A Prospective, Single Centre, Single-blinded, Within-subject Investigation, on the Effect of Stimulation Parameter Changes, and Monopolar and Dual-electrode Mode Changes, on Speech Perception in Experienced Adult Cochlear Implant Recipients
Phase: NA
Conditions: Hearing Loss, Sensorineural
Sponsor: Cochlear

CLTD5853 DUAL study Clinical Investigation Plan I VV-TMF-32365 I l.0 
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Cochleare 
Clinical Investigation Plan: CL TD5853 
Clinical Investigation Plan 
Investigation Title: A prospective, single centre, single-blinded, within-subject 
investigation, on the effect of stimulation parameter changes, and monopolar and 
dual-electrode mode changes, on speech perception in experienced adult cochlear 
implant recipients. 
Short Title: 
CIP Number: 
Version and Date: 
Sponsor: 
DUAL study 
CLTD5853 
Refer to system version control 
Cochlear Limited 
1 University Avenue, 
Macquarie University 
NSW 2109 
Phone: 02 9428 6555 
NCT06298396
This clinical investigation shall be conducted in accordance with ethical principles that have their origin in the 
Declaration of Helsinki, International Standard ISO 14155:2020 Clinical investigation of medical devices for 
human subjects - Good Clinical Practice, and any regional or national regulations, as applicable. 
Confidential Information 
The information contained in this document is confidential and should not be copied or distributed to persons not involved in the 
conduct or oversight of the clinical investigation 
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Manufacturer 
Cochlear Limited 
1 University Avenue,  
Macquarie University 
NSW   2109 
Phone:  02 9428 6555 
Sponsor Organisation 
 
Cochlear Limited 
1 University Avenue,  
Macquarie University 
NSW   2109 
Phone:  02 9428 6555 
Funding Source 
Sponsoring Organisation 
Principal Investigator 
 
 
 
  
 
 
Clinical Research Organisation  
 
Avania Pty Limited 
13/76 Reserve Road 
Artarmon, NSW 2064 
Contract Services 
N/a  
Safety Contact 
CLTD-SafetyMonitor@cochlear.com 
 
 
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INVESTIGATOR AGREEMENT 
Principal Investigator Approval and Declaration 
By my signature below, I confirm my review and approval of this Clinical Investigational Plan (CIP). 
I also confirm that I will strictly adhere to the requirements therein and undertake to ensure that all staff with 
delegated responsibilities in the conduct of this CIP have read, understood and will strictly adhere to the 
requirements therein. This CIP will not be implemented without prior written approval from the Ethics 
Committee, any applicable National Competent Authorities, and the Sponsor. If amendments to this plan 
become necessary, written approval by the Ethics Committee and any applicable National Competent 
Authorities will be obtained before the changes are clinically implemented per the amendment, except under 
emergency circumstances to protect the rights, safety, and well-being of subjects. 
I also agree that my personal information may be provided to regulatory agencies and public clinical trial 
registry platforms, and stored in their systems in order to comply with regulatory requirements. Examples of 
the type of personal information include my name, signature and summary of qualifications. 
Name 
Title 
 
Principal Investigator 
Signature 
Date 
 
 
 
 
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TABLE OF CONTENTS 
1 
Definitions and Abbreviations ......................................................................................................... 7 
2 
Clinical Investigation Synopsis ........................................................................................................ 9 
3 
Schedule of Events ....................................................................................................................... 12 
4 
Background Information and Rationale ........................................................................................ 14 
4.1 
Introduction ......................................................................................................................... 14 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 15 
4.2.1 
Nonclinical Data .................................................................................................... 15 
4.2.2 
Clinical Data .......................................................................................................... 15 
4.3 
Study Rationale .................................................................................................................. 16 
5 
Medical Device Information ........................................................................................................... 17 
5.1 
Identity and Description of the Investigational Medical Device (IMD) ................................ 17 
5.2 
Identity and Description of the Comparator ........................................................................ 18 
5.3 
Accessory Device Requirements ........................................................................................ 19 
6 
Objectives ..................................................................................................................................... 19 
6.1 
Primary Objectives .............................................................................................................. 19 
6.2 
Secondary Objectives ......................................................................................................... 19 
6.3 
Exploratory Objectives ........................................................................................................ 19 
7 
Design of the Clinical Investigation ............................................................................................... 20 
7.1 
General ............................................................................................................................... 20 
7.1.1 
Design Rationale ................................................................................................... 21 
7.2 
Subjects .............................................................................................................................. 22 
7.2.1 
Inclusion Criteria ................................................................................................... 22 
7.2.2 
Exclusion Criteria .................................................................................................. 23 
7.2.3 
Number of Subjects Required ............................................................................... 23 
7.2.4 
Vulnerable Populations ......................................................................................... 23 
7.2.5 
Recruitment and Study Duration ........................................................................... 23 
7.2.6 
Criteria and Procedures for Subject Withdrawal ................................................... 24 
7.2.7 
Randomisation Procedures .................................................................................. 24 
7.2.8 
Post-investigation Medical Care ........................................................................... 25 
7.3 
Evaluations and Procedures ............................................................................................... 25 
7.3.1 
Screening/eligibility ............................................................................................... 25 
7.3.2 
Performance/Effectiveness ................................................................................... 26 
7.3.3 
Safety Evaluations and Procedures ...................................................................... 28 
7.4 
Equipment Used for Evaluations and Procedures .............................................................. 29 
7.4.1 
Software ................................................................................................................ 29 
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7.4.2 
Sound room equipment......................................................................................... 29 
7.4.3 
Questionnaires ...................................................................................................... 29 
7.5 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 29 
8 
Benefits and Risks of the Investigational medical device and Clinical Investigation .................... 30 
8.1 
Anticipated Clinical Benefits ............................................................................................... 30 
8.2 
Anticipated Adverse Device Effects .................................................................................... 30 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 30 
8.4 
Risk Mitigation .................................................................................................................... 31 
8.5 
Benefit-to Risk Rationale .................................................................................................... 31 
9 
Statistical Considerations .............................................................................................................. 32 
9.1 
General Considerations ...................................................................................................... 32 
9.2 
Endpoints ............................................................................................................................ 32 
9.2.1 
Primary Endpoints ................................................................................................. 32 
9.2.2 
Secondary Endpoints ............................................................................................ 32 
9.2.3 
Exploratory Endpoints ........................................................................................... 32 
9.3 
Hypotheses ......................................................................................................................... 32 
9.3.1 
Primary Hypotheses .............................................................................................. 33 
9.3.2 
Secondary Hypotheses ......................................................................................... 33 
9.3.3 
Exploratory Hypothesis ......................................................................................... 34 
9.4 
Sample Size Determination ................................................................................................ 34 
9.5 
Analysis Populations ........................................................................................................... 35 
9.6 
Endpoint Analyses .............................................................................................................. 36 
9.6.1 
Primary Endpoint Analyses ................................................................................... 36 
9.6.2 
Secondary Endpoint Analyses .............................................................................. 36 
9.6.3 
Exploratory Endpoint Analyses ............................................................................. 36 
9.7 
Safety Analyses .................................................................................................................. 37 
9.8 
Interim Analyses ................................................................................................................. 37 
10 Informed Consent Process ........................................................................................................... 37 
11 Adverse Events and Device Deficiencies ..................................................................................... 37 
11.1 Definitions ........................................................................................................................... 37 
11.1.1 
Adverse Event ...................................................................................................... 37 
11.1.2 
Adverse Device Effect .......................................................................................... 38 
11.1.3 
Serious Adverse Event ......................................................................................... 38 
11.1.4 
Serious Adverse Device Effect ............................................................................. 38 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 38 
11.1.6 
Adverse Events of Special Interest ....................................................................... 39 
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11.1.7 
Device Deficiency ................................................................................................. 39 
11.1.8 
Serious Health Threat ........................................................................................... 39 
11.2 Recording and Handling of Adverse Events ....................................................................... 39 
11.2.1 
Assessment of Severity ........................................................................................ 39 
11.2.2 
Assessment of Causality ...................................................................................... 40 
11.2.3 
Assessment of Seriousness ................................................................................. 41 
11.2.4 
Assessment of Expectedness .............................................................................. 41 
11.3 Recording and Handling of Device Deficiencies................................................................. 41 
11.4 Reporting Responsibilities .................................................................................................. 42 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 42 
11.4.2 
Sponsor Notification of Events ............................................................................. 42 
11.5 Independent Data Monitoring Committee ........................................................................... 42 
12 Device Accountability .................................................................................................................... 43 
13 Deviations from the Clinical Investigation Plan ............................................................................. 43 
14 Data Management ........................................................................................................................ 43 
14.1 Source Data ........................................................................................................................ 43 
14.2 Methods for Data Entry and Collection ............................................................................... 44 
14.3 Database Lock .................................................................................................................... 44 
15 Confidentiality ................................................................................................................................ 45 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 45 
17 Suspension or Premature Termination ......................................................................................... 45 
18 Amendments to the Clinical Investigation Plan ............................................................................. 46 
19 Record Keeping and Retention ..................................................................................................... 46 
20 Publication Policy .......................................................................................................................... 46 
21 Statements of compliance ............................................................................................................. 47 
22 Quality Control and Assurance ..................................................................................................... 47 
22.1 Monitoring ........................................................................................................................... 47 
22.2 Audits .................................................................................................................................. 47 
23 Trademarks and Copyright ........................................................................................................... 48 
24 References .................................................................................................................................... 48 
24.1 Internal references .............................................................................................................. 48 
24.2 External references ............................................................................................................. 48 
25 Change History ............................................................................................................................. 49 
26 Appendix 1: Switching acceptability rating .................................................................................... 50 
27 Appendix 2: Clinician log ............................................................................................................... 51 
 
