Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantat
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.
| Condition(s) | Hearing Loss |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | NYU Langone Health |
| Locations | New York, New York, United States |
| Start date | 2025-10-17 |
| NCT ID | NCT07011927 |
| Official listing | https://clinicaltrials.gov/study/NCT07011927 |