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NCT Number: NCT07011927

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

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.

Recruiting

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. AzBio Sentence Recognition Test Score

    Time frame: Up to Year 1 post cochlear implant activation

    The AzBio Sentence Recognition Test is a clinical tool used to evaluate a person's ability to understand speech in noisy environments. The total score is the percentage of words correctly understood, ranging from 0-100%.

Study contacts

Contact information is provided by the study sponsor or research team.

J. Thomas Roland, Jr., MD

CONTACT

[email protected]

1-212-263-0460

Nicole Capach

CONTACT

[email protected]

646-501-6905

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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