 
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3) To evaluate adult cochlear implant subjective 
hearing performance and sound quality with LP1 and 
LP3 MAPs 
3) Paired difference in global SSQ12 scores after 
experience with LP1 and LP3 MAPs 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction 
Mapping is an essential part of programming Nucleus cochlear implants (CIs) to provide electrical stimulation 
to the auditory system, which is perceived within the brain as sound. Generally, a program or "MAP" is 
created for the CI patient by setting threshold levels (T-levels; the minimal amount of electrical stimulation 
required for the auditory system to perceive sound) and comfort levels (C-levels; the upper limit of electrical 
stimulation judged to be most comfortable, or loud but comfortable). This process is typically done 
approximately 2-4 weeks post-implantation and is repeated at regularly scheduled intervals throughout the 
patient's lifetime to ensure maximum benefit. To ensure effective stimulation with a CI, the MAP levels need 
to be set below the voltage compliance limits of the system. Several parameters listed below can affect the 
ability to set levels within compliance limits. CI recipients use their sound processors all day, every day. 
Therefore, it is important to ensure that the battery life is as long as possible. Some of the MAP parameters 
listed below may also influence battery life.   
Pulse width (PW): In Nucleus CIs, a biphasic pulse is used to stimulate the auditory nerve fibers in the cochlea. 
PW refers to the duration of each phase of the biphasic pulse used for stimulation and is expressed in 
microseconds (µs). Figure 1 shows a schematic illustrating PW. A low PW of 25 or 37µs is used by default for 
creating MAPs with Nucleus CI to allow for high stimulation rates. Increasing the PW helps reduce the T and C 
levels, ensuring that the MAP levels are within compliance limits. Wider PW is also useful in reducing non-
auditory sensations such as facial nerve stimulation. The Custom Sound 5.2 software and newer versions have 
an “Auto Pulse Width” feature that automatically widens the PW on all channels to bring them back into 
compliance. 
Inter-phase gap (IPG): The IPG refers to the duration of the interval between the two phases of a biphasic 
electrical pulse used for stimulation. Figure 1 shows a schematic illustrating IPG. T and C levels reduce when 
IPG is increased, and this may help ensure that the MAP levels are within compliance limits. One of the 
strategies to reduce non-auditory sensations such as facial nerve stimulation is to increase the IPG. 
 
Figure 1: Schematic illustrating pulse width and interphase gap 
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this study. Since LP2 uses a lower rate and LP3 uses DE mode along with a lower rate, although they have 
greater battery life saving potential, they are harder to implement as a low power option as they produce a 
greater change in the sound quality. Thus, the comparison of LP1 with LP2 and LP3 forms the second primary 
objectives for this study. If the LP3 program provides suboptimal hearing performance, it may still be used as 
a low-power program on days when the CI recipient desires extended battery life and is willing to trade off 
hearing performance. However, in those instances, switching from one program to another (LP2 to LP3) will 
need to be acceptable. Thus, the ease of switching from LP2 to LP3 is a secondary objective in this study. We 
are also interested in hearing performance comparisons between LP2 and LP3 and real-world feedback, and 
thus they form the exploratory objectives of the study. 
Table 2: MAP parameter combinations to improve battery life.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This clinical study aims to confirm the in-booth performance of MAPs that use wider PW with 900Hz 
stimulation rate and MAPs with a combination of low rate (500Hz), wide PW (100µs), and wider IPG (12µs) in 
dual-electrode mode, compared with the default stimulation parameters currently used in Custom Sound 7.0. 
This study will build on the evidence collected in previous clinical studies listed in section 4.2.2. 
5 MEDICAL DEVICE INFORMATION 
5.1 
Identity and Description of the Investigational Medical Device (IMD) 
The IMD for this investigation is dual-electrode mode configuration of stimulation mode in the firmware of 
the Nucleus 7 (CP1000), Nucleus 8 (CP1110) and Kanso 2 (CP1150) sound processors outside of the 
functionality of the commercial system. Dual-electrode mode programs will be created using research 
software called Cochlear Device Interface Tool (CDI Tool). The investigational ACE MAPs include changes in 
electrical stimulation parameters such as stimulation rate, PW, stimulation mode and IPG listed in Table 2. 
This investigational MAPs are used solely for the purpose of clinical investigation. Figure 3 shows a screenshot 
of the CDI Tool software. 
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Figure 3: Screenshot of Cochlear Device Interface Tool (CDI Tool). 
The clinical hardware used in this study includes a computer with the research CDI Tool software, a 
commercially available programming pod, and a commercially available CP1000, CP1110 and CP1150 sound 
processor. The computer is connected to the programming pod, which is then connected to the sound 
processor. 
The development of the research tool (CDI) followed a design control process that is part of Cochlear’s 
ISO13485 compliant quality management system. The research tool has been verified for safety and technical 
correctness before use in a human trial. The research software tool underwent safety and performance 
testing according to Cochlear product risk management procedures, in accordance with EN ISO 14971, 
Medical devices – Application of risk management to medical devices (ISO 14971, 2004) standard. The overall 
residual risks associated with the investigational devices are acceptable. All risk reduction measures shown in 
the essential requirements document have been implemented into the final design and verified to be 
effective. 
Subjects will use the MAPs created using the research tool exclusively for the duration of the study. The 
research tool will be clearly labeled as such on the personal computer. The build number will be documented 
in the tracking forms, such as the Software Tracking Form (1302326), as mentioned in section 12 of this 
document. The investigator will undergo training on how to use the IMD and the research tool, and the 
completion of this training will be recorded in a training log.  
5.2 
Identity and Description of the Comparator 
The commercially available ACE coding strategy programmed with the default 900Hz stimulation rate will 
serve as the comparator. The investigator will use CDI Tool to create the comparator MAP. MAPs will be 
written to the commercially available CP1000, CP1110 and CP1150 sound processors. 
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5.3 
Accessory Device Requirements 
Not applicable. 
6 OBJECTIVES 
Table 3: Schematic overview of the objectives 
 
Primary 
objective 
Secondary 
objective 
Exploratory 
objective 
Quiet testing 
Default Vs LP1 
 
LP1 Vs LP2 
LP1 Vs LP3 
LP2 Vs LP3 
Noise testing 
Default Vs LP1 
LP1 Vs LP2 
LP1 Vs LP3 
LP2 Vs LP3 
Questionnaire 
- 
LP2 Vs LP3 (SAR) 
LP1 Vs LP3 (SSQ) 
6.1 
Primary Objectives  
1) To evaluate speech perception in quiet with default and LP11 MAPs. 
2) To evaluate speech perception in noise with default and LP1 MAPs 
6.2 
Secondary Objectives 
1) To evaluate speech perception in quiet with LP1 and LP22 MAPs 
2) To evaluate speech perception in noise with LP1 and LP2 MAPs 
3) To evaluate speech perception in quiet with LP1 and LP33 MAPs.  
4) To evaluate speech perception in noise with LP1 and LP3 MAPs  
5) To evaluate acceptance of switching between LP2 and LP3 MAPs 
6.3 
Exploratory Objectives 
1) To evaluate speech perception in quiet with LP2 and LP3 MAPs 
2) To evaluate speech perception in noise with LP2 and LP3 MAPs 
3) To evaluate adult cochlear implant subjective hearing performance and sound quality with LP1 and 
LP3 MAPs 
___________________________________________ 
 
 
 
 
 
 
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7 DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
This is a prospective, single centre, single-blind, single-subject repeated measure investigation, of hearing 
outcomes when adult CI recipients are programmed with different rates or pulse-widths along with dual-
electrode mode compared with standard programming parameters. 
The subjects include adults aged 18 years and older with sensorineural hearing impairment who are current 
users of a Nucleus CI system. Subjects will be screened, and 20 eligible subjects will be recruited in the clinical 
investigation from a single investigational site located in Australia. After enrolment, ACE MAPs will be created 
with the parameters in  Table 2 using CDI tool in visit 1. 
 
  
 
Figure 4: Simplified schematic of study procedures 
Subjects will attend a minimum of three scheduled study visits over an eight-week study period as described 
in the CIP Schedule of Events (Section 3). Additional study visits may be scheduled if all study procedures 
could not be completed during a scheduled visit. At study visits, subjects will undergo hearing assessments 
and complete questionnaires. The primary objectives are to determine the hearing performance of LP1 MAP 
compared to default MAP at the end of the study, as assessed by speech perception performance. Safety will 
be assessed by recording and summarising all Adverse Events (AE)/ Adverse Device Effects (ADE) and Device 
Deficiencies (DD). No data monitoring committee will be used for this clinical investigation. All subjects will 
attend an end-of-study visit at the time they complete the study. 
 
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7.1.1 
Design Rationale 
Subjects 
• 
Only CI recipients implanted with the CI500 series, CI600 series or Freedom series CIs in one or both 
ears are included as the CDI tool only supports these CIs. 
• 
Hearing ability and the MAPs undergo significant changes in the first months after implantation. Thus, 
CI recipients with at least three months experience with their CI will be enrolled so that any changes 
in their hearing function do not act as confounding variables. 
• 
Only adult CI recipients rather than children have been chosen as the study population due to their 
ability to compare MAPs, in and outside of the booth. Additionally, performance benefits achieved by 
adults can generally be extrapolated to younger age groups, avoiding the need to recruit this 
vulnerable population. 
• 
Only subjects who are able to score 20% or more for English CNC words presented at 60dB SPL RMS 
with CI alone in the test ear will be recruited to avoid floor effects. 
• 
Only subjects willing and able to provide written informed consent will be enrolled to be compliant 
with ISO 14155. 
• 
Investigator site personnel directly affiliated with this study and/or their immediate families; 
immediate family is defined as a spouse, parent, child, or sibling or Cochlear employees or employees 
of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this 
investigation will be excluded to avoid enrolment of a vulnerable population. 
• 
Only subjects with all 22 electrodes active in the MAP used regularly will be enrolled as all 22 
electrodes are required to create a MAP with dual-electrode mode that is comparable across subjects. 
Blinding 
• 
Blinding of the study subject will be undertaken, to reduce any bias. Subjects will not be told which 
MAP will be loaded in the sound processor for take home use and which MAP order to be tested at 
Visit 2 and Visit 3. 
• 
There will be no blinding of the study investigators. 
Visit window 
• 
The stimulation rate and dual-electrode mode is likely to be novel to the study subjects. Subjects will 
be asked to use MAPs with 900Hz (default & LP1) and 500Hz (LP2 & LP3) for at least four weeks so 
that they have sufficient experience with the MAP prior to the speech perception tests with those 
MAPs.  
Outcome measures 
• 
CNC words: Speech perception in quiet will be measured using recorded CNC monosyllabic words 
(Peterson & Lehiste, 1962) at 60dBSPL from S0 position. CNC words in quiet at 60dB SPL presentation 
level will be used to emulate conversational levels. The goal of speech perception assessment in quiet 
is to compare % words correct for each of the conditions. This outcome measure is routinely used in 
clinical practice and research studies.  
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• 
Australian Speech Test In Noise (AuSTIN): Speech perception in noise will be measured using the 
AuSTIN (Dawson et al., 2013), which is a test that uses recorded BKB like target sentences. The goal of 
the speech perception test in noise is to provide the SNR for 50% speech intelligibility. AuSTIN speech 
perception test will be used to evaluate hearing in noise ability in the sound booth. The test is used 
routinely in clinical practice and research studies. 
• 
The Speech and spatial qualities questionnaire (SSQ12) is designed to measure a range of hearing 
disabilities across several domains (Noble et al., 2013) in real world conditions. This questionnaire is 
routinely used in clinical practice and research studies. 
• 
Switching acceptability rating (SAR): The SAR is an unvalidated rating scale designed to gather 
subjective feedback on the sound quality differences between two programs and assess the difficulty 
in acclimating to a new MAP after using it for 10 minutes to listen to recorded and live speech 
(Appendix 1). 
• 
Clinician log: The clinician log will capture the MAP changes made by the clinician in response to the 
subject’s feedback.  
• 
Comparisons will be made within-subject with repeated measures for each of the MAPs to be 
evaluated so that any subject specific variable that can potentially affect the outcomes has equal 
effect on all conditions. 
• 
Counterbalancing of the test order will be undertaken where possible to limit the influence of order 
effects on results. 
7.2 
Subjects 
Written, informed consent must be obtained from the subject before any study procedures are initiated. 
Eligibility of subjects must be supported by a CNC word test score at 60dB (available within 12 months prior to 
enrolment or conducted at screening) to confirm that the subject is able to score 20% or more in the ear to be 
studied. Custom Sound data can be used to confirm age, suitable implant type, duration of CI use, and 
number of active electrodes. 
7.2.1 
Inclusion Criteria 
Subjects must meet all of the inclusion criteria described below to be eligible for this clinical investigation. 
1) Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) 
or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422) 
2) At least three months after activation of the cochlear implant. 
3) Eighteen years or older at the time of consent. 
4) User of 900Hz ACE (Advanced Combination Encoder) strategy MAP. 
5) Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear. 
6) Fluent speaker in English. 
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7) Willing and able to provide written informed consent. 
7.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical 
investigation. 
1) One or more electrodes turned off in the MAP used regularly. 
2) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the 
Investigator. 
3) Investigator site personnel directly affiliated with this study and/or their immediate families; 
immediate family is defined as a spouse, parent, child, or sibling. 
4) Cochlear employees or employees of Contract Research Organisations or contractors engaged by 
Cochlear for the purposes of this investigation.  
5) Current participation, or participation in another interventional clinical study/trial in the past 30 days, 
involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored 
investigation and determined by the investigator or Sponsor to not impact this investigation). 
7.2.3 
Number of Subjects Required 
Twenty subjects will be enrolled in the study to meet sample size calculation requirements stated in section 
9.4 with the allowance for dropout rate (25%) and to ensure balanced subgroups. 
7.2.4 
Vulnerable Populations 
Not applicable for the current clinical investigation. 
7.2.5 
Recruitment and Study Duration 
The following subject status definitions apply: 
• 
Enrolled: A subject that has signed the Informed Consent form for the study.  
• 
Screen Fail: An Enrolled subject that has been determined to not meet one or more eligibility criteria. 
• 
Participated: Subjects who have met eligibility criteria and have commenced visit 1 procedures. 
• 
Discontinued: An Enrolled subject who withdrew consent, was discontinued by the Investigator or 
Sponsor before the expected End of Study visit or lost to follow-up. Discontinued subjects may still 
have safety follow up data collection until their scheduled End of Study visit, for reasons described in 
section 7.2.6. 
• 
Completed: Enrolled subjects who complete the required treatment and visit schedule.  
The recruitment period for the clinical investigation is estimated to be seven months from the time of first 
subject consent to recruitment of the last subject. This is to allow the replacement of any subjects who 
withdraw from the study. 
The expected minimum duration of each subject’s participation in the clinical investigation, is eight weeks, 
from the time of informed consent through to the End of Study when devices are returned. The anticipated 
total duration of the clinical investigation is 12 months. 
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Clinical Investigation completion is last subject last visit. In the event of an ongoing SAEs/SADEs at the time of 
this last visit, the clinical investigation completion will be extended for a further 30 days, or until resolution or 
stabilisation of the event, whichever comes first. 
7.2.6 
Criteria and Procedures for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the reason(s), 
however subjects have the right to withhold their reason if preferred. The reason for withdrawal should be 
documented in the subject’s source files and the case report form (CRF), if provided. 
The Investigator or Sponsor may also decide to withdraw a subject from the clinical investigation or stop the 
use of the investigational device if it is considered to be in the subject’s best interests. 
Subject withdrawal may be for any of the following reasons: 
• 
Adverse Event (AE) 
• 
Device Deficiency (DD) 
• 
CIP or GCP deviation 
• 
Subject withdrew consent 
• 
Subject lost to follow-up 
• 
Subject death 
• 
Sponsor decision 
• 
Investigator decision 
• 
Other (specify) 
If subject withdrawal is due to problems related to the IMD safety or performance, the Investigator shall ask 
for the subject's permission to continue in safety follow up (for example, adverse events and device 
deficiencies) until their scheduled End-of-Study visit. 
If a subject is lost to follow-up, every possible effort must be made by the study site personnel to contact the 
subject and determine the reason for discontinuation. At least 3 separate attempts taken to contact the 
subject must be documented. 
Participating subjects who are withdrawn/discontinued before the data for primary and secondary endpoints 
have been collected, may be replaced to meet the minimum sample size criteria or to maintain 
counterbalancing between the groups.  
7.2.7 
Randomisation Procedures 
Subjects will be randomly allocated to one of four groups. Programming of sound processors for take home 
use and test order during visits 2 and 3 will be performed as per the randomisation table (Table 4).  
 
 
 
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Table 4: Randomisation table 
 
Take home 
programs 
Visit 2 test 
order 
Take home 
programs 
Visit 3 test 
order 
Group 1A 
P1: Default 
P2: LP1 
Test 1: Default 
Test 2: LP1 
P1: LP2 
P2: LP3 
Test 1: LP2 
Test 2: LP3 
Group 1B 
P1: LP1 
P2: Default 
Test 1: LP1 
Test 2: Default 
P1: LP3 
P2: LP2 
Test 1: LP3 
Test 2: LP2 
Group 2A 
P1: LP2 
P2: LP3 
Test 1: LP2 
Test 2: LP3 
P1: Default 
P2: LP1 
Test 1: Default 
Test 2: LP1 
Group 2B 
P1: LP3 
P2: LP2 
Test 1: LP3 
Test 2: LP2 
P1: LP1 
P2: Default 
Test 1: LP1 
Test 2: Default 
 
7.2.7.1 
Blinding Procedures 
 For in-booth speech perception testing, the test order will not be revealed to the study subject. The 
counterbalancing procedures will be used to ensure that there is a balanced order of test conditions.  
7.2.8 
Post-investigation Medical Care 
As this clinical investigation is non-surgical in nature, no specific medical care will be provided for the subjects 
after the clinical investigation has been completed. All IMD management during the study will be done by the 
study investigators. Subjects will be able to see their regular clinicians when wearing their own sound 
processors. At the end of the study, subjects will return all loaner and investigational devices to the 
investigator and return to using their own sound processors programmed with commercial programming 
software versions.  Subjects will continue to be clinically managed by their regular clinician according to their 
clinic’s standard practice after the clinical investigation has been completed.  
7.3 
Evaluations and Procedures 
7.3.1 
Screening/eligibility 
• 
Informed consent: Informed consent will be obtained as per procedures detailed in section 10 
• 
Eligibility: The subject’s Custom Sound data will be reviewed to assess the eligibility in terms of age, 
implant type, number of active electrodes and duration of CI experience. Historical CNC word test 
results (60dB) will be reviewed to ascertain eligibility. If historical data in the last 12 months is not 
available, then one list of CNC words at 60dB presentation level will be administered on each 
implanted ear to determine eligibility after informed consent is obtained. For bilateral CI recipients, 
the better ear in terms of CNC word scores will be chosen as the test ear. The subject’s preferred ear 
will be chosen in the event that both ears are eligible and have the same test scores for CNC words. 
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• 
Standard CRFs: CRFs including demographics, eligibility, medical, hearing and device history, 
concomitant medications and device exposure will be completed. 
 
7.3.2 
Performance/Effectiveness 
Section 3 shows the overall schedule of events to be followed in this study. Figure 4 shows a simple schematic 
of the study procedures. Below each visit procedures are provided in greater detail. The subjects will be 
randomly allocated to groups 1A, 1B, 2A or 2B.  
Visit 1:  
• 
Mapping: Four MAPs using parameters listed in Table 2 will be created. The default MAP will be 
created by measuring T-levels on electrodes 22, 16, 11, 6, 3, and 1. If required, additional T-levels may 
be measured by the clinician. The Hughson-Westlake method will be used for T-level measurement, 
aiming for two out of three detections on an ascending run with step sizes of 2 CL up and 4 CL down. 
Two beeps will be used to determine the T-levels. The C-level profile will use the T-level profile as the 
starting point. C-levels will be raised globally in live mode until ongoing conversational speech is 
comfortably loud. The C-levels will be balanced in overlapping groups of three channels. Additional 
T/C level modifications may be made by the clinician to address any sound quality issues. The T and C 
levels from the default MAP will be converted to create the LP1, LP2 and LP3 MAPs. For LP3, the T and 
C levels for each dual channel will be configured to be an average of the two single electrodes 
comprising the channel. The clinician may change the levels as required to ensure that the LP MAPs 
are acceptable and have the same loudness as the default MAP by global C-level adjustments and 
ensuring loudness balance across channels. Loudness balancing will be performed to ensure all MAPs 
are equally loud. The investigators will be provided hands on training by the sponsor on the use of CDI 
Tool research software for the creation of the MAPs.  
• 
Clinician log: The clinicians creating the different MAPs will be asked to complete a log (Appendix 2) 
to record the steps undertaken during creation and optimisation of the different MAPs. The log will 
capture the clinician’s action and the feedback from the CI recipient. To aid in the completion of the 
log, screen recording with audio recording will be captured.  
• 
Preparation of take-home sound processor: Group 1 will be provided with 900Hz MAPs (Default and 
LP1), and group 2 will be provided with 500Hz MAPs (LP2 and LP3) as per the randomisation table 
(Table 4). The SmartSound environments in the frequently used program in their own sound 
processor will be replicated in the study sound processor with the exception of automatic forward 
focus (SCAN2FF). Subjects using a SCAN2FF program in their own sound processor will be provided a 
SCAN2 program with user-controlled ForwardFocus enabled.  
• 
Issue of SSQ12: The SSQ12 questionnaire will be issued, and the subjects will be counselled on how to 
complete the questionnaire as needed. The subjects will be asked to rate their ability to hear speech 
in a variety of competing contexts during their take home period. Subjects are also asked about their 
spatial hearing abilities including the impact of direction, distance and movement associated with 
spatial hearing. 
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• 
Counselling for take home use: Subjects will be asked to switch from program 1 to program 2 on a 
daily basis so that they acclimate to both programs and to get equal opportunity to use both 
programs during the take home period. Subjects who typically used the SCAN2FF program prior to 
enrolment will be asked to use user-controlled ForwardFocus during the take home period. 
• 
Standard CRFs: CRFs including concomitant medications, adverse events and device deficiencies will 
be completed. 
 
Take home use:  
• 
Subjects will be asked to use two MAPs for four weeks. The subjects will be asked to use P1 on day 1, 
P2 on day 2, P1 on day 3 etc. 
• 
Subjects will be asked to complete the SSQ12 in the fourth week of take home use. 
 
Visit 2:  
• 
Collection of SSQ12: 
• 
Acclimatization: Subjects will be asked to use the specified test MAP for a period of minimum 10 
minutes and listen to live or recorded speech to acclimate to two conditions prior to speech 
perception testing. Contralateral device will be turned off (if applicable). 
• 
SAR: The subjects will be asked to provide responses to the questions in the SAR as soon as they have 
switched to the new MAP at the end of the acclimatisation period.     
• 
CNC word test (60dB):  Two lists with 50 words each will be administered per condition. The 
contralateral ear will be plugged. The test order will be determined using the randomisation table (Table 
4) 
• 
AuSTIN sentence test: Both recorded speech and noise (adaptive four talker babble noise) will be 
presented from 0 degrees azimuth (S0N0). The signal level will be fixed at 65 dB SPL. One practice list 
will be administered at the beginning of the session to overcome learning effects. Two lists with 20 
sentences each will be administered per condition. If the standard deviation (SD) for any list exceeds 
4.12, then the run will be considered as invalid and additional list will be administered. The 
contralateral ear will be plugged.  
• 
Loading MAPs to processors:   CDI Tool will be used to load the test MAPs into a study sound 
processor for take home use as per the randomisation table (Table 4).   
• 
Issue of SSQ12: The SSQ12 questionnaire will be issued, and the subjects will be counselled on how to 
complete the questionnaire  as needed.  
• 
Standard CRFs: CRFs including concomitant medications, adverse events, device deficiencies and 
device exposure will be completed. 
 
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Take home use:  
• 
Subjects will be asked to use two MAPs for four weeks. The subjects will be asked to use P1 on day 1, 
P2 on day 2, P1 on day 3 etc. 
• 
Subjects will be asked to complete the SSQ12 in the fourth week of take home use. 
Visit 3:  
• 
Collection of SSQ12: 
• 
Acclimatization: Subjects will be asked to use the specified test MAP for a period of minimum 10 
minutes and listen to live or recorded speech to acclimate to the two conditions prior to speech 
perception testing. Contralateral device will be turned off (if applicable). 
• 
SAR: The subjects will be asked to provide responses to the questions in the SAR as soon as they have 
switched to the new MAP at the end of the acclimatisation period.     
• 
CNC word test (60dB):  Two lists with 50 words each will be administered per condition. The 
contralateral ear will be plugged. The test order will be determined using the randomisation table (Table 
4) 
• 
AuSTIN sentence test: Both recorded speech and noise (adaptive four talker babble noise) will be 
presented from 0 degrees azimuth (S0N0). The signal level will be fixed at 65 dB SPL. One practice list 
will be administered at the beginning of the session to overcome learning effects. Two lists with 20 
sentences each will be administered per condition. If the SD for any list exceeds 4.12, then the run will 
be considered as invalid and additional list will be administered. The contralateral ear will be plugged.  
• 
Standard CRFs: CRFs including concomitant medications, adverse events, device deficiencies and 
device exposure will be completed. 
Additional visits 
• 
Additional visits may be conducted in case any of the procedures in any of the visits could not be 
completed. 
End of study 
• 
Return of devices: The study devices will be collected back from the subjects. 
• 
Programming own device: The subject’s own sound processor will be checked to ensure that it 
contains their own MAPs and is programmed with the commercial version of Custom Sound fitting 
software. 
7.3.3 
Safety Evaluations and Procedures 
The risks and anticipated ADEs for the IMD, as identified in Sections 8.2 and 8.3 of the CIP, will be assessed in 
the clinical investigation via reporting of all AEs/ADEs from the time of first subject first visit until last subject 
last visit. 
 
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Safety data adjudication will be conducted by the Sponsor in accordance with the Sponsor’s standard 
operating procedures. 
7.3.3.1 
Concomitant Medication and Therapies 
All concomitant medical treatments will be collected as part of this study.  
7.4 
Equipment Used for Evaluations and Procedures 
7.4.1 
Software 
Speech testing in quiet and noise will be performed using the SRT software. The printed test report will be 
considered as source data. The electronic data generated from the tests will be stored in a secure network 
drive at the site. 
The programming will be performed using CDI Tool and Custom Sound 7.0. The electronic data generated 
from the programming will be stored in a secure network drive at the site. 
A commercially available screen recording software will be used for screen recording to aid the completion of 
the clinician log. 
7.4.2 
Sound room equipment 
Speech perception performance in quiet and in noise will be assessed using a loudspeaker configuration with 
the speech from the front (S0) and speech and noise from the front (S0N0) respectively. 
There will be defined locations for the loudspeakers and subject within the test environment. The 
loudspeakers will be located at head height for a seated subject (reference point). The distance of the 
loudspeaker from the reference point will be fixed.  
To ensure accurate and reliable results, the equipment in the sound room will undergo an annual calibration. 
Additionally, a quick calibration check will be performed routinely to maintain the quality of the equipment.  
7.4.3 
Questionnaires 
Paper-based questionnaires will be used to gather responses on SSQ12 from subjects and to be entered into 
EDC by site staff.  
7.5 
Sponsor Role in Conduct of the Clinical Investigation 
Sponsor and investigator roles are assumed by Cochlear employees.  
This clinical investigation will be conducted by an internal site. Internal sites are clinical research facilities 
owned and operated by Cochlear. The internal site at Cochlear in Sydney consists of a small team of 
Investigators, trained as clinical audiologists, to execute this research activity including subject recruitment, 
programming and study evaluations and data entry into eCRF. Investigators are qualified audiologists familiar 
with CI development, surgery and programming. The list of authorised personnel and their roles will be 
recorded in the delegation log. Investigators’ trial materials, programming and testing rooms (sound booths) 
will only be accessible to the study team and will be securely separated from rest of the organisation.  
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8 BENEFITS AND RISKS OF THE INVESTIGATIONAL MEDICAL DEVICE AND CLINICAL 
INVESTIGATION 
8.1 
Anticipated Clinical Benefits  
There is no anticipated clinical benefit for subjects. The investigational MAPs and research tools will be used 
within the study period only. The indirect benefit could be that in future, through this clinical investigation, 
Cochlear may bring product improvements to the market that improve battery life for CI recipients. 
 
8.2 
Anticipated Adverse Device Effects 
The subjects of this clinical investigation are already implanted with a commercially available Nucleus implant 
device, independent of this study. No medication will be prescribed for the study. 
The expected risks with use of commercially available CP1000, CP1110 and CP1150 sound processors are 
described in user guides. 
The investigation is focused solely on hearing therapy, specifically fitting. The electrical stimulation can be 
different from their own sound processor device due to changes in the MAPs. Subjects will have access to 
their standard baseline MAP on their own sound processor that they can return to at all times.  
 
8.3 
Risks Associated with Participation in the Clinical Investigation 
Potential clinical risks associated with participation in the clinical investigation include: 
Uncomfortably loud stimulation: The subjects will undergo programming of their CI using research software. 
Fitting is a key step of the study, and the associated risk is not exceeding the risk during normal clinical 
handling of a CI. To mitigate this risk, the same level of control measures is implemented in the research 
software as in the standard commercial clinical fitting software. Furthermore, the fitting is conducted or 
overseen by an experienced clinician. 
Non-auditory stimulation: In rare cases, stimulation of the CI can lead to stimulation of non-auditory 
structures such as the facial nerve. It is a standard hazard in clinical management of hearing implant users. It 
is essentially controlled during fitting of the implant. Also, this will always be known already from the clinical 
experience with the subject and can be prevented by e.g., stimulating just below the level when the non-
auditory stimulation occurs or by deactivating specific electrode channel(s). Also, the fitting is conducted or 
overseen by an experienced clinician. The associated risk is not exceeding the normal clinical handling of a CI. 
Wrong stimulation delivered (within safety limits): It is conceivable that due to an implementation error in 
research firmware or software a wrong stimulus would be delivered. Through thorough formal verification the 
probability that unintended electrical pulses would be delivered is low. 
Sub-optimal fitting of the device resulting in sub-optimal performance: It is possible that investigational 
MAPs result in a decline of hearing outcomes. It is well known that some types of changes to a MAP may lead 
to an acute minor decline in hearing outcomes. As the CI user adapts to the new sound quality, this decline is 
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often temporary. But in the worst case a user may not adapt. In this study a CI clinician will be available to 
provide hearing care, and address reports of degraded performance. In the case of prolonged observed 
systematic decrease in performance the particular test set-up/condition can be halted. Subjects will also have 
access to their standard baseline MAP on their own sound processor that they can return to at all times. 
Again, this risk is similar to the risk in normal clinical management. 
After the study has been finished, the patients will return to their original/preferred MAP using their own 
sound processor.  
It is expected that there may be increased inconvenience and potential discomforts to study subjects, but no 
potential risk of physical or psychological harms have been identified. In summary, the risks involved with the 
clinical investigation procedures are not substantially different from the risks associated with a normal clinical 
session with CI users.  
8.4 
Risk Mitigation 
The investigational software and firmware to be assessed will undergo safety and performance testing 
according to Cochlear product risk management procedures, in accordance with EN ISO 14971 (Medical 
devices – Application of risk management to medical devices) standards. 
The following will be performed during the clinical investigation to mitigate the risks identified above: 
• 
Detailed study procedure instructions are provided to the investigator to mitigate the risks of 
inappropriate use of the investigational device. 
• 
Investigators are trained to avoid over-stimulation and/or non-auditory stimulation and the recipient 
has the possibility to remove the coil of the sound processor from their head to stop stimulation.  
• 
Subjects may revert to using their own Nucleus sound processor programs, if in a situation where it is 
felt that performance is not sufficient with the new program(s).  
All reported ADEs and DDs will be regularly reviewed by the Sponsor’s Clinical Review Board for the 
duration of the study to facilitate early detection and appropriate intervention if events are unanticipated 
with respect to incidence, severity, or outcome. 
8.5 
Benefit-to Risk Rationale 
The risks involved with the investigational devices to be evaluated under this clinical investigation are not 
substantially different from the risks associated with normal CI users, and the risks involved with the clinical 
investigation procedures are not substantially different from the risks associated with a normal clinical session 
for CI users. 
The potential temporary inconveniences and discomforts associated with participation in this investigation is 
proportional to the indirect benefits, as described in section 8.1.  
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9 STATISTICAL CONSIDERATIONS 
9.1 
General Considerations 
See sections 9.2 to 9.8 for statistical considerations. 
9.2 
Endpoints 
For speech in quiet (CNC) endpoints, two lists of words will be measured per sound processor condition, and 
the two percentage words correct values will be averaged to produce a single value per condition, per subject.  
For speech in noise (AuSTIN) endpoints, two lists of sentences will be measured per sound processor 
condition, and the two dB SRT values will be averaged to produce a single value per condition, per subject.  
Each SSQ questionnaire which includes 12 questions will be measured per sound processor condition per 
person. The score is a continuous numeric score, and a single value will be recorded per question.  For the 
SSQ12 endpoint, the total scores will be compared. 
 
9.2.1 
Primary Endpoints 
1) Paired difference in percentage CNC Words correct between default and LP1 MAPs in quiet setting 
2) Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise   
9.2.2 
Secondary Endpoints 
1) Paired difference in percentage CNC Words correct between LP1 MAP and LP2 MAP in quiet setting 
2) Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise  
3) Paired difference in percentage CNC Words correct between LP1 and LP3 MAPs in quiet setting  
4) Paired difference in dB SRT (AuSTIN) between LP1 and LP3 MAPs in noise  
5) Ratings on switching acceptability rating 
9.2.3 
Exploratory Endpoints 
1) Paired difference in percentage CNC Words correct with LP2 and LP3 MAPs 
2) Paired difference in dB SRT (AuSTIN) between LP2 and L3 MAPs  
3) Paired difference in global SSQ12 scores after experience with LP1 and LP3 MAPs  
 
9.3 
Hypotheses 
For the non-inferiority test of CNC words, the 95% CI (alpha=0.025 one-sided) for the mean paired difference 
will be estimated. If the lower limit of the 95% CI of the mean paired difference is above -10%, the treatment 
condition is regarded as non-inferior to the control on that measure.  
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For the non-inferiority test of SRT sentences for both primary and secondary endpoints, the 95% CI 
(alpha=0.025 one-sided) for the mean paired difference will be calculated. If the upper limit of the 95% CI of 
the mean paired difference is lower than 1dB, the treatment condition is regarded as non-inferior to the 
control on that measure.  
9.3.1 
Primary Hypotheses 
Primary endpoint 1: Paired difference in percentage CNC Words correct between default and LP1 MAPs in 
quiet setting  
H0: Words in quiet (60 dB CNC words) scores (% words correct) with the LP1 MAP are inferior to those 
with the default MAP.  
LP1 – default < -10% 
H1: Words in quiet (60 dB CNC words) scores (% words correct) with the LP1 MAP are non-inferior to 
those with the default MAP.  
LP1 – default > -10% 
 
Primary endpoint 2: Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise 
H0: Sentence in noise scores (dB SRT) with the LP1 MAP are inferior to those with the default MAP.  
LP1 MAP – default ≥ 1 dB (NB: higher SRT scores represent poorer performance) 
H1: Sentence in noise scores (dB SRT) with the LP1 MAP are non-inferior to those with the default 
MAP  
LP1 MAP – default < 1 dB 
 
9.3.2 
Secondary Hypotheses 
Secondary endpoint 1: Paired difference in percentage CNC Words correct between LP1 MAP and LP2 MAP in 
quiet setting 
H0: Words in quiet (60 dB CNC words) scores (% words correct) with the LP2 MAP are inferior to those 
with the LP1 MAP  
LP2 – LP1 < -10% 
H1: Words in quiet (60 dB CNC words) scores (% words correct) with the LP2 MAP are non-inferior to 
those with the LP1 MAP  
LP2 – LP1 > -10% 
 
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Secondary endpoint 2: Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise 
H0: Sentence in noise scores (dB SRT) with the LP2 MAP are inferior to those with the LP1 MAP  
LP2 MAP – LP1 ≥ 1 dB (NB: higher SRT scores represent poorer performance) 
H1: Sentence in noise scores (dB SRT) with the LP2 MAP are non-inferior to those with the LP1 MAP  
LP2 MAP – LP1 < 1 dB 
Secondary endpoint 3: Paired difference in percentage CNC Words correct between LP1 and LP3 MAPs in 
quiet setting 
H0: Words in quiet (60 dB CNC words) scores (% words correct) with the LP3 MAP are inferior to those 
with the LP1 MAP  
LP3 – LP1 < -10%  
H1: Words in quiet (60 dB CNC words) scores (% words correct) with the LP3 MAP are non-inferior to 
those with the LP1 MAP  
LP3 – LP1 > -10% 
 
Secondary endpoint 4: Paired difference in dB SRT (AuSTIN) between LP1 and LP3 MAPs  in noise 
H0: Sentence in noise scores (dB SRT) with the LP3 MAP are inferior to those with the LP1 MAP  
LP3 MAP – LP1 ≥ 1 dB (NB: higher SRT scores represent poorer performance) 
 
H1: Sentence in noise scores (dB SRT) with the LP3 MAP are non-inferior to those with the LP1 MAP  
LP3 MAP – LP1 < 1 dB 
 
Secondary endpoint 5: Ratings on switching acceptability rating. 
There are no hypotheses for this endpoint. 
 
9.3.3 
Exploratory Hypothesis 
There are no exploratory hypotheses. 
9.4 
Sample Size Determination 
This study is a non-inferiority design, and sample size calculation was based on non-inferiority tests for CNC 
word scores and SRT (Speech Recognition Threshold) scores.  
To reject the null hypothesis of inferior CNC Words correct in quiet (60 dB) scores, a sample size of 14 will 
provide more than 90% power to detect non-inferiority of CNC word scores and 90% power to detect non-
inferiority of SRT with the following parameters:  
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• 
A clinically important difference value of 10% for CNC words and 1 dB SRT for AuSTIN. This margin is 
based on clinical consensus. 
• 
A SD of change or difference scores of 6.914% for CNC words and 1.037 dB for AuSTIN. The expected 
standard deviation of difference scores for CNC words was based on a previous dual electrode mode 
study (CRC 5523) on the relevant endpoints. 
• 
A significance level α = 0.025 (one-tailed).  
 
There are four subgroups in the randomisation table (Table 4); to ensure equal number of subjects in each 
subgroup a minimum of sample size of 16 (or a higher multiple of 4) is required.  Twenty subjects will be 
enrolled in total to allow for any unforeseen subject withdrawal with a possible attrition rate of 25% and to 
ensure equal number of subjects in the four subgroups. Replaced subjects will be recruited if the minimum 
sample size of 16 could not be met due to subject withdrawal or loss to follow up.  
9.5 
Analysis Populations 
The analysis of the primary endpoint will be based on the Intent-To-Treat (ITT) and Per Protocol (PP) analysis 
populations in order to support a conclusion of non-inferiority. The inclusion of both ITT and PP populations 
has been chosen to assess the robustness of the study results and the consistency of the study measures 
under different analysis populations.  
This study has a non-inferiority design; therefore, the primary analysis will be based on the PP population.  
For cases in which the ITT and PP populations lead to the same conclusions and final interpretations about the 
LP MAP effect, the results will be considered to not be influenced by underlying factors such as missing data 
and protocol deviations, and the results would be considered to be robust and consistent under different 
analysis populations. A statement to reflect this will be included in the CIR. 
For cases in which the ITT and PP populations lead to different final interpretations or conclusions, all of the 
results will be reported and the differences in outcomes will be identified and explored. 
Intent-to-Treat Population 
The Intent-to-Treat Population will include all subjects who receive the MAPs and have at least one set of 
paired MAPs measurements from any endpoint, regardless of protocol deviations and missing data.   
Per Protocol Population 
The Per Protocol Population will include all subjects who receive the MAPs and have at least one set of paired 
MAPs measurements without major protocol deviations from any endpoint. Major deviations will be defined 
and documented at the clean file meeting before data base lock.  
It is possible that a LP MAPs has not been administered in the intended counterbalanced order of 
presentation. It is also expected that the sequence and period effects are minimal in this study if any. This 
study is not a full cross-over design, so period and sequence effects will not be assessed, without the 
consequence to bias the study conclusion.  
Safety Population 
The Safety Population will include all subjects who used the investigational MAPs. The Safety Population will 
be used for the safety data analysis. 
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9.6 
Endpoint Analyses 
For all hypothesis testing to be performed on primary and secondary endpoints, the overall type I error rate 
will be maintained via a gatekeeping approach whereby statistical tests will proceed in order as stated under 
the section 9.3 until a non-significant test is obtained, at which point, formal testing for the purposes of 
labelling claims will cease. However, summary statistics on the remaining endpoints will still be performed.  
9.6.1 
Primary Endpoint Analyses 
SRT sentence scores in noise and words in quiet scores at different speech testing conditions will be listed and 
summarised descriptively by treatment group and study population. A Scatter plot or similar plot will be used 
to present the individual data by treatment group, and bar chart will be used to present the average paired 
difference and its standard error.  
For the non-inferiority test of words in quiet scores, the 95% CI (alpha=0.025 one-sided) for the mean paired 
difference will be estimated. If the lower limit of the 95% CI of the mean paired difference is above -10%, the 
treatment condition is regarded as non-inferior to the control in term of words in quiet perception. The non-
inferiority margin of -10% for words in quiet scores (monosyllables) is also based on clinical consensus.  
For the non-inferiority test of SRT sentence scores the 95% CI (alpha=0.025 one-sided) for the mean paired 
difference will be estimated. If the upper limit of the 95% CI of the mean paired difference is lower than 1dB, 
the treatment condition is regarded as non-inferior to the control in term of SRT sentence perception. The 
non-inferiority margin of 1dB for SRT is based on clinical consensus.  
9.6.2 
Secondary Endpoint Analyses 
SRT sentence scores in noise and words in quiet scores at different speech testing conditions will be listed and 
summarised descriptively by treatment group and study population. A Scatter plot or similar plot will be used 
to present the individual data by treatment group, and bar chart will be used to present the average paired 
difference and its standard error. Non-inferiority test of words in quiet and SRT sentence scores will be 
performed as described above in section 9.6.1. 
Data from SAR will be summarised descriptively including mean, standard deviation and min/max for 
quantitative data. Qualitative data will be presented in the appendix of the report and summarised in the 
results. 
9.6.3 
Exploratory Endpoint Analyses 
SSQ12 and SAR data will be listed and summarised descriptively by treatment group and study population. A 
Scatter plot or similar plot will be used to present the individual data by treatment group, and bar chart or 
scatter plot will be used to present the average paired difference and its standard error.  
Data from the clinician log and the results for individual questions on the SSQ12 will be summarised 
descriptively including mean, standard deviation and min/max for quantitative data. Qualitative data will be 
presented in the appendix of the report and summarised in the results.  
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9.7 
Safety Analyses 
For AE, the incidence of occurrence, defined as the proportion of patients who have experienced at least one 
event, will be reported by intervention group. Similar summaries will be provided for ADEs and DDs.  The 
number and proportion of subjects who died, who discontinued an intervention due to an AE/ADEs, or who 
experienced a severe or an SAE/SADEs will be summarised separately. 
9.8 
Interim Analyses 
No formal interim analysis will be conducted.  
10 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject using an approved ICF prior to any 
clinical investigation-related examination or activity. The rationale of the clinical investigation, as well as the 
benefits and risks, what participation will involve, and established alternatives to participation will be 
explained to the subject in native non-technical language, understandable to the subject. Ample time will be 
provided for the subject to enquire about details of the clinical investigation and to decide whether to 
participate. 
All questions about the clinical investigation shall be answered to the satisfaction of the subject or the 
subject’s legally acceptable representative. Subjects shall not be coerced or unduly influenced to participate 
or to continue to participate in a clinical investigation. They shall not waive or appear to waive their legal 
rights. 
Each subject (or their legally designated representative) and the person who conducted the informed consent 
discussion, shall sign and personally date the Informed Consent Form (ICF). Where required, an independent 
and impartial witness shall sign and personally date the ICF. A copy of the signed ICF shall be given to the 
subject. The original signed ICF shall be archived in the Investigator’s Site File or subject file at the 
investigational site. 
This process shall be documented in the subject’s source documents. 
The subject, or the subject’s legally designated representative, shall be informed in a timely manner if new 
information becomes available that may be relevant to the subject’s willingness to continue participation in 
the clinical investigation. The communication of this information must be documented as an update to the ICF 
and re-consent of the subject. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 Definitions 
11.1.1 Adverse Event  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons whether or not related to 
the medical device or the procedures required for implant or use, and whether anticipated or unanticipated. 
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NOTE 1: This definition includes events related to the medical device or the comparator device. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users and other persons, this definition is restricted to events related to the use of medical 
devices. 
11.1.2 Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of a medical device. 
NOTE 1: This includes any AE resulting from insufficiencies or inadequacies in the instructions for use, the 
deployment, the implantation, the installation, the operation, or any malfunction of the medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the medical 
device. 
NOTE 3: This includes ‘comparator’ if the comparator is a medical device. 
11.1.3 Serious Adverse Event 
A serious adverse event (SAE) is any AE that led to any of the following: 
1) death,  
2) serious deterioration in the health of the subject, users, or other persons as defined by one or 
more of the following: 
- 
a life-threatening illness or injury, or 
- 
a permanent impairment of, or damage to, a body structure or a body function including chronic 
diseases, or 
- 
in-patient hospitalisation or prolonged hospitalisation, or 
- 
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment or damage to a body structure or a body function, 
3) foetal distress, foetal death or a congenital physical or mental abnormality, or birth defect 
including physical or mental impairment. 
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, without serious 
deterioration in health, is not considered a SAE. 
11.1.4 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an ADE that has resulted in any of the consequences characteristic of 
a SAE. 
11.1.5 Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is a SADE, which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the hazards analysis. 
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, severity, or 
outcome has been identified in the hazards analysis. 
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12 DEVICE ACCOUNTABILITY 
Subjects in the study will be loaned commercially released sound processors that use approved firmware 
versions. However, these devices will be programmed with dual-electrode mode stimulation mode, using CDI 
Tool research software which is outside the functionality of the commercial system. As a result, the devices 
used in this study will follow procedures used for unapproved devices. 
Supply of investigational medical devices (loaner study sound processors and CDI Tool software) will be 
recorded using the Sponsor Device Tracking Form (1295388) and Software Tracking Form (1302326). 
Investigational medical device(s) software and loaner sound processors will be quarantined at the 
investigational site and clearly labelled to identify exclusively for use in a clinical investigation. 
Subject level device supply will be tracked using the Individual Subject Device Accountability Log Form 
(1295295). All device(s) that have been identified with Device Deficiencies will be returned to Device Analysis 
for analysis and archiving. At the end of the clinical investigation, all loaner and unused medical devices shall 
be returned to the Sponsor. 
13 DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
The Investigator(s) must not deviate from the CIP, except in case of an emergency to protect the safety and 
well-being of the subject(s). Such deviations will be documented by the site personnel in the source 
documentation for the subject and reported to the relevant EC as per institutional requirements and to the 
Sponsor as soon as possible, but not later than 5 working days from the date of the emergency. 
If there is a deviation from CIP-defined assessments or parts thereof are omitted or completed incorrectly, the 
deviation will also be documented by the site personnel in the source documentation for the subject. 
Depending on the type or severity of the deviation the Investigator may be required to notify the EC, 
particularly if the deviation potentially impacts subject safety, performance of IMD and/or comparator, or 
data integrity. 
All CIP deviations will be documented in the eCRF to enable analysis and reporting by the Sponsor in the 
Clinical Investigation Report (CIR), or to the relevant regulatory authority(s), if applicable. 
Gross misconduct on behalf of an Investigator, such as intentional non-compliance with CIP or GCP 
requirements or fraud, will result in disqualification of the Principal Investigator and/or Investigational Site 
from participation in the investigation. Data provided by the Principal Investigator or Investigational Site will 
be excluded from the per-protocol analysis group. 
14 DATA MANAGEMENT 
The CRF will capture the datapoints necessary to determine the subject status according to the criteria 
described in section 7.2.5. 
14.1 Source Data 
Source data will be captured in clinic notes, paper-based source data worksheets, or printed directly from 
testing software. If electronic medical records do not permit read only access for monitoring purposes, a 
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certified printout must be provided, indicated by a dated signature by a member of the site team or 
generated through a validated process. 
An Origin of Source Data Form will be used to capture the location of source data kept at each site, outlining 
the individual site’s process for certification. 
14.2 Methods for Data Entry and Collection 
Data collection will be performed using a commercial electronic data capture (EDC) system on electronic Case 
Report Forms (eCRFs). Site staff will be trained on the completion of the eCRFs prior to obtaining access to the 
system and will have their own login/password. Access to clinical study information will be based on an 
individual’s role and responsibilities.  
The EDC will use role-based user permissions for data entry, viewing, and reporting options. All 
communications between users and the EDC server are encrypted. Web servers are protected by a managed 
firewall. This application is designed to be in compliance with applicable regulations including 21 CFR Part 11.  
The application will include programmed data consistency checks and supports manual generation of data 
clarifications/queries, including documentation of site responses. The application maintains a comprehensive 
audit trail for all data entered, including updates and queries, and documents the time that each entry 
occurred and who made the entry.  
Principal Investigators will affirm that the data for each subject at their site is accurate and complete by way 
of an electronic signature.  
In addition, de-identified electronically generated data will be collected from clinical fitting software and 
questionnaires. The unamended data file shall be regarded as the source.  
14.3 Database Lock 
At the conclusion of the study, the Study Data Manager in consultation with the Clinical Project Manager shall 
confirm that: 
• 
No further subject visits will be conducted. 
• 
All required forms have been completed in the EDC. 
• 
All required data, including resolution to ongoing Adverse Events in accordance with CIP 
requirements, have been entered into the EDC. 
• 
All required monitoring, including review of clinical data and Source Document Verification 
(SDV) according to the Monitoring Plan, has been performed. 
• 
All data queries have been closed. 
• 
All completed eCRFs have been signed by the Principal Investigator or delegate. 
• 
The Statistical Analysis Plan (SAP) is final. 
• 
The Clean File Meeting has been conducted. 
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15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance with 
governing data privacy regulations [such as the EU GDPR regulations]. 
Data will be reported to the Sponsor on CRFs or related documents (for example, questionnaires). Subjects 
will be identified on CRFs and other related documents only by a unique subject identification code and shall 
not include the subject’s name or other personal identifiable information. Completed CRFs or related 
documents are confidential and will only be available to the Investigator and site staff, the Sponsor and their 
representatives, and if requested to the Ethics Committee and national regulatory authorities. Publications or 
submission to a regulatory authority shall not disclose the identity of any subject. 
16 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
This clinical investigation will be conducted under a Clinical Trial Notification (CTN) to the Therapeutic Goods 
Administration. 
The clinical investigation will not commence prior to the written favourable opinion or approval from the EC 
and or regulatory authority (if appropriate) is obtained. 
The final Sponsor-approved version of the CIP, Informed Consent Form, and other necessary documents shall 
be submitted to the EC. A copy of the EC opinion/approval shall be provided to the Sponsor. 
The Investigator shall forward to the Sponsor, for review and approval, any amendment made to the 
approved ICF and any other written information to be provided to the subject prior to submission to the EC. 
The Sponsor and Principal Investigator will continue communications with the EC, as required by national 
regulations, the clinical investigational plan, or the responsible regulatory authority. 
Any additional requirements imposed by the EC or regulatory authority will be implemented by the Sponsor. 
The Investigator shall submit the appropriate documentation if any extension or renewal of the EC approval is 
required.  In particular, substantial amendments to the CIP, the ICF, or other written information provided to 
subjects will be approved in writing by the EC. 
The Investigator shall report to the EC any new information that may affect the safety of the subjects or the 
conduct of the clinical investigation. The Investigator will send written status summaries of the investigation 
to the EC regularly, as per local EC requirements. 
Upon completion of the clinical investigation, the Investigator shall provide the EC with a brief report of the 
outcome of the clinical investigation, as per local EC requirements. 
The clinical investigation is covered by clinical trial insurance, meeting the requirements of the participating 
countries. 
17 SUSPENSION OR PREMATURE TERMINATION 
The Sponsor will discontinue the clinical investigation site if: 
1) major non-adherence to the CIP or GCP principles is occurring 
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2) it is anticipated that the subject recruitment will not be adequate to meet the objectives of the clinical 
investigation 
An ongoing clinical investigation may be discontinued in case of: 
1) device failure 
2) serious or intolerable ADE, leading to the explant or discontinued use of the device 
3) subject’s death 
 
18 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
No changes in the CIP or investigation procedures shall be made without mutual agreement of the Principal 
Investigator and the Sponsor.  This agreement will be documented as a CIP amendment.  Amendments will 
require notification to the Ethics Committees (ECs) by the Principal Investigators (and to the relevant 
regulatory authority(s) by the Sponsor, if applicable). 
19 RECORD KEEPING AND RETENTION 
Data generated from the clinical investigation will be stored in a limited-access file area and be accessible only 
to representatives of the study site, the Sponsor and its representatives, and relevant health 
authorities/regulatory agencies. All reports and communications relating to study subjects will identify 
subjects only by subject unique identification code. Complete subject identification will be maintained by the 
Investigator. This information will be treated with strict adherence to professional standards of 
confidentiality. 
The investigator must retain study-related records for a period of at least 15 years after completion of the 
investigation or after the last device was placed on the market, if the IMD has market authorisation. 
The Sponsor will notify the Principal Investigator when records are no longer needed. The Investigator will not 
discard any records without notifying the Sponsor. If the Principal Investigator moves from the current 
investigational site, the Sponsor should be notified of the name of the person who will assume responsibility 
for maintenance of the records at the investigational site or the new address at which the records will be 
stored. The Investigator will notify the Sponsor as soon as possible in the event of accidental loss or 
destruction of any study documentation. 
20 PUBLICATION POLICY 
This clinical investigation will be prospectively registered on a public clinical trial registry ClinicalTrials.gov. 
A publication authored by the clinical investigator(s) and Sponsor will be prepared. In addition, the results of 
the clinical investigation may also be disseminated as conference presentations (for example, abstract and 
poster session). If a joint peer-reviewed manuscript is deemed appropriate, the authorship and 
responsibilities will be discussed and agreed upon prior to investigation start and in accordance with 
guidelines and recommendations provided by the International Committee of Medical Journal Editors (ICMJE) 
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to enable communication within 12 to 18 months of the Clinical Investigation Report (CIR) approval. All 
contributors who do not meet the criteria for authorship will be listed in an acknowledgments section of the 
publication. 
21 STATEMENTS OF COMPLIANCE 
This clinical investigation shall be conducted in accordance with ethical principles that have their origin in the 
Declaration of Helsinki (World Medical Association, 2013), International Standard ISO 14155:2020 Clinical 
investigation of medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable. 
22 QUALITY CONTROL AND ASSURANCE 
In accordance with Cochlear’s Quality Management System, all clinical investigations shall be conducted 
according to internationally recognised ethical principles for the purposes of obtaining clinical safety and 
performance data about medical devices. 
The Sponsor employees (or designee) shall use standard operating procedures (SOP) to ensure that clinical 
study procedures and documentation are consistently conducted and compliant with the ISO 14155 Standard, 
Good Clinical Practice (GCP), and applicable local regulations. 
22.1 Monitoring 
The Sponsor will perform on-site and remote monitoring visits as frequently as necessary to oversee conduct, 
data collection and record keeping by sites. The clinical investigation monitoring plan is a separate document 
for the sponsor to follow, describing all the activities performed during monitoring, and close out. 
In accordance with applicable regulations, GCP, and sponsor’s/CRO’s procedures, monitors will contact the 
site prior to the start of the study to review with the site staff the CIP, study requirements, and their 
responsibilities to satisfy regulatory, ethical, and sponsor’s requirements. When reviewing data collection 
procedures, the discussion will also include identification and documentation of source data items. 
The sponsor/designee will monitor the site activity to verify that the: 
• 
Data are authentic, accurate and complete 
• 
Safety and rights of subjects are being protected 
• 
Study is conducted in accordance with the currently approved CIP 
• 
Any other study agreements, GCP, and all applicable regulatory requirements are met. 
The investigator and the head of the medical institution (where applicable) agrees to allow the monitor direct 
access to all relevant documents. 
22.2 Audits 
To ensure compliance with GCP, the CIP, study procedures and applicable regulatory and EC requirements, an 
independent audit of the study may be conducted. The investigator/institution will be informed of the 
outcome for audits involving their site.  
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26 APPENDIX 1: SWITCHING ACCEPTABILITY RATING 
 
The SAR is designed to measure the sound quality differences between two programs and assess the difficulty 
in acclimating to a new program after listening to it for 10 minutes.   
 
Question 1 is to be answered soon after switching to a different program. 
1) How does the sound quality of the new program compare with the earlier program in terms of sound 
quality? 
1. Very different 
2. Somewhat different 
3. Similar 
4. Same 
 
Question 2 is to be answered after the subject had an opportunity to listen with the different program for a 
minimum of 10 minutes. 
2) How difficult was it to get used to the new program after listening to it for 10 minutes? 
1. Very Difficult 
2. Difficult 
3. Neutral 
4. Easy 
5. Very Easy 
 
Additional comments 
___________________________________________________________________________________________________ 
___________________________________________________________________________________________________ 
___________________________________________________________________________________________________ 
___________________________________________________________________________________________________ 
___________________________________________________________________________________________________ 
___________________________________________________________________________________________________ 
 
 
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27 APPENDIX 2: CLINICIAN LOG 
 
No. 
Date 
Condition 
Clinician action 
Patient response 
1 
01/01/2024 
LP3 
Went live with default MAP 
converted to DE mode 
All sounds too loud 
2 
01/01/2024 
LP3 
Reduced all C levels by 2 CL 
Still too loud 
3 
01/01/2024 
LP3 
Reduced all C levels by 2 CL 
Sound is comfortable 
4 
 
 
 
 
5 
 
 
 
 
6 
 
 
 
 
7 
 
 
 
 
(Grey text indicates examples of log entries)  
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