Navigation Links
Sonitus Medical Receives European CE Mark for SoundBite™ Hearing System
Date:3/11/2011

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.

About SoundBite

SoundBite hearing system is the world's first and only non-surgical and removable hearing solution designed to imperceptibly transmit sound via the teeth to help people who are essentially deaf in one ear regain their spatial hearing ability and 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. This system currently has FDA 510(k) clearance and CE Mark certification to treat 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 the teeth. Relying on the principle of bone conduction, this nearly invisible ITM (in-the-mouth) hearing device is a simple and non-invasive hearing and communication platform that is currently FDA cleared for the treatment of single sided deafness. Intended future applications include indications for hearing disorders such as conductive and/or mixed hearing loss and tinnitus, as well as consumer and covert communications.  Founded in June 2006, Sonitus Medical is headquartered in San Mateo, California. To learn more about Sonitus Medical, please visit www.sonitusmedical.com.


'/>"/>
SOURCE Sonitus Medical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Sonitus Medical Technology Ranks #1 on Cleveland Clinics Top 10 Medical Innovations for 2010
2. BridgePoint Medical Closes $9.1 Million Series C Financing
3. International Prostate Cancer Treatment Expert Dr. David B. Samadi Supports Kenyan Minister of Medical Services, Peter Anyang Nyongos Decision to Travel to the U.S. for Prostate Cancer Treatment
4. MPO Symposium Offers Medical Device Manufacturers the Opportunity to Tour Plants in Costa Rica
5. Pew Applauds Introduction of Preservation of Antibiotics for Medical Treatment Act of 2011
6. Cantel Medical Corp. to Present at The Sidoti & Company LLC Fifteenth Annual Emerging Growth Institutional Investor Forum
7. Reportlinker Adds EMR 2011: The Market for Electronic Medical Record Systems
8. Lilly CEO Calls for Biopharmaceutical Industry Changes and Policies That Encourage Medical Innovation
9. Six Health Plans Pay $1.5 Million in Incentives to Create Medical Homes for Nearly Half a Million Hudson Valley Residents
10. Aethlon Medical Receives FDA Approval to Export its Hemopurifier® to India
11. Xeridiem Medical Devices Appoints Renae Moomjian, Vice President, Business Development
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
(Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
(Date:6/23/2016)... the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in Bogota. Colombia ... ... Sandra ... ... Astellas is a pharmaceutical company ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from PsychTests.com reveals ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
(Date:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and ... women in the world, and the most handsome men, look naturally attractive. Plastic ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Venture Construction ... Classic Tournament held on June 20th at the Woodmont Country Club at 1201 ... Wings, an organization dedicated to helping service members that have been wounded in battle ...
Breaking Medicine News(10 mins):