CI532 - Early Experience Study
Status: | Completed |
---|---|
Conditions: | Other Indications, Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 4/17/2018 |
Start Date: | May 2016 |
End Date: | September 2017 |
Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532
electrode array.
electrode array.
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.
Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing
status.
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
We found this trial at
6
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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