Mi2000 TICI Follow-up
Key facts
- Where
- Nadarzyn, PolandSee the site
Where in Poland
- The Institute of Physiology and Pathology of HearingNadarzyn, PolandContact: Piotr Skarzynski, Prof. Dr.Not yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- MED-EL Elektromedizinische Geräte GmbH
- Trial code
- NCT07902414
- Record updated
- 12 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Recipient of an Mi2000 TICI in one of the pre-market studies; Signed and dated informed consent before the start of any study-specific procedure.
Exclusion: Lack of compliance with any inclusion criterion; Anything that, in the opinion of the Investigator, would; place the subject at increased risk; preclude the subject's full compliance with or completion of the study.