Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-04-30
2027-07-01
Brief Summary
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Detailed Description
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The Sentio system is a transcutaneous bone conduction hearing system (an implant and an external sound processor) for individuals with certain types of hearing losses. The implant is implanted into the bone behind the ear (mastoid and temporal bone area). After a period of skin healing, a sound processor which transmits sound waves to the implant can be magnetically attached. The implant transforms the sound waves to vibrations, which are then transmitted to the inner ear via the bone. 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.
The study includes eight study visits; one before surgery, the surgery visit, and six follow-up visits, with the last visit taking place 12 months after surgery.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sentio system
Prospective, open label, single-arm multicentre investigation designed to follow clinical practice for bone conduction devices.
Active transcutaneous bone conduction system
The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.
Interventions
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Active transcutaneous bone conduction system
The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject aged 3 to 11 years
3. Subject with:
3.1 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.
3.2 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.
4. Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures/ requirements, as determined by the investigator.
5. 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).
6. For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.
7. Sufficient bone quality/quantity/depth or skull size for implantation of a Sentio Ti implant as assessed according to clinical practice.
Exclusion Criteria
2. Untreated ongoing middle ear infection at the time of surgery.
3. Known or suspected contact allergy to silicone or other material used in the Sentio system.
4. Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.
5. Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
6. Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
7. Any other known condition that the investigator determines could interfere with compliance or investigation assessments.
8. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
9. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
10. For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds.
11. Known chronic or non-revisable vestibular or balance disorder.
12. Known abnormally progressive hearing loss.
13. 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.
14. 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.
15. Known need for frequent MRI investigations for follow-up of other diseases.
16. Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.
3 Years
11 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Birmingham Women's and Children's NHS Foundation Trust
OTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER
Hospital Universitario La Fe
OTHER
Hospital Universitario Virgen Macarena
OTHER
Hospital Donostia
OTHER
Oticon Medical
INDUSTRY
Responsible Party
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Locations
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University Medical Center Groningen
Groningen, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Hospital Universitario de Donostia
San Sebastián, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
Birmingham, , United Kingdom
The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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CIV-4-12-050315
Identifier Type: OTHER
Identifier Source: secondary_id
CI/2024/0074/GB
Identifier Type: OTHER
Identifier Source: secondary_id
BC119
Identifier Type: -
Identifier Source: org_study_id
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