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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03467399




Registration number
NCT03467399
Ethics application status
Date submitted
16/09/2016
Date registered
16/03/2018
Date last updated
16/03/2018

Titles & IDs
Public title
Clinical Evaluation of a Cochlear Implant System
Scientific title
Clinical Evaluation of a Cochlear Implant System
Secondary ID [1] 0 0
CLTD5620
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sensorineural Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Nucleus 7 Cochlear Implant System

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.


Treatment: Devices: Nucleus 7 Cochlear Implant System
A new cochlear implant sound processor system.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
One year

Eligibility
Key inclusion criteria
1. Eighteen years of age or older

2. At least 6 months experience with a Nucleus 24 series or later implant in at least one
implanted ear

3. At least 3 months experience with the CP810,CP920 or CP910 sound processor

4. Fluent speaker in the language used to assess speech perception performance

5. Willingness to participate in and to comply with all requirements of the protocol

6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unrealistic expectations on the part of the subject, regarding the possible benefits,
risks and limitations that are inherent to the procedure and prosthetic device

2. Additional disabilities that would prevent participation in evaluations

3. Nucleus 22 Implant

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cochlear Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to assess the usability of a Cochlear implant system.
Trial website
https://clinicaltrials.gov/show/NCT03467399
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mary Beth Brinson
Address 0 0
Cochlear Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications