A couple years ago I remember when I first posted about the development of the product and it sounded a bit out there but here it is with FDA approval and the sound system will be going on sale this fall in the US. In March of this year the product received the CE Mark of Approval. There is a piece you wear behind your ear as well and it is small so the part on the teeth communicates with the part behind the ear.
In addition to the doctor, this also requires a visit to the dentist as the device is custom made to fit inside your mouth. For reimbursement the website states that the device is a DME and they seek reimbursement directly from the patient’s insurance company. The device is programmed via software with a regular PC with the device attached via a cable and settings are stored on the BTE microphone unit.. BD
SAN MATEO, Calif., July 1, 2011 /PRNewswire/ -- 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.