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Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Sponsor: NYU Langone Health
Summary
This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.
Official title: Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-06-03
Completion Date
2028-07-01
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
Cochlear Implant
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
Modified Implant Procedure
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Locations (1)
NYU Langone Health
New York, New York, United States