Swedish hearing solutions provider Oticon Medical has received the US Food and Drug Administration (FDA) approval for the Sentio transcutaneous bone conduction hearing system.
Sentio System is indicated for people aged 12 years and above, who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.
The transcutaneous bone conduction hearing system contains Sentio 1 Mini, an external sound processor and Sentio Ti Implant, placed under the skin.
The Sentio 1 Mini processor is designed to deliver user comfort and ease of use, and offers a 360-degree sound experience, along with the widest bandwidth of 9.5kHz.
Oticon said that its Sentio System will provide the benefits of its previous bone conduction hearing solution, Ponto System, in a transcutaneous option.
Also, it is the smallest transcutaneous system available to date, and is 26% lighter than an alternative, owing to its design and slim profile, said the hearing solutions provider.
Oticon Medical president and general manager René Govaerts said: “While Ponto and other percutaneous bone-anchored hearing systems use skin-protruding abutments, the Sentio System provides an alternative to keeping the skin intact.
“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.”
According to the company, Sentio Ti is an advanced implant developed to support a patient’s progressive hearing loss, without needing additional surgeries.
Sentio Ti is designed and validated for a higher maximum force output, allowing patients to count on its ability to handle more powerful sound processors.
Also, the implant provides surgical flexibility, ensuring a straightforward procedure for surgeons, said the Swedish hearing solutions provider.
Govaerts added: “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.”
