San Mateo, Calif — Sonitus Medical Inc, manufacturer of the first non-surgical and removable hearing device to transmit sound via the teeth, has received an additional FDA clearance for its SoundBite™ hearing system.
Earlier in 2011, the FDA cleared SoundBite for treating single sided deafness. Now, the FDA has given 510(k) clearance to SoundBite for treating conductive hearing loss.
“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.”
Sonitus says that the SoundBite hearing system will be available early this fall through physicians and audiologists in a few select markets in the United States and eventually nationwide.
Visit www.soundbitehearing.com for more information.