Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study
Conditions: Sensorineural Hearing Loss, Bilateral
Sponsor: Cochlear

Official Title: Barriers to Early Progress in Cochlear Implant Outcomes: a Non-
interventional Feasibility Study 
 
NCT Number: NCT05265260        
 
Document Date: 20 October 2021 

 
 
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Clinical Investigation Plan 
 
Investigation Title:  
Barriers to early progress in cochlear implant outcomes: 
a non-interventional feasibility study 
 
Short Title: 
PROGRESS 
CIP Number: 
EMEA5798 
Date:  
20-OCTOBER-2021 
Sponsor 
Cochlear France SAS 
(a subsidiary of Cochlear Limited) 
135 Route de Saint Simon 
Toulouse, 31100 France. 
Ph. +33 534 638 585 
 
 
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki, International Standard ISO 14155 (2011) Clinical investigation of 
medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable. 
 
Confidential Information 
The information contained in this document is confidential and should not be copied or distributed to persons not involved 
in the conduct or oversight of the clinical investigation 
 

 
 
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Manufacturer 
Cochlear Limited, 1 University Ave, 
Macquarie Park NSW 2113, Australia 
Sponsor Organisations 
 
Cochlear France SAS 
135 Route de Saint Simon 
CS 43574 
31035 Toulouse, France. 
Principal Investigator 
 
 
ORL, otoneurologie et ORL pédiatrique  
Pôle céphalique  
Hôpital Pierre-Paul Riquet  
Place du Docteur Baylac 
TSA 40031 
31059 Toulouse cedex 9 
Clinical Research Organisation  
Data Management: 
 
 
 
  
Safety Contact 
Not applicable 
 
 

 
 
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INVESTIGATOR AGREEMENT 
Principal Investigator Approval and Declaration 
By my signature below, I confirm my review and approval of this Clinical Investigational Plan (CIP). 
I also confirm that I will strictly adhere to the requirements therein and undertake to ensure that all 
staff with delegated responsibilities in the conduct of this CIP have read, understood and will strictly 
adhere to the requirements therein. This CIP will not be implemented without prior written approval 
from the Ethics Committee, any applicable National Competent Authorities, and the Sponsor. If 
amendments to this plan become necessary, written approval by the Ethics Committee and any 
applicable National Competent Authorities will be obtained before the changes are clinically 
implemented per the amendment, except under emergency circumstances to protect the rights, 
safety, and well-being of subjects. 
Name 
Title 
 
Principal Investigator 
Signature 
Date 
 
 
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS 
1 
Definitions and Abbreviations ......................................................................................................... 7 
2 
Clinical Investigation Synopsis ........................................................................................................ 9 
3 
Schedule of Events ....................................................................................................................... 11 
4 
Background Information and Rationale ........................................................................................ 12 
4.1 
Introduction ......................................................................................................................... 12 
4.1.1 
Top-down processing parameters ........................................................................ 13 
4.1.2 
Bottom-up processing parameters ........................................................................ 13 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 15 
4.2.1 
Nonclinical Data .................................................................................................... 15 
4.2.2 
Clinical Data .......................................................................................................... 15 
4.3 
Study Rationale .................................................................................................................. 16 
5 
Medical Device Information ........................................................................................................... 17 
5.1 
Identity and Description of the Approved Medical Device on Test (AMDT) ....................... 17 
5.2 
Identity and Description of the Comparator ........................................................................ 17 
5.3 
Accessory Device Requirements ........................................................................................ 17 
6 
Objectives ..................................................................................................................................... 17 
6.1 
Primary Objective ............................................................................................................... 17 
6.2 
Exploratory Objectives ........................................................................................................ 17 
7 
Design of the Clinical Investigation ............................................................................................... 17 
7.1 
General ............................................................................................................................... 17 
7.1.1 
Design Rationale ................................................................................................... 18 
7.2 
Subjects .............................................................................................................................. 18 
7.2.1 
Inclusion Criteria ................................................................................................... 18 
7.2.2 
Exclusion Criteria .................................................................................................. 19 
7.2.3 
Number of Subjects Required ............................................................................... 19 
7.2.4 
Vulnerable Populations ......................................................................................... 19 
7.2.5 
Recruitment and Study Duration ........................................................................... 19 
7.2.6 
Criteria for Subject Withdrawal ............................................................................. 20 
7.2.7 
Randomisation Procedures .................................................................................. 20 
7.2.8 
Post-investigation Medical Care ........................................................................... 20 
7.3 
Performance Evaluations and Procedures ......................................................................... 20 
7.3.1 
Eligibility and Informed non-opposition form ......................................................... 20 
7.3.2 
Self-reported performance (at time of recruitment) .............................................. 21 
7.3.3 
Restropective study data collected from medical records .................................... 21 
7.4 
Safety Evaluations and Procedures ................................................................................... 22 

 
 
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7.4.1 
Concomitant Medication and Therapies ............................................................... 23 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 23 
7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 23 
8 
Risks and Benefits of the Investigational medical device and Clinical Investigation .................... 23 
8.1 
Anticipated Clinical Benefits ............................................................................................... 23 
8.2 
Anticipated Adverse Device Effects .................................................................................... 23 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 24 
8.4 
Risk Mitigation .................................................................................................................... 24 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 24 
9 
Statistical Considerations .............................................................................................................. 24 
9.1 
General Considerations ...................................................................................................... 24 
9.2 
Endpoints ............................................................................................................................ 24 
9.2.1 
Primary Endpoint .................................................................................................. 24 
9.2.2 
Secondary Endpoints ............................................................................................ 25 
9.2.3 
Exploratory Endpoints ........................................................................................... 25 
9.3 
Hypotheses ......................................................................................................................... 25 
9.3.1 
Primary Hypothesis ............................................................................................... 25 
9.3.2 
Secondary Hypothesis .......................................................................................... 26 
9.3.3 
Exploratory Hypotheses ........................................................................................ 26 
9.4 
Sample Size Determination ................................................................................................ 27 
9.5 
Analysis Population ............................................................................................................ 27 
9.6 
Primary Endpoint Analyses................................................................................................. 28 
9.7 
Secondary Endpoint Analyses ............................................................................................ 28 
9.8 
Exploratory Endpoint Analyses ........................................................................................... 28 
9.9 
Safety Analyses .................................................................................................................. 28 
9.10 Interim Analyses ................................................................................................................. 28 
10 Non-Opposition Process ............................................................................................................... 28 
11 Adverse Events and Device Deficiencies ..................................................................................... 29 
12 Device Accountability .................................................................................................................... 29 
13 Deviations from the Clinical Investigation Plan ............................................................................. 29 
14 Data Management ........................................................................................................................ 29 
15 Confidentiality ................................................................................................................................ 30 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 30 
17 Suspension or Premature Termination ......................................................................................... 31 
18 Amendments to the Clinical Investigation Plan ............................................................................. 31 
19 Record Keeping and Retention ..................................................................................................... 31 

 
 
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20 Publication Policy .......................................................................................................................... 31 
21 Statements of compliance ............................................................................................................. 32 
22 Quality Control and Assurance ..................................................................................................... 32 
22.1 Monitoring ........................................................................................................................... 32 
22.2 Audits .................................................................................................................................. 32 
23 Trademarks and Copyright ........................................................................................................... 32 
24 References .................................................................................................................................... 32 
25 Change History ............................................................................................................................. 33 
 
 
 

 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction 
Outcomes with cochlear implants (CI) are known to be variable. Quite a few studies have sought to 
identify factors which are associated with poor speech recognition scores: particularly word 
recognition scores at or greater than six months after CI activation. At that time point, word 
recognition scores in quiet have often reached a plateau, although speech recognition in noise may 
continue to improve (Cusumano et al, 2017). The most often cited variable which is associated with 
word recognition scores is duration of deafness. This result is also extended to those subjects with 
pre-lingual deafness who are implanted as adults. In the former case one supposes that long-deaf 
adults “forget” how to hear language, while congenitally deaf adults never learnt how to hear 
language fully.  
These two potentially limiting factors (Holden et al., 2014; James et al., 2019) may slow progress in, 
or limit in the long-term speech recognition post-implantation. These two factors are generally 
identified from patient histories: sometimes with objective data such as audiograms, but often only 
from patient reports. This serves as one example of a limiting factor versus a testable effect as in 
Figure 1. 
For this first example the Toulouse team in reviewing the literature on speech and language 
development considered that the resulting deformed representation of language in long-deaf subjects 
Figure 1: Simple schema of potential limiting factors for outcomes 
with CI and testable processing effects 

 
 
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should be detectable by a standard test of phonological representation (subtests on ÉCLA-16+, Gola-
Asmussen et al, 2010). Other root causes and testable effects are given in Figure 1. Self-report by 
patients may not be reliable in either onset or degree, however testable effects which may be linked 
back to root causes can be discovered at the time of treatment with CI. 
The factors and corresponding effects on speech processing are divided into “top-down” and 
“bottom-up” processes in Figure 1, as has been previously defined by authors such as (Moberly et al, 
2016). Here a manageable set of processing parameter tests was chosen by the investigational team 
based on the availability of norms or diagnostic certainty. 
4.1.1 
Top-down processing parameters 
We first address top-down processing parameters, that are assumed to affect signal decoding and 
interpretation. General cognitive disfunction will likely affect performance on nearly any task. The 
MoCa is a screening test designed to detect mild cognitive impairment (Nasreddine et al, 2005). 
When responding to questioning such as “what was said” on speech recognition tests, executive 
function, such as concentration, is also a factor. The Stroop test (“Victoria”, f-SV) is a commonly used 
to evaluate executive functions and has age-adjusted norms. To evaluate implicit linguistic 
knowledge, two subtests (3 and 4) of the ECLA-16+ battery (Gola-Asmussen et al, 2010) were 
employed with visual support. These phonological tests were selected by the clinical team to 
evaluate sub lexical reading (initial phoneme deletion and ability to create Spoonerisms). Finally, the 
amount of time of use of the CI per day, and time listening to speech, may be measured using the 
inbuilt data-recording of the Nucleus 6 and 7 sound processors. Poor-use is common in congenitally 
or long-deaf adult CI users (Holder et al, 2020), who may find it difficult to integrate and interpret new 
sound sensations provided by the implant. In addition, non-use has the direct effect of impeding 
acclimatization to sound provided by the CI. 
4.1.2 
Bottom-up processing parameters 
Bottom-up processing parameters generally relate to auditory sensitivity: both absolute sensitivity to 
sound, but also discriminating different sounds. Standard aided thresholds for tones presented in a 
sound field are used to test access to sounds of sufficiently low levels. Elevated thresholds are 
potentially caused by loss of sensitivity in any part of the CI sound processor function, but also 
insufficient stimulation current levels. However, current levels may be required to be substantially 
higher in cases of poorly positioned electrode arrays or very poor neural survival in the auditory 
nerve. Current levels that would produce aided thresholds in an acceptable range may not be 
obtained either because of device limitations or due to producing side-effects, such as facial nerve 
stimulation. Non-optimal electrode position may be unavoidable due to abnormal cochlear structure 
or morphology (either congenital or developed etiologies). Patchy or overall poor neural survival may 
be similarly present in these cases. We note that normal ranges for current levels (maps) used in CI 
processors are large (for example, larger than the typical individual dynamic ranges) and there is to 
date no evidence in the literature that lower or higher standard monopolar current levels are 
associated with poor speech recognition (excepting extreme cases). Therefore, only aided thresholds 
are directly pertinent to measuring sensitivity to sound. 
Discriminating different sounds, once they are coded by the CI sound processor, relies on both 
temporal and spectral discrimination. Auditory nerve responses to the biphasic current pulses 
produced by the CI are highly synchronized (e.g. Tabibi et al, 2019). The compound action potential 

