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Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)

NCT06459765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-01

No results posted yet for this study

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

Interventions

DEVICE

Mi2000 TICI

Cochlear Implantation

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Principal Investigators

  • Florian Schwarze, PhD · MED-EL Elektromedizinische Geräte GesmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2025-09-24
Completion
2025-09-24

Countries

  • Austria
  • Belgium
  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06459765 on ClinicalTrials.gov