SoundBite, a new device that’s as novel as it’s name, is the world’s first 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. It employs a well-established principle called bone conduction (vibration of bone) to deliver sound to the inner ear. The SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device — which is custom made to fit around the upper left or right back teeth — and a small wireless microphone worn behind the ear which  picks up the sound. 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.

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 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. The device was worn on patients’ natural teeth, as well as on those with fillings, restorations, crowns, root canals, and dental implants.

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