Mi2000 TICI Follow-up (M2FU)

November 11, 2026 updated by: MED-EL Elektromedizinische Geräte GmbH

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
  • Belgium
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Liège, Department ORL
        • Contact:
    • Belgium
      • Antwerp, Belgium, Belgium, 2650
        • Not yet recruiting
        • UZA Antwerpen
        • Contact:
          • Vincent van Rompaey, Prof. Dr.
          • Phone Number: vincent.vanrompaey@uza.be
  • Germany
    • Bavaria
      • München, Bavaria, Germany, 81377
      • Würzburg, Bavaria, Germany, 97080
        • Not yet recruiting
        • Universitätsklinikum Würzburg
        • Contact:
  • Poland
      • Nadarzyn, Poland, 05-830
        • Not yet recruiting
        • The Institute of Physiology and Pathology of Hearing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: OTHER

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mi2000 TICI UNICO recipients

Recipients of a MED-EL Mi2000 TICI UNICO in a previous clinical investigation.
Device: Cochlear Implantation

Participants in this clinical investigation received a totally implantable cochlear implant and will be followed-up for an extended period of time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Word Test in Quiet
Time Frame: Pre-op to 36 months after first fitting

Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes
Pre-op to 36 months after first fitting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time Frame: Pre-op to 36 months after first fitting

Disease specific Quality of Life, overall score is on a scale from 0 to 100, higher numbers indicating better outcomes
Pre-op to 36 months after first fitting
Speech, Spatial, Quality of Hearing (SSQ12)
Time Frame: Pre-op to 36 months after first fitting

Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes
Pre-op to 36 months after first fitting

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Word test in quiet
Time Frame: through study completion, an average of 60 months after first fitting

Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes
through study completion, an average of 60 months after first fitting
Sentence Test in Noise
Time Frame: through study completion, an average of 60 months after first fitting

Oldenburg Matrix Test, results measured in dB signal-to-noise ratio (SNR) with a range of +30 to -10 dB SNR, lower values indicating better outcomes
through study completion, an average of 60 months after first fitting
Health Utility Index Mark 3 (HUI3)
Time Frame: through study completion, an average of 60 months after first fitting

Health utility scale:

1.00: Perfect health. 0.00: Death. Negative values: States worse than death.
through study completion, an average of 60 months after first fitting
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time Frame: through study completion, an average of 60 months after first fitting

Disease specific Quality of Life, overall score is on a scale from 0 to 100, higher numbers indicating better outcomes
through study completion, an average of 60 months after first fitting
Speech, Spatial, Quality of Hearing (SSQ12)
Time Frame: through study completion, an average of 60 months after first fitting

Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes
through study completion, an average of 60 months after first fitting
Hearing Implant Sound Quality Index (HISQUI)
Time Frame: through study completion, an average of 60 months after first fitting

Sound quality score ranging from 19 (very poor sound quality) to 133 (very good sound quality)
through study completion, an average of 60 months after first fitting
Tinnitus functional index (TFI)
Time Frame: through study completion, an average of 60 months after first fitting

Tinnitus questionnaire measures the severity and negative impact of tinnitus on a 0 (Not a Problem / Slight Tinnitus) to 100 (Very Big Problem / Very Severe Tinnitus) scale
through study completion, an average of 60 months after first fitting
Audiogram
Time Frame: through study completion, an average of 60 months after first fitting

Pure-tone air-conduction hearing thresholds will be measured in each ear. The threshold is the lowest sound level, in decibels hearing level (dB HL), at which the participant responds. The outcome is the threshold at each frequency. Higher thresholds mean poorer hearing; lower thresholds better hearing.
through study completion, an average of 60 months after first fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MED-EL Elektromedizinische Geräte GmbH

Investigators

  • Study Director: Florian Schwarze, MED-EL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

October 15, 2026

First Submitted That Met QC Criteria

October 22, 2026

First Posted (Actual)

October 28, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 11, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-EL_CRD_2025_04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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