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The RW-Precision-Coupler Clinical Investigation

NCT04890145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-12-03

No results posted yet for this study

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

DEVICE

RW-Precision-Coupler

Implantation of the RW-Precision-Coupler together with FMT-VORP 503

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Principal Investigators

  • Lenarz Thomas, Prof. h.c. Dr. · Medizinische Hochschule Hannover Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-11-26
Completion
2024-11-26

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04890145 on ClinicalTrials.gov