Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Expanded Indications in the Pediatric BONEBRIDGE Population
NCT05615649 · View on ClinicalTrials.gov ↗
Study Summary
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
Conditions Studied
Interventions
- DEVICE MED-EL BONEBRIDGE Bone Conduction Implant
Study Locations (6)
Colorado
- University of Colorado Health/Children's Hospital of Colorado — Aurora
Florida
- University of Miami — Miami
New Jersey
- University Hospital Newark/Rutgers New Jersey Medical School — Newark
North Carolina
- University of North Carolina — Chapel Hill
Ohio
- The Ohio State University/Nationwide Children's Hospital — Columbus
Utah
- University of Utah Health/Primary Children's Hospital — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-10-03 |
| Est. Completion | 2026-07 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05615649
The ClinicalTrials.gov registry entry for NCT05615649 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Med-El Corporation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hearing Loss, Conductive appearing as the primary indexed condition, and to 1 intervention — of which MED-EL BONEBRIDGE Bone Conduction Implant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05615649 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Colorado, Florida, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05615649 about?
NCT05615649 is a clinical study titled "Expanded Indications in the Pediatric BONEBRIDGE Population". This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
What is the current status of trial NCT05615649?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2023-10-03. Estimated completion is 2026-07.
What conditions does trial NCT05615649 study?
This clinical trial studies the following conditions: Hearing Loss, Conductive, Hearing Loss, Mixed. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05615649?
The interventions under investigation include: MED-EL BONEBRIDGE Bone Conduction Implant (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05615649?
This trial is sponsored by Med-El Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05615649 being conducted?
This trial has 6 study locations across Colorado, Florida, New Jersey, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.