A Pre-Marketing, Prospective, Multi-Site, Open-Label, Within-Subject, Feasibility, Interventional Study of Speech Perception With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor and 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, Multi-Site, Open-Label, 
Within-Subject, Feasibility, Interventional Study of Speech Perception 
with experienced adult cochlear implant recipients using the CP1110 
Sound Processor and compared with the CP1000 Sound Processor 
Short Title: 
N8 Feasibility 
CIP Number: 
CLTD5804 
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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INVESTIGATOR AGREEMENT 
Coordinating 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 
 
Coordinating Investigator 
Signature 
Date 
 
 
 
Principal Investigator Declaration 
By my signature below, I confirm that I have read, understood and will strictly adhere to the 
requirements therein. I undertake to ensure that all staff with delegated responsibilities in the conduct 
of this CIP have also 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 
Site Name 
Site Address 
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 
5.3 
Accessory Device Requirements ........................................................................................ 25 
6 
Objectives ..................................................................................................................................... 25 
6.1 
Primary Objective ............................................................................................................... 25 
6.2 
Secondary Objective ........................................................................................................... 25 
6.3 
Exploratory Objective .......................................................................................................... 25 
7 
Design of the Clinical Investigation ............................................................................................... 25 
7.1 
General ............................................................................................................................... 25 
7.1.1 
Design Rationale ................................................................................................... 26 
7.2 
Subjects .............................................................................................................................. 26 
7.2.1 
Inclusion Criteria ................................................................................................... 26 
7.2.2 
Exclusion Criteria .................................................................................................. 27 
7.2.3 
Number of Subjects Required ............................................................................... 27 
7.2.4 
Vulnerable Populations ......................................................................................... 27 
7.2.5 
Recruitment and Study Duration ........................................................................... 27 
7.2.6 
Criteria for Subject Withdrawal ............................................................................. 28 
7.2.7 
Randomisation Procedures .................................................................................. 28 
7.2.8 
Post-investigation Medical Care ........................................................................... 29 
7.3 
Performance Evaluations and Procedures ......................................................................... 30 
Participant Evaluations and Procedures ............................................................................. 31 
7.4 
Safety Evaluations and Procedures ................................................................................... 35 
7.4.1 
Concomitant Medication and Therapies ............................................................... 36 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 36 
7.5.1 
Speech Perception ................................................................................................ 36 
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7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 36 
8 
Risks and Benefits of the Investigational medical device and Clinical Investigation .................... 36 
8.1 
Anticipated Clinical Benefits ............................................................................................... 36 
8.2 
Anticipated Adverse Device Effects .................................................................................... 37 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 37 
8.4 
Risk Mitigation .................................................................................................................... 37 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 38 
9 
Statistical Considerations .............................................................................................................. 38 
9.1 
General Considerations ...................................................................................................... 38 
9.2 
Endpoints ............................................................................................................................ 38 
9.2.1 
Primary Endpoint .................................................................................................. 38 
9.2.2 
Secondary Endpoints ............................................................................................ 38 
9.2.3 
Exploratory Endpoints ........................................................................................... 39 
9.3 
Hypotheses ......................................................................................................................... 39 
9.3.1 
Primary Hypotheses .............................................................................................. 39 
9.3.2 
Secondary Hypotheses ......................................................................................... 40 
9.3.3 
Exploratory Hypothesis ......................................................................................... 41 
9.4 
Sample Size Determination ................................................................................................ 41 
9.5 
Analysis Populations ........................................................................................................... 41 
9.6 
Primary Endpoint Analyses................................................................................................. 42 
9.7 
Secondary Endpoint Analyses ............................................................................................ 43 
9.8 
Exploratory Endpoint Analyses ........................................................................................... 43 
9.9 
Safety Analyses .................................................................................................................. 43 
9.10 Interim Analyses ................................................................................................................. 43 
10 Informed Consent Process ........................................................................................................... 43 
11 Adverse Events and Device Deficiencies ..................................................................................... 44 
11.1 Definitions ........................................................................................................................... 44 
11.1.1 
Adverse Event ...................................................................................................... 44 
11.1.2 
Adverse Device Effect .......................................................................................... 44 
11.1.3 
Serious Adverse Event ......................................................................................... 44 
11.1.4 
Serious Adverse Device Effect ............................................................................. 45 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 45 
11.1.6 
Adverse Events of Special Interest ....................................................................... 45 
11.1.7 
Device Deficiency ................................................................................................. 45 
11.2 Recording and Handling of Adverse Events ....................................................................... 45 
11.2.1 
Assessment of Severity ........................................................................................ 45 
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11.2.2 
Assessment of Causality ...................................................................................... 46 
11.2.3 
Assessment of Seriousness ................................................................................. 47 
11.2.4 
Assessment of Expectedness .............................................................................. 47 
11.3 Recording and Handling of Device Deficiencies................................................................. 47 
11.4 Reporting Responsibilities .................................................................................................. 48 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 48 
11.4.2 
Sponsor Notification of Events ............................................................................. 48 
11.5 Independent Data Monitoring Committee ........................................................................... 49 
12 Device Accountability .................................................................................................................... 49 
13 Deviations from the Clinical Investigation Plan ............................................................................. 49 
14 Data Management ........................................................................................................................ 50 
15 Confidentiality ................................................................................................................................ 50 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 51 
17 Suspension or Premature Termination ......................................................................................... 51 
18 Amendments to the Clinical Investigation Plan ............................................................................. 52 
19 Record Keeping and Retention ..................................................................................................... 52 
20 Publication Policy .......................................................................................................................... 52 
21 Statements of compliance ............................................................................................................. 52 
22 Quality Control and Assurance ..................................................................................................... 53 
22.1 Monitoring ........................................................................................................................... 53 
22.2 Audits .................................................................................................................................. 53 
23 Trademarks and Copyright ........................................................................................................... 53 
24 References .................................................................................................................................... 53 
25 Change History ............................................................................................................................. 55 
Appendices ........................................................................................................................................... 57 
Appendix 1: Statement/Declaration of Device Conformity ................................................................... 57 
Statement of Conformity for Unapproved Device ................................................................................. 57 
Clinical Investigation Details: ........................................................................................................ 57 
Device and Manufacturer Details: ................................................................................................. 57 
Appendix 2: Configuring Test Conditions for N8 Clinical Study - Setup ............................................... 58 
 
 
 
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To characterise adult cochlear implant speech 
perception in co-located speech and noise 
(S0N0) with the Nucleus 8 Sound Processor with 
ForwardFocus ON (BEAM) compared with the 
Nucleus 7 Sound Processor with ForwardFocus 
ON (commercial version) 
Paired difference in dB SRT (AuSTIN/LIST) 
between the Nucleus 8 Sound Processor with 
ForwardFocus On (BEAM) and the Nucleus 7 
Sound Processor with ForwardFocus On 
(commercial version) (65 dB SPL S0N0 4TB). 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction 
This clinical study aims to investigate the speech performance with the new Nucleus 8 Sound 
Processor (model: CP1110), compared with the commercially available Nucleus 7 Sound Processor 
(model: CP1000), with particular focus on the new microphones available with Nucleus 8 Sound 
Processor, and inclusion of 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 and 
ForwardFocus studies (see section 4.2.2),and will compare the performance across the 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 published1. 
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 
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ratings were higher with ForwardFocus than with Standard, Zoom or Beam(Z). There was no 
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 
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the Nucleus Smart App as very easy to use and half of the respondents wanted ForwardFocus on 
their own processor.  
 
4.3 
Study Rationale 
This study will build on the evidence previously collected on BTE sound processors and 
‘ForwardFocus’, with particular focus on the speech perception performance of the Nucleus 8 SP in 
quiet, 
 and 
also whether the automation of ForwardFocus provides at least the same speech perception 
performance in quiet and noise when compared to the commercially available Nucleus 7 SP. 
A more detailed description of the test conditions and rationale for their inclusion is available in Table 
2. 
To assess the primary and secondary speech perception objectives, the study incorporates a within-
subject repeated-measures design in which each subject will undergo in-booth speech perception 
testing with all combinations of hardware and signal processing settings in a sound booth. The 
average difference scores will indicate the performance difference for each of the paired 
comparisons. 
The speech perception testing will occur at two study visits, ensuring that all tests for a specific 
comparison are measured within the same test session to limit the influence of confounders such has 
tiredness, motivation, and attention. 
5 MEDICAL DEVICE INFORMATION 
5.1 
Identity and Description of the Investigational Medical Device (IMD) 
Nucleus 8 Sound Processor 
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 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) 
- 
CP1000 Earhooks (approved device) 
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, 
ForwardFocus which is an algorithm that reduces noise from behind and beside the listener while 
passing sounds from the front without attenuation. While not available for the current study, 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 and access to sound processor controls via the CR310 Remote Control and the Nucleus 
Smart App on compatible iOS and Android Phones. 
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 enabled by 
miniaturisation of components such as using Micro-Electro-Mechanical System (MEMS) microphones 
and C6 Hybrid chip. While not available for the current study, the commercial version will also include 
an adaptive ForwardFocus incorporated in the SCAN program if enabled by clinicians through the 
programming software (also known as “ForwardFocus in SCAN-X"), low energy audio streaming from 
mobile phones and BTHAP broadcasts and compatibility with next generation Cochlear Smart 
Implants. 
The potential new adaptive “ForwardFocus in SCAN-X" feature 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 commercial feature will, similarly to a SCAN program, automate switching between these 
ForwardFocus enabled configurations based on the Sound Class identified by the SCAN Sound 
Class classifier, which may make it possible for a recipient to have ForwardFocus always on when 
using SCAN. For the current study, using System Release version 2.1, the ForwardFocus enabled 
Standard, Zoom and Beam directionality modes will be available as non-automated (i.e., fixed) 
programs. 
SCAN-X is an improvement to 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. 
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Experienced Audiologists will fit the study device using the above-mentioned software. Any 
necessary training will be provided before study start.  
Study subjects will be exposed to the device during testing sessions at the study site and will return 
to their own device in between test sessions and at the end of the study.   
 
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. 
Intended Population 
The Nucleus 8 SP is intended for patients implanted with a compatible Cochlear™ Nucleus® implant. 
There are no restrictions for the intended patient population of the Nucleus 8 SP in terms of age, 
weight, health or other condition. 
All medical devices used in this investigation are manufactured by Cochlear Limited. 
The IMD and/or the packaging for the device will state that the device is exclusively for use in a 
clinical investigation. 
5.2 
Identity and Description of the Comparator 
For the purpose of speech perception testing, there is one comparator device; Nucleus 7 SP. 
Subjects will be exposed to the devices during two test periods, of up to three hours duration, at the 
study site. The Nucleus 7 SP, either loaned or the subjects’ own device will be used during in the in-
booth test sessions. 
Nucleus 7 
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 incorporate the NEO-XS new processor chip, which allows for a smaller size 
sound processor, lower power usage, improved audio processing and improved support for GN 
ReSound Accessories when compared to previously marketed devices.  
 
 
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Direct Streaming Choice 
Android 
iPhone 
Android* 
iPhone* 
Bluetooth 5.2 Hearing Aid Profile* 
Wireless Accessory support 
Prox 2 
Prox 2* 
Input Processing Technologies  
BEAM 
SNR-NR 
WNR 
FF with Zoom 
Whisper 
 
 
SCAN 
BEAM 
SNR-NR 
WNR* 
FF with standard  
FF with Zoom 
FF with BEAM 
Whisper* 
SCAN X* 
Core Control:  Processor, CR310*, Nucleus Smart App*. 
Core Connected Care:  Remote Check*-ready, CS Pro programming software 
 
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Table 2 Speech perception comparisons and rationale 
Test condition 
Comparison 
Rationale 
CNC/NVA words 
in Quiet (50 dB 
SPL) 
Treatment: Nucleus 8 
standard directionality SNR-
NR on 
 
Control: Nucleus 7 standard 
directionality SNR-NR on 
 
 
 
  
 
 
(
 
  
Treatment: Nucleus 8 
standard directionality SNR-
NR off 
  
 
Control: Nucleus 7 standard 
directionality SNR-NR off 
Treatment: Nucleus 8 
standard directionality FF 
(Moderate) 
 
Control: Nucleus 7 standard 
directionality 
Previous evidence with ForwardFocus (FF) in quiet has shown a small decrease 
in performance in quiet (5% at 50 dB SPL) with a ‘Strong’ attenuation setting 
(CLTD5606).  
It is predicted that ForwardFocus with a Moderate maximum attenuation setting 
will produce a non-inferior result when compared with Nucleus 7 for words in 
quiet (S0).  
Sentences in  
noise S0N0 4-
talker babble (65 
dB SPL) 
Treatment: Nucleus 8 BEAM 
directionality + FF (GT0, 
Strong) 
Previous evidence with FF in S0N0 has shown: 
• 
A decrement compared to Nucleus 6 SCAN when FF was coupled with 
BEAM (GT3) (CRC5589) 
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Test condition 
Comparison 
Rationale 
 
Control: Nucleus 7 Zoom 
directionality + FF (GT0, 
Strong) 
• 
A non-inferior result compared to Nucleus 6 SCAN when FF was coupled 
with Zoom (GT0) (CLTD5606) 
• 
A benefit compared to Nucleus 6 BEAM when FF was coupled with BEAM 
(GT3) (unpublished Kiel data) 
The combination of GT0+BEAM with ForwardFocus is predicted to resolve this 
performance issue. 
Sentences in noise 
S0N90 4-talker 
babble (65 dB 
SPL) 
Treatment: Nucleus 8 BEAM 
directionality +FF (GT0, 
Strong) 
Control: Nucleus 7 Zoom 
directionality + FF (GT0, 
Strong) 
Previous evidence with BEAM in S0N+/-90 showed a significant speech 
perception improvement over Zoom when measured in non-fluctuating speech-
spectrum shaped noise 2. There is no known published evidence with FF in 
S0N90 however a significant improvement is expected over commercially 
available settings due the ability of the adaptive beamformer to steer the null to 
more locations than the fixed directionality Zoom, as currently implemented with 
Nucleus 7. 
The Cochlear Sponsored study CLTD5709 showed a 1.07 dB SRT improvement 
with BEAM over Zoom + FF, it is anticipated that BEAM+FF will further improve 
this benefit. 
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5.3 
Accessory Device Requirements 
The Nucleus 8 SP must be used together with an implanted receiver-stimulator to achieve normal 
operation in clinical use.  
To utilise the sound processor system, in addition to the processing unit, recipients will also use a 
compatible ear hook, battery module, coil, and magnet.  
The Nucleus 8 SP is compatible with the Cochlear™ Wired Programming Pod.  
All study sound processors will be compatible with the Custom Sound Pro fitting software. This 
software will be used by the investigator to program the sound processors.  
The research configurations of FF for N8 SP will be programmed via CDI-Tool.  
6 OBJECTIVES 
6.1 
Primary Objective  
To characterise adult cochlear implant speech perception in spatially separated speech and noise 
(S0N90) with the Nucleus 8 SP with ForwardFocus ON (BEAM) compared with the Nucleus 7 Sound 
Processor with ForwardFocus ON (commercial version) 
6.2 
Secondary Objective 
• 
To characterise adult cochlear implant speech perception in quiet with the Nucleus 8 Sound 
Processor (SNR-NR on) compared with the Nucleus 7 Sound Processor (SNR-NR on) 
• 
To characterise adult cochlear implant speech perception in quiet with the Nucleus 8 Sound 
Processor 
) compared with the Nucleus 7 Sound Processor (SNR-NR off) 
• 
To characterise adult cochlear implant speech perception in quiet with the Nucleus 8 Sound 
Processor with FF (Moderate) and the Nucleus 7 Sound Processor 
• 
To characterise adult cochlear implant speech perception in co-located speech and noise 
(S0N0) with the Nucleus 8 Sound Processor with ForwardFocus ON (BEAM) compared with 
the Nucleus 7 Sound Processor with ForwardFocus ON (commercial version) 
6.3 
Exploratory Objective 
There are no exploratory objectives. 
7 DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
This is a pivotal, prospective, pre-market, multi-site, non-randomised, open-label, within-subject, 
repeated-measures clinical investigation in adults with sensorineural hearing impairment who are 
current users of a Nucleus Cochlear Implant system. 
See section 21 for description of subject population.  
After enrolment, subjects will attend scheduled study visits over a two months 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)/ 
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Adverse Device Effects (ADE) and Device Deficiencies (DD). No data monitoring committee will be 
used for this clinical investigation.  
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. 
Comparison will be made within-subject with repeated measures for each of the sound processing 
conditions to be evaluated. There will be two test sessions with no take home use between sessions. 
The test sessions will include speech perception tests including sentence in noise and words in quiet 
tests. These speech measures are routine outcome measures used to evaluate new signal 
processing algorithms and hardware.  
There will be no blinding of the study investigators. 
Blinding of the study subject will be undertaken where possible, particularly when multiple signal 
processing conditions are loaded onto a single study device. Patients will not be told which program 
will be used in which order, and 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 
The subjects include men and women aged 18 years or older who are current users of a Nucleus 6 
(CP910/920), Kanso (CP950) or Nucleus 7 (CP1000) Sound Processor. 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.   
Written, informed consent must be obtained from the subject before any study procedures are 
initiated.  
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 6 (CP910/920), Kanso (CP950), Kanso 2 
(CP1150) or Nucleus 7 (CP1000) Sound Processor 
6) Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test  
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7) Willingness to participate in and to comply with all requirements of the protocol. 
8) Fluent speaker in language used to measure speech perception 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 may be recruited into the research project without in any way being targeted by 
virtue of their being present in the general population from which the participants are being recruited. 
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. 
• 
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.  
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The recruitment period for the clinical investigation is estimated to be 1 month from the time of first 
subject consent to recruitment of the last subject. 
The expected duration of each subject’s participation in the clinical investigation, is 2 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. The Investigator shall ask the 
reason(s), however, subjects have the right to withhold their reason if preferred. The reason for 
withdrawal should be documented in the subject’s source files and the case report form (CRF). 
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. 
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 as outlined in Section 7.2.7 will be used to ensure that there is a balanced order of 
test conditions.  
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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, 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 
For Belgium: As mentioned in section 4.3, this is a multi-center investigation. The 
investigator of the clinic is responsible for subject recruitment, obtaining Informed Consent, 
assessment of inclusion- and exclusion criteria and assessment of hearing and medical 
history related to the Clinical Investigation Plan. Subjects are then referred to the investigator 
of CTC and will be evaluated as per the investigational procedures in the facilities of CTC.  
Speech perception in quiet 
Speech perception in quiet will be measured using the CNC monosyllabic words3 at 
Australian sites and Nederlandse Vereniging Audiologie (NVA) words4 at Belgian sites at 50 
dB SPL from S0 position. See Figure 2. There will be 2 lists (CNC) or 3 lists (NVA) per 
condition (see Table 3 for input processing conditions). The goal of speech perception 
assessment in quiet is to compare % words correct for each of the conditions.  
The CNC word test consists of 30 lists each with 50 words per list, recorded in a female 
voice. The NVA word test consists of 15 lists, each with 1 practice word and 11 test words 
per list, recorded in male voice.  
Speech perception in noise 
Speech perception in noise will be measured using the Australian Speech Test In Noise 
(AuSTIN)5, which is a test that uses BKB like target sentences presented in adaptive noise in 
Australia, and the Leuven Intelligibility Sentences Test (LIST) in Belgium6. The signal level 
will be fixed at 65 dB SPL and each subject will be tested with 2 lists (AuSTIN) or 3 lists 
(LIST) per condition. 
The AuSTIN corpus comprises 80 lists of 20 sentences each, recorded in female voice5. The 
LIST corpus comprises 35 lists of 10 sentences each, recorded in female and 38 lists of 10 
sentences each, recorded in male voice 4,6. The goal of the adaptive Speech-in-Noise testis 
to obtain the Speech Reception Threshold (SRT) in noise. We define the Speech Reception 
Threshold (SRT) as the Signal to Noise Ratio (SNR) in decibels at which a patient can 
understand 50% of the keywords in the sentences.  
Speech perception performance in noise and quiet will be assessed using a loudspeaker 
configuration as shown in the diagrams of Figure 4. 
 
