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 CI532 Nucleus 7

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
    San Francisco California 94115 United States
  • Spokane ENT
    Spokane Washington 99201 United States
  • Rocky Mountain Ear Center
    Englewood Colorado 80113 United States
  • Hearts for Hearing
    Oklahoma City Oklahoma 73120 United States
  • Ear Medical Group
    San Antonio Texas 78240 United States
  • Dallas Ear Institute
    Dallas Texas 75230 United States
  • Midwest Ear Institute
    Kansas City Missouri 64111 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cochlear
ID
NCT03007472
Study Type
Interventional
Last Updated
April 11, 2018