Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
will be undergoing surgery for a cochlear implant from Cochlear Americas
is willing to participate in the study
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Cochlear Implant
DeviceEligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
Modified Implant Procedure
DeviceImplant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Patients scheduled for Cochlear ImplantationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
AzBio Sentence Recognition Test Score
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%.
Time frame
Up to Year 1 post cochlear implant activationSponsors and contacts
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Source ClinicalTrials.gov