 
 
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(CAP) produced by neuronal responses elicited by a monopolar biphasic current pulse applied to a 
given electrode contact may be recorded using adjacent electrode contacts. The average amplitude 
of the resulting waveform, after removing artifacts via a forward-masking method, can be 
characterized by the N1-P2 amplitude. Nucleus devices use a standard measurement algorithm to 
determine the threshold for neural response (Auto-NRT) in terms of current level across all 22 
electrode contacts. As for subjective stimulation current levels, as described above, Auto-NRT levels 
have a wide normal range, and absolute levels do not appear to be associated with performance 
outcomes with CI. However, CAP threshold levels are required to investigate supra-threshold 
behaviour.  
From the Auto-NRT response threshold for any given electrode contact, the recruitment of neural 
responses with increasing current level may be inferred via the CAP amplitude growth function 
(AGF). Monopolar biphasic pulses used in all standard testing and sound processing are of leading-
negative, following-positive polarity. However, peripheral dendrites are more sensitive to negative 
phases compared with positive phases. Leading phases generally have a greater stimulating effect 
due to the partial cancelling of the following-phase electric field by the leading phase. Therefore, 
more rapid growth in CAP amplitudes for leading-positive (anodic) pulses than for leading-negative 
(cathodic) pulses is indicative of poorer survival of peripheral axons (Hughes et al, 2018).  
Refined measurement of the processing parameters of the cochlear nerve via electrically evoked 
CAP requires sufficient baseline amplitude in order to observe the effects of detuning the optimal 
stimulation parameters. Mapping out the AGF allows one to determine a baseline stimulation current 
level (CL) to obtain sufficient baseline wave amplitude (using standard leading negative phase). The 
effect of increasing the masker-probe interval on the CAP amplitude maps out the recovery function 
of the auditory nerve (Tabibi et al, 2019). Departures from the normal function, such as excessive 
absolute or relative refectory periods could indicate poor neural survival, but in any case low growth 
of amplitude with masker-probe interval would also indicate low effectiveness of stimulation pulses, 
such that the sound amplitude variations coded by the sound processor would be poorly represented 
at the neural level. 
Similarly, the response of the auditory nerve can be mapped in a spatial sense, by varying the probe 
electrode relative to the masker electrode with the forward-masking measurement paradigm (e.g. 
(Cohen et al, 2003). This time, changing the probe electrode relative to the masker would most 
desirably reduce response amplitude indicating that there is low overlap between the regions 
stimulated by the masker and probe, and thus stimulation is tonotopically selective. A large overlap 
indicated by similar amplitudes across probe electrodes would indicate either poor or patchy neural 
survival or poor electrode placement. In both cases the frequency variations coded by the sound 
processor would be poorly represented at the neural level. 
The benefit of using these ECAP measures is that they are objective in nature and therefore are not 
likely to be affected by top-down processing parameters. 
 

 
 
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indicates that for some subjects scores increase considerably between 1 day and 1 month, but that 
sentence scores reliably measure performance within the population and well maintain their relative 
position. We can thus conclude that at least some limiting factors appear to be in place from the time 
of device activation. The primary measure of performance in this study will be the sentence score at 
1-month post-activation, but we will also explore sentence scores at 1 day, and also sentence scores 
in 10 dB SNR noise at 1 month. These three measures are correlated but one or other may be more 
selective than the primary endpoint. 
4.3 
Study Rationale 
In the last 2-3 years routine clinical evaluation of adult CI recipients with tests of top-down and 
bottom-up processing parameters has been undertaken in Toulouse. This provides us with the 
opportunity to determine whether they are related to speech recognition performance. The centre 
also has consistent collection of sentence recognition scores after cochlear implantation (as seen in 
their publications). These two sets of data from the same patient population allow us to test the 
hypothesis that sentence recognition scores are influenced by a certain set of testable limiting factors 
which are generally cited in the literature. Furthermore, the definition of “poor” performance has also 
been established for this centre using the MBAA sentence recognition test. The use of the ≥90/100 
as a criterion is debateable but, as outlined in the previous section, is based upon the idea that 
90/100 is the minimum expected outcome in the absence of limiting factors.  
The results of the top-down and bottom-up processing parameter tests can all be mapped to a 
pass/fail outcome. The novelty then in the design of this study is to understand whether each limiting 
factor contributes to the good/poor performer status categorised using the sentence recognition test 
at 1 month. This contrasts with other methods which aim to develop a continuous outcome model 
where, for example, an expected speech recognition score can be generated and compared to an 
actual speech recognition score. 
Some recent work within Cochlear has shown also large variability in subjective outcomes with CI 
measured via the SSQ12 even in the longer term (one to six years). Therefore, we include self-
assessment of hearing performance outcomes by the CI recipient using the SSQ12. As outlined in 
the previous section, sentence recognition at 1-day could also be associated with the outcomes of 
the processing tests; with the assumption that listening experience during the first month after 
activation may influence the growth in sentence recognition score, and in the longer term. Thus, 
scores can also be collected for the period following 1-month, up until 1-2 years as available. This 
would allow us to investigate the trajectory of speech recognition learning with the CI and relate it to 
subjective performance at the time of data collection. 
Finally, the good/poor criterion could be explored: Like the arbitrary 60/100 at 1-day criterion in 
Figure 2, the switching point for good/poor can be tuned using receiver-operating curve techniques to 
provide the highest level of categorical certainty based on the processing test outcomes. 
 

 
 
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5 MEDICAL DEVICE INFORMATION 
5.1 
Identity and Description of the Approved Medical Device on Test 
(AMDT) 
No device is on test. 
5.2 
Identity and Description of the Comparator 
There is no comparator device or control group in this investigation. 
5.3 
Accessory Device Requirements 
Not applicable. 
6 OBJECTIVES 
6.1 
Primary Objective  
Confirm a selection of testable patient-related and device-related parameters that limit sentence 
recognition performance between 1-day and 1-month post-activation in adult CI users. 
6.2 
Exploratory Objectives 
• 
Evaluate the correlation of testable parameters with sentence score at 1-day in quiet and 
at 1-month in noise. 
• 
Evaluate the correlation of testable parameters, sentence scores and self-reported 
performance (SSQ12) at time of non-opposition. 
• 
Determine whether shifting the good/poor performer 90% cut-off score would improve the 
correlation with pass/fail on the parameter tests. 
• 
Explore the relationships between testable parameters measured post-implantation and 
demographic and hearing-related factors. 
7 DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
This is a study with retrospective part (medical record review) and a minor prospective element with a 
questionnaire completed by the subjects.  
It will be undertaken in a single centre in adult CI recipients with moderately severe to profound 
bilateral sensorineural hearing loss.  
The subjects include adults aged 18+ years who are currently using a Nucleus cochlear implant. 
Subjects will be screened, and 30 eligible subjects with data for the primary end point will be 
recruited to the clinical investigation. 

 
 
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After surgical implantation of the device, subjects will have attended the implant centre for device 
activation, 1-day follow-up and at least 1-month follow-up. During visits to the centre, subjects will 
have undergone hearing assessments and objective and subjective tests included in the centre’s 
specific battery. The primary endpoint is the sentence recognition score at 1 month using their CI. 
The aim is to understand how audiometric, cognitive, and electrophysiological test results relate to 
sentence score. 
Safety will be not be assessed because this is non-interventional study. 
7.1.1 
Design Rationale 
The aim is to recruit all CI patients with a Nucleus device who have been evaluated since the centre’s 
specific test battery was implemented in 2019. This includes some patients implanted as long ago as 
2016. The centre implants approximately 25 eligible adult patients per year. As such therefore there 
is no bias in the selection of patients. Unilateral deaf or single-sided deaf CI recipients are excluded 
since natural hearing may interfere with the measure of performance of the implanted ear. Similarly, 
subjects who received bilateral cochlear implants will be included but their sentence recognition 
scores only considered for the first ear implanted up until they received the second implant.  
Subjects with a cognitive impairment will also be included since the evaluation of cognitive function is 
one of the aims of the test battery. 
The Toulouse centre has extensively studied early performance indicators of CI recipients, as well as 
looking at prognosis of performance in the long-term. Extension of the implications of the study 
findings to the long term is one of the exploratory objectives of the study, as is the subjective 
evaluation of performance by the recipients themselves. 
7.2 
Subjects 
7.2.1 
Inclusion Criteria 
Subjects must meet all the inclusion criteria described below to be eligible for this clinical 
investigation. 
1) Adult subjects, 18 years or older 
2) Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating 
the two cochlear implantations. 
3) Subjects who have been implanted between January 2016 and December 2021.  
4) Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-
rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet 
and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 
off-the-ear types.   
5) Subjects who are fluent in French (language used in the questionnaire and speech tests) 
6) Subjects who are not opposed to participating in the study 
7) Subjects for who the medical record data is available throughout the defined data search 
period. 

 
 
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7.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical 
investigation. 
1) Subjects with single-sided deafness (SSD). 
2) Subjects who are not affiliated to the French Social Security. 
3) Subjects who are under legal protection. 
7.2.3 
Number of Subjects Required 
For a test battery that has an underlying moderate specificity and sensitivity of ~80%, a total of 30 
subjects should be sufficient to conclude that there is a relationship between pass/fail outcome of the 
battery (cumulatively – fail on any test -> fail) and good/poor performance based on sentence test 
score criterion. Therefore, we aim to recruit 30 or more subjects. 
The sample size calculation is to be found in section 9.3.1. 
All patients implanted since the centre started using their specific test battery will be screened for 
eligibility. The centre’s staff currently estimate that 30 or more patients are eligible. 
7.2.4 
Vulnerable Populations 
Not applicable. 
7.2.5 
Recruitment and Study Duration 
The following subject status definitions apply: 
• 
Enrolled: A subject who is has not opposed to participation in the study. 
• 
Screen Fail: An Enrolled subject that has been determined to not meet one or more eligibility 
criteria. 
• 
Participated: Has provided answers to the patient questionnaire.  
• 
Withdrawn: Not applicable.  
• 
Completed: Enrolled subjects who completed the patient questionnaire.  
The recruitment period for the clinical investigation is estimated to be approximately 3 months from 
the time of first subject enrolled to the last subject. 
Recruitment of subjects shall be performed in a back-chronological order from the cochlear 
implantation surgery. Recruitment shall start with the last subject that has undergone this procedure 
in the year 2021 and chronologically working backwards until recruitment targets are met. 
This process will avoid any recruitment bias. 
The expected duration of each subject’s participation in the clinical investigation is the time it takes 
for the subject to read and discuss the non-opposition form with the study team, complete and return 
the questionnaire. Time for completing the questionnaire is estimated to be 30-40 minutes. 
Clinical Investigation completion is defined as the recording and completion of the last medical record 
search for the last enrolled subject in the electronic Case Report Forms (eCRF). 

