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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04890145
Study type Interventional
Source MED-EL Elektromedizinische Geräte GesmbH
Contact Severin Fürhapter, PhD
Phone +4357788
Email allclinicalresearchvibrant@medel.com
Status Recruiting
Phase N/A
Start date May 19, 2021
Completion date March 31, 2024

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