Figure 4. Left – S0N0 with signal and 4 talker babble from 0 degrees azimuth (in front), Middle – 
S0N90 with 4 talker babble at the test ear and signal from the front and Right – S0 CNC/NVA 
words from the front  
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Sound Quality 
Subjective sound quality assessment with the investigational sound processor may occur 
before or after the acute speech perception assessment. 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 around 
the study site.  
Participant Evaluations and Procedures 
Screening Visit and Visit 1 (may be combined) 
Included in this period: 
- 
Screening and informed consent 
- 
SP  fitting 
- 
Sound Quality  
- 
Speech perception in quiet testing 
Screening and informed consent: 
• 
Subjects will be enrolled  
• 
Subjects must be consented to the study and inclusion and exclusion criteria 
confirmed prior to any study activities starting.  
SP Fitting and Optimisation 
Prior to assessing speech perception in quiet, the test sound processors will be loaded 
according to the input processing settings identified in Table 3. 
ADRO is the adaptive dynamic range optimisation processing setting, and ASC is the auto 
sensitivity processing setting, both of which will be enabled or disabled in the test sound 
processors according to each subject’s preferred settings on their own MAP; if the study 
subject uses and prefers ADRO and ASC in their own Sound Processor, then these setting 
will be enabled in the study sound processor.  
SNR-NR is a single channel noise reduction algorithm and directionality refers to the 
microphone directionality that will be enabled. These signal processing settings will be 
enabled/disabled via the fitting software CDI Tool and Custom Sound Pro (see Appendix 2) 
Sound Quality  
Study investigators will ask study subjects to use the investigational medical device in 
settings around the study site. Study investigators may ask the study participants questions 
about the sound quality and general acceptance of the Nucleus 8 (CP1110) Sound 
Processor system. This informal sound quality assessment may occur before or after the 
acute speech perception assessment, handwritten notes will be stored in the subject file and 
all device deficiencies will be stored in the electronic data base (Medidata Rave). 
Words in quiet test 
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The subject will be positioned as per the S0N0 testing outlined above.  
The test material will be presented via software on a PC or laptop . The investigator, or 
suitably qualified delegate will use the software to select: 
- 
Adaptive test (SRT) 
- 
65 dB SPL presentation level 
- 
Signal from in front (0 degrees) 
- 
Four taker babble noise from the side of the test ear (90 or 270 degrees) 
- 
2 lists (AuSTIN) or 3 lists (LIST)  
At the end of each run, the investigator will record the result on the worksheet and in the 
Electronic Data Capture (EDC) system.  
Return devices and study completion 
At the end of the study, subjects will return to their own device with the commercially 
available firmware.  
Adaptive procedure: 
While there are no expected unplanned product changes, early product can be sensitive to 
the low-risk issues identified in  
Table 5. During this feasibility study these product issues may be identified by study subjects 
during the acute testing sessions that require optimisation or correction, and an adaptive 
procedure allows for product feedback to be collected from study subjects, for the product to 
be updated, and for the updated product to be reissued to study subjects for continued 
testing. Table 1 identifies how issues will be investigated and retested by the research 
subjects. 
Before initiating speech perception testing, study investigators may ask study subjects to use 
the investigational medical device in settings around the study site. As identified in the visit 1 
procedures. 
New Device Iteration: 
If a product issue is identified either prior to or during the speech perception evaluation that 
may have an impact on speech perception outcomes, the study will be paused for all 
subjects while the change is made and a new version of the Sound Processor system will be 
developed and issued to study participants. 
If the product issue was present for all subjects, then all subjects will be asked to repeat any 
testing that had occurred. 
 
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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 
There is potential that concomitant medical treatments may influence the outcomes of this study.  All 
concomitant medical treatments will be collected as part of this study.  
7.5 
Equipment Used for Evaluation of Performance and Safety 
7.5.1 
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 and noise from the front (S0N0) and with speech from in front and noise to the side of the test 
ear (S0N90).  
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.  
7.6 
Sponsor Role in Conduct of the Clinical Investigation 
Sponsor and investigator roles are assumed by Cochlear employees.  
Cochlear has designed and will execute this clinical trial in-house at Cochlear Limited, Sydney, at 
Cochlear Limited, Melbourne and at the Cochlear Technology Centre (CTC) in Mechelen, 
Belgium.  The study sites consist of a small team of Investigators, trained as clinical Audiologists, to 
execute this research activity. Investigators are qualified audiologists familiar with cochlear implant 
development, surgery and programming.  Investigators’ trial materials and testing rooms (sound 
booths) are securely separated from Sponsor facilities.  The trial investigators, or delegates within the 
study site, will enter the data into the eCRF. 
The study is planned, designed and developed by a separate group within Cochlear, known as 
Clinical Affairs (the Sponsor).  Cochlear has SOPs to manage the separation of Investigator and 
Sponsor activities as well as ensure they align with all applicable regulations.   
8 RISKS AND BENEFITS OF THE INVESTIGATIONAL MEDICAL DEVICE AND 
CLINICAL INVESTIGATION 
8.1 
Anticipated Clinical Benefits  
Study subjects will be asked to use hearing performance features associated with the Nucleus 7 and 
Nucleus 8 SPs during acute testing sessions, however this is not anticipated to provide benefits to 
the subject due to the acute nature of the testing. 
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Subjects who haven’t previously experienced using the ForwardFocus feature may experience 
benefit of improved communication through reduction of distracting noise while using the feature 
during the session only. 
Due to the limited use of the investigational devices, there are no long-term clinical benefits 
anticipated for the study 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 programs on the Nucleus 7 and Nucleus 8 SPs may sound different to each 
user’s own sound processor; this is unlikely if study subjects enter the study already using a Nucleus 
7 Sound processor and more likely if they enter a study with a legacy device or an off-the-ear sound 
processor. 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. 
Warnings and contraindications 
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; www.cochlear.com). AT this 
preliminary stage in development, the Nucleus 7 SP User Guide will be relevant for Nucleus 8 SP.   
8.4 
Risk Mitigation 
The study investigational devices have been fully tested for safety, and the performance and use of 
the investigational devices is expected to be similar to the approved Nucleus 7 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; investigational 
procedures. 
The residual risks related to the investigational device or procedure will be controlled in the following 
ways: 
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• 
The fitting and use of the Nucleus 8 SP will conducted by a trained audiologist. Test units will 
be used for a short duration (up to 3 hours) and will be used by adults who are able to 
indicate discomfort and remove the sound processor from their head. 
• 
If recipients experience any physical discomfort from the device or if the device produces 
sounds that are uncomfortable, subjects are encouraged to inform the Investigator and return 
to using their own sound processor. 
• 
Dropped devices should be inspected for external damage before re-use, to ensure there are 
no sharp edges/corners or rough surfaces. 
8.5 
Risk-to-Benefit Rationale 
The Nucleus 8 Hazards Analysis indicates that the risk portion of the benefit-risk profile of the 
Nucleus 8 System is acceptable when used as intended by the intended users. The safety, 
performance, and patient benefits of the Nucleus 8 System are designed to be at least comparable to 
the approved Nucleus 7 SP and therefore in line with those expected based on the state of the art for 
the therapy. 
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/LIST) endpoints, two (AuSTIN) or 3 (LIST) 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/NVA) endpoints, two (CNC) or three (NVA) 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.  
9.2.1 
Primary Endpoint 
The primary efficacy measure for the Nucleus 8 Sound processor will be Speech Reception 
Thresholds (SRT) assessed via AuSTIN/LIST Sentence scores in spatially separated adaptive noise. 
The primary efficacy outcome for the study will be determined by the following primary efficacy 
endpoint: 
• 
Paired difference in dB SRT (AuSTIN/LIST) between the Nucleus 8 Sound Processor with 
ForwardFocus On (BEAM) and the Nucleus 7 Sound Processor with ForwardFocus On (commercial 
version) (S0N90 4TB). 
 