 
 
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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). The reason for withdrawal should be documented in the subject’s source files and the 
case report form (CRF). 
Participating subjects who are withdrawn/discontinued will be replaced.  
7.2.7 
Randomisation Procedures 
Not applicable. 
7.2.7.1 
Blinding Procedures 
Not applicable. 
7.2.8 
Post-investigation Medical Care 
The study is non-interventional. Subjects will continue to receive standard care from the centre and 
no specific care will be provided for the subjects after this study has been completed.  
7.3 
Performance Evaluations and Procedures 
7.3.1 
Eligibility and Informed non-opposition form 
Screening of subjects include searches by site personnel in medical records for inclusion and 
exclusion criteria. Eligible subjects will be included based on date of cochlear implant surgery, from 
most recent to least recent. In a first draw, the number of subjects intended to be enrolled plus 20% 
(to account for non-responders) will be contacted. 
Eligible subjects will be contacted by the investigator regarding the investigation. If they agree to 
receive a non-opposition form, this will either be sent to them by mail or shared directly at the clinic if 
they are scheduled for an appointment. Subjects will be given sufficient time to read the non-
opposition form, ask questions and have those questions answered by the site personnel responsible 
for non-opposition process. If the subject is not opposed to participate, the date of the discussion will 
be documented in the subject´s medical records and in the non-opposition form and will be used as 
the date of enrolment. A copy of the non-opposition form, signed by the investigator, will be shared 
with the subject together with the questionnaire. 
When a subject is enrolled in the investigation, data collection can start. In case subjects are due for 
a follow-up appointment at the clinic, as per standard of care, the questionnaire can be completed at 
site. For those subjects where a visit at the clinic during the investigation period is not scheduled, the 
questionnaire (together with a copy of the non-opposition form signed by the investigator) will be sent 
via mail to be completed at home. All questions regarding the questionnaire can be raised with the 
site personnel. If completed at home, the questionnaire shall be sent back to the clinic by registered 
mail using a pre-filled and stamped envelope with the address of the clinic. 
The completeness of the questionnaire will be verified by site personnel. Incomplete data will be 
followed-up with the subject, if answered at home by sending a copy of the questionnaire back to the 
subject where incomplete parts requiring an answer are highlighted. 

 
 
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If the questionnaire is not returned; 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.  
The subjects will be asked to complete the following questionnaire: Speech, Spatial and Qualities of 
Hearing Scale (SSQ-12 version). 
7.3.2 
Self-reported performance (at time of recruitment) 
The SSQ12 questionnaire will be used. The Speech, Spatial, and Qualities of Hearing Scale 
questionnaire (SSQ-12) (Noble et al, 2013) was developed in the MRC Institute of Hearing Research, 
UK, and is a scaled-down version of the 49 items SSQ questionnaire (Gatehouse & Noble, 2004). It 
is designed to compile a sub-set of items from the longer original 49 version to represent the scale as 
a whole, measuring self-reported auditory disability, reflecting the reality of hearing in the everyday 
world. It has been shown to provide similar results to SSQ-49 (Noble et al, 2013). It covers: 
• Hearing speech in a variety of competing contexts 
• The directional, distance and movement components of spatial hearing 
• Segregation of sounds and attending to simultaneous speech streams 
• Ease of listening 
• The naturalness, clarity and identifiability of different speakers, different musical pieces and 
instruments, and different everyday sounds. 
7.3.3 
Restropective study data collected from medical records 
7.3.3.1 
Demographic information 
Demographic, hearing history, device information and general medical history will be collected from 
the centre’s files once written informed non-opposition has been received. Comorbidities and 
concomitant prescription medications or therapies from activation to 1-month as reported to the 
clinician. 
7.3.3.2 
Pre-operative and intra-operative data 
Surgical and imaging parameters from reports. Pre-op AC & BC audiograms, if available. Pre-op 
Fournier monosyllable test score in quiet (presented at 60 dB SPL). 
7.3.3.3 
Device parameters 
The centre will provide anonymised data collected from the Nucleus CustomSound programming 
system “CDX” data files: This will include threshold and comfortable stimulation levels used in sound 
processors, and other sound processor parameters and data logging. All ECAP bottom-up 
processing test data are also stored in CDX data file (next section 7.3.3.4). 
7.3.3.4 
ECAP-based bottom-up tests (post-surgery) 
Specific ECAP-based standard tests of bottom-up processing were established at the centre. Firstly, 
automatic ECAP thresholds using “AutoNRT” are measured for each intracochlear electrode using 
default parameters. Then one basal electrode (number 8) and one apical electrode (16) is used for 
subsequent tests. If there is no AutoNRT response on one of these electrodes, then an adjacent one 

 
 
