RecruitingHearing Loss, SensorineuralHearing LossHearing Loss, Bilateral
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Eligible age
18–79 yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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).
Sponsor: Ohio State University
You may qualify if…
- ✓ 1. Provision of signed and dated informed consent form.
- ✓ 2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
- ✓ 3. 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.
- ✓ 4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
- ✓ 1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
- ✓ 2. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
- ✓ 5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
- ✓ 6. 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.
You may not qualify if…
- ✕ 1. Previous cochlear implantation.
- ✕ 2. Prelingual onset of hearing loss.
- ✕ 3. Abnormal inner ear anatomy on CT imaging.
- ✕ 4. Auditory neuropathy spectrum disorder.
- ✕ 5. Retrocochlear pathology such as a vestibular schwannoma or stroke.
- ✕ 6. Unwillingness or inability to comply with all investigational requirements including the randomization process.
- ✕ 7. Additional medical, or social barriers that would prevent completion of all study requirements.
- ✕ 8. Medical condition contraindicated for surgery.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04707885 · last updated 2025-09-12