A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Actual-Use, Interventional Study of Acceptance and Performance With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor Compared With the CP1000 Sound Processor
Phase: NA
Conditions: Adult Cochlear Implant Recipients
Sponsor: Cochlear

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Clinical Investigation Plan 
Investigation Title: A Pre-Marketing, Prospective, Single-Site, Open-Label, 
Within-Subject, Pivotal, Interventional Study of Acceptance and 
Performance with experienced adult cochlear implant recipients using the 
CP1110 Sound Processor compared with the CP1000 Sound Processor 
Short Title: 
PINNA Study 
CIP Number: 
CLTD5810 
Date:  
Refer to header 
Sponsor 
Cochlear Limited 
1 University Ave 
Macquarie University, NSW, 2109 
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. 
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 Ave  
Macquarie University, NSW, 2109 
Investigator 
 
  
Principal Research Audiologist 
Cochlear Limited 
1 University Ave  
Macquarie University, NSW, 2109 
Safety Contact 
 
 
 
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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. 
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 ........................................................ 14 
4.2.1 
Nonclinical Data .................................................................................................... 14 
4.2.2 
Clinical Data .......................................................................................................... 14 
4.3 
Study Rationale .................................................................................................................. 17 
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 ........................................................................ 20 
6 
Objectives ..................................................................................................................................... 24 
6.1 
Primary Objective ............................................................................................................... 24 
6.2 
Secondary Objective ........................................................................................................... 24 
6.3 
Exploratory Objective .......................................................................................................... 24 
7 
Design of the Clinical Investigation ............................................................................................... 24 
7.1 
General ............................................................................................................................... 24 
7.1.1 
Design Rationale ................................................................................................... 24 
7.2 
Subjects .............................................................................................................................. 25 
7.2.1 
Inclusion Criteria ................................................................................................... 25 
7.2.2 
Exclusion Criteria .................................................................................................. 26 
7.2.3 
Number of Subjects Required ............................................................................... 26 
7.2.4 
Vulnerable Populations ......................................................................................... 26 
7.2.5 
Recruitment and Study Duration ........................................................................... 26 
7.2.6 
Criteria for Subject Withdrawal ............................................................................. 27 
7.2.7 
Randomisation Procedures .................................................................................. 27 
7.2.8 
Post-investigation Medical Care ........................................................................... 28 
7.3 
Performance Evaluations and Procedures ......................................................................... 29 
7.3.1 
Speech perception in quiet ................................................................................... 29 
7.3.2 
Speech perception in noise .................................................................................. 29 
7.3.3 
Subjective ratings .................................................................................................. 29 
7.3.4 
Usability Assessments .......................................................................................... 30 
7.3.5 
Sound Quality ....................................................................................................... 30 
7.3.6 
Participant Evaluations and Procedures ............................................................... 30 
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7.3.7 
Procedural mitigation relating to COVID-19 ......................................................... 39 
7.4 
Safety Evaluations and Procedures ................................................................................... 39 
7.4.1 
Concomitant Medication and Therapies ............................................................... 39 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 40 
7.5.1 
Software ................................................................................................................ 40 
7.5.2 
Speech Perception ................................................................................................ 40 
7.5.3 
Questionnaires ...................................................................................................... 40 
7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 40 
8 
Risks and Benefits of the Investigational medical device and Clinical Investigation .................... 41 
8.1 
Anticipated Clinical Benefits ............................................................................................... 41 
8.2 
Anticipated Adverse Device Effects .................................................................................... 41 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 41 
8.4 
Risk Mitigation .................................................................................................................... 42 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 43 
9 
Statistical Considerations .............................................................................................................. 43 
9.1 
General Considerations ...................................................................................................... 43 
9.2 
Endpoints ............................................................................................................................ 43 
9.2.1 
Primary Endpoint .................................................................................................. 43 
9.2.2 
Secondary Endpoints ............................................................................................ 44 
9.2.3 
Exploratory Endpoints ........................................................................................... 44 
9.3 
Hypotheses ......................................................................................................................... 44 
9.3.1 
Primary Hypothesis ............................................................................................... 44 
9.3.2 
Secondary Hypotheses ......................................................................................... 45 
9.3.3 
Exploratory Hypothesis ......................................................................................... 46 
9.4 
Sample Size Determination ................................................................................................ 46 
9.5 
Analysis Populations ........................................................................................................... 46 
9.6 
Primary Endpoint Analyses................................................................................................. 47 
9.7 
Secondary Endpoint Analyses ............................................................................................ 48 
9.8 
Exploratory Endpoint Analyses ........................................................................................... 48 
9.9 
Safety Analyses .................................................................................................................. 48 
9.10 Interim Analyses ................................................................................................................. 48 
10 Informed Consent Process ........................................................................................................... 48 
11 Adverse Events and Device Deficiencies ..................................................................................... 49 
11.1 Definitions ........................................................................................................................... 49 
11.1.1 
Adverse Event ...................................................................................................... 49 
11.1.2 
Adverse Device Effect .......................................................................................... 49 
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11.1.3 
Serious Adverse Event ......................................................................................... 49 
11.1.4 
Serious Adverse Device Effect ............................................................................. 50 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 50 
11.1.6 
Device Deficiency ................................................................................................. 50 
11.2 Recording and Handling of Adverse Events ....................................................................... 50 
11.2.1 
Assessment of Severity ........................................................................................ 51 
11.2.2 
Assessment of Causality ...................................................................................... 51 
11.2.3 
Assessment of Seriousness ................................................................................. 52 
11.2.4 
Assessment of Expectedness .............................................................................. 52 
11.3 Recording and Handling of Device Deficiencies................................................................. 53 
11.4 Reporting Responsibilities .................................................................................................. 53 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 53 
11.4.2 
Sponsor Notification of Events ............................................................................. 53 
11.5 Independent Data Monitoring Committee ........................................................................... 54 
12 Device Accountability .................................................................................................................... 54 
13 Deviations from the Clinical Investigation Plan ............................................................................. 54 
14 Data Management ........................................................................................................................ 55 
15 Confidentiality ................................................................................................................................ 55 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 56 
17 Suspension or Premature Termination ......................................................................................... 56 
18 Amendments to the Clinical Investigation Plan ............................................................................. 57 
19 Record Keeping and Retention ..................................................................................................... 57 
20 Publication Policy .......................................................................................................................... 57 
21 Statements of compliance ............................................................................................................. 57 
22 Quality Control and Assurance ..................................................................................................... 58 
22.1 Monitoring ........................................................................................................................... 58 
22.2 Audits .................................................................................................................................. 58 
23 Trademarks and Copyright ........................................................................................................... 58 
24 References .................................................................................................................................... 58 
25 Change History ............................................................................................................................. 59 
Appendix 1: Statement/Declaration of Device Conformity ................................................................... 60 
 
 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction 
This clinical study aims to investigate acceptance, actual-use usability and speech performance with 
the new Nucleus 8 Sound Processor (model: CP1110) system, compared with the commercially 
available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the 
acceptance of and satisfaction with the noise reduction feature ForwardFocus in the Automatic 
Scene Classifier ‘SCAN’. 
This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home 
studies (see section 4.2.2), and will also aim to confirm the in-booth performance of Nucleus 8 and 
Nucleus 7 Sound Processors. 
In this document, Nucleus 7 Sound Processor will be abbreviated to Nucleus 7 SP and will always 
refer to the sound processing unit model name CP1000, and Nucleus 8 Sound Processor will be 
abbreviated to Nucleus 8 SP and will always refer to the sound processing unit model name CP1110. 
4.2 
Findings of Previous Nonclinical and Clinical Studies 
4.2.1 
Nonclinical Data 
Biological safety evaluation of the Nucleus 8 SP and accessories was conducted in compliance with:  
• 
ISO / EN ISO 10993-1:October 2009 Biological evaluation of medical devices Part 1: 
Evaluation and testing within a risk management process 
• 
EN45502-2-3:2010 Active implantable medical devices Part 2-3: Particular requirements for 
cochlear and auditory brainstem implant systems 
Testing has confirmed that materials of the Nucleus 8 SP and accessories that are in contact with 
skin are biologically safe and suitable for use. 
4.2.2 
Clinical Data 
Clinical data relevant for the current trial fall under two main categories 1) Evidence on previous 
Behind the Ear (BTE) SP generations and 2) Evidence on the development and approval of 
ForwardFocus. These clinical data are summarized below: 
Behind the Ear Clinical Data 
Most clinical evidence on the previously marketed BTE SP, Nucleus 7 SP is available from two 
Cochlear-sponsored clinical studies that have been carried out in Australia.  These studies included 
some assessments very similar to those planned in the present study.  These Cochlear sponsored 
studies and reports from published literature are summarized below: 
Clinical Evaluation of Nucleus 7 Cochlear Implant System (CLTD5620) 
The in-house study aimed to collect subjective impressions of the Nucleus 7 SP and associated 
accessories (CR310 and Nucleus Smart App) and to evaluate speech recognition performance of the 
Nucleus 7 SP in quiet and noise. A total of 46 subjects were enrolled in the study.  
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The Client Orientated Scale of Improvement (COSI) indicated a greater proportion of “benefit” vs. “no 
benefit” in eight of the nine categories covered by the responses. An additional custom questionnaire 
was devised to assess listening benefits provided by the CI system for specific aspects of hearing. 
Mean scores favoured the Nucleus 7 SP for all 27 questions, with significant differences for 11 
questions. Cochlear implant specific quality of life (QoL) was measured via the Nijmegen 
questionnaire and for all three sub-domains (physical, psychological and social) there were 
significant improvements in QoL change greater than that expected by chance.  
Mean speech recognition scores in quiet (CNC monosyllables) were not significantly different among 
the Nucleus 5, Nucleus 6, and Nucleus 7 SPs. The results of the adaptive sentences in noise test in 
the S0N0 condition showed that the mean speech recognition performance in noise with both the 
Nucleus 7 SP (SCAN) and Nucleus 6 SP (SCAN) was significantly better than with the Nucleus 5 SP 
(Zoom). In spatially separated noise, there were statistically significant performance differences 
between the Nucleus 5 SP (Zoom) and Nucleus 7 SP (SCAN). Overall, the speech recognition 
outcomes demonstrated equivalent performance for the Nucleus 7 SP (SCAN) and Nucleus 6 SP 
(SCAN) in both quiet and noisy test conditions. 
The use of the Cochlear MiniMic 2+ and Phonak Roger 20 wireless microphones was compared with 
the Nucleus 7 SP SCAN baseline. Sentence recognition scores in both microphone conditions were 
significantly better than baseline. Performance with the MiniMic 2+ was significantly better than 
performance with the Roger 20 when speech was presented in noise.  
Results of this study have been published(Warren, Nel, & Boyd, 2019). 
ForwardFocus Clinical Data 
Signal processing strategies are designed to remove some or all competing noise, while maintaining 
the target speech with little or no modification. The 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, ForwardFocus 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 ForwardFocus. The two 
noise reduction algorithms complement each other due to their different principles of operation. 
Hersbach et al. (2013) found that ForwardFocus provided a significant improvement in group mean 
speech reception threshold compared with BEAM. 
A clinical evaluation of ForwardFocus performance (CRC5513), using the Nucleus 6 Sound 
Processor (Model CP910), revealed higher group mean speech perception scores with 
ForwardFocus (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 
ForwardFocus 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 ForwardFocus than with Standard, Zoom or Beam(Z). There was no 
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significant group difference in SSQ rating between ForwardFocus and the comparator programs 
(Standard, Zoom or Beam(Z)). There was an overall preference for “SCAN” with ForwardFocus over 
“SCAN” alone. The investigators concluded that ForwardFocus 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 ForwardFocus 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 ForwardFocus programs than N6 SCAN. Word 
recognition scores in quiet and questionnaire ratings for all ForwardFocus 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 ForwardFocus only. A decrement compared with 
ForwardFocus Strong was found. Sentence in noise scores with speech presented to the cochlear 
implant side or from behind the listener with mild ForwardFocus were inferior to the baseline. Based 
on these findings the investigators recommended that ForwardFocus be introduced as a custom 
programme that could be selected for specific listening conditions. 
Study CLTD5606 was designed to assess the effectiveness of ForwardFocus for speech reception in 
noise compared with the Nucleus 6 SCAN (SCAN + SNR-NR). The study included twenty-five 
conventional CI recipients. For sentence recognition with four-talker babble from the rear, all three 
levels of ForwardFocus (strong, medium and mild) were found to be superior to the Nucleus 6 SCAN. 
For speech-weighted noise presented behind the listener ForwardFocus Strong was demonstrated to 
be superior to the Nucleus 6 SCAN. When speech and either speech-weighted noise or four-taker 
babble were co-located in front of the listener, sentence recognition with ForwardFocus strong was 
similar to the Nucleus 6 SCAN. For CNC words in quiet ForwardFocus Strong was inferior to the 
Nucleus 6 SCAN. The investigators concluded that acceptable performance and safety of the 
ForwardFocus program can be anticipated for Nucleus 7 SP users in noisy environments, and the 
risk versus benefit profile is acceptable when ForwardFocus be used in quiet environments. 
The in-house study CLTD5709 investigated the effect of ForwardFocus 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 ForwardFocus On was 
superior to ForwardFocus 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 ForwardFocus On and ForwardFocus Off, and 
therefore no difference in listening effort. 
Questions from the Speech domain of the ‘Speech, Spatial and Qualities of Hearing Scale’ (SSQ) 
and 3 questions from the Qualities of Hearing domain were completed by subjects at baseline and 
after at least 4 weeks of use with ForwardFocus. 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 ForwardFocus. The majority of respondents found the ForwardFocus controls within 
the Nucleus Smart App as very easy to use and half of the respondents wanted ForwardFocus on 
their own processor.  
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4.3 
Study Rationale 
This investigation is planned to investigate the performance and clinical benefits of features that are 
new to the Nucleus 8 Sound Processor compared with the predicate device, the Nucleus 7 Sound 
Processor. This study will build on the evidence previously collected on BTE sound processors and 
‘ForwardFocus’, with particular focus on the acceptance and satisfaction of the automation of 
ForwardFocus, and the sound processor system in general.  
The key indicators of clinical performance and benefit include: 
• 
AuSTIN Sentences in noise (hearing performance) 
• 
Monosyllabic words in quiet (hearing performance) 
• 
The subjective Speech and Spatial Qualities scores (as available) 
A more detailed description of the test conditions and rationale for their inclusion is available in Table 
2. 
5 MEDICAL DEVICE INFORMATION 
5.1 
Identity and Description of the Investigational Medical Device (IMD) 
Nucleus 8 Sound Processor (CP1110) 
The Nucleus 8 SP is a Behind-The-Ear sound processor to be used with a compatible Cochlear 
Implant and is manufactured by Cochlear Limited. The Nucleus 8 SP is an incremental refinement of 
the Nucleus 7 SP, and re-uses many of the existing technology and features of the Nucleus 7 SP.  
The minimum components required for normal operation of the Nucleus 8 SP are: 
- 
CP1110 processing unit 
- 
CP1110 Slimline coil, 
- 
CP1110 Rechargeable Battery module  
- 
CP1000 Magnets (approved devices) 
- 
CP1110 Earhooks 
The Nucleus 8 SP incorporates the NEO-XS processor chip and C6 Hybrid chip, which allows for a 
smaller size sound processor, improved audio processing and improved support for GN ReSound 
Accessories when compared to previously marketed devices. 
 
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Figure 1: Image of the Nucleus 8 SP 
The key component similarities compared with the previous generation (Nucleus 7) include 
swappable rechargeable or 2ZincAir batteries, an integrated coil and coil cable, a single push button, 
manual selection of ForwardFocus which is an algorithm that reduces noise from behind and beside 
the listener while passing sounds from the front without attenuation. The product features intended 
for commercialisation also include three different receiver sizes for hybrid support, compatibility with 
True Wireless accessories, GN Resound hearing aids to enable bimodal operation.  
The Nucleus 8 SP includes access to sound processor controls via the CR310 Remote Control and 
the Nucleus Smart App on compatible iOS and Android Phones. The Nucleus 8 Sound Processor will 
be programmable using Custom Sound Pro fitting software. 
The key component differences compared with the previous generation (Nucleus 7) include Bluetooth 
5.2 Hearing Aid Profile (BTHAP) capable hardware (C6 Hybrid), and reduced size 
 
 
. The Nucleus 8 SP also includes access to low energy audio streaming from 
mobile phones and BTHAP broadcasts and compatibility with next generation Cochlear 
 
Implants. 
Additional features introduced in the sound processor include improved accuracy of the SCAN 
algorithm (SCAN-X), automation of ForwardFocus in SCAN-X, 
 
  
SCAN-X is a development of the SCAN automation system. Like SCAN, it switches directional 
processing modes based on an environmental classifier, that predicts whether the recipient is in a 
Quiet, Speech, Speech in Noise, Noise or Music environment from the microphone signal. The 
underlying environmental classifier in SCAN-X does additional analysis on the spectrum of the signal 
to improve its prediction accuracy.  
The new adaptive ForwardFocus in SCAN-X feature (SCAN+FF) will apply the ForwardFocus noise 
attenuation processing algorithm using different strengths in conjunction with the microphone 
directionality modes already used in SCAN (namely Standard, Zoom, and Beam directionality 
modes).  
The additional features and upgrades in technology of the Nucleus 8 Sound Processor are 
anticipated to improve the usability, hearing performance and aesthetics of the device in comparison 
to currently marketed devices. 
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Processing Unit  
The main functions of the Nucleus 8 Sound Processor are executed by the CP1110 Processing Unit. 
The CP1110 Processing Unit houses the electronics and processing unit firmware necessary for the 
sound processor to function and provides the interfaces for other devices and accessories. The 
CP1110 Processing Unit will be available in six colours and is supplied with the Cochlear Earhook 
(medium).  
The CP1110 Processing Unit will be commercially called Nucleus® 8 Processing Unit. The CP1110 
Processing Unit consists of a printed circuit board assembly (PCBA) held together in a PCBA 
skeleton which is encapsulated by the top cover and the processor case. The 
 microphones 
are protected by the microphone cover sitting on top of the top cover. The processor case is closed 
with a Cochlear proprietary NEUF connector which is used to connect to the battery module or other 
accessories.  
• 
The materials in contact with skin are:  
o Processing unit casing: Co-polyester Tritan MX731 
o Earhook (hard part): Polyamide Grilamid TR90 Clear  
o Earhook (soft part): Silicone ShinEtsu KE 2090/70  
Nucleus 8 Coils  
The Nucleus 8 coils will be based on the Nucleus 7 coils design. The mechanical shells of the coils 
are identical between the Nucleus 7 and Nucleus 8 coils, but the Nucleus 8 coils incorporate a new 
coil connecter and coil printed circuit boards (PCBs). The materials in contact with skin include:  
• 
Coil overmould and strain relief overmould: TPE 27A70  
• 
Coil cable sheath: Totoku PVC  
Magnets  
Nucleus 8 Sound Processor will use the same magnets as the Nucleus 7 Sound Processor. The 
materials in contact with skin are:  
• 
Magnet casing: ABS Colorcomp HMG94MDC  
Battery Modules  
The CP1110 Processing Unit in stand-alone mode can be powered by three different battery options:  
• 
Compact Rechargeable battery (91mAh)  
• 
Power compact Rechargeable battery (142mAh)  
• 
Power Extend Rechargeable battery (183 mAh) 
The materials in contact with skin include:  
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• 
Battery casing: Co-polyester Tritan MX731 
Intended Use 
The Nucleus 8 Processing Units are intended to be used in combination with other devices as part of 
a hearing implant system to provide hearing sensation.  The processing unit converts sounds into 
electrical signals, which it sends, via a coil, to an implant.  The processing unit also provides power to 
the implant.   
When used in combination with an audio receiver, the sound processor also delivers sound to the ear 
canal in recipients with residual hearing. 
The IMD and/or the packaging for the device will state that the device is exclusively for use in a 
clinical investigation. 
Intended Population 
The SP is indicated for a recipient with a compatible Cochlear Nucleus implant. The SP is compatible 
with the following Cochlear Nucleus implants:  
• 
CI600 Series Implants: CI612, CI622, CI624, CI632 
• 
CI500 Series Implants: CI512, CI522, CI532, ABI541 
• 
CI24RE Series Implants: CI422, CI24REH (Hybrid L24), CI24RE (CA), CI24RE (ST)  
• 
CI24R and CI24M Series Implants: CI24R (CA), CI24R (CS), CI24R (ST), CI24M, ABI24M, 
CI11+11+2M 
 
All medical devices used in this investigation are manufactured by Cochlear Limited. 
5.2 
Identity and Description of the Comparator 
Nucleus 7 Sound Processor (CP1000) 
Nucleus 7 is a sound processor system manufactured by Cochlear Limited. The Nucleus 7 SP is 
commercially available. The sound processor is controlled by either the Nucleus Smart App (on iOS 
or Android), the MFi Control (on the iPhone, iPad or iPod Touch), the Remote Control (CR310) or the 
button on the sound processor. Recipients can monitor the sound processor using the Android or 
iPhone Nucleus Smart App. Clinicians can program the Nucleus 7 SP with Custom Sound Pro (6 or 
later). 
The Nucleus 7 SP incorporates the NEO-XS processor chip, which allows for a small sound 
processor, low power usage, improved audio processing and improved support for GN ReSound 
Accessories when compared to the previous CP910/CP920 Sound Processors.  
 
