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A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
Sponsor: Cochlear
Summary
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.
Official title: A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
66
Start Date
2026-05
Completion Date
2028-09
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Cochlear Nucleus Nexa Cochlear implant (CI1032)
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1022)
Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1012)
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
Locations (1)
University Hospital Düsseldorf
Düsseldorf, Germany