Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Last updated: June 5, 2024
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Deafness

Hearing Loss

Hearing Impairment

Treatment

Electrocochleography

Clinical Study ID

NCT04707885
2020H0477
U01DC018920-01
  • Ages 18-79
  • All Genders

Study 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

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.

  2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearingloss with postlingual onset.

  3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified withreal ear measurements within 5 dB SPL of targets.

  4. Limited benefit from conventional amplification in the best aided condition asdefined by test scores of:

  5. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBiosentences (+10, +5 dB SNR ≤ 60% correct)

  6. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80%correct)

  7. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to beimplanted.

  8. Severe to profound mid to high-frequency sensorineural hearing loss (thresholdaverage of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.

  9. Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to highfrequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.

  10. Proficient in English.

  11. Undergoing implantation with a current generation CI device from either CochlearLimited or Advanced Bionics AG.

  12. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624

  13. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala

  14. Stated willingness and ability to complete testing and all associated study visits.

Exclusion

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 includingthe randomization process.

  7. Additional medical, or social barriers that would prevent completion of all studyrequirements.

  8. Medical condition contraindicated for surgery.

  9. Device selection of Med El CI (per the patient's selection).

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Electrocochleography
Phase:
Study Start date:
November 10, 2021
Estimated Completion Date:
December 31, 2027

Study Description

The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual hearing. However, recent developments in hearing monitoring systems during CI surgery have shown promise for providing the surgeon with live feedback of how the cochlear implant insertion process is proceeding, allowing the surgeon to make intraoperative adjustments during the insertion, potentially minimizing any trauma caused by the insertion of the implant, ultimately helping preserve residual hearing. This ultimately could lead to improvements in the rates of hearing preservation. Therefore, the current study seeks to investigate: 1) the advantage of using a hearing monitoring system (electrocochleography) monitoring guided CI surgery on hearing preservation rates, 2) determine the benefit that hearing aid/cochlear implant combined hearing provides participants over non-hearing preservation CI (electric-only stimulation from the CI) on measures of speech perception and quality of life.

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Ohio State University Eye and Ear Institute

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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