Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Description

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

Hearing Loss, Sensorineural, Hearing Loss, Hearing Loss, Bilateral

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Condition
Hearing Loss, Sensorineural
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63110

Chapel Hill

University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Columbus

Ohio State University Eye and Ear Institute, Columbus, Ohio, United States, 43210

Nashville

Vanderbilt University, Nashville, Tennessee, United States, 37232

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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).

Ages Eligible for Study

18 Years to 79 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Oliver Adunka, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Amanda Ortmann, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2027-12-31