Sonitus Medical Receives Second FDA Clearance for SoundBite™ Hearing System;
|New Conductive Hearing Loss Clearance Expands SoundBite Indications For Use
Press Release 7/1/11
San Mateo, California (July 1, 2011) – Sonitus Medical, Inc., a medical device company that manufactures the world’s first non-surgical and removable hearing device to transmit sound via the teeth, today announced that it has received an additional FDA clearance for its SoundBite Hearing System. The FDA 510(k) clearance for Conductive hearing loss is the second for the SoundBite prosthetic device and marks another significant milestone for the company.
“We are pleased that the uses of the SoundBite system continue to expand,” said Amir Abolfathi, CEO of Sonitus Medical. “As we begin the roll out of our product in partnership with Otologists, ENTs, and Audiologists, we remain committed to increasing the number of patients who may benefit from our non-surgical treatment option.”
Expanding upon the FDA clearance for the treatment of Single Sided Deafness attained by the company earlier this year, this second indication for use in treating patients with Conductive hearing loss further establishes SoundBite as a non-surgical and cost-effective alternative to bone anchored surgical 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.
SoundBite hearing system is the world’s first and only non-surgical and removable hearing solution that imperceptibly transmits sound via the teeth to help people with single sided deafness or conductive hearing loss 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. The SoundBite prosthetic device currently has FDA 510(k) clearance to treat single sided deafness and conductive hearing loss and CE Mark certification. Intended future indications include mixed hearing loss.
To learn more about the Sound Bite Hearing System please click here.