Feasibility, Prospective, Multicentric, Cross-sectional Investigation to Characterize Daily Impedance Fluctuations and Satisfaction in Challenging Listening Environments in Experienced Adult CI Recipients Using the Mobile Research App (MRA)
Phase: NA
Conditions: Hearing Loss
Sponsor: Cochlear

 
 
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Clinical Investigation Plan 
Redacted Version 
Company sensitive commercial information was removed from the original document to generate 
this redacted public version. 
NCT number: NCT06173687 
Document date: 07-Feb-2024 
Investigation Title: Feasibility, prospective, multicentric, cross-sectional 
investigation to characterize daily impedance fluctuations and satisfaction in 
challenging listening environments in experienced adult CI recipients using the 
Mobile Research App (MRA)  
Short Title: 
DICE 
CIP Number: 
AI5846 
CIV-ID 
CIV-23-08-043857 
Version and Date:  
Refer to system version control 
Sponsor: 
Cochlear Limited 
1 University Avenue  
Macquarie University NSW 2109 
Australia 
Phone: +61 294 28 65 55 
 
This clinical investigation shall be conducted in accordance with ethical principles that have their origin in the 
Declaration of Helsinki, International Standard ISO 14155:2020 Clinical investigation of medical devices for 
human subjects - Good Clinical Practice, and any regional or national regulations, as applicable. 
 
 
 

 
 
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Manufacturer 
Cochlear Limited 
1 University Avenue 
Macquarie University NSW 2109 
Australia 
Sponsor Organisation(s) 
 
Cochlear Limited 
1 University Avenue 
Macquarie University NSW 2109 
Australia 
Funding Source 
Sponsoring Organisation 
Legal Representative in the EU 
Cochlear France SAS 
135 Route de Saint Simon 
CS43574 
31035 Toulouse 
France 
Coordinating Investigator 
Not applicable 
Clinical Research Organisation  
 
Belgium: Support submission 
QbD Clinical NV 
Groenenborgerlaan 16 
2610 Wilrijk 
Belgium  
Safety Contact 
CLTD-SafetyMonitor@cochlear.com 
A complete list of participating Principal Investigators’ names, titles and addresses, and the names and 
addresses of participating institutions (sites) will be maintained by the Sponsor and will be provided as a 
separate Principal Investigator List. The definitive Principal Investigator list will be provided in the Clinical 
Investigation Report. 
 
 

 
 
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INVESTIGATOR AGREEMENT 
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. 
I also agree that my personal information may be provided to regulatory agencies and public clinical trial 
registry platforms, and stored in their systems in order to comply with regulatory requirements. Examples of 
the type of personal information include my name, signature and summary of qualifications. 
Name 
Title 
 
 
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 ........................................................................................ 15 
4.1 
Introduction ......................................................................................................................... 15 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 16 
4.2.1 
Nonclinical Data .................................................................................................... 16 
4.2.2 
Clinical Data .......................................................................................................... 17 
4.3 
Study Rationale .................................................................................................................. 18 
5 
Research tool Information ............................................................................................................. 19 
5.1 
Identity and Description of the research tool ...................................................................... 19 
5.1.1 
Mobile research app ............................................................................................. 19 
5.1.2 
Impedance monitoring .......................................................................................... 21 
5.1.3 
Other research tasks supported by MRA .............................................................. 23 
5.1.4 
Additional components.......................................................................................... 24 
5.2 
Identity and Description of the Comparator ........................................................................ 25 
5.3 
Accessory Device Requirements ........................................................................................ 25 
6 
Objectives ..................................................................................................................................... 26 
6.1 
Primary Objective ............................................................................................................... 26 
6.2 
Secondary Objective ........................................................................................................... 26 
7 
Design of the Clinical Investigation ............................................................................................... 26 
7.1 
General ............................................................................................................................... 26 
7.1.1 
Design Rationale ................................................................................................... 27 
7.2 
Subjects .............................................................................................................................. 28 
7.2.1 
Inclusion Criteria ................................................................................................... 28 
7.2.2 
Exclusion Criteria .................................................................................................. 29 
7.2.3 
Number of Subjects Required ............................................................................... 29 
7.2.4 
Vulnerable Populations ......................................................................................... 29 
7.2.5 
Recruitment and Study Duration ........................................................................... 29 
7.2.6 
Criteria and Procedures for Subject Withdrawal ................................................... 30 
7.2.7 
Randomisation Procedures .................................................................................. 31 
7.2.8 
Post-investigation Medical Care ........................................................................... 31 
7.3 
Evaluations and Procedures ............................................................................................... 31 
7.3.1 
Screening/eligibility ............................................................................................... 31 
7.3.2 
Performance/Effectiveness ................................................................................... 33 

