Status:
RECRUITING
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Hearing Loss, Sensorineural
Hearing Loss
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
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 p...
Detailed Description
The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing assoc...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04707885
Start Date
November 10 2021
End Date
December 31 2027
Last Update
September 12 2025
Active Locations (5)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Washington University in St. Louis
St Louis, Missouri, United States, 63110
3
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
4
Ohio State University Eye and Ear Institute
Columbus, Ohio, United States, 43210