NCT07011927

Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation

Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Cochlear Implant	Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
DEVICE	Modified Implant Procedure	Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.

Timeline

• Start date: 2025-06-03
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-06-10
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study