Sonitus Medical has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its SoundBite hearing system, a removable hearing prosthetic that transmits sound via the teeth.
The FDA 510(k) clearance is the first for the company and the product.
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, according to the company. No modifications to the teeth are required.
The SoundBite system was found to be safe and effective in two pivotal clinical trials, which supported the FDA clearance, the company noted. 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 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.
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