Oticon Medical’s Sentio System Is FDA-Cleared

Oticon Medical announced that the US Food and Drug Administration (FDA) cleared its first active transcutaneous bone conduction hearing system, the Sentio System. This innovative system offers the benefits of the Ponto System with a new transcutaneous option for patients.

Bone conduction hearing aids amplify sound via vibrations through the bones of the skull, directly stimulating the cochlea — which is vital in hearing and sound transduction — without needing any part of the device in the ear canal.

Oticon Medical develops hearing solutions that improve the quality of life for people with hearing loss. The company works with healthcare professionals to create effective and accessible bone-anchored hearing systems.

The Sentio System consists of two main parts: the Sentio 1 Mini, which is worn outside the body, and the Sentio Ti Implant, which is placed under the skin. The Sentio 1 Mini is the smallest transcutaneous system available, making it comfortable and easy to wear. Unlike traditional percutaneous systems where the implant protrudes from the skin, this system keeps the skin intact.

The Sentio 1 Mini is 26 percent lighter than similar alternatives and provides a 360-degree sound experience with a wide bandwidth of 9.5 kHz. This makes hearing more natural and immersive.

The Sentio Ti Implant supports patients with progressive hearing loss, without needing additional surgeries. It can handle stronger sound processors, making it reliable for long-term use. The implant is also designed to make surgery simple, straightforward and efficient.

The Sentio System is indicated for individuals aged 12 and older who are diagnosed with three main audiological conditions: conductive hearing loss, mixed hearing loss or single-sided deafness.

Oticon Medical’s commitment to “freedom of choice” is evident in the Sentio System. “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,” said René Govaerts, Oticon Medical’s president and general manager, in the press release.

XTALKS WEBINAR: Modernize MedTech Sales and Service with Slack

Live and On-Demand: Tuesday, August 20, 2024, at 2pm EDT (11am PDT)

Register for this free webinar designed for MedTech leaders to discover how Slack can enhance sales and service team communication, and how automated workflows can reduce manual tasks and boost productivity.

The Sentio System vs. Conventional Treatments

The Sentio System offers several advantages over conventional air-conduction hearing aids. It works by bypassing the damaged parts of the ear, requiring less amplification and improving sound quality. It also keeps the ear canal open, which helps people with ear infections or ear drainage, and reduces the risk of feedback.

Compared to middle ear surgery, the Sentio System allows patients and audiologists to test the benefits of bone conduction sound processing before surgery using non-surgical solutions like a softband or headband. The implantation itself does not carry the risk of further hearing loss.

The Sentio System also stands out from other bone conduction hearing aids because it requires less care and cleaning and has a lower risk of infection after healing. It also provides better sound quality than passive transcutaneous solutions as sound vibrations are not lost through the skin.

Globally, over 430 million people, including 34 million children, require rehabilitation for disabling hearing loss. By 2050, this number is expected to rise to over 700 million. Most people with disabling hearing loss — a hearing loss greater than 35 decibels in the better ear — live in low- and middle-income countries. Unaddressed hearing loss impacts communication, social interactions, education and employment.

Hearing aids are generally the first line of treatment offered for those suffering from hearing loss. In addition, speech and language therapy, assistive devices and counseling are also available to patients so they may fully engage in daily activities and improve their quality of life.

With its small footprint, sturdy setup and adaptable noise management technology, the Sentio System is a discreet yet powerful hearing aid.