Actively Recruiting

Phase Not Applicable
Age: 18Years - 79Years
All Genders
ID04707885

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

52 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

Researchers are investigating the role of an intraoperative hearing monitoring system called electrocochleography (ECochG) in preserving residual hearing during cochlear implant (CI) surgery. This randomized multi-center clinical trial focuses on adults with bilateral sensorineural hearing loss who face the challenge of losing residual hearing as a result of CI surgery. The study aims to understand how ECochG monitoring might reduce hearing loss during implantation and to evaluate benefits of combined hearing from hearing aids and cochlear implants compared to electric-only stimulation. Participants are randomly assigned to one of two groups. In the experimental group, surgeons use ECochG monitoring during CI surgery by placing a device coil and sound applicator to provide live feedback, allowing adjustments during electrode insertion to minimize trauma and preserve hearing. The control group undergoes standard CI surgery without ECochG monitoring but with adherence to soft surgical principles to enhance hearing preservation. Full electrode insertion is performed in the control group as per usual care. During the study, participants undergo assessments at 3, 6, 12, and 24 months to measure hearing preservation advantages. Researchers will evaluate speech perception and quality of life related to hearing outcomes. Participants complete testing and study visits, and surgeons monitor intraoperative feedback in the experimental group. The total study duration includes these follow-up periods to understand long-term hearing preservation effects after CI surgery.

CONDITIONS

Brief Title

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provision of signed and dated informed consent form.
  • Adults, males and females, ages 18 to 79 with bilateral sensorineural hearing loss of postlingual onset.
  • At least 30 days experience with properly fitted binaural amplification verified with real ear measurements.
  • Limited benefit from conventional amplification shown by specific speech test scores in both ears.
  • Low frequency Pure Tone Average (PTA) of 55 dB HL or less in the ear to be implanted.
  • Severe to profound mid to high-frequency sensorineural hearing loss in the ear to be implanted.
  • Low frequency PTA of 55 dB HL or less 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.
Not Eligible

You will not qualify if you...

  • Previous cochlear implantation.
  • Hearing loss that began before learning to speak.
  • Abnormal inner ear anatomy on CT imaging.
  • Auditory neuropathy spectrum disorder.
  • Retrocochlear pathology such as vestibular schwannoma or stroke.
  • Unwilling or unable to comply with study requirements including randomization.
  • Medical or social barriers preventing study completion.
  • Medical conditions that contraindicate surgery.
  • Selection of Med El cochlear implant device by the patient.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo cochlear implant surgery. Those in the experimental group receive electrocochleography (ECochG) monitoring during electrode insertion to help preserve residual hearing. The control group receives standard cochlear implant surgery without ECochG monitoring.

Surgery and immediate post-operative care visit

Post-operative Follow-up

Duration - Up to 24 months

Participants are followed to assess hearing preservation and benefits of hearing aid/cochlear implant combined hearing over electric-only stimulation.

Visits at 3, 6, 12, and 24 months post-surgery

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

Loading map...

Research Team

B

Beth Miles-Markley

M

Meghan Hiss, AuD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Comparative Analysis of Speech Perception Between Cochlear...

Hearing Loss

Actively Recruiting

6 locations

A Phase I/II Clinical Trial to Evaluate Safety and Efficacy ...

OTOF Gene Mutation

Actively Recruiting

2 locations

A Prospective Cohort Study on Cognitive Changes in Age-Relat...

Age-related Hearing Loss

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Preservation of residual hearing after cochlear implant surgery: an exploration of residual hearing function in a group of recipients at cochlear implant units.

Katherine Gautschi-Mills, Katijah Khoza-Shangase, Dhanashree Pillay

https://pubmed.ncbi.nlm.nih.gov/29631897

Patterns Seen During Electrode Insertion Using Intracochlear Electrocochleography Obtained Directly Through a Cochlear Implant.

Michael S Harris, William J Riggs, Christopher K Giardina...

https://pubmed.ncbi.nlm.nih.gov/28953607