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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07011927
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 17, 2025
Status verified
Apr 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Patients scheduled for Cochlear Implantation
    The experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array.

Primary Outcome Measure

AzBio Sentence Recognition Test Score [ Time Frame: Up to Year 1 post cochlear implant activation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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