Placing the cochlear implant ground electrode near the post-auricular vagus nerve
Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07011927 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.