Oticon noted that the Sentio System delivers the proven benefits of its Ponto bone-anchored hearing system but in a transcutaneous option. Image Credit: Eric Nicholas / Shutterstock.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.”