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Sonitus SoundBite Hearing System wins additional FDA clearance

Sonitus Medical, a manufacturer of non-surgical and removable hearing devices, has received the additional FDA clearance for its SoundBite Hearing System.

SoundBite Hearing System is a non-surgical and removable hearing solution that transmits sound via the teeth to help people with single sided deafness or conductive hearing loss.

The SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device made to fit around either the upper left or right back teeth and a small microphone unit worn behind the ear.

Sonitus Medical CEO Amir Abolfathi said as they began to roll out their product in partnership with Otologists, ENTs, and Audiologists, they remain committed to increase the number of patients who may benefit from their non-surgical treatment option.