Actively Recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Led by Ohio State University · Updated on 2025-09-12
40
Participants Needed
5
Research Sites
320 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Adults aged 18 to 79 with bilateral sensorineural hearing loss that began after language development.
- At least 30 days of experience with properly fitted binaural hearing aids verified by real ear measurements.
- Limited benefit from conventional hearing aids with specific speech test scores in the ear to be implanted and the opposite ear.
- Low frequency hearing thresholds (125, 250, 500 Hz) of 55 dB HL or better in the ear to be implanted.
- Severe to profound mid to high-frequency hearing loss (1000 to 4000 Hz) of 75 dB HL or worse in the ear to be implanted.
- Low frequency hearing thresholds of 55 dB HL or better with moderately severe to profound mid-to-high frequency hearing loss in the opposite ear.
- Proficient in English.
- Scheduled for implantation with a current generation cochlear implant device from Cochlear Limited or Advanced Bionics AG.
- Willing and able to complete all testing and study visits.
You will not qualify if you...
- Previous cochlear implant surgery.
- Hearing loss that started before language development.
- Abnormal inner ear anatomy seen on CT imaging.
- Auditory neuropathy spectrum disorder.
- Retrocochlear problems such as vestibular schwannoma or stroke.
- Unable or unwilling to comply with study procedures including randomization.
- Medical or social barriers preventing study completion.
- Medical conditions that contraindicate surgery.
- Use of Med El cochlear implant device by patient choice.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
3
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
4
Ohio State University Eye and Ear Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
5
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
B
Beth Miles-Markley
CONTACT
M
Meghan Hiss, AuD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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