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Recruiting NCT07011927

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

No phase Interventional Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cochlear Implant, Modified Implant Procedure.
Who it may be relevant to
Registry conditions: Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07011927 · 24-01768

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