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NCT06634784: 2023BB006
Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants. It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation.
trial testing Bone Conduction Implant (BCI) in Hearing Loss, Conductive in 9 participants. Completed in 4 February 2026.
8 October 2025
Quick facts
| Lead sponsor | MED-EL Elektromedizinische Geräte GesmbH |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 9 |
| Start date | 25 September 2024 |
| Primary completion | 8 October 2025 |
| Estimated completion | 4 February 2026 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- Bone Conduction Implant (BCI)
Conditions studied
- Hearing Loss, Conductive — all drugs for Hearing Loss, Conductive →
- Hearing Loss, Mixed — all drugs for Hearing Loss, Mixed →
- Children Under 5 Years — all drugs for Children Under 5 Years →
Sponsor
MED-EL Elektromedizinische Geräte GesmbH — full company profile →
Who can join
Adults 1 to 9, any sex, with Hearing Loss, Conductive or Hearing Loss, Mixed. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant. This observational study, which is both retrospective (looking back) and prospective (looking forward), will take place at multiple hospitals. The main goal is to see if the BONEBRIDGE implant is safe for young children within 12 months after surgery. Primary Goal: The study's main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety. Secondary Goals: Hearing Improvement: Using tests like the Göttinger Speech Intelligibility Test (Word Recognition Scores) to see how much the hearing improves with the implant. Treatment History: Surgeons will fill out questionnaires about how the treatment went. Quality of Life: Parents will answer questions about their child's quality of life using the GCBI questionnaire at least 12 months after the implant. The study will last up to 12 months, including enrolling participants and performing all necessary procedures. The target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data. By collecting detailed information on any problems and assessing the performance of the BONEBRIDGE implant, this study aims to determine if it is safe and effective for young children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06634784
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hearing Loss, Conductive
Currently open trials in the same condition.
- NCT06976086 — Pediatric Expansion Study of the Sentio System · NA · recruiting
- NCT06058767 — Preschool Hearing Screening · NA · recruiting
Other MED-EL Elektromedizinische Geräte GesmbH trials
Trials by the same sponsor.
- NCT07213505 — This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipien · NA · recruiting
- NCT06817928 — Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Inf · completed
- NCT06737185 — Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms · NA · recruiting
- NCT06723262 — Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting · NA · recruiting
- NCT05955469 — Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06634784 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MED-EL Elektromedizinische Geräte GesmbH
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06634784.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing