NCT07011927NARecruiting
Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
NYU Langone Health
Start Date
10/17/2025
Completion Date
7/1/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* will be undergoing surgery for a cochlear implant from Cochlear Americas
* is willing to participate in the study
Exclusion Criteria:
* has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted
* pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
Interventions
DEVICE
Cochlear Implant
DEVICE
Modified Implant Procedure
Conditions
Hearing Loss
Locations
NYU Langone Health
New York, New York 10016
United States