Back to resultsCI532 - Early Experience Study
Primary Purpose
Sensorineural Hearing Loss, Bilateral
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cochlear Nucleus CI532
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss, Bilateral
Eligibility Criteria
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
Sites / Locations
- NorthShore University
- University of Iowa
- The University of Michigan
- Center for Hearing and Balance
- Vanderbilt University Medical Center
- Dallas Ear Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implanted
Arm Description
Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
Outcomes
Primary Outcome Measures
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
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
unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02755935
Brief Title
CI532 - Early Experience Study
Official Title
Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Bilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implanted
Arm Type
Experimental
Arm Description
Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
Intervention Type
Device
Intervention Name(s)
Cochlear Nucleus CI532
Intervention Description
cochlear implantation
Primary Outcome Measure Information:
Title
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
Description
Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.
Time Frame
3 months postactivation of the sound processor
Title
Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
Description
unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise
Time Frame
3 months post-activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
NorthShore University
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Center for Hearing and Balance
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dallas Ear Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CI532 - Early Experience Study
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