To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532
Device: Cochlear Nucleus CI532
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Locations near you
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Full eligibility criteria for NCT02755935
Ages eligible for Study
12 Months and older
Genders eligible for Study
Accepts Healthy Volunteers
Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
Ability to complete age appropriate testing
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
All locations for NCT02755935
United States (6)
Skokie, Illinois, United States, 60201
University of Iowa
Iowa City, Iowa, United States, 52242
The University of Michigan
Ann Arbor, Michigan, United States, 48108
Center for Hearing and Balance
Chesterfield, Missouri, United States, 63017
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Dallas Ear Institute
Dallas, Texas, United States, 75230
Trial results for NCT02755935
Participant Flow: Overall Study
22 / 24
Completed / Started
Serious Adverse Events
3 / 48
Affected / At Risk
Other Adverse Events
6 / 24
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT02755935. The sponsor of the trial is Cochlear and it is looking for 24 volunteers for the current phase.
Official trial title: Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
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