 
 
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7.3.3 
Safety Evaluations and Procedures ...................................................................... 38 
7.4 
Equipment Used for Evaluations and Procedures .............................................................. 39 
7.5 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 39 
8 
Benefits and Risks of the research tool and Clinical Investigation ............................................... 39 
8.1 
Anticipated Clinical Benefits ............................................................................................... 39 
8.2 
Anticipated Adverse Device Effects .................................................................................... 39 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 40 
8.4 
Risk Mitigation .................................................................................................................... 40 
8.5 
Benefit-to Risk Rationale .................................................................................................... 41 
9 
Statistical Considerations .............................................................................................................. 41 
9.1 
General Considerations ...................................................................................................... 41 
9.2 
Endpoints ............................................................................................................................ 41 
9.2.1 
Primary Endpoint .................................................................................................. 41 
9.2.2 
Secondary Endpoints ............................................................................................ 41 
9.3 
Hypotheses ......................................................................................................................... 43 
9.3.1 
Primary Hypothesis ............................................................................................... 43 
9.3.2 
Secondary Hypothesis .......................................................................................... 43 
9.4 
Sample Size Determination ................................................................................................ 43 
9.5 
Analysis Populations ........................................................................................................... 43 
9.6 
Endpoint Analyses .............................................................................................................. 43 
9.6.1 
Primary Endpoint Analyses ................................................................................... 43 
9.6.2 
Secondary Endpoint Analyses .............................................................................. 43 
9.7 
Safety Analyses .................................................................................................................. 43 
9.8 
Interim Analyses ................................................................................................................. 44 
10 Informed Consent Process ........................................................................................................... 44 
11 Adverse Events and Device Deficiencies ..................................................................................... 44 
11.1 Definitions ........................................................................................................................... 44 
11.1.1 
Adverse Event ...................................................................................................... 44 
11.1.2 
Adverse Device Effect .......................................................................................... 45 
11.1.3 
Serious Adverse Event ......................................................................................... 45 
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 ................................................................................................. 46 
11.1.8 
Serious Health Threat ........................................................................................... 46 
11.2 Recording and Handling of Adverse Events ....................................................................... 46 

 
 
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11.2.1 
Assessment of Severity ........................................................................................ 46 
11.2.2 
Assessment of Causality ...................................................................................... 46 
11.2.3 
Assessment of Seriousness ................................................................................. 48 
11.2.4 
Assessment of Expectedness .............................................................................. 48 
11.2.5 
Non-reportable Adverse Events ........................................................................... 48 
11.3 Recording and Handling of Device Deficiencies................................................................. 48 
11.4 Reporting Responsibilities .................................................................................................. 49 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 49 
11.4.2 
Sponsor Notification of Events ............................................................................. 49 
11.5 Independent Data Monitoring Committee ........................................................................... 50 
12 Device Accountability .................................................................................................................... 50 
13 Deviations from the Clinical Investigation Plan ............................................................................. 50 
14 Data Management ........................................................................................................................ 51 
14.1 Source Data ........................................................................................................................ 51 
14.2 Methods for Data Entry and Collection ............................................................................... 51 
14.3 Database Lock .................................................................................................................... 52 
15 Confidentiality ................................................................................................................................ 52 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 52 
17 Suspension or Premature Termination ......................................................................................... 53 
18 Amendments to the Clinical Investigation Plan ............................................................................. 54 
19 Record Keeping and Retention ..................................................................................................... 54 
20 Publication Policy .......................................................................................................................... 54 
21 Statements of compliance ............................................................................................................. 55 
22 Quality Control and Assurance ..................................................................................................... 55 
22.1 Monitoring ........................................................................................................................... 55 
22.2 Audits .................................................................................................................................. 55 
23 Trademarks and Copyright ........................................................................................................... 56 
24 References .................................................................................................................................... 56 
25 Change History ............................................................................................................................. 60 
 
 
 

 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Health of the cochlea can be monitored e.g. through checking the stability of impedances. Currently this 
information is obtained only during clinical visits in consultation with clinician. However, impedance-based 
biomarkers have been proposed for fibrous tissue growth along the CI electrode and for inner ear pathology 
(Shaul et al., 2019), which could possibly predict future residual hearing loss (Choi et al., 2017). Currently we 
know very little about the normal daily variability of impedances. At-home monitoring would allow for enough 
data to establish what daily fluctuations are normal or abnormal for a patient and thus flag issues with the 
health of the inner ear, e.g. to reduce the risk of loss of residual hearing. 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 

 
 
