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
'/>"/>

SOURCE Sonitus Medical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

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:12/17/2014)... and RALEIGH, N.C. , ... Communications, LLC (CTMC), and Integrated Clinical Trial Services, ... and retention for clinical trials announce that they ... Trial Marketing Services (i-CTMS). i-CTMS will provide a ... to pharmaceutical, biotechnology and medical device companies. ...
(Date:12/15/2014)... , Dec. 12, 2014 Research and Markets ... of the "Electrocardiogram (ECG) Devices - Global Trends, ... http://photos.prnewswire.com/prnh/20130307/600769 ... US$330 million by 2016. The North America ... global market share while Europe ...
(Date:12/15/2014)... Israel , Dec. 15, 2014  Immune ... announced today that its Board of Directors has elected Mr. ... Teper who continues as Chief Executive Officer of Immune. ... Directors since 2013. Immune,s new Chairman, Mr. ... interest of shareholders and to continue to support the strategic ...
Breaking Medicine Technology:Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 2Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 3Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 2Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 3Electrocardiogram (ECG) Devices - Global Trends, Estimates and Forecasts, 2012-2018 4Immune Pharmaceuticals Elects Daniel Kazado as New Chairman of the Board. 2Immune Pharmaceuticals Elects Daniel Kazado as New Chairman of the Board. 3Immune Pharmaceuticals Elects Daniel Kazado as New Chairman of the Board. 4
... March 9 Cardium Therapeutics (NYSE Alternext US: ... today reported that positive clinical findings demonstrating faster ... techniques during robotic-assisted radical prostatectomy surgery will be ... Urology and is now available online at ...
... 900-mcg Albuferon (albinterferon alfa-2b) dosed every two weeks ... response comparable to peginterferon alfa-2a dosed weekly in ... - Patients receiving 900-mcg Albuferon had comparable rates ... alfa-2a -- Filing of global marketing applications planned ...
Cached Medicine Technology:Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology 2Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology 3Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology 4Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology 5Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology 6Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology 7Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology 8Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 2Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 3Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 4Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 5Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 6Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 7Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 8Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 9Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C 10
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... several different surgical procedures designed to assist weight loss by ... they absorb during digestion. It has been used for several ... in the journal Clinical Obesity reveals that bariatric ... adolescents., Led by Ange Aikenhead of the International Association for ...
... computers to understand inputs from humans that go beyond the ... and computer vision tries to make using computers easier," says ... comfortable, intuitive and intelligent way to use the computer? It ... also help disabled people use computers the way everyone else ...
... , FRIDAY, March 4 (HealthDay News) -- ... X-rays, ultrasounds, PET and CT scans to receive advanced ... amenable to extra tumor biopsies, according to a new ... with advanced cancer suggests a promising future for personalized ...
... 4, 2011) From its involvement in a healthy immune ... essential mineral for the human body. Zinc deficiency is a ... U.S. alone. Consumed naturally in the human diet, ... yogurt, eggs, and fish. Furthermore, zinc is widely used in ...
... animals use sex chromosomes to determine sex. In fruit ... and XY for males. Cellular mechanisms then kick into ... in females and males. Victoria Meller, Ph.D., ... Woods, Mich., received $301,392 from the National Institute of ...
... , FRIDAY, March 4 (HealthDay News) -- Poor ... of people worldwide at risk for early death, a ... treatment and management in Colombia, England, Iran, Mexico, Scotland, ... of U.S. adult diabetics -- more than 16 million ...
Cached Medicine News:Health News:Researchers use human cues to improve computer user-friendliness 2Health News:Researchers use human cues to improve computer user-friendliness 3Health News:Extra Tests Not a Deterrent to Experimental Cancer Therapy 2Health News:The tooth about zinc 2Health News:WSU study may lead to greater understanding of human genome regulation 2Health News:Diabetes Often Not Diagnosed or Treated Properly 2
... The RELISA ENA Single Well Screening Kit is ... the most common autoantibodies. Each microtiter well is ... Jo-1 autoantigens. This allows the laboratory to cost ... prior to determining the ENA specificity on any ...
Inquire...
The K-ASSAY Rheumatoid Factor Control Set is intended to be used as a consistent test sample of known concentration for monitoring the performance of K-ASSAY immunoturbidimetric assay for quantifying...
... K-ASSAY Microalbumin Urine Controls are ... use liquid requiring no reconstitution ... from human urine, fortified to ... and creatinine. Preservatives including sodium ...
Medicine Products: