|SoundBite consists of a hearing device that fits around the upper back teeth--courtesy of Sonitus Medical|
Sonitus Medical is rolling out its new behind-the-teeth hearing device in Europe and beefing up its executive team as the company expands.
The San Mateo, CA company raised $25 million in Series D venture funding in May, in part to help grow commercial sales of the company's SoundBite hearing system in the U.S. market, where the product has 510(k) clearance from the FDA. In the European Union, it gained a CE mark for patients who are deaf in one ear, and have conductive or mixed hearing loss.
Plans call for a limited product launch at 7 different centers throughout Europe in the United Kingdom, Spain, the Netherlands, Switzerland, Austria and two sites in Germany. Separately, the company is continuing a European pilot study with 20 patients at four different academic medical centers, with the goal of monitoring patient results at one, 6 and 12 months. Eventually, the trial will expand to 35 patients.
Sonitus' SoundBite includes a small hearing device that fits around the upper left or right back teeth, and also a small microphone equipped with a wireless transmitter that sits behind the ear that can't hear. A patient's teeth help conduct the sound waves. Both pieces use rechargeable batteries and as the company describes, no surgery is necessary.
CEO Amir Abolfathi said in a statement that the move represents a first step in trying to build a commercial network for SoundBite in Europe.
Meanwhile, Sonitus named Mike Favet as its new chief operating officer and Jeff Mack as chief financial officer. Favet is credited with having more than 20 years experience at various companies in different therapeutic spaces. The company notes that Mack has more than 25 years experience at various technology companies in areas including fundraising and IPOs, SEC reporting and compliance and M&A work.
- read the release