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Mi2000 TICI Follow-up
Sponsor: MED-EL Elektromedizinische Geräte GmbH
Summary
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI. This PMCF investigation will collect retrospective and prospective clinical data from the use of the Mi2000 TICI and related devices. This PMCF investigation is performed on a new cochlear implant system, which was previously studied in two pre-market clinical investigations with limited follow-up duration. The purpose of the current clinical investigation is to collect further evidence by collecting clinical data on the use of the Mi2000 TICI. The Mi2000 TICI is a state-of-the-art cochlear implant, designed to be totally implantable, indicated to treat severe to profound hearing loss, asymmetric hearing loss and single-sided deafness.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
36
Start Date
2026-10
Completion Date
2030-04
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
Cochlear Implantation
Participants in this clinical investigation received a totally implantable cochlear implant and will be followed-up for an extended period of time.
Locations (6)
AKH Wien
Vienna, Austria
UZA Antwerpen
Antwerp, Belgium
Centre Hospitalier Universitaire de Liège, Department ORL
Liège, Belgium
Klinikum der Universität München, Campus Großhadern
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
The Institute of Physiology and Pathology of Hearing
Nadarzyn, Poland