9.2.2 
Secondary Endpoints 
Secondary efficacy measures will be the percentage words correct as assessed by CNC, NVA  
Monosyllabic word scores in quiet.  
 
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Secondary efficacy outcomes for will be determined by the following endpoints: 
• 
Paired difference in percentage CNC/NVA Words correct in quiet (50 dB) with the Nucleus 8 
Sound Processor (SNR-NR on) and Nucleus 7 Sound Processor (SNR-NR on)  
• 
Paired difference in percentage CNC/NVA Words correct in quiet (50 dB) with the Nucleus 8 
Sound Processor 
 and Nucleus 7 Sound Processor (SNR-NR off)  
• 
Paired difference in percentage CNC/NVA Words correct in quiet with the Nucleus 8 Sound 
Processor (Moderate) and Nucleus 7 Sound Processor (Standard directionality)  
 
An additional secondary efficacy measure will be Speech Reception Thresholds (SRT) assessed via 
AuSTIN Sentence scores in spatially separated adaptive noise according to the following endpoint: 
 
• 
Paired difference in dB SRT (AuSTIN/LIST) between the Nucleus 8 Sound Processor with 
ForwardFocus On (BEAM) and the Nucleus 7 Sound Processor with ForwardFocus On 
(commercial version) (S0N0 4TB). 
9.2.3 
Exploratory Endpoints 
There are no exploratory endpoints 
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 (i.e., ‘Nucleus 8 SP’ versus ‘Nucleus 7 SP’) 
will be calculated. If the upper limit of the 95% CI of the mean paired difference is lower than 1dB, the 
‘Nucleus 8 SP’ is regarded as non-inferior to ‘Nucleus 7 SP’ on that measure.  
For the non-inferiority test of CNC/NVA word score, the 95% CI (alpha=0.025 one-sided) for the 
mean paired difference (i.e., ‘Nucleus 8 SP’ versus ‘Nucleus 7 SP’) will be estimated. If the lower limit 
of the 95% CI of the mean paired difference is above -10%, ‘Nucleus 8 SP’ is regarded as non-
inferior to ‘Nucleus 7 SP’ on that measure.  
9.3.1 
Primary Hypotheses 
Endpoint: Paired difference in dB SRT (AuSTIN/LIST) between the Nucleus 8 Sound Processor with 
ForwardFocus On (BEAM) and the Nucleus 7 Sound Processor with ForwardFocus On (commercial 
version) (S0N90 4TB). 
 
H0: Sentence in noise (S0N90 4TB) scores (dB SRT) with the Nucleus 8 Sound Processor 
with FF On (treatment) are inferior to those with the Nucleus 7 Sound Processor with FF On 
(control)  
Nucleus 8 FF ON – Nucleus 7 FF OFF ≥ 1 dB (NB: higher SRT scores represent poorer 
performance) 
H1: Sentence in noise (S0N90 4TB) scores (dB SRT) with the Nucleus 8 Sound Processor 
with FF On (treatment) are non-inferior to those with the Nucleus 7 Sound Processor with FF 
On (control)  
Nucleus 8 FF ON – Nucleus 7 FF OFF < 1 dB 
 
