Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)

NCT06459765 | Completed

• 1 other identifier: MED-EL_CRD_2021_02
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 6

Brief 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. 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

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Word Test in Quiet

  Word test in quiet

  Pre-op to 6 months after first fitting

Secondary Outcomes (2)

• Health Utility Index Mark 3 (HUI3)

  Pre-op to 6 months after first fitting

• Nijmegen Cochlear Implant Questionnaire (NCIQ)

  Pre-op to 6 months after first fitting

Other Outcomes (5)

• Word test in quiet

  through study completion, an average of 6 months after first fitting

• Sentence Test in Noise

  3- and 6-months after first fitting

• Speech, Spatial, Quality of Hearing (SSQ12)

  through study completion, an average of 6 months after first fitting

Study Arms (1)

Interventional Arm

EXPERIMENTAL

Implantation with Mi2000 TICI

Device: Mi2000 TICI

Interventions

Mi2000 TICI DEVICE

Cochlear Implantation

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (6)

AKH Wien

Vienna, 1090, Austria

Location

UZA Antwerpen

Antwerp, 2650, Belgium

Location

CHU Liège

Liège, 4000, Belgium

Location

LMU Munich

München, Bavaria, 81377, Germany

Location

UKW Würzburg

Würzburg, Bavaria, 97080, Germany

Location

The Institute of Physiology and Pathology of Hearing

Nadarzyn, 05-830, Poland

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Florian Schwarze, PhD

  MED-EL Elektromedizinische Geräte GesmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 14, 2024
• Study Start: June 7, 2024
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); AU (1); BE (2); PL (1)