Pediatric Expansion Study of the Sentio System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-11
SponsorOticon Medical
About this trial
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.
Eligibility criteria
Qualifiers
Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
Subject aged 3 to 11 years
Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures/ requirements, as determined by the investigator.
Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).
Disqualifiers
Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.
Untreated ongoing middle ear infection at the time of surgery.
Known or suspected contact allergy to silicone or other material used in the Sentio system.
Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.
Trial design
Treatments tested in this trial
- Active transcutaneous bone conduction system
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Oticon Medical
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Birmingham Women's and Children's NHS Foundation Trust
Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborator
University Medical Center Groningen
Collaborator
Radboud University Medical Center
Collaborator
Hospital Universitario La Fe
Collaborator
Hospital Universitario Virgen Macarena
Collaborator
Hospital Donostia
Collaborator
Source ClinicalTrials.gov