Auditory Midbrain Implant Study

NCT02984202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-08-03

No results posted yet for this study

Summary

The objectives of the clinical study are to implant five deaf patients (those with Neurofibromatosis Type II, NF2) with a new two-shank auditory midbrain implant array (AMI; developed by Cochlear Limited) into the central nucleus of the inferior colliculus in order to assess the safety, reliability, consistency of placement, and performance of the AMI device. The clinical trial is being performed at Hannover Medical School in Germany in collaboration with University of Minnesota (USA) and Cochlear Limited (Australia). The clinical trial is being managed by Hannover Clinical Trial Center in Germany.

Conditions

  • Deafness; Perception

Interventions

DEVICE

auditory midbrain implant (AMI)

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-17
Primary Completion
2020-06-25
Completion
2020-06-25

Countries

  • Germany

Study Locations

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Entities

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 NCT02984202 on ClinicalTrials.gov