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RECRUITING
NCT06268340
NA

Hearing and Structure Preservation Via ECochG

Sponsor: Advanced Bionics AG

View on ClinicalTrials.gov

Summary

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

Official title: Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2024-05-15

Completion Date

2026-12-31

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

PROCEDURE

ECochG monitored CI surgery incl. corrective action guide

Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide

PROCEDURE

Routine CI surgery without ECochG monitoring

Routine CI surgery with access to ECochG monitoring by surgeon

Locations (7)

Universitair Ziekenhuis Gent

Ghent, Gent, Belgium

Le Centre Hospitalier Régional Universitaire de Tours

Tours, Tours, France

Universitätsklinikum Freiburg Klinik

Freiburg im Breisgau, Freiburg, Germany

Ospedale Martini

Torino, TO, Italy

World Hearing Center

Warsaw, Nadarzyn, Poland

Hospital Universitario Clinico San Cecilio

Granada, Granada, Spain

Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom