Recruiting

Cochlear Implantation

Sponsor:

NYU Langone Health

Code:

NCT07011927

Conditions

Hearing Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cochlear Implant

Modified Implant Procedure

Study Details

Brief 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

Study ID

NCT07011927

Start date

Oct 17, 2025

Status verified date

Apr, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Cochlear Implant

Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.

Modified Implant Procedure

Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nicole Capach

646-501-6905nicole.capach@nyulangone.org

J. Thomas Roland, Jr., MD

1-212-263-0460j.thomas.rolandjr@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-01.