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4.2 
Findings of Previous Nonclinical and Clinical Studies 
4.2.1 Nonclinical Data 
Most animal studies investigating impedance fluctuations focus on the period between surgery and a few 
months postop (Clark et al., 1995; Huang et al., 2007; Needham et al., 2020; Tykocinski et al., 2001; Wilk et al., 
2016; Xu et al., 1997). This period is characterized by strong changes due to (1) fibrous tissue formation along 
the electrode array and (2) passivation and reactivation of the electrode contacts before and after device 
switch-on, respectively. The latter phenomenon may be the result of Pt-oxidation due to the inactivity of the 
electrode in this period but might be attributed as well to inflammatory reactions following electrode 
insertion at implantation. Some studies sample the impedance with an interval of a couple of days. The most 
intense measurement schedules in literature record the impedance twice a day. Most of the latter studies 
measure it before and after device switch-on, focusing on the impedance change after overnight inactivity 
(Needham et al., 2020). Other studies measure the impedance at two unspecified instances (Tykocinski et al., 
2001; Xu et al., 1997). As such, these studies do not provide information on impedance changes in a period of 
a few months post-op. 
Only one study was found that investigated impedance changes in four implanted cats during a 4-weeks 
period six months after implantation. During this period, strong implantation-related modifications of the 
intracochlear environment are assumed to have settled and normal daily impedance fluctuations may be 
distinguished more easily. This work by Newbold et al. (2014) recorded the impedance in the morning before 
device switch-on and several times within four hours after device switch-on. As such, it addresses specifically 
the effect of overnight inactivity of the cochlear implant and subsequent device switch-on. The study reported 
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for animals exhibiting higher impedances at the implanted electrodes. This study did, however, not provide 
more insight in impedance changes within a day.  
4.2.2 Clinical Data 
Studies of impedance fluctuations on humans typically have in common that the sampling interval of the 
measurements follows that of the routine clinical visits of the subjects. This means a measurement interval of 
at least one week during the postoperative period up to three months. Thereafter, the interval is at least a 
couple of months or more (Brkic et al., 2020; Busby et al., 2002; Choi et al., 2017; Jia et al., 2011; Leblans et 
al., 2022; Molisz et al., 2015; Paasche et al., 2006; Sanderson et al., 2019; Shaul et al., 2019; Tykocinski et al., 
2005; Zarowski et al., 2020). Several of them investigate the strong variations directly induced by CI-
implantation, either due to electrode passivation/reactivation, tissue formation around the electrode, the 
influence of medication or surgical procedure on those phenomena, or due to adverse issues related to the 
electrode (Busby et al., 2002; Leblans et al., 2022; Molisz et al., 2015; Paasche et al., 2006; Tykocinski et al., 
2005; von Mitzlaff et al., 2021). Two of the exceptions are (Choi et al., 2017; Shaul et al., 2019). They 
investigated in the postoperative period of 3 months up to 3 years the relation between impedance changes 
and episodes of hearing loss, vertigo or tinnitus, using an impedance sampling period of at least a few 
months. Their work illustrates very well the limitations when monitoring these medical events, which are 
often transient in nature, by means of in-clinic impedance measurements. They try to correlate substantial 
impedance increases, which had disappeared in 50% of the cases at the subsequent visit, to medical events 
that occurred in the period four weeks before and after the observed increase. This raises two questions: (1) 
How many relevant impedance changes/medical events have been missed? (2) What is the reliability of 
relating the impedance increase and the medical event in the case of such a broad time interval?  
An exception is the work of (Newbold et al., 2014), investigating the effect of overnight inactivity of the 
cochlear implant and subsequent device switch-on in experienced human CI-users (1.5 – 5.5y postop), which 
is similar to their animal study. Three CI-users are followed only for three subsequent days, while electrode 
impedances were recorded three times a day: before device activation in the morning, half an hour later and 
just before device switch-off at the end of the day. An average impedance reduction of 5% after device 
switch-on was reported. This study, however, focussed on overnight activity and not on impedance variation 
throughout the day. Furthermore, the number of datapoints in this study was limited.  
The following work also measured impedances multiple times per day in humans, but during 1-month post-
op. Parreño et al. (2020) recorded impedances twice a day (with a 12h difference) over the first 30 days after 
implantation, using a self-developed system for at-home monitoring. Because the data are acquired before 
initial stimulation, the data are dominated by huge impedances mostly attributable to the passivation of the 
electrode contact, building up during the first 2 weeks. Ausili et al. (2022) used the same setup to record 
complex impedances daily (once per day) over the first 30 days after implantation. The dynamics of total 
impedance changes between days were Similar to the findings by Parreno et al. In addition, it was found that 
the main contributor to changes are the capacitive components of the impedance. The dynamics of 
impedances during a day (before and after stimulation) have not been analyzed. Overall, published studies 
lack information on impedance variation during a day and as day-to-day variation, especially during a period 
of at least six months post-implantation.  
 
 

 
 
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4.3 
Study Rationale 
The possibility to continuously monitor the health of the implanted cochlea, with associated algorithms to 
detect events such as inflammations and scar tissue formation (fibrosis) will address a major challenge in our 
field, namely long-term preservation of residual hearing. A candidate biomarker for cochlear health may be 
found through the measurement of the different components of the complex electrode contact impedances. 
A prerequisite to develop detection algorithms for abnormal events, is the collection of normative data. 
However, as mentioned in section 4.2, data on impedance variation during a day and as day-to-day variation, 
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analysed clinical impedance measurements retrospectively or data prospectively in-clinic at scheduled visits of 
the subjects. Consequently, the availability of data is limited to irregular and rather coarse time intervals of 
week(s) or months, while the phenomena contributing to the impedance often fluctuate on a faster time 
scale. Therefore, when measuring the impedance in-clinic, it is impossible to control the appropriate sampling 
times in case of several potential origins of the impedance fluctuations, such as infections of the upper 
respiratory pathways (Zarowski et al., 2020), (over-night) inactivity of the cochlear implant prior to the 
measurement, the intensity of implant use, the use of medication, and clinical events such as vertigo, 
Ménière-like symptoms, tinnitus, and loss of residual hearing (McNeill and Eykamp, 2016; Parreño et al., 
2020; Shaul et al., 2019). This motivates the primary objective of this investigation, which is to collect and 
describe time series data for complex impedances collected at home. 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
5 RESEARCH TOOL INFORMATION 
5.1 
Identity and Description of the research tool  
The primary interest of this investigation is the impedance measurement collected in the home environment 
of the participant. To collect this data a research system is used consisting of Mobile Research App (MRA) 
(participant facing app) V3.0 and above. 
 
  
 
 
 
 
 

 
 
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All research tools are manufactured by Cochlear Limited. The iOS device® with the MRA installed will labelled 
exclusively for use in a clinical investigation. The study data will result in learnings that will be useful towards 
the design of a future daily impedance feature in the commercial software. CI recipients/investigators will use 
the research tools for the duration of the study only. Traceability of the build number will be documented in 
the tracking forms such as the Software Tracking Form (1302326). The investigators will receive 
comprehensive, specific training in the use of the research tools and in ongoing support during the execution 
of the study procedures as needed. This training will be logged on a training log. The CI-recipients will receive 
specific training in the use of the research tool and will receive ongoing support from the investigator during 
the execution of the study procedures. The research tools are software-only and will not be in contact with 
body fluid or tissue. Further details regarding the research tools are provided in the IB and Instructions for Use 
(IFU). 
 
 
 
 
 
 
 
 
 

 
 
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6 OBJECTIVES 
6.1 
Primary Objective  
To collect and describe time series data for complex impedances (access resistance & polarization) collected 
between clinic visits. 
 
 
 
 
 
 
 
  
 
 
 
7 DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
This is a feasibility, prospective, multi-country, multi-centre, cross-sectional interventional clinical 
investigation in adults with a CE labelled cochlear implant. 
The early feasibility categorisation relates to the use of research tools and the purpose of the investigation 
being to collect pilot data on impedance measurements in real-world environments, reflecting any situation 
the subjects encounter during their normal life outside of the clinic. 
In total, 50 eligible subjects are planned to be recruited in the clinical investigation. The subjects include 
adults from the age of 18 years or above who are currently using a commercial available Nucleus CIC4-based 
implant with a Contour Advance, Slim Straight or Slim Modiolar electrode array with a minimum of 6 months 
experience. Subjects will be screened according to the inclusion and exclusion criteria as described in section 
7.2. No Randomisation nor blinding to avoid bias is applicable in this study since there is no comparator. 
Subjects will attend two scheduled study visits over a two-month study period as described in the Clinical 
Investigation Plan (CIP) Schedule of Events (Section 3). At and in between study visits, subjects will undergo 
hearing assessments and safety monitoring. The time of each visit is estimated to be less than 2 hours. During 
the first two weeks of the take-home the subjects will start to perform daily impedance test tasks and 
complete a questionnaire five times a day and a speech test once per day with the MRA application in order 
to obtain the first primary endpoint, i.e. characterization of Daily Impedance Fluctuations. For the rest of the 
two months study two daily impedance tests with questionnaire and one speech test will be measured per 
day.  In case of any of symptoms or impacted hearing (sound quality) reported by the participant in the 

 
 
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questionnaire, one additional week of daily impedance tests with questionnaire for five times a day will be 
done. 
 
 
 
  
 
 
 
   
 
Safety will be assessed by recording and summarising all adverse events (AEs)/advice device effects (ADEs) 
and device deficiencies (DDs). The investigator will be able to view and monitor results during take-home, 
however this is not required for the study. Given the feasibility nature of this study, characterisation as 
primary endpoint and monitoring of results by the investigator, the data can be analysed continuously. The 
purpose is acquiring knowledge at this stage. No data monitoring committee will be used for this clinical 
investigation. All subjects will attend an End-of-Study visit at the time they complete the study. 
The principal Investigator List will specify where evaluations will be conducted and who will be responsible. 
The principal investigator may determine to do study visit measurements remotely where possible, like in the 
home situation. 
7.1.1 Design Rationale 
This is one of the first exploratory studies investigating daily impedance fluctuations at the CI-electrode 
contacts with a high sampling frequency over a longer period in a population of CI users who are expected to 
have reached a stable state of impedances. Because there is no clear evidence yet which underlying factors 
may be expressed most prominently that explain impedance fluctuations, the inclusion criteria are chosen 
broad with respect to implant type and medical/hearing background of the subjects. Also, medical, hearing, 
medication and device usage parameters are collected to find possible correlations with impedance 

 
 
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fluctuations, which may be the subject of future investigations with well-founded hypothesis. Because the 
subjects have their own specific conditions and because the study also addresses events that may occur in an 
uncontrolled way, it has a single-subject repeated measures design, in which each participant is acting as 
his/her own control. 
The study will investigate both impedance fluctuations within a single day and over a total period of 2 months. 
The sample frequency of the impedance, the monitoring period and the number of subjects is chosen to be 
superior to available data, to detect subtle changes that may not be apparent with less frequent data 
collection and to allow for a realistic chance on recording impedances and related measures during 
uncontrolled medical/hearing events. The measurement schedule aims to result in a high subject compliance, 
resulting in a consistent data set.  
 
 
 
 
 
  
 
 
  
 
 
 
 
7.2 
Subjects 
Written, informed consent must be obtained from the subject before any study procedures are initiated. 
Eligibility of subjects must be supported by medical, demographics and audiological information as well as 
their mobile proficiency that confirm the subject inclusion as stated in Section 7.2. 
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 (no upper age limit). 
2) Implanted with CIC4-based implant with a Contour Advance, Slim Straight or Slim Modiolar 
electrode array with at least 6 months experience. 
3) Candidate is a fluent speaker in the language used to assess speech perception performance, as 
determined by the investigator. 
4) Willing and able to provide written informed consent. 

 
 
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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) Score below 3 on the screening subset of questions from the Mobile Device Proficiency 
Questionnaire (digital literacy check). 
2) A failed ECE1 or ECE2 (i.e. flagged, open circuit or short circuit) 
3) Additional health factors, known to the investigator, that would prevent or restrict participation 
in the evaluations, including significant visual impairment and/or dexterity issues. 
4) Unable or unwilling to comply with the requirements of the clinical investigation as determined 
by the Investigator. 
5) Investigator site personnel directly affiliated with this study and/or their immediate families; 
immediate family is defined as a spouse, parent, child, or sibling. 
6) Cochlear employees or employees of Contract Research Organisations or contractors engaged by 
Cochlear for the purposes of this investigation. 
7) Current participation, or participation in another interventional clinical study/trial in the past 30 
days, involving an investigational drug or device (unless the other investigation was/is a Cochlear 
sponsored investigation and determined by the investigator or Sponsor to not impact this 
investigation). 
8) Pregnant or breastfeeding 
7.2.3 Number of Subjects Required 
As the current study is a feasibility study, no sample size calculation using power analysis can be done. 
 
 
 
 
Overall, a sample size of 50 subjects of 
which 10 subjects are expected to show fluctuating impedances is considered appropriate for this feasibility 
study. Cross-regional pooling of data is justified due to the within-subject study design. 
7.2.4 Vulnerable Populations 
Pregnant or breastfeeding woman will be excluded in this clinical investigation as this study will not give direct 
benefit to this vulnerable population group. 
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. 

 
 
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• 
Participated: Subjects who have met eligibility criteria and have commenced baseline 
assessments.  
• 
Discontinued: An Enrolled subject who withdrew consent, was discontinued by the 
Investigator or Sponsor before the expected End of Study visit, or lost to follow-up. 
Discontinued subjects may still have safety follow up data collection until their scheduled 
End of Study visit, for reasons described in section 7.2.6. 
• 
Completed: Enrolled subjects who complete the required treatment and visit schedule.  
The recruitment period for the clinical investigation is estimated to be 8 months 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 End of Study visit. 
Clinical Investigation completion is last subject last visit. In the event of an ongoing Serious AEs (SAEs)/Serious 
ADEs (SADEs) at the time of this last visit, the clinical investigation completion will be extended for a further 
30 days, or until resolution or stabilisation of the event, whichever comes first. 
7.2.6 Criteria and Procedures for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the reason(s), 
however subjects have the right to withhold their reason if preferred. The reason for withdrawal should be 
documented in the subject’s source files and the case report form (CRF), if provided. 
The Investigator or Sponsor may also decide to withdraw a subject from the clinical investigation or stop the 
use of the investigational device if it is considered to be in the subject’s best interests. 
Subject withdrawal may be for any of the following reasons: 
• 
Adverse Event (AE) 
• 
Device Deficiency (DD) 
• 
CIP or GCP deviation 
• 
Subject withdrew consent 
• 
Subject lost to follow-up 
• 
Subject death 
• 
Sponsor decision 
• 
Investigator decision 
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. 
In case more than 10 % of the participating subjects are withdrawn/discontinued, the subjects will be 
replaced to ensure 45 subjects adhere to both conditions: 

 
 
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• 
During the initial ‘intense’ 2 weeks, the participant performed a minimum of 20% of the target 
complex impedance and TIM measurements.  
• 
After the initial ‘intense’ 2 weeks, the participant performed a minimum of 10% of the target complex 
impedance and TIM measurements. 
7.2.7 Randomisation Procedures 
Not applicable 
7.2.7.1 
Blinding Procedures 
This is a pilot study with the aim to collect data on impedances in the home environment to be potentially 
used to inform larger data collection initiatives for characterisation and/or diagnostic purposes.  The subjects 
will not see the impedance data collected. Blinding is not applicable in this study.  
7.2.8 Post-investigation Medical Care 
Following the investigation, subjects will continue with standard of care treatment. 
 
 No 
extra medical care needs to be provided after the clinical investigation. 
 
 
 
 
 
7.3.1 Screening/eligibility 
Screening will only be conducted after the participant has consented into the study. Eligibility will be 
confirmed according to the eligibility criteria in section 7.2. The following must be completed prior to any 
study procedures not related to screening: 
• 
Written informed consent: must be completed before any study-specific procedures are completed  
• 
Demographics: document month and year of birth and sex 
• 
Eligibility: confirm subject meets all inclusion criteria and no exclusion criteria. Source documentation 
must be available before confirming eligibility. For pregnancy or breastfeeding subject reporting is 
sufficient. 
• 
Hearing History: document history of hearing loss (may be subject reported) 
• 
Device history: document history with hearing aids and hearing implants (may be subject reported) 
• 
Medical History: document medical history (may be subject reported) 
• 
Mobile Device Proficiency Questionnaire: must be completed at screening (see below) 

 
 
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7.3.1.1 
Mobile Device Proficiency Questionnaire (MDPQ)   
The purpose of this questionnaire is to screen subjects on their proficiency with a mobile device. 
Eligible subjects must be able to perform basic tasks with a (smart) mobile device for them to successfully 
complete tasks associated with the MRA app. Proficiency with a mobile device will be screened using the 
Mobile Device Proficiency Questionnaire (Roque & Boot, 2018). The MDPQ is a validated questionnaire which 
measures the ability of older adults (over 65 years old) to perform certain tasks with a mobile device, 
specifically smartphones. The questionnaire is comprised of 46 statements, split into eight (8) sections: 
1. Mobile Device Basics 
2. Communication 
3. Data and File Storage 
4. Internet 
5. Calendar 
6. Entertainment 
7. Privacy 
8. Troubleshooting and Software Manager 
Each statement is prefaced with “Using a mobile device I can:” and scored on a 5-point Likert scale, where 1 
corresponds to “Never tried” and 5 corresponds to “Very easily”. All subjects will be asked to complete the full 
questionnaire, however, only a subset of the tasks are directly relevant to the ability to use the MRA app. 
Therefore, only scores from a subset of the statements in sections 1 (Mobile Device Basics) and 8 
(Troubleshooting and File Storage) will be used to determine eligibility for the study. Subjects will need to 
score an average of 3 (suggesting at least some level of ability to perform the tasks) or higher to proceed in 
the study. Scores from the following questions will be used to determine eligibility: 
Section 1 – Device Basics 
Using a mobile device I can: 
a. Turn the device on and off 
b. Charge the device when the battery is low 
c. Navigate onscreen menus using the touchscreen 
d. Use the onscreen keyboard to type 
e. Copy and paste text using the touchscreen (Will not be used for eligibility) 
f. Adjust the volume of the device 

