Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)

September 30, 2025 updated by: MED-EL Elektromedizinische Geräte GesmbH

Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI): Pivotal Study

The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant. The main question it aims to answer is, whether the device is able to improve speech perception compared to the pre-operative score.

Participants will undergo cochlear implantation and fitting, and will be asked to perform the following tests pre- and post-operatively:

  • Word test in quiet
  • Sentence test in noise
  • Audiograms
  • Health Utilities Index 2 and 3 (HUI2&3), a generic quality-of-life questionnaire
  • Nijmengen Cochlear Implant Questionnaire (NCIQ), a disease specific quality-of life questionnaire
  • Speech, Spatial and Qualities of Hearing Scale (SSQ12), a disease specific questionnaire
  • Hearing Implant Sound Quality Index (HISQUI19), a sound quality questionnaire

Study Overview

Status

Status

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

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

Cochlear implants (CI) provide a large majority of recipients with a significant degree of speech understanding. However, CI systems rely on external audio processors to function. This can have several disadvantages: for instance, the hardware is exposed to external trauma and to the effects of head movement and gravity. The device is also put at risk by humid, dusty, or dirty conditions as well as by physical activities that lead to water exposure such as swimming or sports in general (e.g. perspiration).

In addition, some patients are concerned with the cosmetic appearance of the external parts which are visible (more so than modern behind-the-ear hearing aids), something that may not be desirable to many potential candidates.

This clinical investigation aims to collect confirmatory data on the use of the Mi2000 Totally Implantable Cochlear Implant system used in combination with compatible devices.

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.
Interventional

Enrollment (Actual)

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.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • Vienna, Austria, 1090
        • Akh Wien
  • Belgium
      • Antwerp, Belgium, 2650
        • UZA Antwerpen
      • Liège, Belgium, 4000
        • Chu Liege
  • Germany
    • Bavaria
      • München, Bavaria, Germany, 81377
        • LMU Munich
      • Würzburg, Bavaria, Germany, 97080
        • UKW Würzburg
  • Poland
      • Nadarzyn, Poland, 05-830
        • The Institute of Physiology and Pathology of Hearing

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Minimum age of eighteen (18) years at time of enrolment
  • Bilateral sensorineural hearing loss with no or limited benefit from a hearing aid (>70 dB HL PTA4)
  • Post-lingual onset of deafness
  • No or limited benefit from hearing aids for less than 10 years and an expected benefit from cochlear implantation
  • A maximum score of 50% on a word test in the language of the test centre in the ear to be implanted in the best aided condition
  • Fluency in the test language with excellent proficiency, as appropriate to perform speech testing
  • Functional auditory nerve
  • General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study
  • Pre-operative assessment according to the local professional standards
  • Candidate is highly motivated and has realistic expectations about the expected benefit of the implant and shall understand the importance of returning to the implant centre for regular speech processor programming, assessment sessions and training
  • Realistic expectations, as deemed appropriate by the implanting surgeon/implant board
  • Evidence of up-to-date vaccinations against meningitis, as per recommendations by the applicable national body
  • Signed and dated informed consent before the start of any study-specific procedure

Exclusion Criteria:

  • Lack of compliance with any inclusion criterion
  • Previously having received an implant on the location chosen for placing the cochlear implant
  • Having received a hearing implant from another manufacturer than MED-EL on the contralateral ear
  • Pre-existing condition known to necessitate MRI scans after implantation of the Mi2000 TICI
  • Women being pregnant or nursing
  • Women of childbearing age not reporting to use effective contraception
  • The individual is known to be intolerant of the materials used in the implant or other required accessories including medical grade silicone, parylene C, titanium, platinum iridium, platinum, stainless chromate steel, thermoplastic elastomere (TPE-S), thermoplastic elastomere (SEBS), mixture of polycarbonate and acrylonitrile-butadiene-styrol polymer (PC/ABS), polyamide, liquid crystal polymer, silicone and polyurethane-coated silicone rubber)
  • Absence of cochlear development
  • The cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway
  • Medical contra-indications to middle ear and/or inner ear surgery, and/or anaesthesia
  • External or middle ear infections are present
  • The tympanic membrane is perforated in the ear to be implanted
  • Anatomic abnormalities are present that would prevent appropriate placement of the stimulator housing in the bone of the skull, or prevent placement of the chosen electrode array into the cochlea (including ossification of the cochlea)
  • The psychological status of the individual is unstable
  • The individual has unrealistic expectations
  • Acute cholesteatoma
  • History of vestibular schwannoma
  • Unstable Meniere's disease
  • Auditory Neuropathy
  • Epilepsy not responding to treatment
  • Permanent inability and/or unwillingness to participation in post-operative care and rehabilitation
  • Known intellectual disability and/or psychological diseases
  • Participation in other pharmacological clinical trials within four weeks prior to enrolment
  • 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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Interventional Arm
Implantation with Mi2000 TICI
Device: Mi2000 TICI
Cochlear Implantation

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 6 months after first fitting
Word test in quiet
Pre-op to 6 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
Health Utility Index Mark 3 (HUI3)
Time Frame: Pre-op to 6 months after first fitting
Generic Quality of Life
Pre-op to 6 months after first fitting
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time Frame: Pre-op to 6 months after first fitting
Disease specific Quality of Life
Pre-op to 6 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 6 months after first fitting
Word test in quiet
through study completion, an average of 6 months after first fitting
Sentence Test in Noise
Time Frame: 3- and 6-months after first fitting
Oldenburg Matrix Test
3- and 6-months after first fitting
Speech, Spatial, Quality of Hearing (SSQ12)
Time Frame: through study completion, an average of 6 months after first fitting
Speech, Spatial and Quality of hearing scale
through study completion, an average of 6 months after first fitting
Hearing Implant Sound Quality Index (HISQUI)
Time Frame: through study completion, an average of 6 months after first fitting
Sound quality questionnaire
through study completion, an average of 6 months after first fitting
Audiograms
Time Frame: through study completion, an average of 6 months after first fitting
Audiograms
through study completion, an average of 6 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 GesmbH

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, PhD, MED-EL Elektromedizinische Geräte GesmbH

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.
June 7, 2024

Primary Completion (Actual)

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.
September 24, 2025

Study Completion (Actual)

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.
September 24, 2025

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).
June 3, 2024

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.
June 10, 2024

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.
June 14, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
October 1, 2025

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.
September 30, 2025

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.
September 1, 2025

More Information

Terms related to this study

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_2021_02

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

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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