U.S., May 17 -- ClinicalTrials.gov registry received information related to the study (NCT06976086) titled 'Pediatric Expansion Study of the Sentio System' on April 25.
Brief Summary: 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....