Sonitus Medical, Inc., a medical device company that manufactures the world's first nonsurgical and removable hearing prosthesis to transmit sound via the teeth, has received FDA clearance for its SoundBite™ Hearing System.
"Over the coming months, we look forward to introducing the product to the U.S. market in partnership with otologists and ENT physicians with an audiology practice, with a focus on good clinical practice and giving patients with single-sided deafness the choice of a new and nonsurgical treatment option," says Amir Abolfathi, CEO of Sonitus Medical.
The SoundBite Hearing System was found to be safe and effective in two pivotal clinical trials. One study evaluated the safety and efficacy of the system for 1 month in 28 patients. A second study evaluated the long-term safety of the device over a 6-month period in 22 patients.
Principal Investigator for the studies was Michael Murray, MD, an otologist with Camino Ear Nose and Throat of San Jose, Calif. "My patients were extremely happy with the SoundBite system in terms of how well it addressed their hearing problem without requiring them to undergo an invasive surgery," says Dr. Murray. "This new approach gives me a great new treatment option for my patients with single-sided deafness—patients who until now have chosen to go untreated due to the lack of an acceptable alternative."
Key safety and efficacy measures evaluated in the studies included the system's benefit and impact on auditory performance, improvement in speech intelligibility, oral health, and overall comfort. The company reports that: • 95% of patients were either satisfied or very satisfied with the performance of the SoundBite device after 6 months of wear, • 95% were also either likely or very likely to recommend the device to a friend with the same hearing problem, and • The device was found to be safe for long-term use, as there were no medical, dental, or audiologic product- or procedure-related adverse events after 6 months of wearing the SoundBite system. The removable In-The-Mouth (ITM) device showed no long-term effects on dental or periodontal tissues and was determined to be safe for long-term dental wear. It was worn on patients' natural teeth, as well as on those with fillings, restorations, crowns, root canals, and dental implants.