Hearing Loss, SensorineuralNCT06459765
Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)
A study testing Mi2000 TICI in people with Hearing Loss, Sensorineural, run by MED-EL Elektromedizinische Geräte GmbH at 6 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Mi2000 TICI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 7 Jun 2024to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany2 sites
LMU Munich
München, Bavaria, 81377
UKW Würzburg
Würzburg, Bavaria, 97080
Poland1 site
The Institute of Physiology and Pathology of Hearing
Nadarzyn, 05-830
About this study
Official title: 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
Read the 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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Mi2000 TICI
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mi2000 TICIDevice
Cochlear Implantation
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Implantation with Mi2000 TICI Receives: Device: Mi2000 TICI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word Test in Quiet
Word test in quiet
Measured: Pre-op to 6 months after first fitting
Secondary outcomes (2)
Health Utility Index Mark 3 (HUI3)
Generic Quality of Life
Measured: Pre-op to 6 months after first fitting
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Disease specific Quality of Life
Measured: Pre-op to 6 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 posted14 Jun 2024
- Study start7 Jun 2024
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Schwarze, PhD, Study director, MED-EL Elektromedizinische Geräte GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459765
- Sponsor's protocol ID
- MED-EL_CRD_2021_02
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2024
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI): Pivotal Study
- ClinicalTrials.gov ID
- NCT06459765
- Acronym / sponsor ID
- MED-EL_CRD_2021_02
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 14 Jun 2024 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Mi2000 TICIImplantation with Mi2000 TICI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (24 listed)
- 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
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 |
|---|---|---|
| Mi2000 TICICochlear Implantation | Device | Interventional Arm |
Primary outcome
Word Test in Quiet
Time frame: Pre-op to 6 months after first fitting
Word test in quiet
2 secondary outcomes
Health Utility Index Mark 3 (HUI3)
Time frame: Pre-op to 6 months after first fitting
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time frame: Pre-op to 6 months after first fitting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Florian Schwarze, PhD study director
MED-EL Elektromedizinische Geräte GmbH
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mi2000 TICI in people with Hearing Loss, Sensorineural, 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 13 inclusion and 24 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: finished, as of the sponsor's last update on 1 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word Test in Quiet (time frame: Pre-op to 6 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 1 Oct 2025.