Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
Status: | Active, not recruiting |
---|---|
Conditions: | Other Indications, Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 4/17/2018 |
Start Date: | December 2016 |
End Date: | July 2019 |
Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear
implant, and CP1000 (Nucleus 7) sound processor
implant, and CP1000 (Nucleus 7) sound processor
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.
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.
Inclusion Criteria:
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 -
Exclusion Criteria:
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-
We found this trial at
13
sites
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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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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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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