Clinical Evaluation of a Cochlear Implant System
1 other identifier
interventional
46
1 country
1
Brief Summary
The primary objective of this study is to assess the usability of a Cochlear implant system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2017
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedMarch 16, 2018
March 1, 2018
1.2 years
September 16, 2016
March 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
One year
Secondary Outcomes (1)
Speech perception performance of the CP1000 Sound Processor in quiet and in noise.
One year
Study Arms (1)
Cochlear implant users
EXPERIMENTALThis 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.
Interventions
A new cochlear implant sound processor system.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (1)
Cochlear Ltd
Sydney, New South Wales, 2109, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Beth Brinson
Cochlear Ltd
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2016
First Posted
March 16, 2018
Study Start
July 1, 2016
Primary Completion
September 7, 2017
Study Completion
September 7, 2017
Last Updated
March 16, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share