Evaluating the safety of BONEBRIDGE implants in young children
The BONEBRIDGE in Children Below Five Years of Age Premarket Clinical Investigation
This study tests how safe the BONEBRIDGE hearing implant is for children under five and looks at any problems that might come up in the first year after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 1 Year to 9 Years |
| Sex | All |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH Industry-sponsored |
| Locations | 2 sites (Hanover, Niedersachsen and 1 other locations) |
| Trial ID | NCT06634784 on ClinicalTrials.gov |
What this trial studies
This study examines the safety of the BONEBRIDGE BCI 602 hearing implant in children under five years old. It is an observational study that collects data both retrospectively and prospectively from multiple hospitals. The primary goal is to identify any complications or issues related to the device or surgery within the first year post-operation. Additionally, the study assesses hearing improvement and quality of life through various tests and questionnaires.
Who should consider this trial
Good fit: Ideal candidates are children under five who have received the BONEBRIDGE BCI 602 implant and have had it for at least 12 months.
Not a fit: Patients who cannot perform audiological tests due to psychological or physical disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of BONEBRIDGE implants for young children with hearing loss.
How similar studies have performed: While this specific approach is observational, similar studies on hearing implants in children have shown promising results in terms of safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Children who received the BONEBRIDGE BCI 602 implant before the age of five and have had the implant for at least 12 months. Ability to perform the German language test. Willingness and ability to undergo all tests required by the study. Signed and dated informed consent obtained before any study-specific procedure and collection of retrospective data. Exclusion Criteria: Inability to perform audiological tests due to psychological, emotional, or related physical disorders. Failure to meet any inclusion criteria. Any condition that, in the investigator's opinion, poses an increased risk to the patient or prevents full compliance or completion of the study.
Where this trial is running
Hanover, Niedersachsen and 1 other locations
- Medizinische Hochschule Hannover — Hanover, Niedersachsen, Germany (Not_yet_recruiting)
- Universitätsklinikum Schleswig-Holstein, Klinik für Hals-, Nasen- und Ohrenheilkunde — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Severin Fuerhapter
- Email: allclinicalresearchvibrant@medel.com
- Phone: +43577885254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.