CI532 - Early Experience Study

Completed · Not applicable

Conditions studied: Sensorineural Hearing Loss, Bilateral

In brief

To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

Key facts

Study ID

NCT02755935

Run by

Cochlear

People needed

24

Starts

2016-05-01

Expected to finish

2017-09-01

Last updated by the study team

2018-03-20

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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