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
Qualifiers
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
Treatments tested in this trial
- Cochlear Implant
- Modified Implant Procedure
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov