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Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Official Title

Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults

Details

Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.

Keywords

Hearing Loss, Sensorineural cochlear implant, sound processor Hearing Loss

Eligibility

You can join if…

  1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
  2. Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
  3. Bilateral moderate sloping to profound hearing loss
  4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized NAL fitting method
  5. Proficient in English
  6. Ability to complete testing -

You CAN'T join if...

  1. Previous cochlear implantation
  2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  4. Duration of severe to profound hearing loss greater than 20 years
  5. Diagnosis of retro-cochlear pathology
  6. Diagnosis of auditory neuropathy
  7. 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
  8. Unwillingness or inability to comply with all investigational requirements
  9. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-

Locations

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94115, United States
  • Spokane ENT accepting new patients
    Spokane, Washington, 99201, United States
  • Rocky Mountain Ear Center accepting new patients
    Englewood, Colorado, 80113, United States
  • Hearts for Hearing accepting new patients
    Oklahoma City, Oklahoma, 73120, United States
  • Ear Medical Group accepting new patients
    San Antonio, Texas, 78240, United States
  • Dallas Ear Institute accepting new patients
    Dallas, Texas, 75230, United States
  • Midwest Ear Institute accepting new patients
    Kansas City, Missouri, 64111, United States
  • University of Iowa accepting new patients
    Iowa City, Iowa, 52242, United States
  • The Center for Hearing and Balance Disorders accepting new patients
    Chesterfield, Missouri, 63017, United States
  • Washington University accepting new patients
    Saint Louis, Missouri, 63110, United States
  • University of Michigan accepting new patients
    Ann Arbor, Michigan, 48108, United States
  • The Ohio State University accepting new patients
    Columbus, Ohio, 13212, United States
  • New York University accepting new patients
    New York, New York, 10016, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cochlear
ID
NCT03007472
Study Type
Interventional
Last Updated
September 5, 2017
I’m interested in this study!