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is used. All subsequent ECAP testing uses the forward masking artifact reduction technique with 
equal masker and probe levels. 
Firstly, a negative-leading AGF is measured up until 220 CL or the subject indicates that the sound is 
too loud. Then an AGF is measured using the positive-leading polarity pulses. 
The CL to obtain 100 µV is determined from the standard AGF, or the maximum tolerable CL if 100 
µV was not obtained. This CL is used for subsequent recovery function and SOE tests. 
Recovery functions are obtained using a standard sequence of masker-probe intervals and the 
CustomSound EP software computes the absolute and relative refractory periods. 
SOE functions are obtained using a specific sequence of maskers so reduce overall test time. The 
maskers span 14 electrode locations but not all locations are used. The CustomSound EP software 
computes the 50% maximum amplitude width (in electrodes). The area under the curve can be 
computed manually (up to 14 electrode units). 
7.3.3.5 
Functional cognitive tests (post-surgery) 
MoCA test score and number of words given in fluency subtest; raw Stroop subtest scores and 
number of noted errors; ÉCLA-16+ subtest 3 and 4 scores and completion times will be collected. 
Tests can have been performed at any time post-surgery. 
7.3.3.6 
Post-operative audiometric data 
Aided sound-field warble-tone thresholds (dB HL: 250, 500, 1000, 2000, 4000 Hz) performed soon 
after activation will be collected. 
The Toulouse centre presents sentence material at 65 dB SPL in quiet and in 8-talker babble 
presented in front from the same speaker. French MBAA2 sentence recognition scores (/100, single 
list per condition) will be collected for the implant ear alone where performed: 
• 
In quiet at 1-day 
• 
In quiet at 1-month 
• 
10 dB SNR at 1-month (or verify as zero) 
• 
5 dB SNR at 1-month (or verify as zero) 
French MBAA dB SNR50 at 1-month (or verify non-convergent or score in quiet <80/100) will be 
collected. The SNR50 is derived from several fixed-SNR test scores using logistic interpolation. 
7.3.3.7 
Long-term sentence recognition scores (up until time of recruitment) 
French MBAA sentence recognition scores in quiet and in noise the implant ear alone will be 
collected where performed between one-month post-activation and the time of recruitment. Logistic 
interpolation may be used to obtain scores for missing test levels or SNR50 (data analysis stage). 
Dates of tests will also be collected to enable longitudinal extrapolation. 
7.4 
Safety Evaluations and Procedures 
Not applicable. Non-interventional study. 

 
 
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7.4.1 
Concomitant Medication and Therapies 
Not applicable. 
7.5 
Equipment Used for Evaluation of Performance and Safety 
No special equipment required. 
7.6 
Sponsor Role in Conduct of the Clinical Investigation 
The Sponsor employees (or designee) shall use standard operating procedures to ensure that clinical 
study procedures and documentation are consistently conducted and compliant with Declaration of 
Helsinki and applicable parts of GCP and any regional or national regulations. 
The Sponsor shall ensure that the study is quality controlled (monitored) by a monitor who is 
independent from the study, scientifically and clinically competent and has good knowledge of the 
study plan, non-opposition process, sponsor´s SOPs, GCP and applicable laws and regulations. 
The Sponsor shall monitor tasks delegated to other organizations/persons (Sponsor’s oversight) e.g. 
contract research companies (CRO) or other consultants. 
The Sponsor is responsible for developing a study plan and compile a clinical study report when the 
study is completed.  
The Sponsor shall make sure that electronic systems used in the study are validated; that a Trial 
Master File is created; subjects’ identities are coded so that reported data is coded but can be linked 
to the respective research person; that all essential study documentation is available in a safe place 
before, during and after the study according to applicable laws and regulations. 
The Sponsor shall also make sure that the investigators have sufficient qualifications, enough 
resources are available at site, collect signed study plans from respectively responsible investigator 
and establish agreements with participating clinics. 
It is the Sponsor´s responsibility to check that there is an EC approval for the study, to register the 
study in a public database and assure that the study results are reported within one year. 
All study deviations will be documented in the CRF to enable analysis and reporting by the Sponsor 
in the Study Report, or to the relevant regulatory authority(s), if applicable. 
8 RISKS AND BENEFITS OF THE INVESTIGATIONAL MEDICAL DEVICE AND 
CLINICAL INVESTIGATION 
8.1 
Anticipated Clinical Benefits  
Participation in this study will not directly benefit the subject nor will it alter the subject´s course of 
care. However, information gained from the study may identify parameters that affect the hearing 
outcomes, which may be used to guide more effective and personal rehabilitation in the future. 
8.2 
Anticipated Adverse Device Effects 
Not applicable, non-interventional study. 

 
 
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8.3 
Risks Associated with Participation in the Clinical Investigation 
Participation in the study presents no risk for the subject and does not alter the subject´s course of 
care. Sensitive data concerning the subject’s health is being handled in the study. 
8.4 
 Risk Mitigation 
All data collected will be pseudonymised and therefore the risk that any sensitive data will be 
disclosed to unauthorized persons is minimal. Registered post will be used when sending the non-
opposition form signed by the investigator and questionnaire. For questionnaire, clinical personnel 
will complete header with subject identification code and request that no personal data is shared on 
this document, making it pseudo anonymised.  
8.5 
Risk-to-Benefit Rationale 
The benefit of the clinical investigation of potentially identifying parameters that affect clinical hearing 
outcome and hence being able to guide more effective interventions in the future is regarded to 
outweigh the minimal anticipated risk for the subjects participating in the clinical investigation. We 
therefore consider it ethical to conduct the investigation.  
9 STATISTICAL CONSIDERATIONS 
9.1 
General Considerations 
Descriptive statistics will be derived for all data points. All analyses will be made on the full data set. 
All analyses will be presented as aggregated data without the possibility of identifying data from 
individual subjects. 
Sentence recognition scores form the basis for most study endpoints. Missing test scores will be 
resolved with the study team. For example, if subjects can be assumed to have scored zero at 1-day 
or 1-month. 
For the secondary endpoints such as longitudinal sentence test scores, logarithmic interpolation can 
be used for data missing for any given time-point. For missing fixed SNRs, logistic interpolation from 
present SNRs will be used. Longitudinal data for all subjects will be fit to the standard 1-day, 1-
month, 3-month, 6-month, 1-year, 2-year, 3-year follow-up schema, with scores in quiet and 10 dB, 
5 dB, 2 dB and 0 dB SNR. (NB certain levels are often omitted in standard clinical testing where the 
subject is known to be performing at ceiling or at floor for the condition.)  
There is no criterion for termination of the study on statistical grounds. 
9.2 
Endpoints 
9.2.1 
Primary Endpoint 
Good or poor performer based on sentence recognition score at 1-month ≥90/100 or <90/100. 
Good/poor performer status will be compared to pass/fail on the processing parameter tests. (binary 
classification) 
“Fail” status on the processing parameter tests is established as: 

