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)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... Forecast to 2022" report to their offering. ... date financial data derived from varied research sources to present ... impact on the market during the next five years, including ... sub markets, regional and country level analysis. The report provides ...
(Date:6/23/2016)... Ill. and INDIANAPOLIS , ... students receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is ... 2016 scholarship winners, announced today online at www.diabetesscholars.org ... let type 1 diabetes stand in the way of ... has supported the Foundation,s scholarship program since 2012, and ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, the ... affiliation with Tennessee Counseling Association. This new relationship allows TherapySites to ... Counseling Association, adding exclusive benefits and promotional offers. , "TCA is extremely excited ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star ... , Millions of individuals in the United States and Canada wear eyeglasses. Once considered ... both correct vision and make a fashion statement. Even celebrities use glasses as a ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, ... editors can give their videos a whole new perspective by using the title ... Pixel Film Studios. , ProSlice Levels contains over 30 Different presets to choose ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
Breaking Medicine News(10 mins):