Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
- DeviceCochlear Implant
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
- DeviceModified Implant Procedure
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Location
- NYU Langone HealthNew York, New York