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Secondary endpoint 4 
Paired difference in dB SRT (AuSTIN/LIST) between the Nucleus 8 Sound Processor with 
ForwardFocus On (BEAM) and the Nucleus 7 Sound Processor with ForwardFocus On (commercial 
version) (S0N0 4TB). 
H0: Sentence in noise (S0N0 4TB) scores (dB SRT) with the Nucleus 8 Sound Processor with 
FF On (treatment) are inferior to those with the Nucleus 7 Sound Processor with FF On 
(control)  
Nucleus 8 FF ON – Nucleus 7 FF OFF ≥ 1 dB (NB: higher SRT scores represent poorer 
performance) 
H1: Sentence in noise (S0N0 4TB) scores (dB SRT) with the Nucleus 8 Sound Processor with 
FF On (treatment) are non-inferior to those with the Nucleus 7 Sound Processor with FF On 
(control)  
Nucleus 8 FF ON – Nucleus 7 FF OFF < 1 dB 
9.3.3 
Exploratory Hypothesis 
There are no hypotheses for the exploratory endpoints 
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.  
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This study has a non-inferiority design; therefore, the primary analysis will be based on the PP 
population.  
For cases in which the ITT and PP populations lead to the same conclusions and final interpretations 
about the treatment effect, the results will be considered to not be influenced by underlying factors 
such as missing data and protocol deviations, and the results would be considered to be robust and 
consistent under different analysis populations. A statement to reflect this will be included in the CIR. 
For cases in which the ITT and PP populations lead to different final interpretations or conclusions, all 
of the results will be reported and the differences in outcomes will be identified and explored. 
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 measurement from treatment and control, without major protocol deviations. Major 
deviations will be defined at the clean file meeting before data base lock. 
It is possible that a treatment has not been administered in the intended counterbalanced order of 
presentation. It is also expected that the sequence and period effects are minimal in this study if any. 
This study is not a full cross-over design, so period and sequence effects will not be assessed, 
without the consequence to bias the study conclusion.  
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 
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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. 
9.7 
Secondary Endpoint Analyses 
See section 9.6 
9.8 
Exploratory Endpoint Analyses 
See section 9.6 
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 
The sound quality reports and general feedback form study participants will be analysed on an 
ongoing basis and these will be used to improve the product.  No formal interim analysis is planned 
for the speech perception assessments. 
10 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject using an approved ICF prior 
to any clinical investigation-related examination or activity. The rationale of the clinical investigation, 
as well as the 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. 
For Belgium only: The principal investigator of the clinic (GZA Sint-Augustinus Antwerp) or study staff 
of the principal investigator shall be responsible for subject recruitment and obtaining Informed 
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Consent of the clinical investigation. The sponsor principal investigator of CTC will receive a copy of 
the signed Informed Consent Form. 
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,  
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. 
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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 Nucleus 8 SP Hazards 
Analysis. 
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, 
severity, or outcome has been identified in the Nucleus 8 SP Hazards Analysis. 
11.1.6 Adverse Events of Special Interest 
Not applicable 
11.1.7 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 of the IMD. AE recording will continue for each 
subject until completion of their End of Study visit. Ongoing SAEs and 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 study procedures. If an 
AE changes in severity, the most severe (highest) grade will be captured for that event on the 
Adverse Events CRF. 
11.2.1 Assessment of Severity 
The Principal Investigator (or qualified delegate) will make an assessment of severity for each event 
based on clinical judgement. The intensity of each event recorded in the CRF should be assigned to 
one of the following categories: 
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The Investigator shall assess if the DD led to an AE or could have led to a serious medical 
occurrence (serious adverse device effect) if; 
a) suitable action had not been taken,  
b) intervention had not been made, or, 
c) circumstances had been less fortunate 
All DDs will be documented in the source notes and the DD page of the CRF.   
11.4 Reporting Responsibilities 
The Investigator is responsible for reporting all AEs and DDs in the CRF.   
11.4.1 Investigator Reporting of Serious Adverse Events 
All AEs meeting the criteria for an SAE, or DD that could have led to an SADE, must be reported to 
the Sponsor by five working days. 
Reporting is achieved through completion of the events details in the Adverse Event page of the 
eCRF 
The Investigator shall always provide an assessment of causality at the time of the initial report, as 
described in section 11.2.2 ‘Assessment of Causality’. If data obtained after reporting indicates that 
the assessment of causality is incorrect, then the SAE form may be appropriately amended, signed, 
dated, and resubmitted to the Sponsor. 
If the Investigator does not have all other information regarding an SAE, he/she will not wait to 
receive additional information before reporting the event.  The reporting forms shall be updated when 
additional information is received. 
The Investigator is responsible for reporting of safety events to their local EC using the applicable 
report form, in accordance with local regulations. 
11.4.2 Sponsor Notification of Events 
The Sponsor is responsible for reviewing all safety data to evaluate potential causality and 
anticipation of all ADEs. 
The Sponsor is also responsible for reporting all reportable events according to the requirements and 
timelines of the regulatory authorities relevant to this clinical investigation, and shall conduct an 
expedited assessment of all SAEs, unanticipated ADEs, DDs that could have led to an SADE. 
For Belgium only: The sponsor is responsible for reporting serious adverse events (SAE) to Famhp 
(Federal Agency for Medicines and Health Products): ct.rd@famhp.be, by using the European form. 
Reporting must be a) immediately for any SAE or device deficiency (DD) that might have led to a 
SAE resulting in death or threat to life, or is associated with imminent risk of death, or for any serious 
injury or disease warranting rapid curative therapy or any new information relating thereto, and b) 
immediately and in any case no later than 7 days for other SAE/SADEs. In case an initial notification 
of an SAE/SADE would be incomplete, on receipt of additional information the Sponsor must submit 
a clearly referenced and numbered follow-up report of the event. 
The Safety Monitor for AE/DD assessment and any AE/DD related queries is: 
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notify the EC, particularly if the deviation potentially impacts subject safety, performance of IMD, 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 
 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. 
Data will be reported to the Sponsor on CRFs or related documents (for example, questionnaires). 
Subjects will be identified on CRFs and other related documents only by a unique subject 
identification code and shall not include the subject’s name or other personal identifiable information. 
Completed CRFs or related documents are confidential and will only be available to the Investigator 
and site staff, the Sponsor and their representatives, and if requested to the Ethics Committee and 
national regulatory authorities. Publications or submission to a regulatory authority shall not disclose 
the identity of any subject. 
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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 
 
