Trials / Completed
CompletedNCT04890145
The RW-Precision-Coupler Clinical Investigation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- MED-EL Elektromedizinische Geräte GesmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial. The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the treatment of hearing loss. As secondary aims are to evaluate the clinical performance of VSB together with RWP-Coupler by measuring Sound Field audiometry (SF), to evaluate the safety of VSB together with RWP-Coupler by measuring bone conduction (BC) thresholds and collecting and assessing adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RW-Precision-Coupler | Implantation of the RW-Precision-Coupler together with FMT-VORP 503 |
Timeline
- Start date
- 2021-05-19
- Primary completion
- 2024-11-26
- Completion
- 2024-11-26
- First posted
- 2021-05-18
- Last updated
- 2024-12-03
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04890145. Inclusion in this directory is not an endorsement.