CI532 – Early Experience Study
Overview
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
Full Title of Study: “Implantation With the Cochlear Nucleus® CI532 Implant – Early Experience Study”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2017
Detailed Description
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
Interventions
- Device: Cochlear Nucleus CI532
- cochlear implantation
Arms, Groups and Cohorts
- Experimental: Implanted
- Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
Clinical Trial Outcome Measures
Primary Measures
- Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
- Time Frame: 3 months postactivation of the sound processor
- Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.
- Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
- Time Frame: 3 months post-activation
- unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise
Participating in This Clinical Trial
Inclusion Criteria
- 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 Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 12 Months
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Cochlear
- Provider of Information About this Clinical Study
- Sponsor
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