New dental hearing aid: “Soundbite” technology uses the teeth to arrive to the cochlea


SoundBite hearing system is the world's first and only non-surgical and removable hearing solution designed to transmit sound via the teeth to help people who are essentially deaf in one ear regain their spatial hearing ability. It is appropriate for patients who are 18 years or older, with good oral health and have moderately severe, severe, or profound sensorineural hearing loss (deafness) in one ear (with normal hearing in the other ear), or conductive hearing loss.

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 prosthetic device has received FDA 510(k) clearances to treat single sided deafness and conductive hearing loss and European CE Mark certification. 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. 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.

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.

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.

The SoundBite hearing system will be available starting early this fall through physicians and audiologists in a few select markets in the US (see where at www.soundbitehearing.com/find/), with expansion to additional markets nationwide over the following several months.

Sources: Sonitus Medical and Soundbite Hearing.