Mi2000 TICI - Post-market Implantation Study (TUPIS)

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.

Study Overview

• Status: Recruiting
• Conditions: Cochlear Implantation; Hearing Loss, Binaural
• Intervention / Treatment: Device: Cochlear Implantation

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Schwarze, PhD; Phone Number: +4357788; Email: studies@medel.com

Study Locations

• Austria
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1090
      • Not yet recruiting
      • AKH Wien
      • Contact: Christoph Arnoldner, Prof. Dr.; Email: christoph.arnoldner@meduniwien.ac.at
• Belgium
  • Liège, Belgium, 4000
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Liège, Department ORL
    • Contact: Philippe Lefebvre, Dr.med.
  • Belgium
    • Antwerp, Belgium, Belgium, 2650
      • Not yet recruiting
      • UZA Antwerpen
      • Contact: Vincent van Rompaey, Prof. Dr.
• Germany
  • Würzburg, Germany
    • Not yet recruiting
    • Universitätsklinikum Würzburg
    • Contact: Kristen Rak, Prof. Dr.
  • Bavaria
    • München, Bavaria, Germany, 81377
      • Recruiting
      • Klinikum der Universität München, Campus Großhadern
      • Contact: Joachim Müller, Dr.med.
• Poland
  • Poland
    • Nadarzyn, Poland, Poland, 05-830
      • Not yet recruiting
      • The Institute of Physiology and Pathology of Hearing
      • Contact: Piotr Skarzynski, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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(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
• 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

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

• The individual is known to be intolerant of the materials used in the implant or other required accessories

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TICI recipients; Participants in this clinical investigation will be implanted with an Mi2000 TICI totally cochlear implant	Device: Cochlear Implantation; Participants in this clinical investigation will receive a totally implantable cochlear implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Word Test in Quiet	Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes	Pre-op to 6 months after first fitting
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	Pre-op to 6 months after first fitting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Utility Index Mark 3 (HUI3)	Health utility scale: 1.00: Perfect health. 0.00: Death. Negative values: States worse than death.	Pre-op to 6 months after first fitting
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	Pre-op to 6 months after first fitting
Change in body sound perception	Participant reported scale on body sound perception (0 - no disturbance to 10 - very disturbing)	through study completion, an average of 12 months after first fitting
Change in stigma perception	Participant reported scale on stigma perception (0 - no stigmatization to 10 - strong stigmatization)	through study completion, an average of 12 months after first fitting
Change in comfort perception	Participant reported scale on stigma perception (0 - not comfortable to 10 - very comfortable)	through study completion, an average of 12 months after first fitting

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Word test in quiet	Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes	through study completion, an average of 12 months after first fitting
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	through study completion, an average of 12 months after first fitting
Health Utility Index Mark 3 (HUI3)	Health utility scale: 1.00: Perfect health. 0.00: Death. Negative values: States worse than death.	through study completion, an average of 12 months after first fitting
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	through study completion, an average of 12 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	through study completion, an average of 12 months after first fitting
Hearing Implant Sound Quality Index (HISQUI)	Sound quality score ranging from 19 (very poor sound quality) to 133 (very good sound quality)	through study completion, an average of 12 months after first fitting
Tinnitus Functional Index (TFI)	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 12 months after first fitting
Audiogram	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 12 months after first fitting

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GmbH
• Investigators: Study Director: Florian Schwarze, MED-EL

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: October 15, 2026
• First Submitted That Met QC Criteria: October 22, 2026
• First Posted (Actual): October 27, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 11, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Cochlear Implant; Totally Implantable Cochlear Implant; TICI; Fully Implantable Cochlear Implant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss; Surgical Procedures, Operative; Prosthesis Implantation; Otorhinolaryngologic Surgical Procedures; Otologic Surgical Procedures; Cochlear Implantation
• Other Study ID Numbers: MED-EL_CRD_2026_03

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