Electrocochleography Monitoring for Hearing Loss Preservation During Cochlear Implant Surgery
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Electrocochleography (ECochG) for hearing loss preservation during cochlear implant surgery?
Is Electrocochleography (ECochG) safe for use in humans during cochlear implant surgery?
How is the treatment Electrocochleography (ECochG) different from other treatments for hearing loss during cochlear implant surgery?
Electrocochleography (ECochG) is unique because it involves monitoring the electrical activity of the inner ear during cochlear implant surgery to help preserve hearing. Unlike other treatments that may focus on post-surgery recovery, ECochG is used during the surgery itself to provide real-time feedback, potentially improving hearing outcomes by minimizing damage to the cochlea.123910
What is the purpose of 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).
Research Team
Oliver Adunka, MD
Principal Investigator
Ohio State University
Amanda Ortmann, PhD
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cochlear implantation surgery with or without ECochG monitoring
Follow-up
Participants are monitored for hearing preservation and quality of life improvements
Treatment Details
Interventions
- Electrocochleography
Electrocochleography is already approved in European Union, United States for the following indications:
- Diagnosis and monitoring of Meniere's disease/endolymphatic hydrops
- Intraoperative nerve monitoring
- Assessment of auditory neuropathy
- Diagnosis and monitoring of Meniere's disease/endolymphatic hydrops
- Intraoperative nerve monitoring
- Assessment of auditory neuropathy
- Identification of wave I of the auditory brainstem response in patients with profound hearing loss
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator