The SoundBite™ Hearing System by Sonitus Medical 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 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 is currently for investigational use only with clinical trials now underway intended to support an initial filing for FDA 510(k) clearance to treat single sided deafness. Intended future indications include conductive and mixed hearing loss.
The Technology
SoundBite is different than conventional hearing aids, which employ air conduction to simply turn up the volume of sound traveling into the ear. As a bone conduction device, SoundBite hearing system does not require a functional middle or outer ear to deliver sound. SoundBite hearing system is designed to allow sound to travel via the teeth, through the bones, to both cochleae, bypassing the middle and outer ear entirely. By using bone conduction via the teeth, SoundBite is intended to restore normal hearing to patients with single sided deafness, conductive, or mixed hearing loss, all without surgery.
The SoundBite hearing system consists of both a BTE (behind the ear) microphone unit, housing the receiver, wireless transmitter, and attached microphone, and a discreet, removable ITM (in the mouth) hearing device. An inductive charger unit is provided to charge the BTE microphone unit and ITM hearing device.
