Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
NYU Langone Health
12 participants
Oct 17, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- will be undergoing surgery for a cochlear implant from Cochlear Americas
- is willing to participate in the study
Exclusion Criteria2
- 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.
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Interventions
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07011927