Oticon Medical’s transcutaneous bone conduction hearing system receives FDA clearance
Oticon Medical has announced that its Sentio System, the company’s first active transcutaneous bone conduction hearing system, has received clearance from the U.S. Food and Drug Administration (FDA). This innovative system aims to provide the established benefits of the company’s Ponto System whilst offering a transcutaneous option.
The Sentio System comprises two main components: the Sentio 1 Mini, an external sound processor, and the Sentio Ti Implant, which is surgically placed beneath the skin. Notably, this system is currently the smallest transcutaneous option available in the market.
Unlike percutaneous bone-anchored hearing systems such as Ponto, which utilise skin-protruding abutments, the Sentio System maintains skin integrity. This alternative approach aligns with Oticon Medical’s commitment to providing patients with a range of options.
Expanding treatment options for hearing loss
René Govaerts, President & General Manager of Oticon Medical, emphasised the significance of this launch: “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.”
Govaerts further explained the company’s rationale behind offering a comprehensive portfolio, stating that it is crucial in achieving their mission to “Help more people” and improve the quality of life for a broader range of potential users.
Technical specifications and design considerations
The Sentio 1 Mini has been engineered with a focus on user comfort and ease of use. Its slim profile contributes to a 26% reduction in weight compared to alternative options. The device offers a 360-degree sound experience and boasts the widest bandwidth of 9.5kHz in its class.
The Sentio Ti implant is designed to accommodate progressive hearing loss without necessitating additional surgical interventions. It has been developed and verified for a higher maximum force output, allowing patients to benefit from more powerful sound processors as their needs evolve.
Surgical considerations and patient eligibility
From a surgical perspective, the Sentio Ti implant is designed to offer flexibility, ensuring a straightforward procedure for otolaryngologists.
The Sentio System is indicated for patients aged 12 and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.
This FDA clearance represents a significant milestone for Oticon Medical in its ongoing mission to deliver innovative hearing solutions. By expanding its portfolio to include both percutaneous and transcutaneous options, the company aims to cater to a wider range of patient needs and preferences.
The introduction of the Sentio System not only provides healthcare professionals with an additional treatment option but also aligns with the growing trend towards less invasive medical interventions. As the smallest transcutaneous system currently available, it may offer particular benefits for patients concerned about aesthetics or those with specific anatomical considerations.
- For more information, visit: oticonmedical.com
