- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467399
Clinical Evaluation of a Cochlear Implant System
March 9, 2018 updated by: Cochlear
The primary objective of this study is to assess the usability of a Cochlear implant system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2109
- Cochlear Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cochlear implant users
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.
|
A new cochlear implant sound processor system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: One year
|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech perception performance of the CP1000 Sound Processor in quiet and in noise.
Time Frame: One year
|
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.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary Beth Brinson, Cochlear Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
September 7, 2017
Study Completion (Actual)
September 7, 2017
Study Registration Dates
First Submitted
September 16, 2016
First Submitted That Met QC Criteria
March 9, 2018
First Posted (Actual)
March 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 16, 2018
Last Update Submitted That Met QC Criteria
March 9, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLTD5620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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