 
 
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• 
MoCA: score <26/30. 
• 
Stroop test: score below the confidence interval for age 50 years with elementary education, 
or one or more corrected or non-corrected errors are noted. 
• 
ÉCLA-16+ subtests 3 or 4:  one or two scores below normal range, or time taken greater than 
established confidence intervals. 
• 
Aided thresholds: more than two of five thresholds greater than 30 dB SPL. 
The following will be extracted from the CustomSound software database records: 
• 
Datalogging: None-use is defined as less than 2 hours’ average time-on-air per day between 
activation and 1-month (mean -2 standard deviations re. data of Holder et al, 2020). 
• 
AutoNRT: Absent for more than six electrodes. Inability to run AutoNRT or all of the following 
three NRT tests due to lack of response at maximum comfortable level or non-auditory 
stimulation leading to termination of the test. 
• 
AGF polarity: For either probe electrode, a slope of negative leading significantly smaller than 
positive leading, and less than 70% of positive leading. 
• 
Recovery function: For either probe electrode, a relative or absolute recovery period 
significantly longer than the confidence interval for normal range (Tabibi et al, 2019). 
• 
Spread-of-excitation: For either probe electrode, greater than 35% area under the curve (>5 
across the 14-electrode range). 
9.2.2 
Secondary Endpoints 
There are no secondary endpoints. 
9.2.3 
Exploratory Endpoints 
• 
Sentence recognition score at 1-day in quiet. 
• 
SSQ12 score at time of inclusion. 
• 
Sentence recognition score at 1-month: In quiet and in fixed levels of babble 10 dB & 5 dB SNR, 
and SNR50. 
• 
Score/s at 1-day, 1-month, and later time points post activation up until the time of recruitment for 
various fixed SNRs. 
9.3 
Hypotheses 
9.3.1 
Primary Hypothesis 
The primary objective is to confirm a selection of testable patient-related and device-related 
processing parameters that limit performance between 1-day and 1-month post-activation in adult CI 
users. Therefore, we will test the association between being good/poor performer and the outcome of 
the centre’s test battery. A contingency table between the performer status and processing test result 
can be generated (Figure 3, top left): 

 
 
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Figure 3: Sample size calculation with contingency table (upper left). 
H1: The primary hypothesis is that there is a significant relationship between the good/poor 
classification and the test battery pass/fail. 
H0: The alternative to the primary hypothesis is that there is no significant relationship. 
A chi-squared test (at alpha=0.05, so p<0.05) can be used to test this hypothesis. If insufficient 
numbers are found in a single cell, a Fisher’s exact test can be used instead.  
9.3.2 
Secondary Hypothesis 
There is no secondary hypothesis. 
9.3.3 
Exploratory Hypotheses 
9.3.3.1 
Relationships between performance and test battery outcome 
H1: The hypothesis is that there is a significant difference between: 
H0: The hypothesis is that there is no significant difference between: 
1) Sentence scores in quiet at 1-day 
2) Sentence scores in 10 dB SNR at 1-month 
3) SSQ12 scores 
For pass versus fail groups from the test battery. 
9.3.3.2 
Value of classification criterion as good/poor performer 
Receiver-operating characteristic analysis techniques will be applied to determine if the strength of 
the relationship between binary performance threshold score criterion (good vs poor) and pass/fail 
test-battery outcome can be increased. 
9.3.3.3 
 Relationship between demographic and hearing-characteristics and pass/fail on 
processing parameter tests 
H1: The hypothesis is that there is a significant relationship between duration of deafness/congenital 
hearing loss and: 

 
 
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H0: The hypothesis is that there is no significant relationship between duration of 
deafness/congenital hearing loss and: 
1) The phonological processing test score. 
2) The percent difference in slopes between negative and positive leading phase ECAP 
amplitude growth. 
3) The width of the ECAP SOE functions. 
 
9.3.3.4 
Relationship between subjective hearing performance and sentence recognition 
threshold in noise 
H1: The hypothesis is that there is a significant relationship between SSQ12 score and SNR50 for 
sentence recognition in noise. 
H0: The hypothesis is that there is no significant relationship between SSQ12 score and SNR50 for 
sentence recognition in noise. 
9.4 
Sample Size Determination 
Two scenarios with different underlying good/poor performer proportions were simulated (see 
figures 3 and 4): 50/50 and 40/60. ≥80% power is obtained under both scenarios. Higher specificity 
and sensitivity would increase the power. Increasing the total number of subjects would also increase 
power. 
 
 
Figure 4: Power calculations for a 40%/60% good/poor performer scenario. 
Based on sample size calculations, a total of 30 eligible subjects are required to provide >80 % 
power to reject the null hypothesis for the statistical test for the primary objective.  
9.5 
Analysis Population 
There are no sub-populations. 

 
 
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9.6 
Primary Endpoint Analyses 
The contingency table between good/poor performer and pass/fail of processing tests will be 
analysed using a chi-squared or Fischer’s exact tests.  
9.7 
Secondary Endpoint Analyses 
Not applicable.  
9.8 
Exploratory Endpoint Analyses 
Parametric (e.g., Students t) or non-parametric (e.g., Mann-Whitney U) tests will be used to test 
differences between groups depending on normal or non-normal value distributions. 
Parametric or non-parametric correlation tests, or linear models will be used to test relationships 
between variables depending on normal or non-normal value distributions. 
9.9 
Safety Analyses 
Not applicable. 
9.10 Interim Analyses 
Not applicable. 
 