 
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Telecoil 
Telecoil 
Bluetooth 5.2 Hearing Aid Profile* 
Wireless Accessory support 
Prox 2 
Prox 2 
Input Processing Technologies  
ADRO 
ASC 
Whisper 
Standard 
Zoom 
BEAM 
SNR-NR 
WNR 
FF Manual 
 
SCAN 
ADRO 
ASC 
Whisper 
Standard 
Zoom 
BEAM 
SNR-NR 
WNR 
FF Manual 
SCAN+FF 
SCAN X 
Core Control: CR310, Nucleus Smart App. 
Core Connected Care:  Remote Check*-ready, CS Pro programming software 
 
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Table 2 Outcome measure comparisons and rationale 
Test condition 
Comparison 
Rationale 
Sentences in noise 
S0Nrearhalf 
babble (65 dB 
SPL) 
Treatment: Nucleus 8 
SCAN+FF 
Control: Nucleus 8 SCAN 
ForwardFocus is designed to reduce sounds that originate from behind the 
listener. The inclusion of S0Nrearhalf and S0N3 speaker configurations, with the 
noise originating from behind, will facilitate confirmatory testing of SCAN+FF 
compared with the default SCAN configuration while controlling for the sound 
processor hardware including new microphones, and the new underlying scene 
classifier.  
This will be the first evaluation of SCAN+FF using a more disparate and variable 
noise type (S0Nrearhalf) and fixed-speaker noise (S0N3), and will provide an 
indication of the performance of ForwardFocus Auto in a variety of noise 
positions. 
Sentences in noise 
S0N3 babble (65 
dB SPL) 
Treatment: Nucleus 8 
SCAN+FF 
Control: Nucleus 8 SCAN 
CNC words in 
Quiet (50 dB SPL) 
Treatment: Nucleus 8 
standard directionality  
Control: Nucleus 7 standard 
directionality  
 
 
 
  
 
 
SSQ12  
Treatment: Nucleus 8 Sound 
Processor  
Control: Nucleus 7 Sound 
Processor 
 
The SSQ includes a variety of hearing situations that reflect the reality hearing in 
the everyday world. The inclusion of this measure, coupled alongside the in-
booth testing, allows for a complete picture of benefit associated with the signal 
processing technology.  
Study subjects will be asked to complete the SSQ12 at two time points in the 
study; 1) at study entry, where scores will reflect their experience with their own 
sound processor, 2) after take home use with the Nucleus 8 Sound Processor. 
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6 OBJECTIVES 
6.1 
Primary Objective  
To evaluate adult cochlear implant speech perception in spatially separated speech and noise 
(S0Nrearhalf) with the CP1110 Sound Processor with ForwardFocus ON (SCAN) compared with 
ForwardFocus OFF (SCAN) 
 
6.2 
Secondary Objective 
• 
To evaluate adult cochlear implant speech perception in spatially separated speech and noise 
(S0N3) with the CP1110 Sound Processor with ForwardFocus ON (SCAN) compared with 
ForwardFocus OFF (SCAN) 
• 
To evaluate adult cochlear implant speech perception in quiet with the CP1110 Sound 
Processor and the Nucleus 7 Sound Processor 
• 
To evaluate adult cochlear implant subjective hearing performance and sound quality with the 
CP1110 Sound Processor and Nucleus 7 Sound Processor  
• 
To evaluate acceptance and satisfaction of the CP1110 Sound Processor 
6.3 
Exploratory Objective 
To evaluate the ease of use and user experience of the CP1110 Sound Processor System when 
used in real world conditions 
7 DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
This is a pre-market, prospective, single-site, non-randomised, open-label, within-subject, pivotal, 
interventional clinical investigation. 
The subjects include adults aged 18 years and older with sensorineural hearing impairment who are 
current users of a Nucleus Cochlear Implant system and Nucleus 7 Sound processor system. After 
enrolment, subjects will attend scheduled study visits over a twelve month study period as described 
in the CIP Schedule of Events (Section 3). At study visits, 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. All subjects will attend an end-of-study visit at the time they 
complete the study. 
7.1.1 
Design Rationale 
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. 
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Comparison will be made within-subject with repeated measures for each of the sound processing 
conditions to be evaluated. There will be at least 5 in-clinic sessions with take home use between 
each sessions. The test sessions will include speech perception tests including sentence in noise 
and words in quiet tests and may include the completion of questionnaires and usability assessment. 
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 due to the similar form factor of the SP generations, it may also be 
possible to conceal which SP is being used during testing. 
Counter-balancing 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 or subject’s legally authorised 
representative before any study procedures are initiated. 
To maintain confidentiality, subject names will not be recorded on any study document other than the 
informed consent form and Subject ID Log; neither document will be provided to the Sponsor. All 
individuals who provide informed consent are considered enrolled into the study and will be assigned 
a unique identifier. If a subject signs consent and either exits the study or fails the screening 
assessments prior to initiating Visit 1, they will be considered a screen failure and will not be counted 
as part of the required 20 subjects for the study. 
The subjects include men and women aged 18 years or older with at least 3 months experience with 
a Nucleus 7 (CP1000) Sound Processor system. Subjects will be screened, and 20 eligible subjects 
will be recruited in the clinical investigation. For speech perception testing, all subjects will receive all 
treatment and control conditions; however, the test order will be counterbalanced/ randomised to 
control for order effects.   
7.2.1 
Inclusion Criteria 
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 (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, 
CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422) 
4) 
At least 6 months experience with a cochlear implant. 
5) 
At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor 
6) 
Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test  
7) 
Willingness to participate in and to comply with all requirements of the protocol. 
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8) 
Fluent speaker in English as determined by the investigator 
9) 
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) Additional disabilities that would prevent participation in evaluations. 
2) Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and 
limitations that are inherent to the procedures. 
3) Unable or unwilling to comply with the requirements of the clinical investigation as determined by 
the Investigator. 
4) Investigator site personnel directly affiliated with this study and/or their immediate families; 
immediate family is defined as a spouse, parent, child, or sibling. 
5) Cochlear employees or employees of Contract Research Organisations or contractors engaged by 
Cochlear for the purposes of this investigation.  
6) Currently participating,or participated in another interventional clinical study/trial in the past 30 days 
or if less than 30 days, the prior investigation was Cochlear sponsored and determined by the 
investigator to not impact clinical findings of this investigation. 
7.2.3 
Number of Subjects Required 
See Section 9.4 Sample size considerations 
7.2.4 
Vulnerable Populations 
Pregnant women will not be excluded from this study. The study procedures including the 
investigational devices will have no impact on the health and safety of this population.  
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 prior to initiating Visit 1. 
• 
Participated: Subjects who have met eligibility criteria and have commenced baseline 
assessments. 
• 
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. 
• 
Completed: Enrolled subjects who have completed the required treatment and visit schedule.  
The recruitment period for the clinical investigation is estimated to be 2 months from the time of first 
subject consent to recruitment of the last subject. 
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The expected duration of each subject’s participation in the clinical investigation, is up to 12 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. 
7.2.6 
Criteria for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time and are not obliged to provide any 
justification for their decision. 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: 
• 
Adverse Event (AE) 
• 
Device Deficiency (DD) 
• 
CIP or GCP deviation 
• 
Subject withdrew consent 
• 
Subject lost to follow-up 
• 
Subject death 
• 
Sponsor decision 
• 
Investigator decision 
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. 
7.2.7 
Randomisation Procedures 
Subjects will not be randomised to a treatment condition. To control for order effects, 
counterbalancing of the test order will be implemented for the primary and secondary speech 
perception endpoints. All permutations will be represented evenly across the subjects where 
possible. 
SRT S0Nrearhalf Test order 
Primary: Nucleus 8 (SCAN+FF) vs Nucleus 8 (SCAN)  
Subjects assigned a study ID including ODD numbers (01, 03, 05 etc) will be tested in the following 
order: 
1. Nucleus 8 (SCAN+FF) 
2. Nucleus 8 (SCAN) 
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SRT S0N3 Test order 
Secondary: Nucleus 8 (SCAN+FF) vs Nucleus 8 (SCAN)  
Subjects assigned a study ID including EVEN numbers (02, 04, 06 etc) will be tested in the following 
order: 
1. Nucleus 8 (SCAN+FF) 
2. Nucleus 8 (SCAN) 
 
CNC Words Test Order 
Secondary: Nucleus 8 vs Nucleus 7   
Subjects assigned a study ID including ODD numbers (01, 03, 05 etc) will be tested in the following 
order: 
1. Nucleus 8 
2. Nucleus 7 
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 
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 each test session 
and take-home periods, subjects will return all 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.
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7.3 
Performance Evaluations and Procedures 
7.3.1 
Speech perception in quiet 
Speech perception in quiet will be measured using the CNC monosyllabic words (Peterson & Lehiste, 
1962) at 50 dB SPL from S0 position. See Figure 3. There will be 2 lists per condition. The goal of 
speech perception assessment in quiet is to compare % words correct for each of the conditions.  
7.3.2 
Speech perception in noise 
Speech perception in noise will be measured using the Australian Speech Test In Noise (AUSTIN) 
(Dawson, Hersbach, & Swanson, 2013), which is a test that uses BKB like target sentences 
presented in adaptive noise. The goal of the speech perception test in noise is to provide the SNR for 
50% speech intelligibility. The signal level will be fixed at 65 dB SPL. All sentence in noise tests will 
be measured using this procedure.  
Speech perception performance in noise and quiet will be assessed using a loud-speaker 
configuration as shown in the diagrams of Figure 3 
 
Figure 3. Left – S0N3 with babble noise from 90, 180 and 270 degrees (3 talkers in total). Middle – 
S0Nrearhalf with roving babble noise presented from 4 speakers in the rear hemisphere (4 talkers in 
total). The rear hemisphere will consist of 7 speakers and the 4 noise speakers will change for every 
sentence in the test list. Right – S0 CNC words  
7.3.3 
Subjective ratings 
Baseline Questionnaire – At study entry subjects will be asked a series of questions on their 
experience with their own sound processor system, including use of and satisfaction with the 
automatic scene classifier, SCAN, and ForwardFocus.  
Nucleus 8 Questionnaire 1 and 2 - After at least 2 weeks of take home use with the Nucleus 8 Sound 
Processor system, subjects will be asked to return to the study clinic and complete a short list of 
questions based on the experience with the Nucleus 8 Sound Processor system, including questions 
on hearing performance, comfort, usability and overall satisfaction. Some questions will be absolute 
ratings of Nucleus 8 Sound processor, and some will be compared to their experience wearing their 
own sound processor. 
Speech, Spatial and Qualities of Hearing Scale (SSQ12) – The SSQ is designed to measure a range 
of hearing disabilities across several domains. Subjects are asked to rate their ability to hear speech 
in a variety of competing contexts, subjects are also asked about their spatial hearing abilities 
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including the impact of direction, distance and movement associated with spatial hearing. Subjects 
are also asked about their ease of listening, and the naturalness, clarity and identifiability of different 
speakers (Gatehouse & Noble, 2004; Noble, Jensen, Naylor, Bhullar, & Akeroyd, 2013). A shortened 
form of the 49-question SSQ, the SSQ12, will be used in this study.  
Study subjects will be asked to complete the SSQ12 at two time points in the study; 1) at study entry, 
where scores will reflect their experience with their own sound processor, 2) after take home use with 
the Nucleus 8 Sound Processor. 
 
7.3.4 
Usability Assessments 
Usability of the Nucleus 8 Sound Processor system may be assessed during study visits and take-
home periods. See section 7.3.7 for the procedural provisions relating to usability testing that may be 
introduced if COVID restrictions are in place during this study period. All subjects will be asked to 
take part in a usability interview, however participation may be restricted by the video call technology 
owned by the study subject.  
Study subjects may be asked to undertake typical tasks in a simulated use environment and the 
study investigators will observe the tasks and log any device deficiencies experienced during this 
time. 
7.3.5 
Sound Quality 
Subjective sound quality assessments with the investigational sound processor may occur during 
study visits. Handwritten notes will be stored in the subject file and all device deficiencies will be 
stored in the electronic data base (Medidata Rave). These assessments may be undertaken in real 
world environments at Cochlear Ltd or on campus at Macquarie University. 
 
7.3.6 
Participant Evaluations and Procedures 
Visit 0 
Included in this period: 
- 
Screening  
- 
Informed consent 
- 
Other standard CRFs including demographics, medical, hearing and device history 
Screening and informed consent: 
• 
20 subjects will be enrolled  
• 
Subjects must be consented to the study and inclusion and exclusion criteria confirmed prior 
to any study activities starting.  
Visit 0 and 1 may be at the same visit. 
 
Visit 1 
Included in this period: 
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Take-home use 
At the end of the study visit the Nucleus 8 SP programs will be re-programmed onto the study 
devices. See instructions under visit 1 ‘Take-home use’ for programs to be used and instructions.  
 
Visit 3 
Included in this period: 
- 
Take-home feedback 
- 
Device optimisation including the issuance of new firmware and new features as made available 
throughout the course of the trial (if required) 
- 
Adverse Events and Device Deficiencies   
 
Take-home feedback 
After the take home period, study subjects will be asked about their experience with the Nucleus 8 
Sound Processor. The study investigator will optimize the devices if required. Device deficiencies and 
adverse events experienced during this take home period will be recorded if not already. 
 
Take-home use 
At the end of the study visit the Nucleus 8 SP programs will be re-programmed onto the study 
devices. See instructions under visit 1 ‘Take-home use’ for programs to be used and instructions.  
 
Visit 4 
Included in this period: 
- 
Take-home feedback 
- 
Device optimisation including the issuance of new firmware and new features as made available 
throughout the course of the trial (if required) 
- 
Nucleus 8 Questionnaire 2 
- 
Adverse Events and Device Deficiencies   
 
Take-home feedback 
After the take home period, study subjects will be asked about their experience with the Nucleus 8 
SP. The study investigator will optimize the devices if required. Device deficiencies and adverse 
events experienced during this take home period will be recorded if not already. 
 
