Sonitus Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for SoundBite Hearing System, a non-surgical hearing prosthetic for the treatment of single-sided deafness.
SoundBite is a removable hearing device designed to transmit sound via the teeth to enable patients with single-sided deafness regain their spatial hearing ability.
The device uses the principle of bone conduction to deliver high quality sound to the inner ear.
SoundBite consists of an easy to insert and remove in-the-mouth hearing device and a small microphone unit which is to be worn behind the ear.
Results of two pivotal studies demonstrated that SoundBite Hearing System was safe and effective, which supported the FDA clearance.