NCT04707885 · Ohio State University
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
What this study is about
The current study is a randomly assigned 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).
View original scientific description
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).
Interventions
DEVICE
Electrocochleography
The 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.
Primary outcome measures
Preservation Advantage
Time frame: 3, 6, 12, 24 months
Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
- The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
- Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
- Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
- 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.
- 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.
- Proficient in English.
- Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.
- Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
- Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
- Stated willingness and ability to complete testing and all associated study visits.
Exclusion criteria
- Previous cochlear implantation.
- Prelingual onset of hearing loss.
- Abnormal inner ear anatomy on CT imaging.
- Auditory neuropathy spectrum disorder.
- Retrocochlear pathology such as a vestibular schwannoma or stroke.
- Unwillingness or inability to comply with all investigational requirements including the randomization process.
- Additional medical, or social barriers that would prevent completion of all study requirements.
- Medical condition contraindicated for surgery.
- Device selection of Med El CI (per the patient's selection).
Where
- Rochester, Minnesota
- St Louis, Missouri
- Chapel Hill, North Carolina
- Columbus, Ohio
- Milwaukee, Wisconsin
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 12, 2025 · Source of record for eligibility and locations