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Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study (NCT02755935)

To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
  • Device: Cochlear Nucleus CI532
    cochlear implantation
    Ages eligible for Study
    12 Months and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
    • Post-linguistically deafened
    • Ability to complete age appropriate testing
    Exclusion Criteria:
    • Previous cochlear implantation in the ear to be implanted
    • Pre-linguistically deafened (onset of hearing loss at less than two years of age)
    • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
    • Diagnosis of retro-cochlear pathology
    • Diagnosis of auditory neuropathy
    • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
    • Unwillingness or inability to comply with all investigational requirements
    • Additional cognitive handicaps that would prevent participation on all study requirements
    To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.

    6 locations

    United States (6)
    • NorthShore University
      Not specified
      Skokie, Illinois, United States, 60201
    • University of Iowa
      Not specified
      Iowa City, Iowa, United States, 52242
    • The University of Michigan
      Not specified
      Ann Arbor, Michigan, United States, 48108
    • Center for Hearing and Balance
      Not specified
      Chesterfield, Missouri, United States, 63017
    • Vanderbilt University Medical Center
      Not specified
      Nashville, Tennessee, United States, 37203
    • Dallas Ear Institute
      Not specified
      Dallas, Texas, United States, 75230
    Participant Flow: Overall Study
    Implanted
    Serious Adverse Events
    Implanted
    Other Adverse Events
    Implanted
    Status:
    completed
    Type:
    Interventional
    Phase:
    -
    Start:
    30 April, 2016
    Updated:
    19 February, 2018
    Participants:
    24
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