Oticon Wins FDA Nod for Sentio Hearing System

Oticon Medical has received U.S. Food and Drug Administration (FDA) clearance for Sentio, its first transcutaneous bone conduction hearing system. It’s indicated for patients 12 and older with conductive hearing loss, mixed hearing loss, or single-sided deafness.

The system is comprised of the Sentio 1 Mini external sound processor and Sentio Ti implant, which is placed under the skin. The company said it’s the smallest transcutaneous system currently available.

Sentio 1 Mini’s design and slim profile, according to Oticon, make it 26% lighter than an alternative. It allows a 360-degree sound experience and has a bandwidth of 9.5 kHz.

The Sentio Ti implant was designed for a higher maximum force output so patients can trust its ability to handle more powerful sound processors. The implant was also engineered for surgical flexibility for a straightforward procedure.

“With the launch of Sentio System, we provide best-in-class and the smallest active transcutaneous system,” said Oticon’s president and GM René Govaerts. “More importantly, Oticon Medical now offers a complete portfolio of bone-anchored hearing systems. This portfolio meets the needs of patients and customers, and fits diverse clinical settings and global reimbursement schemes for the treatment. We strongly believe that offering a broad portfolio is the path to achieving our mission to “Help more people” and give more potential users the quality of life improvements these systems offer.”