We’ve already seen the main of bone conduction be applied to headphones, but Sonitus Medical is taking the premise to an entire new level with its SoundBite dental hearing aid, which has just received the mandatory European CE Mark certification (it already has FDA approval). As you can most likely surmised, the device is a hearing aid that’s put on your teeth, even though it’s not actually implanted or attached by any means — it’s simply custom suited for the man’s upper back teeth. The opposite portion of the package is a more standard-type hearing aid unit that’s worn behind the ear, which processes and wirelessly transmits to the device to your mouth. That’s obviously not intended for cases when an easy hearing aid will do, but Sonitus says the system might actually help those who are “essentially deaf” in a single ear regain their spatial hearing ability.
European Mark Indicates Compliance With Globally Recognized Quality Management And Assurance Systems.
SAN MATEO, Calif., March 11, 2011 /PRNewswire/ — Sonitus Medical, Inc., a medical device company that manufactures the area’s first non-surgical and removable hearing prosthetic to transmit sound via teeth, today announced that it has received CE Mark certification for its SoundBite Hearing System. The corporate has received its EC Certificate, which indicates Full Quality Assurance System Approval. Here is the primary European regulatory certification for the corporate and the product.
“Receiving the CE Mark for our SoundBite Hearing System is a major milestone toward the worldwide commercialization of our non-surgical bone-conduction hearing device,” said Amir Abolfathi, CEO of Sonitus Medical. “We intend to pursue the method of reimbursement registration within the key EU countries within the coming months after which gain initial European clinical experience with the product in partnership with a limited variety of Otologists, ENTs, and Acousticians within the EU.”
Except the FDA clearance attained by the corporate earlier this year, CE Marking indicates that Sonitus Medical’s design and manufacturing processes for the SoundBite Hearing System follow certain manufacturing and design standards under the ecu directive concerning medical devices. This certification enables Sonitus Medical to commercialize the SoundBite Hearing System in Europe.
About SoundBite
SoundBite hearing system is the area’s first and only non-surgical and removable hearing solution designed to imperceptibly transmit sound via enamel to assist those people who are essentially deaf in a single ear regain their spatial hearing ability and rejoin the conversation of life. It employs a well-established principle called bone conduction to deliver clear, positive sound to the internal ear. Nearly invisible when worn, the SoundBite system contains a simple to insert and take away ITM (in-the-mouth) hearing device-that is custom made to suit around either the higher left or right back teeth-and a small microphone unit worn behind the ear. No modifications to teeth are required. This method currently has FDA 510(k) clearance and CE Mark certification to regard single sided deafness. Intended future indications include conductive and mixed hearing loss.
About Sonitus Medical
Sonitus Medical Inc. is a privately held medical device company developing the SoundBite hearing system, a non-surgical and removable hearing solution that imperceptibly transmits sound via tooth. Hoping on the primary of bone conduction, this nearly invisible ITM (in-the-mouth) hearing device is an easy and non-invasive hearing and communication platform this is currently FDA cleared for the treatment of single sided deafness. Intended future applications include indications for hearing disorders akin to conductive and/or mixed hearing loss and tinnitus, in addition to consumer and covert communications. Founded in June 2006, Sonitus Medical is headquartered in San Mateo, California. To profit more about Sonitus Medical, please visit www.sonitusmedical.com.
SOURCE Sonitus Medical, Inc.
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