Sonitus Medical Inc, San Mateo, Calif, a privately held medical device company, reports the development of its SoundBite hearing system, a nonsurgical and removable hearing solution that the company says is designed to imperceptibly transmit sound via the teeth.
Relying on the principle of bone conduction, the hearing and communication platform is initially intended as a simple and noninvasive treatment for hearing disorders such as single-sided deafness and tinnitus.
Nearly invisible when worn, the SoundBite system consists of an easy-to-insert and remove ITM (in-the-mouth) hearing device—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, says the company.
This system is currently for investigational use only with clinical trials now under way 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.
[Sourse: Sonitus Medical Inc]