Placing the cochlear implant ground electrode near the post-auricular vagus nerve
Official title: Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Run by NYU Langone Health · NCT07011927 · Data updated 2026-11-12
This will test whether placing the cochlear implant's ground electrode near the post-auricular vagus nerve works as well as placing it under the temporalis muscle for people getting a Cochlear Americas implant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 17, 2025 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2028 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07011927 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People scheduled to receive a Cochlear Americas cochlear implant who have no prior ear surgery, no congenital ear malformation, and who are not pregnant or breastfeeding are the intended participants.
✕Probably not a fit
Individuals with prior ear surgery, congenital ear malformations, a previous cochlear implant in the ear to be implanted, or who are pregnant or breastfeeding would not be eligible and therefore would not benefit from this procedure in this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two surgical placements of the ECE1 ground electrode during cochlear implantation: an extra-cochlear location near the post-auricular vagus (Arnold's) nerve versus the standard placement under the temporalis muscle. Eligible participants are people scheduled to receive a Cochlear Americas device who have not had prior ear surgery or congenital ear malformations and who are not pregnant or breastfeeding. Hearing outcomes after surgery will be compared using a non-inferiority design to determine whether the alternative placement provides comparable auditory performance. The procedure and follow-up are performed at a single center (NYU Langone Health) with standard post-operative assessments of hearing.
Why it matters
Potential benefit: If successful, this approach could offer a safe alternative electrode placement that maintains hearing outcomes while potentially simplifying or reducing tissue manipulation during surgery.
How similar studies have gone: This specific extra-cochlear placement near Arnold's nerve is relatively novel with limited published data, although other studies have tested alternative electrode placements in cochlear implantation.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: J. Thomas Roland, Jr., MD — NYU Langone Health
- Study coordinator: Nicole Capach
- Email: nicole.capach@nyulangone.org
- Phone: 646-501-6905
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.