Back to resultsClinical Evaluation of a Cochlear Implant System
Primary Purpose
Sensorineural Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Nucleus 7 Cochlear Implant System
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Eighteen years of age or older
- At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
- At least 3 months experience with the CP810,CP920 or CP910 sound processor
- Fluent speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
- Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
Exclusion Criteria:
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
- Additional disabilities that would prevent participation in evaluations
- Nucleus 22 Implant
Sites / Locations
- Cochlear Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cochlear implant users
Arm Description
This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.
Outcomes
Primary Outcome Measures
Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.
Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset.
Secondary Outcome Measures
Speech perception performance of the CP1000 Sound Processor in quiet and in noise.
Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03467399
Brief Title
Clinical Evaluation of a Cochlear Implant System
Official Title
Clinical Evaluation of a Cochlear Implant System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
September 7, 2017 (Actual)
Study Completion Date
September 7, 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
The primary objective of this study is to assess the usability of a Cochlear implant system.
Detailed Description
Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cochlear implant users
Arm Type
Experimental
Arm Description
This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.
Intervention Type
Device
Intervention Name(s)
Nucleus 7 Cochlear Implant System
Intervention Description
A new cochlear implant sound processor system.
Primary Outcome Measure Information:
Title
Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.
Description
Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Speech perception performance of the CP1000 Sound Processor in quiet and in noise.
Description
Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Eighteen years of age or older
At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
At least 3 months experience with the CP810,CP920 or CP910 sound processor
Fluent speaker in the language used to assess speech perception performance
Willingness to participate in and to comply with all requirements of the protocol
Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
Exclusion Criteria:
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
Additional disabilities that would prevent participation in evaluations
Nucleus 22 Implant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Brinson
Organizational Affiliation
Cochlear Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochlear Ltd
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of a Cochlear Implant System
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