 
 
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g. Adjust the screen brightness 
h. Adjust text size (Will not be used for eligibility) 
i. 
Connect to a Wi-Fi network 
Section 8 – Troubleshooting & Software Management 
Using a mobile device I can: 
a. Restart the device when it is frozen or not working right 
b. Update games and other applications 
c. Close games and other applications 
d. Delete games and other applications (Will not be used for eligibility) 
e. Upgrade device software 
In case of a score of less than 3 to the MDPQ, the subject will not be enrolled into the study and routine 
ongoing management and care will be scheduled with the clinic.  
7.3.2 Performance/Effectiveness 
7.3.2.1 
Data collection at site visit 
 
 
 
 
 
 
  
 
  
 
  
 
  
 
  
 
 
  
 
 
 
 

 
 
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7.3.2.1.3 
Objective measures: Standard impedances and Trans-Impedance Matrix test (TIM)  
Standard clinical impedances will be collected using the CSS Software. The TIM is an electrophysiological 
method based on electric field imaging that can provide images of electrode position and electrode folding. In 
TIM, the CI stimulates one contact and records the electrical potential decay along the cochlea on all contacts. 
In general, the decay constants may depend on the electrode type and location, the cochlear anatomy and 
tissue properties (Ramos, et al., 2022). TIM measurements will be obtained on all enabled electrodes post-
operatively, using the commercially available CSS software. Electrodes flagged in the MAP will be excluded if 
necessary. No protocol deviation will be created in case TIM measurement cannot be obtained on all enabled 
electrodes. 
 
 
 
 
 

 
 
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7.3.3 Safety Evaluations and Procedures 
The risks and anticipated ADEs for the investigational device, as identified in Sections 8.2 and 8.3 of the CIP, 
will be assessed in the clinical investigation via reporting of all AEs/ADEs from the time of first subject first 
visit until last subject last visit. The stimulation characteristics of the electrode sweep are standard charge-
balanced bi-phasic pulses presented sub-threshold, with an associated medium-risk anticipated device effect 
possible. The subject is requested to complete a well-being questionnaire each day to provide information 
relating to the association between impedance fluctuations and clinical symptoms, and to capture adverse 
events. The investigator is required to capture any adverse event or any new information in the CRF on each 
study visit.  
Safety data adjudication will be conducted by the Sponsor in accordance with the Sponsor’s standard 
operating procedures. Upon review of data available in the CRF, the Sponsor may query data or request 
deidentified source documents to review the event. 
7.3.3.1 
Concomitant Medication and Therapies 
Concomitant medications will be recorded in the subject’s CRF at the screening visit and updated during the 
clinical investigation when changes to medication and/or therapies occur. The subject can report any change 
in these conditions through self-reporting by means of the wellbeing questionnaire on the Mobile Research 
App. As long as the subject is capable of performing the self-test and self-reporting, concomitant medication 
and therapies do not obstruct the validity of the study data. To the contrary, identifying the potential effects 
of concomitant medication and therapies on the impedance measured at the CI-electrode contacts is a 
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7.4 
Equipment Used for Evaluations and Procedures 
Tools including software, firmware, and sound equipment (e.g., speakers or audio streaming accessories) will 
be used to write the investigational firmware to the loaner sound processor, measure TIM responses, collect 
subject’s self-reporting during take-home, collect audio recordings, collect datalogs and assess hearing 
performance. Software and firmware should be kept current at the direction of the Sponsor. 
The investigational firmware will be written to the loaner CP1000 or CP1150 sound processor using an 
application on a standard personal computer. 
 
 
 
 
 
 
Impedances, 
 will be administered to subjects via the MRA on a 
compatible iOS device. Subjects will be instructed to complete the Impedances, 
 
 in a quiet room in the home environment with low ambient noise, free from distractions. 
7.5 
Sponsor Role in Conduct of the Clinical Investigation 
Employees of the Sponsor organisation may act as investigators, conducting all study visits and procedures.  
In case Cochlear employees acting as investigators will be involved in Sponsor procedures, this will be clearly 
documented in the study documentation. 
A Sponsor representative may provide support during study procedures performed by the investigational 
sites. They may also attend study visits to trouble-shoot issue that may arise during the investigation. The 
duration and level of support provided by the Sponsor will be guided by the investigators.  
8 BENEFITS AND RISKS OF THE RESEARCH TOOL AND CLINICAL INVESTIGATION 
8.1 
Anticipated Clinical Benefits  
Participation in this clinical investigation is not expected to provide individual clinical benefit to the subjects.  
8.2 
Anticipated Adverse Device Effects 
Residual risks have been assessed in accordance with Cochlear’s Product Risk Management Procedure. Only 
the following residual risk is relevant for this study and is classified as medium risk:  
• 
During the execution of measurements, some of the stimulation pulses may be perceived as 
uncomfortable or result in pain or non-auditory stimulation for a short period of time. The users will be 
informed that they have the option to use a stop button in the app or take off the coil from their head. 
 

