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NCT04929470

Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss

Sponsor: Advanced Bionics AG

View on ClinicalTrials.gov

Summary

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is approved for this device. Participants receive interventions as part of routine medical care.

Official title: Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM SlimJ Electrode (Cl-1600-05) and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Cl-1601-05) (Ultra X) in Adults With Severe-to-profound Hearing Loss

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2021-07-06

Completion Date

2026-05

Last Updated

2025-09-29

Healthy Volunteers

Not specified

Interventions

DEVICE

cochlear implantation

patients receive a cochlear implantation within clinical routine

Locations (3)

HNO-Klinik Düsseldorf

Düsseldorf, Düsseldorf, Germany

Unfallkrankenhaus Berlin (UKB)

Berlin, State of Berlin, Germany

Westfälische Wilhelms-Universität Münster

Münster, Germany