Health Trials

About this trial

The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form.

Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.

Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.

The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)

Disqualifiers

Previous cochlear implantation.

Prelingual onset of hearing loss.

Abnormal inner ear anatomy on CT imaging.

Auditory neuropathy spectrum disorder.

Trial design

Treatments tested in this trial

  • Electrocochleography

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

5
Mayo Clinic55905, RochesterMinnesota, United States
Washington University in St. Louis63110, St LouisMissouri, United States
University of North Carolina, Chapel Hill27599, Chapel HillNorth Carolina, United States
Ohio State University Eye and Ear Institute43210, ColumbusOhio, United States

Sponsors and collaborators

Ohio State University

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov