Oticon Medical’s Sentio™ System Approved for US Market

Oticon Medical announced today that the U.S. Food and Drug Administration (FDA) has approved its Sentio™ System, the company’s first active transcutaneous bone conduction hearing system. Offering enhanced features over the existing Ponto™ System, Sentio System includes the Sentio 1 Mini external sound processor and the Sentio Ti implant, the smallest of its kind available.

Unlike traditional percutaneous systems like Ponto, which have protruding abutments, Sentio System preserves intact skin while delivering comparable benefits. This innovation expands options for patients, emphasizing freedom of choice.

“With the launch of Sentio System, we introduce the smallest and most advanced active transcutaneous solution in its category,” said René Govaerts, President and General Manager of Oticon Medical. “This comprehensive portfolio enhances our ability to meet diverse clinical needs and global reimbursement requirements, ultimately improving quality of life for more individuals.”

The Sentio 1 Mini is designed for comfort and simplicity, weighing 26% less than alternative solutions. It enables 360-degree acoustic perception and offers a wide bandwidth up to 9.5 kHz. Meanwhile, the Sentio Ti implant is a high-powered option suitable for patients with progressive hearing loss, eliminating the need for additional surgeries and ensuring reliable performance with advanced sound processors.

Approved for patients aged 12 and older with conductive hearing loss, mixed hearing loss, or single-sided deafness, Sentio System represents a significant milestone for Oticon Medical’s commitment to innovation in hearing healthcare.

About Oticon Medical:

Oticon Medical is a global leader in implantable hearing solutions, dedicated to enhancing auditory experiences across all stages of life. For over a decade, Oticon Medical has focused on making bone-anchored hearing systems accessible and user-friendly for patients, audiologists, and healthcare professionals worldwide. The company’s commitment to “Freedom of Choice” ensures that patients receive the most compatible and effective solutions, tailored to their individual needs.

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