Sonitus Medical, a manufacturer of non-surgical and removable hearing prosthetic to transmit sound via the teeth, has received CE mark certification for its SoundBite Hearing System to commercialize in Europe.
Sonitus Medical has received its EC Certificate, which indicates Full Quality Assurance System Approval.
This is the first European regulatory certification for the company and the product.
Apart from the FDA clearance attained by the company earlier this year, CE marking indicates that Sonitus Medical’s design and manufacturing processes for the SoundBite Hearing System comply with certain manufacturing and design standards under the European directive concerning medical devices.
Sonitus Medical CEO Amir Abolfathi said receiving the CE mark for SoundBite Hearing System is a milestone towards the global commercialization of their non-surgical bone-conduction hearing device.
"We intend to pursue the process of reimbursement registration in the key EU countries in the coming months and then gain initial European clinical experience with the product in partnership with a limited number of Otologists, ENTs, and Acousticians in the EU," Abolfathi said.