Objectives: To share the first clinical experience from a novel active transcutaneous bone conduction implant system in users with mixed/conductive hearing lossess and single sided deafness. 

Methods: There is an ongoing long term clinical investigation on the first version of the novel active transcutaneous bone conduction implant system Sentio, Oticon Medical AB, Sweden where so far 16 out of 50 planned patients have been implanted by 2 out of the 6 participating clinics clinicaltrials.gov identifier NCT05166265. This report includes the first observations and clinical reflections on the surgical installation and clinical follow-up for these patients.

Results: The first implanted 16 patients had a mean age of 47 years and with the type of hearing loss being either conductive (n = 12), mixed (n = 3), or single sided deafness (n = 1) on the implanted side. Surgery duration from incision to last suture varied between 45 and 85 minutes, being of influence on the surgical learning curve. Implant installations could be done without any specific preoperative planning. The small size and the design of the implant enabled a smooth surgery installation with minimal bone preparation and with limited impact on surrounding tissue. Implant performance outcomes and safety profile follow expected patterns after the initial observed follow-up period of 6 months, currently. The overall patient satisfaction is highly positive. 

Conclusion: These initial clinical observations indicate that the implant is indeed small and less invasive to install without compromising clinical outcomes. This may indicate opportunity for treatment with an active transcutaneous implant system also in younger ages where bone quantity may be limited. 


First clinical experience from a novel active transcutaneous bone conduction implant system

It is with great pleasure and enthusiasm, that on behalf of the Cochlear Implant centers of the Radboud UMC in Nijmegen and Erasmus MC Sophia Children’s Hospital in Rotterdam to invite you to attend the 16th European Symposium on Pediatric Cochlear Implantation to Rotterdam, the Netherlands in 2023.

Yours sincerely, on behalf of the CI Centers at Radboud UMC and Erasmus MC,