Investigating how hearing monitoring during cochlear implant surgery can preserve residual hearing
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
This study tests if using a special hearing monitor during cochlear implant surgery can help people with some hearing loss keep their remaining hearing and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 5 sites (Rochester, Minnesota and 4 other locations) |
| Trial ID | NCT04707885 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized multi-center investigation focusing on the use of an intraoperative hearing monitoring system, specifically electrocochleography, to help preserve residual hearing in patients undergoing cochlear implantation. The study aims to assess the effectiveness of this monitoring system in minimizing trauma during the implant insertion process, which is a common cause of hearing loss in candidates who do not have complete deafness. By providing real-time feedback to surgeons, the trial seeks to improve hearing preservation rates and evaluate the benefits of combined hearing from hearing aids and cochlear implants on speech perception and quality of life. The trial includes adults aged 18-79 with bilateral sensorineural hearing loss who have limited benefit from conventional amplification.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-79 with bilateral sensorineural hearing loss who have limited benefit from hearing aids.
Not a fit: Patients with complete deafness or those who do not meet the specific hearing loss criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hearing preservation for cochlear implant patients, enhancing their overall auditory experience.
How similar studies have performed: Other studies have shown promise in using intraoperative monitoring systems for hearing preservation, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rochester, Minnesota and 4 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Ohio State University Eye and Ear Institute — Columbus, Ohio, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Oliver Adunka, MD — Ohio State University
- Study coordinator: Beth Miles-Markley
- Email: beth.miles-markley@osumc.edu
- Phone: 614-366-9244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.