For Belgium only: Upon end of the clinical investigation, the sponsor shall notify the regulatory 
authority within 15 days. In the case the clinical investigation is temporarily halted or terminated early, 
notification of this shall be made to the regulatory authority within 15 days. Justification for the halt or 
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termination shall be included. If either situation is on safety grounds, then the reporting timeframe is 
24 hours. 
18 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
No changes in the CIP or investigation procedures shall be made without mutual agreement of the 
Principal Investigator and the Sponsor.  This agreement will be documented as a CIP amendment.  
Amendments will require notification to the Ethics Committees (ECs) by the Principal Investigators 
(and to the relevant regulatory authority(s) by the Sponsor, if applicable). 
19 RECORD KEEPING AND RETENTION 
Data generated from the clinical investigation will be stored in a limited-access file area and be 
accessible only to representatives of the study site, the Sponsor and its representatives, and relevant 
health authorities/regulatory agencies. All reports and communications relating to study subjects will 
identify subjects only by subject unique identification code. Complete subject identification will be 
maintained by the Investigator. This information will be treated with strict adherence to professional 
standards of confidentiality. 
The investigator must retain study-related records for a period of at least 15 years after completion of 
the investigation or after the last device was placed on the market, if the IMD has market 
authorisation. 
The Sponsor will notify the Principal Investigator when records are no longer needed. The 
Investigator will not discard any records without notifying the Sponsor. If the Principal Investigator 
moves from the current investigational site, the Sponsor should be notified of the name of the person 
who will assume responsibility for maintenance of the records at the investigational site or the new 
address at which the records will be stored. The Investigator will notify the Sponsor as soon as 
possible in the event of accidental loss or destruction of any study documentation. 
20 PUBLICATION POLICY 
This clinical investigation will be prospectively registered at a public clinical trial registry. 
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 Helsinki7, International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice8, 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/TRIUM Clinical Consulting 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 
Internal 
Clinical Investigation Report: Acceptance and Performance with the Nucleus 7 Cochlear Implant 
System with Adult Recipients (D1376556) 
Clinical Investigation Report: Clinical Evaluation of Spatial NR (BTE) Investigation (556125) 
Clinical Investigation Report: Clinical Evaluation of the Spatial NR Noise Reduction Algorithm 
(D1309506)  
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Clinical Investigation Report: Phase 2, Clinical Evaluation of Spatial Noise Reduction Integrated with 
SCAN in the CP900 Sound Processor (D1119540) 
External 
1.  
Warren CD, Nel E, Boyd PJ. Controlled comparative clinical trial of hearing benefit outcomes 
for users of the CochlearTM Nucleus ® 7 Sound Processor with mobile connectivity. Cochlear 
Implants Int. 2019;20(3). doi:10.1080/14670100.2019.1572984 
2.  
Sivonen V, Willberg T, Aarnisalo AA, Dietz A. The efficacy of microphone directionality in 
improving speech recognition in noise for three commercial cochlear-implant systems. 
Cochlear Implants Int. 2020;21(3). doi:10.1080/14670100.2019.1701236 
3.  
Peterson GE, Lehiste I. Revised CNC lists for auditory tests. J Speech Hear Disord. 
1962;27(February):62-70. doi:10.1044/jshd.2701.62 
4.  
Wouters J, Damman W, Bosman A. Vlaamse opname van woordenlijsten voor 
spraakaudiometrie. Vlaam Ver voor Logop. 1994;7(6):28-34. 
5.  
Dawson PW, Hersbach AA, Swanson BA. An adaptive Australian Sentence Test in Noise 
(AuSTIN). Ear Hear. 2013;34(5):592-600. doi:10.1097/AUD.0b013e31828576fb 
6.  
Van Wieringen A, Wouters J. LIST and LINT: Sentences and numbers for quantifying speech 
understanding in severely impaired listeners for Flanders and the Netherlands. Int J Audiol. 
2008;47(6). doi:10.1080/14992020801895144 
7.  
World Medical Association Declaration of Helsinki. World Medical Association. World Medical 
Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human 
Subjects. Vol 15.; 2004. doi:10.3917/jib.151.0124 
8.  
ISO. Clinical investigation of medical devices for human subjects — Good clinical practice. 
2011;14155:14155. 
 
 
 
 
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APPENDICES 
APPENDIX 1: STATEMENT/DECLARATION OF DEVICE CONFORMITY 
STATEMENT OF CONFORMITY FOR UNAPPROVED DEVICE 
 
Clinical Investigation Details: 
Clinical Investigation ID: 
CLTD5804 
Sponsor of Investigation:  
Cochlear Limited, 1 University Avenue, Macquarie University, NSW 
2109, Australia 
 
Device and Manufacturer Details: 
Device Manufacturer: 
Cochlear Limited, 1 University Avenue, Macquarie University, NSW 
2109, Australia 
Investigational Device: 
Nucleus 8 Sound Processor including:  
CP1110 Processing Unit   
CP1110 Rechargeable Battery Modules  
CP1110 Slimline Coil with CP1000 retention magnets 
Custom Sound (Version 7.0)  
CDI Tool (Version 4.20.10.1) 
 
We, Cochlear Limited, declare that, where appropriate, technical and biological and pre-clinical 
evaluations have been conducted and, as a result, the investigational devices conform to the 
applicable general safety and performance requirements (as specified in Annex I of Regulation (EU) 
2017/745), apart from the aspects covered by the clinical investigation and that, with regard to those 
aspects, every precaution has been taken to protect the health and safety of the subjects, the users 
and third persons.  
The Device incorporates no materials of animal or human origin. 
All supporting documentation is retained under the premises of the manufacturer. 
 
Name: 
 
Position: 
Senior Manager, Regulatory Affairs – External Devices 
Signature: 
 
Date: 
 
 
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APPENDIX 2: CONFIGURING TEST CONDITIONS FOR N8 CLINICAL STUDY - SETUP 
 
 
 
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Signature Page for VV-TMF-04139 v3.0
Signature Page for VV-TMF-04139 v3.0
Reason for signing: Approved
Name: 
Role: A
Date of signature: 16-Sep-2021 10:07:04
GMT+0000
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