NCT04707885 Clinical Utility of Residual Hearing in the Cochlear Implant Ear
| NCT ID | NCT04707885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Hearing Loss, Sensorineural |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-11-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-11-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 patients undergoing cochlear implantation (CI).
Eligibility Criteria
Inclusion Criteria: 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. 7. 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. 8. Proficient in English. 9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG. 1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624 2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala 10. Stated willingness and ability to complete testing and all associated study visits. Exclusion Criteria: 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. 9. Device selection of Med El CI (per the patient's selection).
Contact & Investigator
Oliver Adunka, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT04707885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Hearing Loss, Sensorineural. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04707885 currently recruiting?
Yes, NCT04707885 is actively recruiting participants. Contact the research team at beth.miles-markley@osumc.edu for enrollment information.
Where is the NCT04707885 trial being conducted?
This trial is being conducted at Rochester, United States, St Louis, United States, Chapel Hill, United States, Columbus, United States and 1 additional location.
Who is sponsoring the NCT04707885 clinical trial?
NCT04707885 is sponsored by Ohio State University. The principal investigator is Oliver Adunka, MD at Ohio State University. The trial plans to enroll 40 participants.