Questionnaires 
Based on their experience with the Nucleus 8 SP, study subjects will be asked to complete the 
Nucleus 8 Questionnaire 2. 
Take-home use 
At the end of the study visit the Nucleus 8 SP programs will be re-programmed onto the study 
devices. See instructions under visit 1 ‘Take-home use’ for programs to be used and instructions.  
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Study subjects may provide 
feedback that the Sound 
Processor is unacceptably noisy 
or has an unacceptably noticeable 
buzzing. 
If the issue has an impact on 
performance the product will be 
updated and speech perception 
will be re-evaluated by subjects. 
Intermittency  
Study subjects may provide 
feedback that the Sound 
Processor is not outputting a 
consistent signal with gaps in 
stimulation.  
If the issue has an impact on 
performance the product will be 
updated and speech perception 
will be re-evaluated by subjects. 
General bugs and 
product issues: 
 
While all measures have been 
undertaken to test each of the 
features with the Nucleus 8 
(CP1110) Sound Processor, there 
may be unforeseen issues that are 
exposed through usage in the 
environments used in the study.  
 
General issues will be judged on a 
case by case basis. If it is judged 
that the issue has an 
unacceptable impact on 
performance, the product will be 
updated and re-evaluated by 
subjects. 
 
All product issues will be recorded as device deficiencies. The Sound Processor will be considered 
mature for speech perception testing when all product optimisations that impact on performance have 
been made. 
Multiplicity and Type I error 
This adaptive procedure will only be incorporated when subjective issues are raised by study 
subjects, and will not be based on the speech perception scores collected during the session.   
No repetition of speech perception will occur after the database has been locked. As such, no control 
of Type I error is necessary when sound quality or intermittencies are identified during data 
collection. 
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Visit 0
•Screen
•Consent
•Demographics
•Eligibility
•Medical History
•Hearing History
•Device History
Visit 1
•SP Fitting
•Usability 
Interview
•Baseline 
Questionnaire
•Sound Quality
•Usability
•SSQ12 Nucleus 7
Visit 2
•Take-home 
feedback
•SP Optimisation 
(as required)
•Nucleus 8 
Questionnaire 1
•SSQ12 Nucleus 8
Visit 3
•Take-home 
feedback
•SP Optimisation 
(as required)
Visit 4
•Take-home 
feedback
•Nucleus 8 
Questionnaire 2
•Start extended 
take-home use
Additional Visit(s)
•Take-home 
feedback
•SP Fitting 
Optimisation (as 
required)
•Troubleshooting
•S0Nrearhalf
•S0N3
•CNC Words
Visit 5
•Take-home 
feedback
•Study 
completion (all 
devices returned 
and subjects 
reverted to own 
SP)
Periods of take-home use 
Figure 4. Overview of planned visits 
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7.3.7 
Procedural mitigation relating to COVID-19 
Due to the physical distancing restrictions in place during the COVID-19 pandemic, optional device 
programming and procedural provisions may be introduced. These measures are to support the 
continuation of this project, while ensuring the safety of subjects and study staff.  
• 
Screening and consent: See section 10 for the consent process. If COVID-19 restrictions also 
restrict research candidates from attending the study site, screening and consent may be 
performed via phone call or video conference. Paper copies of the consent form will be 
provided via mail/courier and subjects will be asked to use a prepaid envelope to return one 
original signed copy to the site.  
• 
Device programming: Subjects may be asked to commence take-home testing through 
remote management. Devices, accessories, questionnaires, and instructions may be sent to 
subjects via courier, so that they do not need to attend the clinic. Prior to shipping, each 
subject’s Nucleus 8 study sound processor(s) will be connected to the fitting software, 
Custom Sound Pro. The subject’s MAP(s) from their own processor(s) are saved in their 
individual Custom Sound Pro file. This will be converted to their Nucleus 8 sound processor 
MAP(s), and their preferred programs written to the study processor. If a subject’s most 
recent MAP(s) are not retrievable either from the site’s database or the subject’s clinical 
audiologist, remote management will not be possible until they are able to attend the site to 
have their own processor(s) connected to the software. For subjects who do not wish to 
participate in remote study and device management, the device programming and fitting will 
be performed in clinic once restrictions in New South Wales are eased.   
• 
Usability interviews: Usability assessments may be conducted remotely to accommodate 
situations where test participants are unable to, or would prefer not to, travel to a site in order 
to perform testing. In the remote scenario,  the usability interview will be conducted via video 
conferencing software. Subjects will be provided with all devices, accessories and user 
manuals required for the testing.  
• 
Speech perception: Speech perception testing can only be conducted at the study sites. If 
restrictions are ongoing at the planned time of these study visits, these tests may be moved to 
later in the study. As such, speech perception tests have been decoupled from specific visits. 
If time permits, and study subjects are willing, all speech perception tests may be conducted 
on the same day. All comparisons for a specific endpoint test will be completed on the same 
day.  
7.4 
Safety Evaluations and Procedures 
The risks and anticipated ADEs for the Nucleus 8 SP, 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. 
 
Safety data adjudication may be conducted by the Sponsor’s Medical Officer in accordance with the 
Sponsor’s standard operating procedures. 
7.4.1 
Concomitant Medication and Therapies 
All concomitant medical treatments will be collected as part of this study.  
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7.5 
Equipment Used for Evaluation of Performance and Safety 
7.5.1 
Software 
Speech testing in quiet and noise will be performed via the adaptive Australian Sentence Test in 
Noise (AuSTIN) test software (Dawson et al., 2013) 
Devices and signal processing configurations will be programmed using Custom Sound 7.0. 
7.5.2 
Speech Perception 
Speech perception performance in quiet will be assessed using a loudspeaker configuration with the 
speech from the front (S0). 
Speech perception performance in noise will be assessed using a loudspeaker configuration with the 
speech from the front and noise from four roving locations in the rear hemisphere (S0Nrearhalf) and 
with speech from in front and noise from 90, 180 and 270 degrees azimuth (S0N3).  
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.  
7.5.3 
Questionnaires 
Subjective ratings of the test sound processors will be evaluated via paper-based questionnaires. 
7.6 
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. Investigators 
are qualified audiologists familiar with cochlear implant development, surgery and 
programming.  Investigators’ trial materials, programming 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.  
Activities to be performed by sponsor representative excluding monitoring include: 
1. Application of clinical quality assurance and quality control principles to the processes of the 
clinical investigation  
a. Implement and maintain written clinical quality procedures to ensure the clinical 
investigation is designed, conducted and that data generated is compliant with the ISO 
14155:2011 Standard (ISO, 2011).  
b. Clinical quality assurance and quality control will be implemented according to sponsors 
quality system (Cochlear Quality Manual reference [7]) 
2. Clinical investigation planning and conduct 
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a. Selection of clinical personnel for project management of the clinical investigation 
b. Preparation of documents and materials for the clinical investigation 
c. Project management for the clinical investigation. i.e. accountability of investigational 
devices, clinical trial insurance coverage, submission of application(s) and investigation 
updates to the appropriate regulatory authority(ies). 
3. Safety evaluation and reporting of adverse events (AE) to the TGA and ethics committee  
4. Clinical investigation close-out, statistical analyses and final report 
 
