Sonitus Medical has received FDA clearance for a second indication for its innovative dental hearing aid, the SoundBite. In addition to single-sided hearing loss, for which the company previously received FDA and CE approvals, it is now also approved in the U.S. for treating conductive hearing loss.
This further establishes SoundBite’s position as an alternative to bone anchored surgical implants, while another indication, mixed hearing loss, should also follow soon. In the meantime, the SoundBite system has yet to come to market, with a planned U.S. release sometime early this fall.
Product page: SoundBite Hearing System
Flashbacks: Dental Hearing Aid Technology from Sonitus Medical; SoundBite, a Cochlear Hearing Aid Without The Implant; SoundBite Dental Hearing Aid Wins European Approval; SoundBite Cochlear-Dental Hearing Aid Gets FDA Clearance