Summary: Oticon Medical received FDA clearance for its active transcutaneous bone conduction hearing system, offering an alternative to existing percutaneous systems while maintaining skin integrity.
Key Takeaways:
- Innovative Hearing Solution: The Sentio System, including the Sentio 1 Mini sound processor and Sentio Ti implant, is a small active transcutaneous bone conduction system, providing a new option that keeps the skin intact.
- Comprehensive Portfolio: With the launch of Sentio, Oticon Medical now offers a complete range of bone-anchored hearing systems, addressing diverse patient needs and clinical settings globally.
- Enhanced User Experience: The Sentio 1 Mini is designed for comfort and ease of use, delivering a 360-degree sound experience with the widest bandwidth of 9.5kHz, while the Sentio Ti implant supports progressive hearing loss without additional surgeries.
Oticon Medical announced U.S. Food and Drug Administration (FDA) clearance of its first active transcutaneous bone conduction hearing system, the Sentio System. Sentio System delivers the proven benefits of the Ponto System—and more—in a transcutaneous option.
A New Active Transcutaneous Bone Conduction Hearing System
The system includes Sentio 1 Mini, an external sound processor, and Sentio Ti Implant, placed under the skin. It is the smallest transcutaneous system available to date1.
While Ponto and other percutaneous bone-anchored hearing systems use skin-protruding abutments, the Sentio System provides an alternative keeping the skin intact. The Sentio System offers an additional solution for patients and supports our commitment to “freedom of choice.”
“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,” says René Govaerts, president & general manager, 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.”
Further reading: Oticon Hearing Aid with User-Intent Sensors Now Available to Veterans
More About the Sentio 1 Mini
The Sentio 1 Mini is designed with a focus on user comfort and ease of use. The device’s design and slim profile make it 26% lighter than an alternative(1). It gives access to a 360-degree sound experience and offers the widest bandwidth of 9.5kHz.
Sentio Ti is a SuperPowerful implant developed to support patient’s progressive hearing loss, without the need for additional surgeries. Sentio Ti is designed and verified for a higher maximum force output, so that patients can rely on its ability to handle more powerful sound processors(2). From a surgeon’s perspective, the implant is designed for surgical flexibility, ensuring a straightforward procedure.
Sentio System is indicated for candidates aged 12 and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.
Photo: Oticon Medical
References:
- Sentio implant and sound processor physical features and comparison to other devices (Doc-00123204)
- 275144en Product Information Sentio 1 Mini
