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Procedure
Electrocochleography Monitoring for Hearing Loss Preservation During Cochlear Implant Surgery
N/A
Recruiting
Led By Amanda Ortmann, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted
Limited benefit from conventional amplification in the best aided condition as defined by test scores
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 24 months
Awards & highlights
Study Summary
This trial is testing whether a monitoring system during cochlear implant surgery can help preserve residual hearing.
Who is the study for?
This trial is for adults aged 18-79 with severe to profound sensorineural hearing loss who have had limited benefit from hearing aids. They must be proficient in English, willing to complete study visits, and not have prelingual deafness or inner ear abnormalities. Candidates should not have had a previous cochlear implant and must be getting an implant from Cochlear Limited or Advanced Bionics AG.Check my eligibility
What is being tested?
The study tests if using electrocochleography during cochlear implant surgery can help preserve residual hearing. It's a randomized trial across multiple centers where participants are chosen by chance to receive this monitoring technique while being implanted.See study design
What are the potential side effects?
While the document does not specify side effects related to electrocochleography, typical risks of cochlear implants include loss of residual hearing, infection, tinnitus, nerve injury, dizziness or balance problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe hearing loss in the high-frequency range in one ear.
Select...
Hearing aids don't help me much, according to tests.
Select...
I have severe hearing loss in the high-frequency range in one ear.
Select...
I am between 18 and 79 years old with hearing loss that occurred after learning to speak.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Preservation Advantage
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ECochG monitoringExperimental Treatment1 Intervention
For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.
Group II: Control GroupActive Control1 Intervention
For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,580 Total Patients Enrolled
5 Trials studying Hearing Loss
246 Patients Enrolled for Hearing Loss
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,431 Total Patients Enrolled
56 Trials studying Hearing Loss
20,113 Patients Enrolled for Hearing Loss
Amanda Ortmann, PhDPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have difficulty understanding certain words or sentences even with a hearing aid.I am willing and able to follow all study requirements.I have used hearing aids in both ears for at least 30 days, fitted and verified by a professional.I am willing and able to attend all study visits and complete tests.I have severe hearing loss in the high-frequency range in one ear.Hearing aids don't help me much, according to tests.I have severe hearing loss in the high-frequency range in one ear.Your hearing loss at certain frequencies in the ear to be implanted is not too severe.You have severe hearing loss in one ear and profound hearing loss in the other ear.You are currently getting a specific type of hearing implant from Cochlear Limited or Advanced Bionics AG.Your hearing loss at certain frequencies is not too severe in the ear that will receive the implant.You have a specific type of severe hearing loss in one ear.I have a health condition that makes surgery unsafe for me.The patient has chosen the Med El CI device for their treatment.You have had a cochlear implant in the past.You started losing your hearing before learning to speak.I am between 18 and 79 years old with hearing loss that occurred after learning to speak.Your inner ear does not look normal on CT scans.I have been diagnosed with auditory neuropathy spectrum disorder.I have a nerve-related ear condition, like a tumor or stroke.You have recently received a specific type of hearing implant from either Cochlear Limited or Advanced Bionics AG.Your other ear has hearing loss, making it difficult for you to understand words or sentences.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ECochG monitoring
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Hearing Loss Patient Testimony for trial: Trial Name: NCT04707885 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to become a participant in this clinical trial?
"This trial is enrolling 40 patients afflicted with bilateral deafness, aged between 18-79. Candidates must meet the following criteria to be eligible: Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear; Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear for implantation; Poor performance on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 60% correct"
Answered by AI
In which geographical areas are the research participants recruited for this clinical experiment?
"This medical trial is running at 7 sites, including Vanderbilt University in Nashville, the University of North carolina, Chapel Hill and Mayo Clinic in Rochester. There are also 4 other locations being utilized for this study."
Answered by AI
What is the current enrollment count for this clinical research?
"To complete this clinical trial, 40 individuals that meet the predetermined requirements must take part in it. Locations where prospective participants can join include Vanderbilt University in Nashville and University of North carolina Chapel Hill."
Answered by AI
Does the clinical trial extend to elderly individuals aged 75 and over?
"To be eligible for this particular research trial, patients must be between 18 and 79 years old. Conversely, there are 55 studies recruiting minors (under 18) and 129 trials targeting elderly citizens (over 65)."
Answered by AI
Are there any available spots left for participants in this research?
"Affirmative. According to clinicaltrials.gov, this research trial is currently enrolling participants and was initially published on November 10th 2021. At present, the study requires 40 individuals across 7 different sites."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
Ohio
How old are they?
65+
What site did they apply to?
University of Iowa
Ohio State University Eye and Ear Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
When does the trial start? When will I be contacted to see if I meet the criteria?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Hearing aids are not helping me to hear. Hearing aids are not helping me to hear. Cannot hear emergent fire trucks, ambulances, police sirens, home fire alarm & I miss almost all conversations.
PatientReceived 2+ prior treatments
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