Auditory Midbrain Implant Study
NCT02984202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2020-08-03
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
- collaborator OTHER
-
Cochlear
collaborator INDUSTRY -
Hannover Medical School
lead OTHER
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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