Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorOhio State University
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 groupsSponsors and collaborators
Ohio State University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov