Actively Recruiting
Pediatric Expansion Study of the Sentio System
Led by Oticon Medical · Updated on 2026-01-12
50
Participants Needed
8
Research Sites
113 weeks
Total Duration
On this page
Sponsors
O
Oticon Medical
Lead Sponsor
G
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pediatric Expansion Study of the Sentio System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by parent or legal guardian and child as applicable
- Age between 3 and 11 years
- Conductive or mixed hearing loss with bone conduction threshold ≤ 45 dB HL in the ear to be implanted
- OR profound sensorineural hearing loss in one ear with normal hearing (air conduction threshold ≤ 20 dB HL) in the other ear (single-sided deafness)
- OR indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid but unable or unwilling to use it
- Ability and willingness of subject and parent/legal guardian to comply with study procedures
- Prior experience with amplified sound via hearing aid, CROS device, or non-surgical bone anchored solution
- Sufficient air-bone gap for conductive or mixed hearing loss cases
- Adequate bone quality, quantity, and skull size for implantation as determined clinically
You will not qualify if you...
- Medical conditions contraindicating implant surgery or anesthesia
- Untreated ongoing middle ear infection at surgery time
- Known or suspected allergy to silicone or materials in the Sentio system
- Conditions impairing wound healing or skin condition (e.g., uncontrolled diabetes)
- Skin or scalp conditions interfering with sound processor attachment or use
- Conditions preventing good speech recognition potential
- Any condition interfering with compliance or study assessments
- Use of ototoxic drugs harmful to hearing
- Previous or planned radiotherapy near implantation site during study
- Candidates already treated with bone-anchored hearing solution on the better hearing side for bilateral asymmetric cases
- Known chronic or irreversible vestibular or balance disorders
- Abnormally progressive hearing loss
- Recent or current participation in other clinical trials affecting safety or effectiveness
- Use of active implantable or body-worn devices that cannot be removed medically
- Need for frequent MRI scans for other diseases
- Deemed unsuitable for study enrollment per Declaration of Helsinki guidelines
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Actively Recruiting
2
Radboud University Medical Center
Nijmegen, Netherlands, 6525EX
Actively Recruiting
3
Hospital Universitario de Donostia
San Sebastián, Spain, 20014
Actively Recruiting
4
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
5
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
6
Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
7
The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
8
Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
S
Sara Svensson, MSc, PhD
CONTACT
M
Marianne Philipsson, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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