Hearing Loss, BinauralM2FUNCT07902414
Mi2000 TICI Follow-up
An observational study of Hearing Loss, Binaural and Cochlear Implantation, run by MED-EL Elektromedizinische Geräte GmbH at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Binaural, Cochlear Implantation
- What is being tested?
- Cochlear Implantation
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Oct 2026to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Belgium2 sites
UZA Antwerpen
Antwerp, 2650
Vincent van Rompaey, Prof. Dr., vincent.vanrompaey@uza.be
Centre Hospitalier Universitaire de Liège, Department ORL
Liège, 4000
Philippe Lefebvre, Prof. Dr., pp.lefebvre@uliege.be
Germany2 sites
Klinikum der Universität München, Campus Großhadern
München, Bavaria, 81377
Joachim Müller, Prof. Dr., Joachim.Mueller@med.uni-muenchen.de
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Anja Kurz, Dr., Kurz_A@ukw.de
Austria1 site
AKH Wien
Vienna, 1090
Christoph Arnoldner, Prof. Dr., christoph.arnoldner@meduniwien.ac.at
Poland1 site
The Institute of Physiology and Pathology of Hearing
Nadarzyn, 05-830
Piotr Skarzynski, Prof. Dr., p.skarzynski@csim.pl
About this study
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.
Read the detailed description
This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.
- Conditions
- Hearing Loss, Binaural, Cochlear Implantation
- Being tested
- Cochlear Implantation
- Keywords
- cochlear implant, totally implantable cochlear implant, fully implantable cochlear implant, TICI
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantationDevice
Participants in this clinical investigation received a totally implantable cochlear implant and will be followed-up for an extended period of time.
| Study group | Role | What they receive |
|---|---|---|
| Mi2000 TICI UNICO recipients | Recipients of a MED-EL Mi2000 TICI UNICO in a previous clinical investigation. Receives: Device: Cochlear Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word Test in Quiet
Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes
Measured: Pre-op to 36 months after first fitting
Secondary outcomes (2)
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Disease specific Quality of Life, overall score is on a scale from 0 to 100, higher numbers indicating better outcomes
Measured: Pre-op to 36 months after first fitting
Speech, Spatial, Quality of Hearing (SSQ12)
Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes
Measured: Pre-op to 36 months after first fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BinauralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Schwarze, Study director, MED-EL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902414
- Sponsor's protocol ID
- MED-EL_CRD_2025_04
- Acronym
- M2FU
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mi2000 TICI Follow-up
- ClinicalTrials.gov ID
- NCT07902414
- Acronym / sponsor ID
- M2FU / MED-EL_CRD_2025_04
- Conditions
- Hearing Loss, Binaural, Cochlear Implantation
- Keywords
- cochlear implant, totally implantable cochlear implant, fully implantable cochlear implant, TICI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mi2000 TICI UNICO recipients | – | Device: Cochlear ImplantationRecipients of a MED-EL Mi2000 TICI UNICO in a previous clinical investigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Lack of compliance with any inclusion criterion
- Anything that, in the opinion of the Investigator, would
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear ImplantationParticipants in this clinical investigation received a totally implantable cochlear implant and will be followed-up for an extended period of time. | Device | Mi2000 TICI UNICO recipients |
Primary outcome
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
2 secondary outcomes
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time frame: Pre-op to 36 months after first fitting
Speech, Spatial, Quality of Hearing (SSQ12)
Time frame: Pre-op to 36 months after first fitting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Binaural
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
RecruitingObservational study
Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants
Cochlear Implant Users, Cochlear Hearing Loss
RecruitingObservational study
Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
Bilateral Sensorineural Hearing Loss, Cochlear Implant
Recruiting
Understanding Aided Speech Perception in Noise
Hearing Impairment, Sensorineural, Spatial Perception
Recruiting
Combined Electric and Acoustic Hearing (EAS) in Children and Adults
Cochlear Implant, Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Schwarze study director
MED-EL
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Binaural and Cochlear Implantation, run by MED-EL Elektromedizinische Geräte GmbH at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Germany, Austria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Schwarze, PhD (+4357788, studies@medel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word Test in Quiet (time frame: Pre-op to 36 months after first fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.