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Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Recruiting
Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Cochlear Implant (device)
- Modified Implant Procedure (device)
Sponsor: NYU Langone Health · Participants: 12 · Started: Oct 17, 2025
Contact the study team
- Nicole Capach · Phone: 646-501-6905
- J. Thomas Roland, Jr., MD · Phone: 1-212-263-0460
Official record on ClinicalTrials.gov — NCT07011927
Locations in the U.S.
| New York | NYU Langone Health, New York |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.