Oticon Medical has received US Food and Drug Administration (FDA) clearance for its active transcutaneous bone conduction hearing system, Sentio.
The Sentio implant is a small transcutaneous system, consisting of an external sound processor, Sentio 1 Mini, and a Sentio Ti implant, which is placed under the skin through a surgical procedure. The implant was cleared to manage conductive hearing loss, mixed hearing loss, and single-sided deafness in patients aged 12 years and older.
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The Swedish company stated that the Sentio implant is 26% lighter than the alternative bone-anchored implants currently on the market. The hearing implant has a bandwidth of 9.5kHz and offers a 360° sound experience.
Oticon noted that the Sentio system delivers the proven benefits of its Ponto bone-anchored hearing system but in a transcutaneous option. The Ponto system was approved by the FDA to treat conductive and mixed hearing losses, bilateral fitting, and single-sided deafness.
The Sentio system clearance comes two months after Australian company Cochlear closed the acquisition of Oticon’s cochlear implant (Neuro system) business. Oticon’s neuro system was approved to treat bilateral severe-to-profound sensorineural hearing loss in adults. The acquisition did not include the bone-conduction (Ponto system) business, which Oticon retains ownership of.
The market for hearing implants is expected to expand to be worth approximately $1.6bn in 2023 to over $2.4bn in 2033, as per GlobalData analysis. The market segment for bone-anchored hearing implants is also forecasted to expand from $66.4m to $115.6m over the same period.
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By GlobalData“With the launch of Sentio System, we provide best-in-class and the smallest active transcutaneous system,” said René Govaerts, president and general manager, Oticon Medical.
“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.”