10 NON-OPPOSITION PROCESS 
The Investigator shall contact eligible subjects regarding the investigation and if they are interested in 
taking part, a non-opposition form containing all relevant study information will be sent to them via 
mail or shared at the clinic if a follow-up appointment is planned. 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. 
Subjects shall not be coerced or unduly influenced to non-oppose participation or to continue to 
participate in a clinical investigation. 
If the subject is not opposed to participating in the investigation, the date of the discussion must be 
recorded in the subject´s medical records as well as in the non-opposition form and will be used as 
the date of enrolment. This process needs to be done prior to any data collection for the purpose of 
this investigation. A copy of the non-opposition form, signed by the investigator, will be shared with 
the subject, either at the clinic or by registered mail, together with the questionnaire. The original 
signed non-opposition form shall be archived in the Investigator’s Site File at the investigational site. 
The subject 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 non-opposition form and 
confirmation of non-opposition of the subject. 

 
 
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11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
Not applicable 
12 DEVICE ACCOUNTABILITY 
Not applicable.  
13 DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
The Investigator(s) must not deviate from the CIP, except in case of an emergency to protect the 
safety and well-being of the subject(s). Such deviations will be documented by the site personnel in 
the source documentation for the subject and reported to the relevant EC as per institutional 
requirements and to the Sponsor as soon as possible. 
If there is a deviation from CIP-defined assessments or parts thereof are omitted or completed 
incorrectly, the deviation will also be documented by the site personnel in the source documentation 
for the subject. Depending on the type or severity of the deviation the Investigator may be required to 
notify the EC. 
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. ECAP measurements made using CustomSound EP 
will be processed by the sponsor. The anonymised CustomSound database records (CDX files) will 
be provided to the sponsor via upload to the data capture portal. 
Data collection will be performed using 
 for electronic data capture (EDC) on electronic 
Case Report Forms (eCRFs). Site staff will be trained on the completion of the eCRFs prior to 
obtaining access to the system and will have their own Login/Password. Access to clinical study 
information will be based on an individual’s role and responsibilities. 
 uses role-based user permissions for data entry, viewing, and reporting options. All 
communications between users and the EDC server are encrypted. Web servers are protected by a 
managed firewall. This application is designed to be in compliance with applicable regulations 
including 21 CFR Part 11. 
The application will include programmed data consistency checks and supports manual generation of 
data clarifications/queries, including documentation of site responses. The application maintains a 

 
 
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comprehensive audit trail for all data entered, including updates and queries, and documents the time 
that each entry occurred and who made the entry. 
Principal Investigators will affirm that the data for each subject at their site is accurate and complete 
by way of an electronic signature. 
In addition, de-identified electronically generated data will be collected from CustomSound clinical 
fitting software and electrophysiology software. The unamended data file shall be regarded as the 
source. 
15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance 
with governing data privacy regulations [such as the EU GDPR regulations]. Subjects have the right 
to access their data and request for its correction or deletion after withdrawal. 
Data will be reported to the Sponsor on CRFs or related documents (for example, questionnaires). 
Subjects will be identified on CRFs and other related documents only by a unique subject 
identification code and shall not include the subject’s name or other personal identifiable information. 
Completed CRFs or related documents are confidential and will only be available to the Investigator 
and site staff, the Sponsor and their representatives, and if requested to the Ethics Committee and 
national regulatory authorities. Publications or submission to a regulatory authority shall not disclose 
the identity of any subject. 
16 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
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, the non-opposition 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 non-opposition form, 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. 

 
 
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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 
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 Committee (EC) by the Principal Investigator (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.   
The Sponsor will notify the Principal Investigator when records are no longer needed. The 
Investigator will not discard any records without notifying the Sponsor. If the Principal Investigator 
moves from the current investigational site, the Sponsor should be notified of the name of the person 
who will assume responsibility for maintenance of the records at the investigational site or the new 
address at which the records will be stored. The Investigator will notify the Sponsor as soon as 
possible in the event of accidental loss or destruction of any study documentation. 
20 PUBLICATION POLICY 
This clinical investigation will be prospectively registered at a public clinical trial registry 
ClinicalTrials.gov or European equivalent if active. 
A joint peer-reviewed publication authored by the clinical investigator(s) and Sponsor will be 
prepared. In addition, the results of the clinical investigation may also be disseminated as conference 
presentations (for example, abstract and poster session). Manuscript authorship and responsibilities 
will be discussed and agreed upon prior to investigation start and in accordance with guidelines and 
recommendations provided by the International Committee of Medical Journal Editors (ICMJE) to 

 
 
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enable communication in a timely manner. All contributors who do not meet the criteria for authorship 
will be listed in an acknowledgments section of the publication. 
21 STATEMENTS OF COMPLIANCE 
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki, International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable. 
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 site will receive an on-site initiation visit by the Cochlear monitor and research scientist. At least 
one onsite monitoring visit will be performed when >80% of patient records have been entered into 
the database. A close-out visit will be performed by the monitor once all patient records have been 
entered or marked as missing. 
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 
AutoNRT, Cochlear, Custom Sound, Kanso, NRT, Nucleus, and the elliptical logo are either 
trademarks or registered trademarks of Cochlear Limited 2021. 
24 REFERENCES 
1) International Organization for Standardization.  ISO 14155:2011 Standard:  Clinical investigation 
of medical devices for human subjects – Good clinical practice. 2011.  Available at: 
https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-2:v1:en