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Hearing Loss, BinauralTUPISNCT07897318

Mi2000 TICI - Post-market Implantation Study

A study testing Cochlear Implantation in people with Hearing Loss, Binaural and Cochlear Implantation, run by MED-EL Elektromedizinische Geräte GmbH.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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 prospectively collect 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
Oct 2026to Dec 2028
Phase
Interventional
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

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(500, 1000, 2000, 4000Hz))
  • 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 center 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 center for regular speech processor programming, assessment sessions and training
  • Realistic expectations, as deemed appropriate by the implanting surgeon/implant board
  • 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
  • The individual is known to be intolerant of the materials used in the implant or other required accessories
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  • 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 anesthesia
  • 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

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Florian Schwarze, PhD contact

+4357788

studies@medel.com

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 prospectively collect clinical data from the use of the Mi2000 TICI and related devices.

This PMCF investigation is performed on a cochlear implant system newly introduced to the market, which was previously studied in two pre-market clinical investigations. The purpose of the current clinical investigation is to collect further evidence by collecting additional clinical data on the use of the Mi2000 TICI.

Being tested
Cochlear Implantation
Keywords
Cochlear Implant, Totally Implantable Cochlear Implant, TICI, Fully Implantable Cochlear Implant
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 will receive a totally implantable cochlear implant.

Study groups in NCT07897318
Study groupRoleWhat they receive
TICI recipientsExperimentalParticipants in this clinical investigation will be implanted with an Mi2000 TICI totally cochlear implant
Receives: Device: Cochlear Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 6 months after first fitting

  2. Sentence Test in Noise

    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

    Measured: Pre-op to 6 months after first fitting

Secondary outcomes (5)

  1. Health Utility Index Mark 3 (HUI3)

    Health utility scale:

    1.00: Perfect health. 0.00: Death. Negative values: States worse than death.

    Measured: Pre-op to 6 months after first fitting

  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 6 months after first fitting

  3. Change in body sound perception

    Participant reported scale on body sound perception (0 - no disturbance to 10 - very disturbing)

    Measured: through study completion, an average of 12 months after first fitting

  4. Change in stigma perception

    Participant reported scale on stigma perception (0 - no stigmatization to 10 - strong stigmatization)

    Measured: through study completion, an average of 12 months after first fitting

  5. Change in comfort perception

    Participant reported scale on stigma perception (0 - not comfortable to 10 - very comfortable)

    Measured: through study completion, an average of 12 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.

  1. First posted27 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07897318
Sponsor's protocol ID
MED-EL_CRD_2026_03
Acronym
TUPIS
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear Implantation in people with Hearing Loss, Binaural and Cochlear Implantation, run by MED-EL Elektromedizinische Geräte GmbH.

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 12 inclusion and 25 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 6 months after first fitting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07897318.

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 27 Oct 2026.

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