SoundBite Cochlear-Dental Hearing Aid Gets FDA Clearance

Sonitus Medical out of San Mateo, California has received FDA clearance for SoundBite, a dental hearing aid for people with deafness in one ear. The system works much like a cochlear implant, except for the implantation. A behind the ear device wirelessly transmits audio from the affected ear to a little receiver attached to a tooth that resonates the teeth, that in turn stimulate both cochlea.

The SoundBite Hearing System was found to be safe and effective in two pivotal clinical trials, which supported the FDA clearance. One study evaluated the safety and efficacy of the SoundBite system over a period of one month in 28 patients. Results of this study have been accepted for publication in a future issue of the well-respected Otology and Neurotology professional journal. A second study evaluated the long-term safety of the device over a six month period in 22 patients.
Key safety and efficacy measures evaluated in the studies included the SoundBite system’s benefit and impact on auditory performance, improvement in speech intelligibility, oral health, and overall comfort. Findings included:

95% of patients were either satisfied or very satisfied with the performance of the SoundBite device in terms of addressing their hearing problem after six months of wear, and 95% were also either likely or very likely to recommend the device to a friend who had the same hearing problem as theirs.

The device was found to be safe for long-term use as there were no medical, dental, or audiological product- or procedure-related adverse events after six months wear of the SoundBite system.

The removable In-The-Mouth (ITM) device showed no long-term effects on dental or periodontal soft or hard tissues and was determined to be safe for long-term dental wear. The device was worn on patients’ natural teeth, as well as on those with fillings, restorations, crowns, root canals, and dental implants.

Press release: SoundBite™ Hearing System Receives FDA Clearance for Treatment of Single Sided Deafness…
Product page: SoundBite Hearing System…
Flashbacks: Dental Hearing Aid Technology from Sonitus Medical; SoundBite, a Cochlear Hearing Aid Without The Implant