Trials / Completed
CompletedNCT04427033
The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 52 (actual)
- Sponsor
- MED-EL Elektromedizinische Geräte GesmbH · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
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 .
Conditions
- Hearing Loss
- Hearing Loss, Conductive
- Hearing Loss, Mixed
- Hearing Loss, Unilateral
- Hearing Loss, Bilateral
- Hearing Loss, Sensorineural
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bone Conduction Implant | Bonebridge system BCI 602 |
Timeline
- Start date
- 2019-12-06
- Primary completion
- 2024-01-18
- Completion
- 2024-01-18
- First posted
- 2020-06-11
- Last updated
- 2024-01-25
Locations
8 sites across 3 countries: Austria, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT04427033. Inclusion in this directory is not an endorsement.