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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MED-EL Elektromedizinische Geräte GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings