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Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
Sponsor: Advanced Bionics AG
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
Conditions
Interventions
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