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Placing a cochlear implant electrode near a nerve behind the ear

Tests a new cochlear implant electrode spot for hearing loss.

Key facts

Who runs it
NYU Langone Health
Where
New York, United StatesSee the site
Trial code
Registry title
Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Status
Recruiting
People taking part
12 people, planned
Started
17 Oct 2025
Expected to end
1 Jul 2028
Type of study
Interventional
Treatments tested
  • Cochlear Implant
  • Modified Implant Procedure
Record updated
1 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with hearing loss who will have surgery for a cochlear implant from Cochlear Americas. It tests placing one implant electrode near a nerve behind the ear.

Age
18 Years and older
Sex
All
Disease stage
Hearing loss, with a planned cochlear implant surgery.
Earlier treatment
People who had prior ear surgery or a prior cochlear implant in the ear to be implanted cannot join.

Main reasons for not taking part

  • Prior ear surgery in the ear to be implanted
  • Ear malformation present from birth in the ear to be implanted
  • Prior cochlear implant in the ear to be implanted
  • Pregnant or planning to become pregnant
  • Breastfeeding

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • will be undergoing surgery for a cochlear implant from Cochlear Americas
  • is willing to participate in the study

Who cannot take part

  • 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

Where in United States

  • NYU Langone HealthNew York, United StatesContact: Nicole CapachTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Patients scheduled for Cochlear ImplantationTreatment being tested

    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: Cochlear Implant and Modified Implant Procedure

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Plain-language title
Placing a cochlear implant electrode near a nerve behind the earGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
1 May 2026