"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 (http://www.sonitusmedical.com/
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 (http://www.soundbitehearing.com/
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;
New Senior Management
With Sonitus' European commercialization plans well underway, the company has deepened its management team (http://www.sonitusmedical.com/
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."