Pediatric Expansion Study of the Sentio System

This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.

NCT Number	NCT06976086
Lead Sponsor	Oticon Medical Collaborators: Guy's and St Thomas' NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, University Medical Center Groningen, Radboud University Medical Center, Hospital Universitario La Fe, Hospital Universitario Virgen Macarena, Hospital Donostia
Conditions	Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
Enrollment	50 participants
Start Date	2025-04-30
Primary Completion	2026-10-01 (estimated)
Study Completion	2027-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-14