Sonitus Medical Announces First European Commercialization with Shipment of SoundBite™ Hearing System to Seven Centers of Excellence
Published: Sep 06, 2012
SAN MATEO, Calif., Sept. 5, 2012 /PRNewswire/ -- Sonitus Medical, Inc., a medical device company that manufactures the world's first non-surgical and removable hearing device to transmit sound via the teeth, today is announcing the global commercialization and a limited market launch in Europe of its SoundBite Hearing System. The first deployment of its prosthetic devices throughout Europe is a measured roll out to seven centers of excellence in key markets in order to conduct a multi-site evaluation of the SoundBite prosthetic device.
"This is a major milestone for our company as we begin to establish a commercial network for SoundBite in Europe," said Amir Abolfathi, CEO of Sonitus Medical. "We are gratified to be working with esteemed hearing specialists in the EU medical community to undertake this post-market evaluation which will document long-term utilization and patient experience."
The SoundBite Hearing System received CE Mark certification in The European Union for the treatment of single sided deafness, or patients who are essentially deaf in one ear, those with conductive hearing loss, and those with mixed hearing loss.
SoundBite uses bone conduction to deliver clear, high quality sound to the inner ear. Many familiar sounds are heard through bone conduction; for example chattering teeth, crunching on potato chips, or scratching the scalp. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove in-the-mouth hearing device and a small microphone unit worn behind the ear.
About the European Pilot Study
Currently underway with 20 patients at four leading academic medical centers, the pilot study will monitor patient experiences and qualitative results at one, six, and 12 months, and will grow to include five patients at each site for a total of 35 subjects.
The seven participating centers of excellence are: The University Hospital Southampton, United Kingdom; University Hospital Ramon y Cajal, Madrid, Spain; University Hospital, Maastricht, Netherlands; University Hospital of Geneva, Switzerland; University Medical Center of Mainz, Germany; Hanusch Hospital, Vienna, Austria; and ENT Practice of Dr. Waldemar Motzko, Bad Soden, Germany.
New Senior Management
With Sonitus' European commercialization plans well underway, the company has deepened its management team with the recent appointment of two high level senior executives with decades of relevant experience.
Mike Favet, named Chief Operating Officer, has been in the medical device industry for more than 20 years, accumulating broad cross-functional experience in companies of various sizes with products in diverse therapeutic areas. Chief Financial Officer Jeff Mack brings more than 25 years of experience, including a strong background with fast-growing, technology-based companies. He has extensive experience in all areas of financial management, including capital events/IPOs, SEC reporting and compliance, M&A and investor relations.
"We are extremely pleased to welcome these two seasoned executives to the company," said Abolfathi. "As we to continue to ramp up our European network, Mr. Favet and Mr. Mack will play integral roles in guiding Sonitus Medical forward in our efforts to offer a novel treatment solution for all patient who suffer from single sided deafness, conductive hearing loss, or mixed hearing loss."
About Sonitus Medical
Sonitus Medical (www.sonitusmedical.com) is a privately held medical device company committed to providing advanced hearing solutions that hearing professionals such as otologists, ENTs, and audiologists can use to help their patients rejoin the conversation of life. Founded in June 2006, the company is headquartered in San Mateo, California. Its SoundBite Hearing System (www.soundbitehearing.com) is the world's first non-surgical and removable hearing solution that relies on bone conduction to imperceptibly transmit sound via the teeth.
Currently FDA cleared for the treatment of both single sided deafness and conductive hearing loss, SoundBite Hearing System has intended future indications for hearing disorders such as tinnitus. The technology also has application in consumer and communications. Additionally, the company has received its CE Mark certification, which indicates full quality assurance system approval and that Sonitus Medical's design and manufacturing processes for the SoundBite device comply with certain manufacturing and design standards under the European directive concerning medical devices.
SOURCE Sonitus Medical, Inc.