Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

Completed · Not applicable

Conditions studied: Hearing Loss, Sensorineural

In brief

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Key facts

Study ID

NCT03007472

Run by

Cochlear

People needed

96

Starts

2017-02-15

Expected to finish

2020-03-06

Last updated by the study team

2020-12-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
• 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.
• Bilateral moderate sloping to profound hearing loss
• Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
• Proficient in English
• Ability to complete testing -

You may not qualify if…

• Previous cochlear implantation
• 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
• Duration of severe to profound hearing loss greater than 20 years
• 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, medical or social handicaps that would prevent completion of all study requirements-

Where it is running

• Rocky Mountain Ear Center — Englewood, Colorado, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Michigan — Ann Arbor, Michigan, United States
• The Center for Hearing and Balance Disorders — Chesterfield, Missouri, United States
• Midwest Ear Institute — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• New York University — New York, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Hearts for Hearing — Oklahoma City, Oklahoma, United States
• Dallas Ear Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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