacturers to submit a request for a device to receive a new classification under categories I or II when a new medical device can be shown to have reasonable safety and efficacy for the intended use when only general or general and special controls are applied, but where there is no legally marketed predicate device to prompt submission under the 510(k) premarket approval programs. Hearing aids are well-established devices, but the Bose Hearing aid uses a mobile application that allows users to adjust the hearing aid settings themselves based on their real-time experience with the device. I can speak from personal experience with aging parents that effective adjustment makes a world of difference between a truly functional hearing aid and a nuisance device. Per federal and state laws, hearing aids must still be marketed through a licensed hearing professional, although that may be changing – see the press release for more details. That page also contains more information about the clinical data reviewed for the decision. For FDA nerds, here’s the link to the device approval record in the De Novo Device Classification database. The new product code will be QDD, Self-Fitting Air-Conduction Hearing Aid.

Text Copyright © 2018 Katrina Rogers