Oticon Medical’s Sentio™ System Receives Regulatory Clearance in the US
July 12, 2024 08:16 AM Eastern Daylight Time
ASKIM, Sweden--(BUSINESS WIRE)--Oticon Medical announced today the 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.
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. 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”, says René Govaerts, President & General Manager, Oticon Medical.
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 alternative1. 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 processors2. 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.
This launch marks a significant milestone for Oticon Medical, as it continues to deliver the innovative hearing solutions that help people live life to the fullest.
For more information visit www.oticonmedical.com.
Not all products are available in all markets. Product availability and indications are subject to regulatory approval and may vary depending on the market.
About Oticon Medical
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the power of sound to people at every stage of life. For more than a decade, we have made bone anchored hearing systems more accessible by simplifying the treatment for physicians, audiologists, and patients alike.
We believe that patients and hearing care professionals should be able to choose the best possible solution at any time along the patient journey. We call it “Freedom of Choice” and it has always been paramount to Oticon Medical. This is the reason why our solutions are designed to be compatible whenever possible. As a result, an implant from Oticon Medical stands as a true testament to our unwavering lifelong support.
We work collaboratively with professionals to ensure that every solution we create is designed with our users’ needs in mind. We have a strong passion to provide innovative solutions and support that enhance quality of life and help people live life to the fullest – now and in the future.
Because we know how much sound matters.
References
1 Sentio implant and sound processor physical features and comparison to other devices (Doc-00123204)
2 275144en Product Information Sentio 1 Mini
Contacts
Erik Lund
Marketing Director, Oticon Medical
E-mail: erld@oticonmedical.com
Mobile: +46 76 304 4482
