The SoundBite Dental Hearing Aid System
Sonitus Medical (San Mateo, CA), having received FDA clearance in January for its SoundBite hearing aid, is now following up with European approval. The dental insert works similar to a cochlear implant, receiving an audio signal from a transmitter in the ear and in turn resonating the cochlea, but via the teeth.
SoundBite hearing system is the world’s first and only non-surgical and removable hearing solution designed to imperceptibly transmit sound via the teeth to help people who are essentially deaf in one ear regain their spatial hearing ability and rejoin the conversation of life. It employs a well-established principle called bone conduction to deliver clear, high quality sound to the inner ear. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device—which is custom made to fit around either the upper left or right back teeth—and a small microphone unit worn behind the ear. No modifications to the teeth are required. This system currently has FDA 510(k) clearance and CE Mark certification to treat single sided deafness. Intended future indications include conductive and mixed hearing loss.