Using the Sentio System to Improve Hearing in Children

A Prospective, Multicenter, Single-arm Clinical Investigation of the Safety and Performance of the Sentio System in a Pediatric Population

This study is testing a new hearing device for children under 12 with certain types of hearing loss to see if it can help them hear better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 3 Years to 11 Years
• Sex: All
• Sponsor: Oticon Medical (Industry-sponsored)
• Locations: 8 sites (Groningen and 7 other locations)
• Trial ID: NCT06976086 on ClinicalTrials.gov

What this trial studies

This study aims to collect safety and performance data for the Sentio system, a bone conduction hearing device, in children under 12 years old with specific types of hearing loss. Conducted across eight hospitals in Europe, the study will enroll 50 pediatric patients to evaluate the effectiveness of the system in improving hearing in the implanted ear compared to the unaided ear. Participants will undergo a series of visits, including pre-surgery assessments, the surgical procedure, and follow-ups over a year to monitor outcomes and safety.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 to 11 years with conductive or mixed hearing loss or single-sided deafness.

Not a fit: Patients with hearing loss conditions not suitable for bone-anchored hearing systems or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for young children with hearing loss, potentially improving their quality of life and communication abilities.

How similar studies have performed: Other studies involving bone conduction hearing systems have shown promising results, indicating that this approach is supported by prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
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:

1. Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.
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.

Where this trial is running

Groningen and 7 other locations

• University Medical Center Groningen — Groningen, Netherlands (Recruiting)
• Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
• Hospital Universitario de Donostia — San Sebastián, Spain (Recruiting)
• Hospital Universitario Virgen Macarena — Seville, Spain (Recruiting)
• Hospital Universitario y Politécnico La Fe — Valencia, Spain (Recruiting)
• Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)
• The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
• Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Sara Svensson, MSc, PhD

Conditions Hearing Loss, Conductive; Hearing Loss, Mixed; Single Sided Deafness; Sentio system; Paediatric; Hearing loss; Children; Bone conduction