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Home » FDA clears Oticon Medical’s hearing loss implant

FDA clears Oticon Medical’s hearing loss implant

July 12, 2024 By Sean Whooley

Oticon Sentio System
The Sentio transcutaneous bone conduction hearing system. [Image courtesy of Oticon Medical]
Oticon Medical announced today that the FDA granted clearance for its Sentio transcutaneous bone conduction hearing system.

The system includes the Sentio 1 Mini external sound processor and Sentio Ti implant, placed under the skin. Askim, Sweden-based Oticon says it’s the smallest transcutaneous bone conduction hearing system to date. The company says it delivers the proven benefits of its Ponto bone-anchored hearing system, but in a transcutaneous option.

Ponto and other percutaneous bone-anchored hearing systems use skin-protruding abutments. Meanwhile, Sentio provides an alternative, keeping the skin intact and providing freedom of choice.

Oticon designed the Sentio 1 Mini processor with a focus on user comfort and ease of use. Its design and slim profile make it 26% lighter than alternatives, the company says. It also provides access to a 360-degree sound experience with a bandwidth of 9.5kHz.

Sentio Ti supports progressive hearing loss without the need for additional surgeries. Oticon designed it for a higher maximum force output so patients can rely on its ability to handle more powerful sound processors.

The FDA clearance covers Sentio for candidates aged 12 and older with conductive hearing loss, mixed hearing loss or single-sided deafness.

“With the launch of Sentio System, we provide best-in-class and the smallest active transcutaneous system. More importantly, Oticon Medical now offers a complete portfolio of bone-anchored hearing systems,” said René Govaerts, president & GM, Oticon Medical. “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.”

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Implants, Neurological, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: FDA, Oticon Medical

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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