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

NCT04929470 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Cochlear Hearing Loss

Interventions

DEVICE

cochlear implantation

patients receive a cochlear implantation within clinical routine

Sponsors & Collaborators

  • Advanced Bionics AG

    lead INDUSTRY

Principal Investigators

  • Arneborg Ernst, Prof. Dr. · Unfallkrankenhaus Berlin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • Germany

Study Locations

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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 NCT04929470 on ClinicalTrials.gov