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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05080283




Registration number
NCT05080283
Ethics application status
Date submitted
19/09/2021
Date registered
15/10/2021
Date last updated
16/09/2022

Titles & IDs
Public title
Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.
Scientific title
A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Actual-Use, Interventional Study of Acceptance and Performance With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor Compared With the CP1000 Sound Processor
Secondary ID [1] 0 0
CLTD5810
Universal Trial Number (UTN)
Trial acronym
PINNA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Cochlear Implant Recipients 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CP1110 Sound Processor System
Treatment: Devices - Nucleus 7 Sound Processor (model: CP1000) system

Experimental: CP1110 Sound Processor System with ForwardFocus On (SCAN) -

Experimental: CP1110 Sound Processor System with ForwardFocus Off (SCAN) -

Active Comparator: Nucleus 7 Sound Processor (model: CP1000) system -


Treatment: Devices: CP1110 Sound Processor System
Sound Processor

Treatment: Devices: Nucleus 7 Sound Processor (model: CP1000) system
Sound Processor
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Speech Reception Thresholds (SRT) assessed in spatially separated speech and noise (S0Nrearhalf).
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Speech Reception Thresholds (SRT) assessed in spatially separated speech and noise (S0N3).
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Adult cochlear implant speech perception in quiet with the CP1110 Sound Processor and the Nucleus 7 Sound Processor.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Adult cochlear implant subjective hearing performance and sound quality with the CP1110 Sound Processor and Nucleus 7 Sound Processor.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
To evaluate acceptance and satisfaction of the CP1110 Sound Processor.
Timepoint [4] 0 0
6 months

Eligibility
Key inclusion criteria
1. Aged 18 years or older.

2. Post lingually deafened.

3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512,
CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422).

4. At least 6 months experience with a cochlear implant.

5. At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor

6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

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

8. Fluent speaker in English as determined by the investigator

9. Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Additional disabilities that would prevent participation in evaluations.

2. Unrealistic expectations on the part of the subject, regarding the possible benefits,
risks and limitations that are inherent to the procedures.

3. Unable or unwilling to comply with the requirements of the clinical investigation as
determined by the Investigator.

4. Investigator site personnel directly affiliated with this study and/or their immediate
families; immediate family is defined as a spouse, parent, child, or sibling.

5. Cochlear employees or employees of Contract Research Organisations or contractors
engaged by Cochlear for the purposes of this investigation.

6. Currently participating, or participated in another interventional clinical
study/trial in the past 30 days or if less than 30 days, the prior investigation was
Cochlear sponsored and determined by the investigator to not impact clinical findings
of this investigation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Crossover
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
2/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2022
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cochlear Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Avania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The clinical study aims to investigate acceptance, actual-use usability and speech
performance with a new behind-the-ear sound processor (model number: CP1110) system, compared
with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with
particular focus on the acceptance of and satisfaction with a noise reduction feature in the
Automatic Scene Classifier 'SCAN'.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05080283
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05080283