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

NYU Langone Health

Status: Not yet enrolling

Conditions: Hearing Loss

Treatments: Device: Modified Implant Procedure; Device: Cochlear Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT07011927

24-01768

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Patients scheduled for Cochlear Implantation

Experimental group

Description:

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.

Treatment:

Device: Cochlear Implant

Device: Modified Implant Procedure