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NCT04427033
The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
trial testing Bone Conduction Implant in Hearing Loss in 52 participants. Completed in 18 January 2024.
18 January 2024
Quick facts
| Lead sponsor | MED-EL Elektromedizinische Geräte GesmbH |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 52 |
| Start date | 6 December 2019 |
| Primary completion | 18 January 2024 |
| Estimated completion | 18 January 2024 |
| Sites | 8 locations across Austria, United Kingdom, Germany |
Drugs / interventions tested
- Bone Conduction Implant
Conditions studied
- Hearing Loss — all drugs for Hearing Loss →
- Hearing Loss, Conductive — all drugs for Hearing Loss, Conductive →
- Hearing Loss, Mixed — all drugs for Hearing Loss, Mixed →
- Hearing Loss, Unilateral — all drugs for Hearing Loss, Unilateral →
Sponsor
MED-EL Elektromedizinische Geräte GesmbH — full company profile →
Who can join
5 and older, any sex, with Hearing Loss or Hearing Loss, Conductive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant improvement in terms of aided sound field (SF) thresholds, word recognition scores (WRS), speech reception thresholds (SRT) and subjective device satisfaction. Safety was established by stable residual hearing and low complication rates. The Bonebridge, implanted in over 600 clinics worldwide, is the world's first active transcutaneous bone conduction implant (BCI) system. This study now focuses on the further developed BCI 602 (marketed since 2019) that has the same indication criteria and performance characteristics. The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for the long-term performance and safety when implanted with the Bonebridge BCI 602 .
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant.
Sprinzl G, Toner J, Koitschev A, Berger N, et al · · 2023 · cited 16× · PMID 36625869 · DOI 10.1007/s00405-022-07792-y -
The Bonebridge BCI 602 Safety and Performance 1 Year Post-Implantation in Adults and Children: A Multicentric Post-Market Study.
Plontke SK, Lenarz T, Toner J, Keintzel T, et al · · 2026 · PMID 41250191 · DOI 10.1097/mao.0000000000004688
Verify or expand the search:
- PubMed search for NCT04427033
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hearing Loss
Currently open trials in the same condition.
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- NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit · NA · recruiting
- NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · 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 NCT04427033 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 25 January 2024
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/NCT04427033.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing