A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Pilot, Interventional Study of Adult Cochlear Implant Speech Perception With the CP1150 Sound Processor Compared With the Next Generation of Signal Processing Technology
Phase: NA
Conditions: Hearing Impairment, Sensorineural
Sponsor: Cochlear

Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
1 of 49
&OLQLFDO,QYHVWLJDWLRQ3ODQ
,QYHVWLJDWLRQ7LWOH$3UH0DUNHWLQJ3URVSHFWLYH6LQJOH6LWH2SHQ/DEHO
:LWKLQ6XEMHFW3LORW,QWHUYHQWLRQDO6WXG\RI$GXOW&RFKOHDU,PSODQW
6SHHFK3HUFHSWLRQZLWKWKH.DQVR&36RXQG3URFHVVRU
&RPSDUHGZLWKWKH1H[W*HQHUDWLRQRI6LJQDO3URFHVVLQJ7HFKQRORJ\
6KRUW7LWOH
237,080
&,31XPEHU
&/7'
6SRQVRU
&RFKOHDU/LPLWHG
8QLYHUVLW\$YHQXH
0DFTXDULH8QLYHUVLW\16:
$XVWUDOLD
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki, International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable.
&RQILGHQWLDO,QIRUPDWLRQ
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
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE
&OLQLFDO7ULDOVJRY,'1&7

Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
2 of 49
0DQXIDFWXUHU
Cochlear Limited
1 University Avenue
Macquarie University, NSW 2109
Australia
6SRQVRU2UJDQLVDWLRQV
Cochlear Limited 
1 University Avenue
Macquarie University, NSW 2109
Australia
3ULQFLSDO,QYHVWLJDWRU
  
Principal Research Audiologist
Cochlear Limited 
1 University Avenue,  
Macquarie University, NSW 2190
&OLQLFDO5HVHDUFK2UJDQLVDWLRQ
6DIHW\&RQWDFW
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
3 of 49
,19(67,*$725$*5((0(17
3ULQFLSDO ,QYHVWLJDWRU $SSURYDODQG'HFODUDWLRQ
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.
1DPH
7LWOH
Principal Investigator
6LJQDWXUH
'DWH
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
4 of 49
7$%/(2)&217(176
1
Definitions and Abbreviations ......................................................................................................... 7
2
Clinical Investigation Synopsis........................................................................................................ 9
3
Schedule of Events ....................................................................................................................... 12
4
Background Information and Rationale ........................................................................................ 13
4.1
Introduction ......................................................................................................................... 13
4.2
Findings of Previous Nonclinical and Clinical Studies........................................................ 13
4.2.1
Nonclinical Data.................................................................................................... 13
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
5.1.1
Kanso 2 and Kanso 2 NF Sound Processor......................................................... 17
5.1.2
CP1150 Sound Processor Accessories................................................................ 19
5.1.3
Additional Components......................................................................................... 19
5.2
Identity and Description of the Comparator ........................................................................ 21
5.3
Accessory Device Requirements........................................................................................ 22
6
Objectives ..................................................................................................................................... 22
6.1
Primary Objective ............................................................................................................... 22
6.2
Secondary Objectives......................................................................................................... 22
6.3
Exploratory Objective.......................................................................................................... 22
7
Design of the Clinical Investigation............................................................................................... 22
7.1
General ............................................................................................................................... 22
7.1.1
Design Rationale................................................................................................... 23
7.2
Subjects .............................................................................................................................. 23
7.2.1
Inclusion Criteria ................................................................................................... 23
7.2.2
Exclusion Criteria.................................................................................................. 24
7.2.3
Number of Subjects Required............................................................................... 24
7.2.4
Vulnerable Populations......................................................................................... 24
7.2.5
Recruitment and Study Duration........................................................................... 24
7.2.6
Criteria for Subject Withdrawal ............................................................................. 25
7.2.7
Randomisation Procedures .................................................................................. 26
7.2.8
Post-investigation Medical Care ........................................................................... 26
7.3
Performance Evaluations and Procedures ......................................................................... 27
Participant Evaluations and Procedures............................................................................. 27
7.4
Safety Evaluations and Procedures ................................................................................... 30
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

 
 
Clinical Investigation Plan: CLTD5818 
 
 
 
Template 1278855 Version 2.0 
 
5 of 49 
 
7.4.1 
Concomitant Medication and Therapies ............................................................... 31 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 31 
7.5.1 
Speech Perception ................................................................................................ 31 
7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 31 
8 
Risks and Benefits of the Investigational medical device and Clinical Investigation .................... 31 
8.1 
Anticipated Clinical Benefits ............................................................................................... 31 
8.2 
Anticipated Adverse Device Effects .................................................................................... 32 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 32 
8.4 
Risk Mitigation .................................................................................................................... 32 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 33 
9 
Statistical Considerations .............................................................................................................. 33 
9.1 
General Considerations ...................................................................................................... 33 
9.2 
Endpoints ............................................................................................................................ 33 
9.2.1 
Primary Endpoint .................................................................................................. 33 
9.2.2 
Secondary Endpoints ............................................................................................ 33 
9.2.3 
Exploratory Endpoints ........................................................................................... 34 
9.3 
Hypotheses ......................................................................................................................... 34 
9.3.1 
Primary Hypothesis ............................................................................................... 34 
9.3.2 
Secondary Hypothesis .......................................................................................... 34 
9.3.3 
Exploratory Hypothesis ......................................................................................... 35 
9.4 
Sample Size Determination ................................................................................................ 35 
9.5 
Analysis Populations ........................................................................................................... 35 
9.6 
Primary Endpoint Analyses................................................................................................. 36 
9.7 
Secondary Endpoint Analyses ............................................................................................ 36 
9.8 
Exploratory Endpoint Analyses ........................................................................................... 36 
9.9 
Safety Analyses .................................................................................................................. 36 
9.10 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 .......................................................................................... 37 
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 ....................................................................... 38 
Clinical Investigation Plan | VV-TMF-08761 | 1.0
Approval Date (GMT+0): 01 Feb 2022

Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
6 of 49
11.1.7
Device Deficiency ................................................................................................. 38
11.2
Recording and Handling of Adverse Events....................................................................... 39
11.2.1
Assessment of Severity ........................................................................................ 39
11.2.2
Assessment of Causality ...................................................................................... 39
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 .................................................................................................. 41
11.4.1
Investigator Reporting of Serious Adverse Events............................................... 41
11.4.2
Sponsor Notification of Events ............................................................................. 42
11.5
Independent Data Monitoring Committee........................................................................... 42
12
Device Accountability.................................................................................................................... 42
13
Deviations from the Clinical Investigation Plan............................................................................. 43
14
Data Management ........................................................................................................................ 43
15
Confidentiality................................................................................................................................ 44
16
Ethics Committee and Regulatory Authority Approval.................................................................. 44
17
Suspension or Premature Termination ......................................................................................... 45
18
Amendments to the Clinical Investigation Plan............................................................................. 45
19
Record Keeping and Retention..................................................................................................... 45
20
Publication Policy.......................................................................................................................... 45
21
Statements of compliance............................................................................................................. 46
22
Quality Control and Assurance ..................................................................................................... 46
22.1
Monitoring ........................................................................................................................... 46
22.2
Audits.................................................................................................................................. 46
23
Trademarks and Copyright ........................................................................................................... 46
24
References.................................................................................................................................... 47
25
Change History ............................................................................................................................. 48
Appendix 1: Statement/Declaration of Device Conformity ................................................................... 49
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
15 of 49

&OLQLFDO'DWD
Clinical data relevant for the current investigation fall under two main categories 1) Evidence on the 
development and approval of FF and 2) Evidence on previous OTE SP generation. These clinical 
data are summarized below:
))&OLQLFDO 'DWD
Signal processing strategies are designed to remove some or all competing noise, while maintaining 
the target speech with little or no modification. The Signal to Noise Ratio – Noise Reduction (SNR-
NR) algorithm that was introduced in CP910/920 uses a single microphone or single channel input, is 
non-directional and performs best in steady-state background noise. The performance benefit is 
reduced in more modulated (non-stationary) noise such as when there are competing talkers 
(Dawson et al., 2011; Hersbach et al., 2012).
In contrast, FF uses two fixed-directional microphones to capture spatial information, enabling noise 
to be filtered based on the location of the sound source. The signal of interest is defined as 
originating from in front of the listener and noise as originating behind or to the sides of the listener. If 
SNR-NR is enabled, it can operate on the output signal from FF. The two noise reduction algorithms 
complement each other due to their different principles of operation. Hersbach et al. (2013) found 
that FF provided a significant improvement in group mean speech reception threshold compared with 
BEAM.
A clinical evaluation of FF performance (CRC5513), using the Nucleus 6 Sound Processor (Model 
CP910), revealed higher group mean speech perception scores with FF (Zoom+Strong) than with 
Standard, Zoom or Beam(Z) (a modification of BEAM that uses Zoom directionality) when speech 
was presented from the front of the listener and noise presented from the rear. Higher group mean 
speech recognition scores were also obtained with FF compared to Standard and Zoom algorithms 
with speech presented from the front of the listener and speech weighted noise (SWN) from the rear. 
Group mean ratings for sound quality ratings were higher with FF than with Standard, Zoom or 
Beam(Z). There was no significant group difference in Speech, Spatial and Qualities (SSQ) rating 
between FF and the comparator programs (Standard, Zoom or Beam(Z)). There was an overall 
preference for SCAN with FF over SCAN alone. The investigators concluded that FF is most useful at 
improving speech intelligibility when the competing sources are to the sides and/or rear of the 
listener.
In study CRC5589/CTC5614, using the Nucleus 6 Sound Processor (Model CP910), speech 
perception outcomes and acceptance for three different strengths of FF integrated with SCAN were 
compared with SCAN plus SNR-NR (N6 SCAN). Sentence recognition scores with noise in rear half 
noise was significantly better with all FF programs than N6 SCAN. Word recognition scores in quiet 
and questionnaire ratings for all FF programs were comparable to N6 SCAN. Sentence-in-noise 
scores obtained with speech and noise presented from the front were non-inferior to N6 SCAN for 
mild FF only. A decrement compared with FF Strong was found. Sentence in noise scores with 
speech presented to the cochlear implant side or from behind the listener with mild FF were inferior 
to the baseline. Based on these findings the investigators recommended that FF be introduced as a 
custom programme that could be selected for specific listening conditions.
Study CLTD5606 was designed to assess the effectiveness of FF for speech reception in noise 
compared with the Nucleus 6 SCAN (SCAN + SNR-NR). The study included twenty-five conventional 
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
16 of 49
CI recipients. For sentence recognition with four-talker babble from the rear, all three levels of FF 
(strong, medium and mild) were found to be superior to the Nucleus 6 SCAN. For SWN presented 
behind the listener FF Strong was demonstrated to be superior to the Nucleus 6 SCAN. When 
speech and either SWN or four-taker babble were co-located in front of the listener, sentence 
recognition with FF strong was similar to the Nucleus 6 SCAN. For CNC words in quiet FF Strong 
was inferior to the Nucleus 6 SCAN. The investigators concluded that acceptable performance and 
safety of the FF program can be anticipated for Nucleus 7 SP users in noisy environments, and the 
risk versus benefit profile is acceptable when FF be used in quiet environments.
The in-house study CLTD5709 investigated the effect of FF noise reduction on adult cochlear implant 
recipients’ speech perception scores, listening effort and subjective ratings using the Nucleus 7 SP. A 
total of 24 subjects were enrolled in the study. 
Speech perception with babble noise from the rear demonstrated that FF On was superior to FF Off
(Nucleus 7 default program SCAN). Listening effort as measured via a dual-task paradigm involving 
both speech perception and a visual reaction time task revealed no significant difference in reaction 
times between FF On and FF Off, and therefore no difference in listening effort.
Questions from the Speech domain of the ‘SSQ of Hearing Scale’ and 3 questions from the Qualities 
of Hearing domain were completed by subjects at baseline and after at least 4 weeks of use with FF. 
The mean Speech domain results collected after 4 weeks of use were not significantly different from 
baseline scores.
Subjective ratings on the custom questionnaires indicated strong satisfaction, ease of use, and 
confidence with FF. The majority of respondents found the FF controls within the Nucleus Smart App 
as very easy to use and half of the respondents wanted FF on their own processor.
&OLQLFDO'DWD IRU27( 6RXQG3URFHVVRUV
The main relevant study with an OTE Sound Processor is the CLTD5754 study, the primary objective 
of this study was to determine the feasibility of FF in an OTE configuration and the secondary 
objective was to collect formative usability information with prototype and early design versions of the 
Kanso 2 (CP1150) Sound Processor. 
Twenty-two adult subjects underwent speech perception testing using Australian Speech Test In 
Noise (AuSTIN) adaptive sentences presented from the front with 4 talker babble noise from 90,180 
& 270 degrees to the subject (S0N3). AuSTIN Speech Reception Threshold (SRT) data comparing 
FF ON and FF OFF demonstrated superiority with FF ON (P=0.002, paired t-test). 
The implementation of FF in the CLTD5754 included the fixed microphone directionality Zoom and no 
automation. This evidence supported the approval of FF with the Kanso 2 Sound Processor. 

6WXG\5DWLRQDOH
This investigation is planned to evaluate the performance of signal processing additions and features 
that may be new to a future version of the OTE Sound Processor. This study will build on the 
evidence previously collected on OTE and behind-the-ear (BTE) Sound Processors and will support 
the design goals for access to the same sound processing algorithms across future OTE and BTE 
variants, including evidence required on the automation of FF and future implant compatibility. This 
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
17 of 49
study is intended to assess the clinical impact of the design choices made to achieve these future
design goals, including:
•
)XWXUHLPSODQWFRPSDWLELOLW\As a result of the proximity of the split link RF coil to the 
acoustic electronics, noise has been measured on the bench with an OTE coupled to a future 
implant design. This study will investigate whether the proposed notch filters have an impact 
on performance in quiet compared to a current commercially available OTE (Kanso 2). 
•
$XWRPDWLRQRI)RUZDUG)RFXVRQDQ27( 6RXQG3URFHVVRUPrevious BTE studies have 
shown a small decrement in speech perception in quiet with ForwardFocus compared to no 
ForwardFocus (D1376556), however parameter changes and automation have been 
implemented to resolve this issue, including the reduction in strength of FF and the inclusion 
of the standard directionality (std) in the ‘Quiet’ class. This study will assess whether FF 
(moderate)+standard directionality provides acceptable performance in quiet compared to the 
current commercially available Kanso 2 with FF.
•
.DQVRYV1XFOHXV&ODLP– The study also aims to provide confirmatory evidence on the 
comparability of OTE and BTE Sound Processors in quiet.
A more detailed description of the test conditions and rationale for their inclusion is available in Table
2.

0(',&$/'(9,&( ,1)250$7,21

,GHQWLW\DQG'HVFULSWLRQRIWKH,QYHVWLJDWLRQDO0HGLFDO'HYLFH,0'

.DQVRDQG.DQVR1) 6RXQG3URFHVVRU
The Kanso 2 (CP1150) Sound Processor is the latest commercially available OTE Sound Processor 
from Cochlear Limited and provides an alternative form factor with similar functionality to current BTE 
Sound Processors.  Functionality of the is enabled by the NEO-XS processing chip, which is also 
used in the current, approved (Nucleus 7) BTE processor. 
The Kanso 2 NF Sound Processor is identical to the Kanso 2 Sound Processor with the addition of 
notch filters at 978Hz, 1956Hz, 2934Hz, 3912Hz. The principal architectural difference between OTE 
processors such as the CP1150 and BTE Sound Processors from Cochlear is that the RF coil that 
supplies power and data to the internal implant is housed within the processor, rather than in a 
separate unit connected by a cable to a BTE processing unit. The CP1150 is smaller than the 
existing CP950 (Kanso) OTE Sound Processor and delivers additional functionality. The external 
appearance and internal layout of the CP1150 are shown in Figure 4 and Figure 5.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
19 of 49
implants, are available in six strengths to prevent magnets becoming a choking hazard for small 
children, the magnets are designed to be tamper resistant and can only be removed from the Sound 
Processors using a specialised tool.
Unlike the CP950 (Kanso) and CP1000 (Nucleus 7) devices, the CP1150 has no control button. The 
processor is turned on by double-tapping the Cochlear logo on the housing and turned off by triple-
tapping. These functions are enabled by an accelerometer, which also enables the Auto On feature, 
detecting the “raise to wake” motion. Other controls can be accessed via the Nucleus Smart App on 
iOS and Android devices or the optional CR310 remote control. 

&36RXQG3URFHVVRU$FFHVVRULHV

&33URJUDPPLQJ$GDSWRU&DEOH
The programming adaptor cable (Figure 6) enables the Sound Processors to be programmed via a 
connection to either a Cochlear Wired Programming Pod or Cochlear Wireless Programming Pod
interface.  
The programming adaptor cable connects the Sound Processors directly to the PIF5.2 programming 
interface. Connection to the PIF4 interface is enabled by connecting the CP1150 programming 
adaptor cable to the CP1000 Programming Cable.
Figure 6: Kanso 2 (CP1150) programming adaptor cable

$GGLWLRQDO&RPSRQHQWV

&RPSDWLEOHLPSODQWV
The CP1150 Sound Processor must be used together with a compatible implanted receiver-
stimulator for normal operation. It is compatible with all CIC3 based implants and CIC4 based 
implants available in the market as listed below (Table 1). The CP1150 is not currently compatible 
with Nucleus 22 Series implants.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
22 of 49

$FFHVVRU\'HYLFH5HTXLUHPHQWV
1XFOHXV6RXQG3URFHVVRU
The Nucleus 8 SP must be used together with an implanted receiver-stimulator to achieve normal 
operation in clinical use. 
To utilise the Sound Processor system, in addition to the processing unit, recipients will also use a 
compatible ear hook, battery module, coil, and magnet. 
The Nucleus 8 Sound Processor is compatible with the Cochlear™ Wired Programming Pod. 
.DQVRDQG.DQVR1)6RXQG3URFHVVRUV
The Kanso 2 Sound Processor and the Kanso 2 NF Sound Processor must be used together with an 
implanted receiver-stimulator to achieve normal operation in clinical use. The Kanso 2 Sound 
Processor and Kanso 2 NF Sound Processors NF are not currently compatible with the Nucleus 22 
Series implants. For the current study, the implants in Table 2 will be used.
All study Sound Processors will be compatible with the Custom Sound Pro fitting software. This 
software will be used by the investigator to program the Sound Processors. 
The research signal processing configurations will be programmed via CDI-Tool Version 7.3.1. 

2%-(&7,9(6

3ULPDU\2EMHFWLYH
To evaluate the impact of NF on adult cochlear implant recipient’s speech perception in quiet using 
an off-the-ear (OTE) Sound Processor.

6HFRQGDU\2EMHFWLYHV
x
To evaluate the performance of FF combined with standard microphone directionality on adult 
cochlear implant recipient’s speech perception in quiet using an OTE Sound Processor.
x
To compare adult cochlear implant recipient’s speech perception in quiet with Kanso 2 and 
Nucleus 8 Sound Processors

([SORUDWRU\2EMHFWLYH
To characterise the impact of NF on adult cochlear implant receipients, phoneme perception in quiet 
using an OTE (Kanso 2) Sound Processor.

'(6,*1 2)7+(&/,1,&$/,19(67,*$7,21

*HQHUDO
This is a pre-marketing, prospective, single-site, open-label, within-subject, pilot, interventional 
clinical investigation in adults with sensorineural hearing impairment who are current users of a 
Nucleus Cochlear Implant system.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
23 of 49
See section 7.2 for description of subject population. 
After enrolment, subjects will attend a single study visit as described in the CIP Schedule of Events 
(Section 3). At the study visit, subjects will undergo hearing assessments. 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. 

'HVLJQ5DWLRQDOH
Experienced adult cochlear implant recipients have been chosen as the study population due to their 
ability to compare Sound Processors across generations, in and outside of the booth. In addition, 
performance benefits achieved by adults can generally be extrapolated to younger age groups, 
avoiding the need to recruit this vulnerable population.
Comparison will be made within subjects with repeated measures for each of the sound processing 
conditions to be evaluated. There will be two test sessions with no take home use between sessions. 
The test sessions will include words in quiet tests. These speech measures are routine outcome 
measures used to evaluate new signal processing algorithms and hardware. 
There will be no blinding of the study investigators.
Blinding of the study subject will be undertaken where possible, particularly when multiple signal 
processing conditions are loaded onto a single study device. Patients will not be told which program 
will be used in which order, and because the Kanso 2, Kanso 2 NF and Kanso 2 FF Sound 
Processors are physically identical, it may also be possible to conceal which Sound Processor is 
being used during testing. 
Counterbalancing of the test order will be undertaken where possible to limit the influence of order 
effects on results.

6XEMHFWV
The subjects include men and women aged 18 years or older who are current users of a Nucleus 6 
(CP910/920), Kanso 2 (CP1150), Kanso (CP950) or Nucleus 7 (CP1000) Sound Processor. Subjects 
will be screened, and 20 eligible subjects will be recruited to the clinical investigation. For speech 
perception testing, all subjects will receive all treatment and control conditions; however, the test 
order will be counterbalanced to control for order effects.  
Written, informed consent must be obtained from the subject before any study procedures are 
initiated. 

,QFOXVLRQ&ULWHULD
Subjects must meet all of the inclusion criteria described below to be eligible for this clinical 
investigation.
1) Aged 18 years or older
2) Post lingually deafened
3) Implanted with the CI600 Series, CI500 Series or Freedom Series 
4) At least 6 months experience with a cochlear implant.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
24 of 49
5) At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 
(CP1150), or Nucleus 7 (CP1000) Sound Processor
6) MAP Total Stimulation Rate of 7.2kHz or greater
7) Able to score 30% or more with CI alone on a monosyllabic word in quiet test
8) Willingness to participate in and to comply with all requirements of the protocol
9) Fluent speaker in English as determined by the investigator
10) Willing and able to provide written informed consent

([FOXVLRQ&ULWHULD
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical 
investigation.
1) Additional disabilities that would prevent participation in evaluations.
2) Implant location that would result in undesirable hearing performance or discomfort with an 
off-the-ear Sound Processor, as determined by the investigator.
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 unless (if less than 30 days) the prior investigation was Cochlear sponsored and 
determined by the investigator to not impact clinical findings of this investigation.
7) Implanted with other active implantable medical devices (e.g., pacemaker, defibrillator). 

1XPEHURI6XEMHFWV5HTXLUHG
The total number of subjects to be enrolled in the study to meet sample size calculation requirements 
is 12, which includes 3 additional subjects to account for an expected dropout rate of 25%.

9XOQHUDEOH3RSXODWLRQV
Pregnant and breastfeeding women have not been excluded from this low-risk study. The are no 
benefits associated for pregnant and breastfeeding women to participate but there also no risks 
identified if they were to participate. It is to be noted that whilst we are not excluding pregnant or 
breastfeeding women, we are also not targeting them either.

5HFUXLWPHQWDQG 6WXG\'XUDWLRQ
The following subject status definitions apply:
x
Enrolled: A subject that has a signed the Informed Consent form for the study. 
x
Screen Fail: An Enrolled subject that has been determined to not meet one or more eligibility 
criteria.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
25 of 49
x
Participated: Subjects who have met eligibility criteria and have commenced baseline 
assessments.
x
Withdrawn: An Enrolled subject who withdrew or was withdrawn by the Investigator or Sponsor 
before the expected End of Study visit. Withdrawn subjects may still continue in safety follow up 
until their scheduled End of Study visit, for reasons described in section 7.2.6.
x
Completed: Enrolled subjects who complete the required treatment and visit schedule. 
The recruitment period for the clinical investigation is estimated to be 4 weeks from the time of first 
subject consent to recruitment of the last subject.
The expected duration of each subject’s participation in the clinical investigation, is up to 3 months, 
from the time of informed consent through to the last study visit.
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.

&ULWHULDIRU6XEMHFW:LWKGUDZDO
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the 
reason(s). The reason for withdrawal should be documented in the subject’s source files and the 
case report form (CRF).
The Investigator or Sponsor may also decide to withdraw a subject from the clinical investigation if it 
is considered to be in the subject’s best interests.
Subject withdrawal may be for any of the following reasons:
x
Adverse Event (AE)
x
Device Deficiency (DD)
x
CIP or GCP deviation
x
Subject withdrew consent
x
Subject lost to follow-up
x
Subject death
x
Sponsor decision
x
Investigator decision
x
Other (specify)
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 will not be replaced. 
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

406'RFXPHQW
Clinical Investigation Plan: CLTD5818
Template 1278855 Version 2.0
26 of 49

5DQGRPLVDWLRQ3URFHGXUHV
No treatment randomisation is planned. However, to control for order effects during speech 
perception testing for the Primary and Secondary Endpoints a 4x4 balanced Latin square order will 
be implemented (see table 3).
7DEOH 2UGHU RI$GPLQLVWUDWLRQRIWKH6SHHFK3HUFHSWLRQ7HVWV
First Sound 
Processor
Second Sound 
Processor
Third Sound 
Processor
Fourth Sound 
Processor
SYD01, 05, 09
Kanso 2
Kanso 2 NF
Nucleus 8
Kanso 2 + FF
SYD02, 06, 10
Kanso 2 NF
Kanso 2 + FF
Kanso 2
Nucleus 8
SYD03, 07, 11
Kanso 2 + FF
Nucleus 8
Kanso 2 NF
Kanso 2
SYD04, 08, 12
Nucleus 8
Kanso 2
Kanso 2 + FF
Kanso 2 NF

%OLQGLQJ3URFHGXUHV
For in booth speech perception testing, the test order will not be revealed to the study subject. The 
counterbalancing as outlined in section 7.2.7 will be used to ensure that there is a balanced order or 
test conditions. 

3RVWLQYHVWLJDWLRQ0HGLFDO&DUH
At the end of the study, subjects will return all investigational devices to the investigator and return to 
their own hearing devices. 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.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
27 of 49

3HUIRUPDQFH(YDOXDWLRQV DQG3URFHGXUHV
6SHHFKSHUFHSWLRQLQTXLHW
Speech perception in quiet will be measured using the CNC monosyllabic words at 50 dB from S0 
(zero degrees azimuth) position. There will be 2 lists per treatment or control (see Table 4 for Input 
processing conditions). The goal of speech perception assessment in quiet is to compare percent
words and phonemes correct for each of the sound processing combinations.
3DUWLFLSDQW(YDOXDWLRQVDQG3URFHGXUHV
6FUHHQLQJ9LVLW
Included in this period:
-
Written informed consent
-
Eligibility including sentence in babble test if required
-
Case Report Form Completion 
Informed consent
See Section 10
Screening
Study investigators will screen each patient according to the inclusion and exclusion criteria. For 
subjects without relevant speech perception data on file, a words in quiet test will be conducted at 50 
dB SPL. A score of 30% or more in the CI alone condition is required to pass that specific inclusion 
criteria. Subjects will be tested with their own sound processor and their own preferred signal 
processing settings for quiet environments.
All subjects will be tested in the unilateral condition and each subject will have their contralateral ear 
(non-test ear) blocked with an ear plug. Subjects with bilateral implants that meet the inclusion 
criteria will be tested using the subject’s preferred ear or if the preferred ear is not known then the 
first implanted ear will be used as the test-ear. 
The subject will be positioned so that the middle-point between the two ears is centred at the 
reference point of the sound field. The loudspeaker should be positioned at the same height as the 
middle-point of the two ears. 
The AuSTIN software will be used to present the test material. The investigator, or suitably qualified 
delegate will use the software to select:
-
CNC word test
-
50 dB SPL presentation level
-
Signal from in front (0 degrees)
-
1 list of 50 words
At the end of each run, the investigator will record the result on the worksheet and in the EDC.
Subjects must be consented and enrolled to the study and inclusion and exclusion criteria confirmed 
prior to any study activities starting. 
Case Report Form
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
29 of 49
All subjects will be tested in the unilateral condition and each subject will have their contralateral ear 
(non-test ear) blocked with an ear plug for all test conditions. Subjects with bilateral implants that 
meet the inclusion criteria will be tested using the subject’s preferred ear or if the preferred ear is not 
known then the first implanted ear will be used as the test-ear. 
The subject will be positioned so that the middle-point between the two ears is centred at the 
reference point of the sound field. The loudspeaker should be positioned at the same height as the 
middle-point of the two ears. 
The AuSTIN software will be used to present the test material. The investigator, or suitably qualified 
delegate will use the software to select:
-
CNC word test
-
50 dB SPL presentation level
-
Signal from in front (0 degrees)
-
2 lists of 50 words each
At the end of each run, the investigator will record the result on the worksheet and in the EDC. 
Case Report Form
x
Concomitant medications/therapies
x
Adverse events 
x
Device deficiencies
x
Device exposure
(QGRIYLVLWDQGUHWXUQRIVWXG\GHYLFHV
Included in this period:
-
End of study and return devices
After the speech perception evaluation has been completed, study subjects will return the study 
devices and will use their own device as normal in their home environment in between speech 
evaluation study visits.
$GDSWLYHSURFHGXUH
Although no product changes are expected during the study period, early product can be sensitive to 
the low-risk issues identified in 
Table 1. During this feasibility study these product issues may be identified by study subjects during 
the acute testing sessions that require optimisation or correction, and an adaptive procedure allows 
for product feedback to be collected from study subjects, for the product to be updated, and for the 
updated product to be reissued to study subjects for continued testing. Table 5 identifies how issues 
will be investigated and retested by the research subjects.
1HZ'HYLFH,WHUDWLRQ
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
31 of 49

&RQFRPLWDQW0HGLFDWLRQDQG7KHUDSLHV
There is potential that concomitant medical treatments may influence the outcomes of this study.  All 
concomitant medical treatments will be collected as part of this study.

(TXLSPHQW8VHGIRU(YDOXDWLRQRI3HUIRUPDQFHDQG6DIHW\

6SHHFK3HUFHSWLRQ
Speech perception performance in quiet will be assessed using a loudspeaker configuration with the 
signal from the front (S0).
The loudspeakers will be located at head height for a seated subject (reference point). The distance 
from the loudspeaker from the reference point will be approximately one meter. There will be defined 
locations for the loudspeakers and subject within the test environment.

6SRQVRU5ROHLQ&RQGXFW RIWKH&OLQLFDO,QYHVWLJDWLRQ
Sponsor and investigator roles are assumed by Cochlear employees. 
Cochlear has designed and will execute this clinical trial in-house at Cochlear Limited, Sydney. The 
study site consists of a small team of Investigators, trained as clinical Audiologists, to execute this 
research activity. Investigators are qualified audiologists familiar with cochlear implant development, 
surgery and programming. Investigators’ trial materials and testing rooms (sound booths) are 
securely separated from Sponsor facilities. The trial investigators, or delegates within the study site, 
will enter the data into the eCRF.
The study is planned, designed and developed by a separate group within Cochlear, known as 
Clinical Affairs (the Sponsor). Cochlear has SOPs to manage the separation of Investigator and 
Sponsor activities as well as ensure they align with all applicable regulations.

5,6.6 $1'%(1(),762)7+(,19(67,*$7,21$/0(',&$/'(9,&($1'
&/,1,&$/,19(67,*$7,21

$QWLFLSDWHG&OLQLFDO%HQHILWV
Study subjects will be asked to use hearing performance features on the Kanso 2 and Nucleus 8 
Sound Processors during acute testing sessions, however this is not anticipated to provide benefits 
to the subject due to the acute nature of the testing.
Subjects who haven’t previously experienced using the ForwardFocus feature may experience 
benefit of improved communication through reduction of distracting noise while using the feature 
during the acute test session only.
Due to the limited use of the investigational devices, there are no long-term clinical benefits 
anticipated for the study subjects.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
32 of 49

$QWLFLSDWHG$GYHUVH'HYLFH(IIHFWV
Cochlear’s internal hazards analysis considers hazardous situations associated with the use of the 
Kanso 2 and Nucleus 8 Sound Processors (including internal battery) and Accessories. This hazards 
analysis considered basic safety, normal function, and reasonably foreseeable misuse, systematic or 
single fault conditions experienced by the user, operator or bystanders and environment.  
The risks associated with the Kanso 2 and Nucleus 8 Sound Processors and Accessories have been 
identified, analysed and evaluated. The residual risk level has been determined to be as low as 
possible in accordance with Cochlear’s Product Risk Management Procedure and are acceptable.
Subjects may be exposed to the anticipated adverse device related effects associated with use of the
Nucleus 8 Sound Processor such as pain or discomfort when wearing the processor and a risk that
some sounds could be uncomfortable.
The following residual risks are disclosed in the Kanso 2 user guide: 
x
Small parts hazards.
x
Suffocation hazard.
x
Risk of high skin contact temperatures.
x
Risk of high skin contact pressures.
Product specific warnings can be found in the respective User Guide and relevant instructions for 
use.

5LVNV$VVRFLDWHGZLWK3DUWLFLSDWLRQLQWKH&OLQLFDO,QYHVWLJDWLRQ
There is a small risk that programs on the Kanso 2, Kanso 2 NF and Nucleus 8 Sound Processors
may sound different to each user’s own Sound Processor; this is unlikely if study subjects enter the 
study already using a Nucleus 7 or Kanso 2 Sound Processor and more likely if they enter a study 
with a legacy device. If subjects experience sound that is uncomfortable, they are counselled to 
remove the Sound Processor off their head or ask the research audiologist to immediately cease
stimulation. Other risks may include exacerbation of existing tinnitus and a reduction in the sound 
quality or intelligibility of the research programs. Subjects are advised to return to their own processor 
and promptly inform the investigators if these events occur.
:DUQLQJVDQGFRQWUDLQGLFDWLRQV
See the Nucleus 7 and Kanso 2 Sound Processors User Guide for all Warnings and 
Contraindications. (user guides can be found within the ‘Support’ section of the country specific 
Cochlear website; www.cochlear.com). At this preliminary stage in development, the Nucleus 7 
Sound Processor User Guide will be relevant for Nucleus 8 Sound Processor.  

5LVN0LWLJDWLRQ
The study investigational devices have been fully tested for safety, and the performance and use of 
the investigational devices is expected to be similar to the approved Nucleus 7 and Kanso 2 Sound 
Processors. Risks have been individually reviewed and found to be clinically acceptable based on 
implemented controls, verification activities, and the relatively low probability of harm. One or more of 
the following risk control options are applied to each identified risk: inherent safety by design; 
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
33 of 49
protective measures in the device itself or in the manufacturing process; Information for safe usage; 
investigational procedures.
The residual risks related to the investigational device or procedure will be controlled in the following 
ways:
x
The fitting and use of the Sound Processors will be supervised by the investigator. Test units 
will be used for a short duration (up to 3 hours) and will be used by adults who are able to 
indicate discomfort and remove the Sound Processor from their head.
x
If recipients experience any physical discomfort from the device or if the device produces 
sounds that are uncomfortable, subjects are encouraged to inform the Investigator and return 
to using their own Sound Processors.
x
Dropped devices should be inspected for external damage before re-use, to ensure there are 
no sharp edges/corners or rough surfaces.

5LVNWR%HQHILW 5DWLRQDOH
Residual risk levels associated with the Nucleus 8 and Kanso 2 Sound Processors (including the 
Kanso 2 NF Sound Processor) and Accessories have been determined to be as low as possible 
when the Sound Processor is used with a compatible cochlear implant and the programming adaptor 
cable. Based on pre-clinical testing of the Kanso 2 and Nucleus 8 Sound Processors along with a 
review of clinical investigations and published data on the Kanso 2 and Nucleus 7 Sound Processors, 
the anticipated clinical benefits have been found to outweigh the potential risks to the subject through 
participation in this clinical investigation.

67$7,67,&$/&216,'(5$7,216

*HQHUDO&RQVLGHUDWLRQV
For general statistical methods for reporting, details on the analysis populations, type-I error control, 
methods for handling missing data, criteria for the termination of the clinical investigation and 
procedures for reporting any deviations are described below.

(QGSRLQWV

3ULPDU\(QGSRLQW
Paired difference in percentage CNC Words correct in quiet (50 dB) with the Kanso 2 NF and Kanso 
2 (CP1150) Sound Processors

6HFRQGDU\(QGSRLQWV
x
Paired difference in percentage CNC Words correct in quiet (50 dB) with the Kanso 2 FF
(standard omni) and Kanso 2 (standard omni) Sound Processors
x
Paired difference in percentage CNC Words correct in quiet (50 dB) with the Kanso 2 and 
Nucleus 8 Sound Processor.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
34 of 49

([SORUDWRU\(QGSRLQWV
Paired difference in percentage phonemes correct in quiet (50 dB) with the Kanso 2 NF and Kanso 2 
Sound Processors

+\SRWKHVHV
For the non-inferiority test of CNCword score, the 95% CI (alpha=0.025 one-sided) for the mean 
paired difference (Kanso 2 NF versus Kanso 2 for the primary endpoint, Kanso 2 (no notch filters) + 
ForwardFocus (standard omni) versus Kanso 2 (no notch filters and standard omni) and Kanso 2 (no 
notch filters) versus Nucleus 8, respectively for the secondary endpoints) will be estimated. If the 
lower limit of the 95% CI of the mean paired difference is above -10%, ‘Nucleus 8 SP’ is regarded as 
non-inferior to ‘Nucleus 7 SP’ on that measure. 

3ULPDU\+\SRWKHVLV
Endpoint: Paired difference in percentage CNC Words correct in quiet (50 dB) with the Kanso 2 
(notch filters) and Kanso 2 (no notch filters) Sound Processors; higher score corresponds with a 
better outcome.
H0: Words in quiet (50 dB CNC words) scores (% words correct) with the Kanso 2 NF Sound 
Processor (treatment) are inferior to those with the Kanso 2 Sound Processor (control) 
Kanso 2 NF – Kanso 2 < -10%
H1: Words in quiet (50 dB CNC words) scores (% words correct) with the Kanso 2 NF Sound 
Processor (treatment) are non-inferior to those with the Kanso 2 Sound Processor SNR-NR on (control)
Kanso 2 NF – Kanso 2 > -10%

6HFRQGDU\+\SRWKHVLV
Endpoint: Paired difference in percentage CNC Words correct in quiet (50 dB) with the Kanso 2 + FF
(standard omni) and Kanso 2 (standard omni) Sound Processors
H0: Words in quiet (50 dB CNC words) scores (% words correct) with the Kanso 2 FF Sound Processor 
(standard omni) (treatment) are inferior to those with the Kanso 2 Sound Processor (standard omni) 
(control) 
Kanso 2 FF – Kanso 2 < -10%
H1: Words in quiet (50 dB CNC words) scores (% words correct) with the Kanso 2 FF Sound Processor 
(treatment) are non-inferior to those with the Kanso 2 Sound Processor (standard omni) (control)
Kanso 2 FF – Kanso 2 > -10%
Endpoint: Paired difference in percentage CNC Words correct in quiet (50 dB) with the Kanso 2 and 
Nucleus 8 Sound Processors
H0: Words in quiet (50 dB CNC words) scores (% words correct) with the Kanso 2 sound processor 
(treatment) are inferior to those with the Nucleus 8 Sound Processor (control) 
Kanso 2 – Nucleus 8 < -10%
H1: Words in quiet (50 dB CNC words) scores (% words correct) with the Kanso 2 sound processor 
(treatment) are non-inferior to those with the Nucleus 8 Sound Processor SNR-NR on (control)
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
35 of 49
Kanso 2 – Nucleus 8> -10%

([SORUDWRU\+\SRWKHVLV
There are no exploratory hypotheses.

6DPSOH6L]H'HWHUPLQDWLRQ
This study is a non-inferiority design, and sample size calculation was based on non-inferiority tests 
for CNC word scores. The sample size using a confidence interval method (two-tailed 95% 
confidence interval) was estimated to have a reasonable power to detect non-inferiority word scores 
for the listed hypotheses.
To reject the null hypothesis of inferior word perception in quiet for the New processor:
x
A margin of non-inferiority of 10% (new-old) has been chosen. That is saying that a true mean 
difference of anything up to 10% is acceptable and not clinically meaningful. This margin is 
based on clinical consensus, and previous feedback from the FDA
x
An expected standard deviation of difference scores of 7.5% for CNC words (50 dB), based 
on previous OTE studies investigating words in quiet.
x
A significance level α = 0.05 (two-tailed).
x
A desired power of 0.9.
Based on these assumptions, a sample size of 9 subjects is required to reject the null hypothesis. An 
increased sample size of 12 subjects will be enrolled, which will allow for the possibility that the 
variability in difference scores will be greater than expected and to account for the possibility of 
subject attrition.

$QDO\VLV3RSXODWLRQV
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 treatment 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.
,QWHQWWR7UHDW3RSXODWLRQ
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
36 of 49
The Intent-to-Treat Population will include all subjects who receive the treatments and have at least 
one set of paired treatment and control measurements from any endpoint, regardless of protocol 
deviations and missing data. 
3HU3URWRFRO3RSXODWLRQ
The Per Protocol Population will include all subjects who receive the treatments and have at least
one paired measurement from treatment and control, without major protocol deviations. Major 
deviations will be defined at the clean file meeting before data base lock.
It is possible that a treatment 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. 
6DIHW\3RSXODWLRQ
The Safety Population will include all treated subjects. The Safety Population will be used for the 
safety data analysis.

3ULPDU\(QGSRLQW$QDO\VHV
Primary and Secondary Speech Perception Endpoints:
Words in quiet scores at different speech testing conditions will be listed and summarised 
descriptively by treatment group and study population. Figures as appropriate to further describe the 
data may be presented. 
For the non-inferiority test of words in quiet scores, the 95% CI (alpha=0.025 one-sided) for the mean 
paired difference will be estimated. If the lower limit of the 95% CI of the mean paired difference is 
above -10%, the treatment condition is regarded as non-inferior to the control in term of words in 
quiet perception. The non-inferiority margin of -10% for words in quiet scores (monosyllables) is also 
based on clinical consensus.
If non-inferiority is demonstrated, the testing will proceed to a test of superiority. 

6HFRQGDU\ (QGSRLQW$QDO\VHV
See section 9.6

([SORUDWRU\ (QGSRLQW$QDO\VHV
Not applicable. 

