Pediatric Expansion Study of the Sentio System
BC119
A Prospective, Multicenter, Single-arm Clinical Investigation of the Safety and Performance of the Sentio System in a Pediatric Population
3 other identifiers
interventional
50
3 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2025
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
January 12, 2026
January 1, 2026
1.4 years
April 25, 2025
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate that the Sentio system improves hearing on the implanted ear.
Functional gain with the Sentio system, i.e. the difference between pre-operative unaided and post-operative aided sound field thresholds on the implanted ear. The functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
3 months post-surgery
Secondary Outcomes (9)
Evaluation of the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
3 months post-surgery
Functional gain
12 months post-surgery
Effective gain
12 months post-surgery
Assessment of speech recognition improvement
3 months post-surgery
Assessment of listening-related fatigue
6 months post-surgery
- +4 more secondary outcomes
Study Arms (1)
Sentio system
EXPERIMENTALProspective, open label, single-arm multicentre investigation designed to follow clinical practice for bone conduction devices.
Interventions
The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.
Eligibility Criteria
You may qualify if:
- Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
- Subject aged 3 to 11 years
- Subject with:
- conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.
- OR subject who has a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3 OR subject indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
- 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).
- For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.
- Sufficient bone quality/quantity/depth or skull size for implantation of a Sentio Ti implant as assessed according to clinical practice.
You may not qualify if:
- 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.
- Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
- Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
- Any other known condition that the investigator determines could interfere with compliance or investigation assessments.
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
- Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
- For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds.
- Known chronic or non-revisable vestibular or balance disorder.
- Known abnormally progressive hearing loss.
- Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Sentio system as determined by the investigator.
- Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.
- Known need for frequent MRI investigations for follow-up of other diseases.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningencollaborator
- Radboud University Medical Centercollaborator
- Hospital Universitario Virgen Macarenacollaborator
- Oticon Medicallead
- Guy's and St Thomas' NHS Foundation Trustcollaborator
- Birmingham Women's and Children's NHS Foundation Trustcollaborator
- Great Ormond Street Hospital for Children NHS Foundation Trustcollaborator
- Hospital Universitario La Fecollaborator
- Hospital Donostiacollaborator
Study Sites (8)
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Radboud University Medical Center
Nijmegen, 6525EX, Netherlands
Hospital Universitario de Donostia
San Sebastián, 20014, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
Birmingham, B4 6NH, United Kingdom
The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2025
First Posted
May 16, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share