Sonitus Medical, the maker of SoundBite, a unique hearing device that is placed in the mouth and transmits sound via teeth, has begun multi-site market testing at seven European medical centers. Additionally, the company announced hiring two new executives.
"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 system received CE Mark certification in the European Union for the treatment of single sided deafness, conductive hearing loss, and mixed hearing loss. It is also FDA cleared in the United States for single sided deafness and conductive hearing loss.
SoundBite is a removable prosthetic device that is placed in the mouth and uses bone conduction to deliver sound to the inner ear. Nearly invisible when seated in the mouth, the SoundBite system also includes a small microphone unit that’s worn behind the ear.
The small market study will monitor patient experiences and qualitative results at 1, 6, and 12 months, and will grow to include five patients at each site for a total of 35 subjects.,
The seven participating European medical centers receiving SoundBites 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.
To facilitate expected growth, Sonitus has hired two high level senior executives: Mike Favet was named chief operating officer. He 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. The company also named Jeff Mack as its chief financial officer. Mack has a reportedly strong executive background in technology-based companies, IPOs, SEC reporting, mergers and acquisition, and investor relations.
SOURCE: Sonitus Medical