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SoundBite™ Hearing System Receives FDA Clearance for Treatment of Single Sided Deafness

SAN MATEO, Calif. Jan. 27, 2011

Amir Abolfathi

Oto l ogy a n d Ne u roto l o g y

Michael Murray Camino Ear Nose San Jose, CA.

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.

A bout S oundBite

SoundBite hearing system is the world’s first and only non-surgical and removable hearing solution designed to imperceptibly transmit sound via the teeth to help people who are essentially deaf in one ear regain their spatial hearing ability and rejoin the conversation of life. It employs a well-established principle called bone conduction to deliver clear, high quality sound to the inner ear. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device—which is 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. This system currently has FDA 510(k) clearance to treat single sided deafness. Intended future indications include conductive and mixed hearing loss.

A bout S onitus Medical

June 2006 San Mateo, California

SOURCE Sonitus Medical, Inc.

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