8 RISKS AND BENEFITS OF THE INVESTIGATIONAL MEDICAL DEVICE AND 
CLINICAL INVESTIGATION 
8.1 
Anticipated Clinical Benefits  
This study provides subjects with the opportunity to trial a new cochlear implant sound processor and 
related components (Nucleus 8) prior to the commercial release date. Subjects may benefit from 
improved usability and performance of the different components of the Nucleus 8 system. For 
subjects who have not previously experienced using the ForwardFocus feature, they may experience 
benefit of improved communication through reduction of distracting background noise. 
Due to the limited use of the IMD (minimum of 4 test blocks over a period of up to 12 months), there 
are no long-term clinical benefits anticipated for the subjects. 
8.2 
Anticipated Adverse Device Effects 
Cochlear’s internal hazards analysis considers probable hazardous situations relating to the Nucleus 
7 and Nucleus 8 SPs. 
The risks associated with the Nucleus 7 and Nucleus 8 SPs 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 7 and Nucleus 8 SPs such as pain or discomfort when wearing the processor and a risk that 
some sounds could be uncomfortable. Product specific warnings can be found in the respective User 
Guide and relevant instructions for use. 
8.3 
Risks Associated with Participation in the Clinical Investigation 
There is a small risk that the programs on the Nucleus 7 SP and Nucleus 8 SP may sound different 
to subjects own SP. 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. Possible interactions with concomitant 
medications and residual risks for the device are not anticipated in this clinical investigation. 
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See the Nucleus 7 SP User Guide for all Warnings and Contraindications. (user guides can be found 
within the ‘Support’ section of the country specific Cochlear website; 
). At this 
preliminary stage in development, the Nucleus 7 SP User Guide will be relevant for Nucleus 8 SP.   
As the study procedures involve planned visits to the Cochlear headquarters research site, there may 
be an increased risk of contracting infectious diseases such as COVID-19 whether in transit to the 
site or moving throughout the building. 
8.4 
Risk Mitigation 
The study investigational devices have been tested for safety, and the performance and use of the 
device is expected to be similar to the approved Nucleus 7 SP. 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; protective measures in the device itself or in the 
manufacturing process; Information for safe usage. 
The fitting and use of the CP1110 SP will be managed by the investigator. In cases where the sound 
becomes at all uncomfortable or uncomfortably loud during fitting, subjects are encouraged to 
remove the SP from their head or inform the investigator so that stimulation is immediately ceased. 
Should any such discomfort occur during take-home use, subjects will be advised to remove the 
CP1110 SP and revert to using their own SP until the cause of the discomfort is understood and 
resolved. 
If subjects 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 processor. 
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. 
Risk mitigation relating to COVID-19 
It is expected that study participants will be taking steps to limit exposure to infectious diseases, for 
example, COVID-19. The site will actively follow the advice of official health authorities and 
governments to ensure the health and wellbeing of site employees and research subjects. These 
include but are not limited to: 
• 
Operational changes to ensure attendance at the site is limited to only those who are 
required to be there. Cochlear headquarters has implemented procedures to enable 
contact tracing for all employees and visitors, as well as processes to scale up, scale 
down and/or deep clean should there be a confirmed positive case of the virus on the 
premises. 
• 
The research site is separated physically, enabling separation of study participants 
from other employees working in the building.  
• 
Increased hygiene etiquette including cleaning of high-touch surfaces before and after 
each study visit, disinfection of any shared study devices or equipment and 
investigators are equipped to use gloves or wear a face masks as required. Hygiene 
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resources such as handwashing/rubbing stations are readily available throughout the 
building and research site. 
• 
Where possible, study participants will be encouraged to drive to Cochlear and utilise 
free on-site parking instead of travelling via public transport. 
• 
Subjects will be provided with any necessary resources required to return study devices to the 
site, should they be unable to attend any of the planned visits. For example, couriers or 
postage may be arranged as necessary. 
 
8.5 
Risk-to-Benefit Rationale  
Residual risk levels associated with the CP1110 SP and accessories have been determined to be as 
low as possible when the sound processor is used with a compatible cochlear implant. The 
probability of occurrence of harm for all hazards was found to be “remote” or “improbable”. Based on 
pre-clinical testing of the CP1110 SP along with a review of clinical investigations and published data 
on the Nucleus 7 SP, the anticipated clinical benefits have been found to outweigh the potential risks 
to the subject through participation in this clinical investigation.  
9 STATISTICAL CONSIDERATIONS 
9.1 
General Considerations 
See sections 9.2 to 9.10 for statistical considerations. 
9.2 
Endpoints 
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.  
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 SSQ12 endpoint, one 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 Questionnaires, Nucleus 8 Questionnaires 1 and 2 and the Baseline Questionnaire, the 
endpoint is the completion of the questionnaire. 
9.2.1 
Primary Endpoint 
The primary efficacy measure for the Nucleus 8 Sound Processor will be Speech Reception 
Thresholds (SRT) assessed via AuSTIN Sentence scores in spatially separated adaptive noise. 
The primary efficacy outcome for the study will be determined by the following primary efficacy 
endpoint: 
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• 
Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with 
ForwardFocus ON (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0Nrearhalf 4TB). 
 
9.2.2 
Secondary Endpoints 
• 
Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with 
ForwardFocus On (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0N3 Babble). 
• 
Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound 
Processor and Nucleus 7 Sound Processor 
• 
Paired difference in Global SSQ12 scores after experience with the CP1110 Sound Processor 
and Nucleus 7 Sound Processor 
• 
Ratings on the ‘CP1110 Questionnaire 1’ and ‘CP1110 Questionnaire 2’ after at least 2 weeks 
of experience with the CP1110 Sound Processor 
• 
Take home use with the CP1110 Sound Processor System 
 
9.2.3 
Exploratory Endpoints 
Feedback from take home use with the CP1110 Sound Processor System. 
 
9.3 
Hypotheses 
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.  
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.  
For the non-inferiority test of SSQ12 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 -1, 
the treatment condition is regarded as non-inferior to the control on that measure.  
 
9.3.1 
Primary Hypothesis 
Endpoint: Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with 
ForwardFocus ON (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0Nrearhalf 4TB). 
 
H0: Sentence in noise (S0Nrearhalf 4TB) scores (dB SRT) with the CP1110 Sound Processor 
with FF On (treatment) are inferior to those with the CP1110 Sound Processor with FF Off 
(control)  
CP1110 FF ON – CP1110 FF OFF ≥ 1 dB (NB: higher SRT scores represent poorer 
performance) 
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H1: Sentence in noise (S0Nrearhalf 4TB) scores (dB SRT) with the CP1110 Sound Processor 
with FF On (treatment) are non-inferior to those with the CP1110 Sound Processor with FF 
Off (control)  
CP1110 FF ON – CP1110 FF OFF < 1 dB 
9.3.2 
Secondary Hypotheses 
Secondary endpoint 1 
Endpoint: Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with 
ForwardFocus On (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0N3 Babble). 
 
 
H0: Sentence in noise (S0N3 Babble) scores (dB SRT) with the CP1110 Sound Processor 
with FF On (treatment) are inferior to those with the CP1110 Sound Processor with FF Off 
(control)  
CP1110 FF ON – CP1110 FF OFF ≥ 1 dB  
 
H1: Sentence in noise (S0N3 Babble) scores (dB SRT) with the CP1110 Sound Processor 
with FF On (treatment) are non-inferior to those with the CP1110 Sound Processor with FF 
Off (control)  
CP1110 FF ON – CP1110 FF OFF < 1 dB 
Secondary endpoint 2 
Endpoint: Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 
Sound Processor and Nucleus 7 Sound Processor 
 
H0: Words in quiet (50 dB CNC words) scores (% words correct) with the CP1110 Sound 
Processor (treatment) are inferior to those with the Nucleus 7 Sound Processor  
CP1110 – Nucleus 7 < -10% 
H1: Words in quiet (50 dB CNC words) scores (% words correct) with the CP1110 Sound 
Processor are non-inferior to those with the Nucleus 7 Sound Processor  
CP1110 – Nucleus 7 > -10% 
 
Secondary endpoint 3 
Endpoint: Paired difference in Global SSQ12 scores after experience with the CP1110 Sound 
Processor and Nucleus 7 Sound Processor 
 
H0: Hearing performance ratings (SSQ12) with the CP1110 Sound Processor (treatment) are 
inferior to those with subject’s own processor (control)  
CP1110 – Nucleus 7 ≤ -1  
H1: Hearing performance ratings (SSQ12) with the CP1110 Sound Processor (treatment) are 
non-inferior to those with subject’s own processor (control)  
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CP1110 – Nucleus 7 > -1  
 
There are not hypotheses for the following endpoints; 
• 
Ratings on the ‘CP1110 Questionnaire 1’ and ‘CP1110 Questionnaire 2’ after at least 2 weeks 
of experience with the Nucleus 8 Sound Processor 
• 
Take home use with the CP1110 Sound Processor System 
 
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 SRT (Speech Recognition Threshold) scores and CNC word scores. The sample size using a 
confidence interval method (one-tailed 97.5% confidence interval) was estimated to have a 
reasonable power to detect non-inferiority of sentence and word scores for the above-mentioned 
hypotheses. 
To reject the null hypothesis of inferior sentence in noise scores (SRT scores), the following 
parameters for sample size calculation were chosen: 
• 
A clinical important difference value of 1 dB SRT. This margin is based on clinical consensus. 
NB: higher SRT scores represent poorer performance. 
• 
A standard deviation (SD) of change or difference scores of 1.36 dB. This SD is calculated 
from 256 paired differences and is an indicative test re-test SD for both S0N3 and S0N0. 
• 
A significance level α = 0.025 (one-tailed). 
• 
A desired power of 0.8 
Based on these assumptions, a sample size of 17 are required to reject the null hypotheses. Twenty 
subjects will be enrolled to allow for any unforeseen subject withdrawal.  
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 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. 
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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 treatments and have at least 
one set of paired treatment and control 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 treatments and have at least 
one paired measurements 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.  
Safety Population 
The Safety Population will include all treated subjects. The Safety Population will be used for the 
safety data analysis. 
9.6 
Primary Endpoint Analyses 
Primary and Secondary Speech Perception Endpoints: 
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 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. 
The same analysis method will be applied to the non-inferiority test for words in quiet scores 
(monosyllables).  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. 
Only when the non-inferiority test for the above specified endpoint is successful, then a superiority 
test for the endpoint will be further conducted to assess the treatment effect. 
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9.7 
Secondary Endpoint Analyses 
SSQ12 and other questionnaire 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.  
 
For the non-inferiority test of Global SSQ12 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 -1, the treatment condition is regarded as non-inferior to the control.  
Data from the other questionnaires including the results for individual questions on the SSQ 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. 
 
9.8 
Exploratory Endpoint Analyses 
Not applicable 
9.9 
Safety Analyses 
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. 
9.10 Interim Analyses 
After the first take home period with the Nucleus 8 SP system, an analysis is planned on the following 
tests and comparisons: 
- 
Speech perception in noise (S0Nrearhalf, S0N3) 
- 
Baseline Questionnaire and Demographics 
- 
Nucleus 8 Questionnaire 1 
- 
Usability Assessment 
- 
Adverse Events and Device Deficiencies at the point of interim database lock 
This analysis will include the complete data set for the primary endpoint, as such no multiplicity 
adjustment will be made for this analysis as all data for the outcome measures outlined above will be 
analysed together. It is not anticipated that these results will have an unacceptable influence on the 
remainder of the trial. 
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, 
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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. 
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. 
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. 
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. 
11.1.3 Serious Adverse Event 
A serious adverse event (SAE) is any AE that: 
1) led to a death,  
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2) led to a serious deterioration in the health of the subject that either resulted in: 
• 
a life-threatening illness or injury, or 
• 
a permanent impairment of, or damage to, a body structure or a body function, 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, or 
• 
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. 
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 Investigator’s Brochure. 
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, 
severity, or outcome has been identified in the Investigator’s Brochure. 
11.1.6 Device Deficiency 
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. 
11.2 Recording and Handling of Adverse Events 
Subjects shall be carefully monitored during the clinical investigation and the investigator should 
enquire about AEs at investigation visits.  
All AEs will be recorded from the time of first use/contact with the IMD and/or comparator. AE 
recording will continue for each subject until completion of their End of Study visit. Ongoing SAEs, 
and/or SADEs will be followed for 30 days, or until resolution or stabilisation of the event, whichever 
comes first. 
Source notes should indicate the evaluation for AEs, even if there was none to report. All required 
AEs will be reported if observed, even if anticipated and/or acknowledged as a risk factor in the 
consent. 
All AEs will have the following information documented: start and stop dates, action taken, outcome, 
severity and investigators opinion on the potential relationship to the IMD and/or comparator and 
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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. 
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 certified printout must be provided. 
Data collection will be performed using 
 for electronic data capture (EDC) 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. 
 uses 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. 
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. 
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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 
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 
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 
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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 10 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 at a public clinical trial registry 
ClinicalTrials.gov. 
Investigators will be able to publish and/or present the data generated from the clinical investigation 
after mutual agreement between the Coordinating Investigator, the Principal Investigators, and the 
Sponsor prior to investigation start. Manuscript authorship and responsibilities will be in accordance 
with guidelines and recommendations provided by the International Committee of Medical Journal 
Editors (ICMJE) to enable communication in a timely manner. 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, International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable. 
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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 describing all the activities performed during monitoring, and close out. 
Monitoring activities may be performed by Avania CRO according to a pre-approved Statement of 
Work 
22.2 Audits 
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. 
23 TRADEMARKS AND COPYRIGHT 
ACE, Advance Off-Stylet, AOS, AutoNRT, Autosensitivity, Beam, Bring Back the Beat, Button, 
Carina, Cochlear, 科利耳, コクレア, 코클리어, 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 2021. 
24 REFERENCES 
Dawson, P. W., Hersbach, A. A., & Swanson, B. A. (2013). An adaptive Australian Sentence Test in 
Noise (AuSTIN). Ear and Hearing, 34(5), 592–600. 
https://doi.org/10.1097/AUD.0b013e31828576fb 
Gatehouse, S., & Noble, I. (2004). The Speech, Spatial and Qualities of Hearing Scale (SSQ). 
International Journal of Audiology, 43(2), 85–99. https://doi.org/10.1080/14992020400050014 
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 
Clinical Investigation Plan | VV-TMF-06258 | 2.0
Approval Date (GMT+0): 31 Aug 2021

Signature Page for VV-TMF-06258 v2.0
Signature Page for VV-TMF-06258 v2.0
Reason for signing: Approved
Name: 
Role: A
Date of signature: 31-Aug-2021 00:31:18
GMT+0000
Clinical Investigation Plan | VV-TMF-06258 | 2.0
Approval Date (GMT+0): 31 Aug 2021