Cochlear Implantation for Treatment of Single-sided Deafness
NCT02532972 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2020-05-05
Summary
This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).
Conditions
- Total Unilateral Deafness
- Unilateral Partial Deafness
Interventions
- DEVICE
-
Med-el MAESTRO Cochlear Implant with Flex 28 electrode array
Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Sponsors & Collaborators
-
University of Wisconsin, Madison
collaborator OTHER -
Dr. Daniel Lee
lead OTHER
Principal Investigators
-
Daniel J Lee, MD, FACS · MEEI / MGH
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2019-02-27
- Completion
- 2019-04-25
- FDA Device
- Yes
Countries
- United States
Study Locations
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