MedTrace Logo

Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.

NCT04571333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-10-08

No results posted yet for this study

Summary

This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.

Conditions

  • Sensorineural Hearing Loss, Bilateral
  • Cochlear Implants

Interventions

DEVICE

Mi2000 Totally Implantable Cochlear Implant

During the surgery visit, the Mi2000 Cochlear Implant will be implanted according to the general surgical guidelines and the Mi2000 specific surgical guidelines under general anaesthesia.

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Principal Investigators

  • Phillippe Lefebvre, Prof. Dr. med. · Centre Hospitalier Universitaire de Liège, ORL

  • Joachim Müller, Prof. Dr. med. · Klinikum der Universität München, HNO

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2021-07-01
Completion
2021-12-31

Countries

  • Belgium
  • Germany

Study Locations

More Related Trials

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 NCT04571333 on ClinicalTrials.gov