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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
Allocation to intervention
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

Brief summary
The primary objective of this study is to assess the usability of a Cochlear implant system.
Trial website
Trial related presentations / publications
Public notes

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