Sonitus Medical has announced the European launch of its SoundBite hearing system following early last year’s approvals in the U.S. and E.U. The system consists of a microphone placed behind the ear and a unit that grips to the teeth in the back of the mouth.
Very much like bone anchored hearing aids, the microphone transmits signals to the dental orthosis that in turn vibrates the teeth and scalp to stimulate the cochlea. Unlike a cochlear implant, the SoundBite doesn’t require holes to be drilled into the scalp, nor even any dental work done.
From the announcement:
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.
Medgadget‘s flashbacks about SoundBite…
Press release: Sonitus Medical Announces First European Commercialization with Shipment of SoundBite™ Hearing System to Seven Centers of Excellence…
Product page: SoundBite Hearing System…