So far in the US, no FDA approval yet. This is an interesting device as there are 2 parts, one behind the ear and one that goes in your mouth.
I first covered the product last year. Technology is getting very interesting and I’m not sure if I were in need if I would want this system or the Cochlear implant to kind of be done with it. If one could not have the surgery then this would prove to be an alternative solution. BD
SAN MATEO, Calif., March 11, 2011 /PRNewswire/ -- Sonitus Medical, Inc., a medical device company that manufactures the world's first non-surgical and removable hearing prosthetic to transmit sound via the teeth, today announced that it has received CE Mark certification for its SoundBite Hearing System. The company has received its EC Certificate, which indicates Full Quality Assurance System Approval. This is the first European regulatory certification for the company and the product.
"Receiving the CE Mark for our SoundBite Hearing System is a significant milestone toward the global commercialization of our non-surgical bone-conduction hearing device," said Amir Abolfathi, CEO of Sonitus Medical. "We intend to pursue the process of reimbursement registration in the key EU countries in the coming months and then gain initial European clinical experience with the product in partnership with a limited number of Otologists, ENTs, and Acousticians in the EU."
Apart from the FDA clearance attained by the company earlier this year, CE Marking indicates that Sonitus Medical's design and manufacturing processes for the SoundBite Hearing System comply with certain manufacturing and design standards under the European directive concerning medical devices. This certification enables Sonitus Medical to commercialize the SoundBite Hearing System in Europe.