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

NCT07011927 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • J. Thomas Roland, Jr., MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-17
Primary Completion
2028-07-01
Completion
2028-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011927 on ClinicalTrials.gov