Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2016-05-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implanted
Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
Cochlear Nucleus CI532
cochlear implantation
Interventions
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Cochlear Nucleus CI532
cochlear implantation
Eligibility Criteria
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Inclusion Criteria
* Post-linguistically deafened
* Ability to complete age appropriate testing
Exclusion Criteria
* 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
12 Months
ALL
Yes
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Locations
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NorthShore University
Skokie, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
The University of Michigan
Ann Arbor, Michigan, United States
Center for Hearing and Balance
Chesterfield, Missouri, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Dallas Ear Institute
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CAM5660
Identifier Type: -
Identifier Source: org_study_id
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