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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Electrocochleography
DeviceThe use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component. For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at \~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ECochG monitoringExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Preservation Advantage
Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.
Time frame
3, 6, 12, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov