Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Overview

About this study

The primary objective of this study is to determine the hearing preservation advantage, defined as the increased chance of preservation of residual hearing (i.e., low frequency pure tone average ≤ 80 dB HL), of ECochG-guided CI electrode insertions in EAS candidates.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
  • Minimum of 30 days experience with appropriately fit binaural amplification (standardized NAL fitting method) verified with real ear measurements within 5 dB SPL of targets.
  • Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
    • The ear to implanted: CNC words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct);
    • Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct);
    • Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted;
    • 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;
    • 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.
  • Proficient in English.
  • Undergoing implantation with a current generation cochlear implant device from either Cochlear Limited or Advanced Bionics AG.
  • Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624.
  • Advanced Bionics AG devices include:  HiFocus SlimJ, Mid-Scala.
  • Stated willingness and ability to complete testing and all associated study visits.

Exclusion Criteria:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
    • Previous cochlear implantation;
    • Prelingual onset of hearing loss;
    • Abnormal inner ear anatomy on CT imaging;
    • Auditory neuropathy spectrum disorder;
    • Retrocochlear pathology such as a vestibular schwannoma or stroke.
  • Unwillingness or inability to comply with all investigational requirements including the randomization process.
  • Additional medical, or social barriers that would prevent completion of all study requirements.
  • Medical condition contraindicated for surgery.
  • Device selection of Med El cochlear implant (per the patient’s selection).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aniket Saoji, Ph.D.

Open for enrollment

Contact information:

Amy Tuchscherer C.C.R.C.

(507) 538-6582

Tuchscherer.Amy@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20520888

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