6DIHW\$QDO\VHV
For AE/ADEs and DDs, the percentage of subjects who experienced at least one occurrence of each, 
will be summarised by intervention group. Any 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.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
37 of 49
 ,QWHULP$QDO\VHV
Not applicable
 ,1)250('&216(17352&(66
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 risks and benefits, what participation will involve, and alternatives to participation will 
be explained 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.
Each subject (or their legally authorised representative) and the person who conducted the informed 
consent discussion, shall sign and date the Informed Consent Form (ICF). Where required, a 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.
The subject, or the subject’s legally authorised 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.
 $'9(56((9(176$1''(9,&('(),&,(1&,(6
 'HILQLWLRQV
 $GYHUVH(YHQW
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.
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 medical 
devices.
 $GYHUVH'HYLFH(IIHFW
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.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
38 of 49
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the
medical device.
 6HULRXV$GYHUVH(YHQW
A serious adverse event (SAE) is any AE that:
1) led to a death, 
2) led to a serious deterioration in the health of the subject that either resulted in:
x
a life-threatening illness or injury, or
x
a permanent impairment of, or damage to, a body structure or a body function, or
x
in-patient hospitalisation or prolonged hospitalisation, or
x
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment or damage to a body structure or a body function, or
x
Chronic disease.
3) led to foetal distress, foetal death or a congenital physical or mental abnormality, or birth defect
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a SAE.
 6HULRXV$GYHUVH'HYLFH(IIHFW
A serious adverse device effect (SADE) is an ADE that has resulted in any of the consequences 
characteristic of a SAE.
 8QDQWLFLSDWHG6HULRXV$GYHUVH'HYLFH(IIHFW
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 Nucleus 8 SP 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 Nucleus 8 SP Hazards Analysis.
 $GYHUVH(YHQWVRI6SHFLDO,QWHUHVW
Not applicable. 
 'HYLFH'HILFLHQF\
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance.
NOTE: Device Deficiencies include malfunctions, use errors, and inadequate labelling or information 
supplied by the manufacturer.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
44 of 49
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.
 &21),'(17,$/,7<
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.
 (7+,&6&200,77(($1'5(*8/$725<$87+25,7<$33529$/
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.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
45 of 49
 6863(16,212535(0$785(7(50,1$7,21
The Sponsor will discontinue the clinical investigation site if:
1) major non-adherence to the CIP or GCP principles is occurring
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
 $0(1'0(176727+(&/,1,&$/,19(67,*$7,213/$1
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).
 5(&25'.((3,1*$1'5(7(17,21
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.
 38%/,&$7,2132/,&<
This clinical investigation will be prospectively registered at clinicaltrials.gov.
No joint peer-reviewed publication is planned from this study.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
46 of 49
 67$7(0(1762)&203/,$1&(
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki, International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable.
 48$/,7<&21752/$1'$6685$1&(
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.
 0RQLWRULQJ
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 describing all the activities performed during site qualification, initiation, 
monitoring, and close out.
 $XGLWV
An Investigator must, in reasonable time, upon request from a relevant health authority or regulatory 
agency, permit access to requested records and reports, and copy and verify any records or reports 
made by the Investigator. Upon notification of a visit by a regulatory authority, the Investigator will 
contact the Sponsor immediately.  
The Investigator will grant the Sponsor representatives the same access privileges offered to relevant 
health authority or regulatory agents, officers, and employees.
 75$'(0$5.6$1'&23<5,*+7
ACE, Advance Off-Stylet, AOS, AutoNRT, Autosensitivity, Beam, Bring Back the Beat, Button, 
Carina, Cochlear, ⛉฼⪥, ࢥࢡࣞ࢔, ਍਽չ߭, Cochlear SoftWear, Codacs, Contour, Contour 
Advance, Custom Sound, ESPrit, Freedom, Hear now. And always, Hugfit, Hybrid, Invisible Hearing, 
Kanso, MET, MicroDrive, MP3000, myCochlear, mySmartSound, NRT, Nucleus, Outcome Focused 
Fitting, Off-Stylet, Slimline, SmartSound, Softip, SPrint, True Wireless, the elliptical logo, and 
Whisper are either trademarks or registered trademarks of Cochlear Limited. Ardium, Baha, Baha 
SoftWear, BCDrive, DermaLock, EveryWear, SoundArc, Vistafix, and WindShield are either 
trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB. © Cochlear [2022]
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
47 of 49
 5()(5(1&(6
Dawson, P. W., Hersbach, A. A., & Swanson, B. A. (2013). An adaptive Australian Sentence Test in
Noise (AuSTIN). Ear and Hearing, 34(5), 592̽600.
https://doi.org/10.1097/AUD.0b013e31828576fb
International Organization for Standardization.  ISO 14155:2011 Standard:  Clinical investigation of 
medical devices for human subjects – Good clinical practice. 2011.  Available at: 
https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-2:v1:en
Peterson GE, Lehiste I. Revised CNC lists for auditory tests. J Speech Hear Disord. 
1962;27(February):62-70. doi:10.1044/jshd.2701.62
World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving 
Human Subjects. 2013.  Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-
ethical-principles-for-medical-research-involving-human-subjects/.
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

CIP Number: CLTD5818
Template 1278855 Version 2.0
49 of 49
$33(1',; 67$7(0(17'(&/$5$7,21 2)'(9,&(&21)250,7<
&OLQLFDO,QYHVWLJDWLRQ'HWDLOV
&OLQLFDO,QYHVWLJDWLRQ,'
CLTD5818
6SRQVRURI,QYHVWLJDWLRQ
Cochlear Limited, 1 University Avenue, Macquarie 
University, NSW
2109, Australia
'HYLFHDQG0DQXIDFWXUHU'HWDLOV
'HYLFH0DQXIDFWXUHU
Cochlear Limited, 1 University Avenue, Macquarie 
University, NSW
2109, Australia
,QYHVWLJDWLRQDO'HYLFH
Kanso 2 Notch Filter (NF) Sound Processor
Kanso 2 with Forward Focus (FF)
CDI Tool Version 7.3.1
Nucleus 8 (CP1110) Sound Processor
We, Cochlear Limited, declare that, where appropriate, technical and biological and pre-clinical
evaluations have been conducted and, as a result, the investigational devices conform to the
applicable general safety and performance requirements (as specified in Annex I of Regulation (EU)
2017/745), apart from the aspects covered by the clinical investigation and that, with regard to those
aspects, every precaution has been taken to protect the health and safety of the subjects, the users
and third persons.
The Device incorporates no materials of animal or human origin.
All supporting documentation is retained under the premises of the manufacturer.
1DPH
3RVLWLRQ
Director, Regulatory Affairs
6LJQDWXUH
'DWH
&OLQLFDO,QYHVWLJDWLRQ3ODQ_9970)_
$SSURYDO'DWH*07)HE

Signature Page for VV-TMF-08761 v1.0
Signature Page for VV-TMF-08761 v1.0
Reason for signing: Approved
Name: 
Role: A
Date of signature: 01-Feb-2022 04:01:59
GMT+0000
Clinical Investigation Plan | VV-TMF-08761 | 1.0
Approval Date (GMT+0): 01 Feb 2022