 
 
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8.5 
Benefit-to Risk Rationale 
The residual risks associated with the MRA system have been reduced to the lowest possible level. 
Verification activities show that the hazards have been effectively mitigated by design.  
It is concluded that the risks related to MRA system and its associated measurements, when used as intended 
by the intended user groups, are acceptable when weighed against the intended benefits to the subject and 
are consistent with current state-of-the-art therapies. Therefore, it is concluded that the benefit-risk ratio is 
favourable for the MRA system. This benefit-risk analysis will continue to be reviewed throughout the use of 
the system as new clinical data becomes available from clinical investigations. Any new risks identified during 
the investigations will be managed according to Cochlear’s Product Risk Management Procedure.  
9 STATISTICAL CONSIDERATIONS 
9.1 
General Considerations 
This clinical investigation plan outlines the statistical considerations for a feasibility multicentre study 
involving 50 subjects. As this is a feasibility study with no formal hypothesis, the primary objective is to 
generate preliminary data and identify trends or associations that may warrant further investigation in future 
studies. 
Descriptive statistics will be used to summarize subjects demographics, clinical characteristics, and outcomes. 
Continuous variables will be presented as means and standard deviations or medians and interquartile ranges, 
depending on the distribution of the data. Categorical variables will be presented as frequencies and 
percentages. 
Given the exploratory nature of the study, inferential statistics will be used cautiously, and any findings should 
be interpreted as hypothesis-generating rather than confirmatory. Potential associations between variables of 
interest may be explored using correlation analyses, time series analysis, or logistic regression models, as 
appropriate.  
9.2 
Endpoints 
9.2.1 Primary Endpoint 
Descriptive summaries of the complex impedance measurements on all enabled electrode-contacts collected 
via the MRA (multiple times per day, every day, long period) between clinic visits. 
 
 
 
 
 
 
 
 
  
 
 
 
 

 
 
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• 
  
 
 
9.3 
Hypotheses 
9.3.1 Primary Hypothesis 
Given the exploratory nature of the objectives, there are no formal hypotheses formulated. Descriptive 
statistics, such as means, standard deviations (SD), confidence intervals will be used to summarise the 
endpoints.  
  
 
  
9.4 
Sample Size Determination 
A total of 50 subjects will be included in this feasibility study. This sample size is not based on formal power 
calculations, as there is no specific hypothesis being tested. Instead, the sample size is chosen to provide a 
reasonable amount of data for preliminary analyses and to identify potential trends or associations that may 
be of interest for future studies. 
9.5 
Analysis Populations 
Analyses will be conducted on the complete dataset.  
The data of the subjects who do not satisfy both of the following conditions will be excluded:  
• 
During the initial ‘intense’ 2 weeks, the participant performed a minimum of 20% of the target 
complex impedance and TIM measurements.  
• 
After the initial ‘intense’ 2 weeks, the participant performed a minimum of 10% of the target complex 
impedance and TIM measurements. 
 
 
9.6 
Endpoint Analyses 
9.6.1 Primary Endpoint Analyses 
The primary objectives will be assessed by using descriptive statistics such as means, SD, confidence intervals. 
 
 
 
9.7 Safety Analyses 
There is no formal statistical hypothesis. Adverse events will be tabulated according to the study interval, the 

 
 
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number of procedure-related events, and the number of device-related events. Procedure- and device-related 
adverse events will be summarized as rates, where the numerator for each rate will be the number of subjects 
with at least one procedure- or device-related event, and the denominator will be the total number of 
subjects. Adverse events will be reported by type, frequency, and severity. No formal statistical comparisons 
will be conducted. 
9.8 Interim Analyses 
No formal interim analysis will be conducted. However, given the feasibility nature of the study, it is planned 
to monitor findings continuously to inform modifications to the research tool and/or study procedures when 
required and to continuously inform the development of the research tool. 
10 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject using an approved Informed Consent 
Form (ICF) prior to any clinical investigation-related examination or activity. The rationale of the clinical 
investigation, as well as the benefits and risks, what participation will involve, and established alternatives to 
participation will be explained to the subject in native non-technical language, understandable to the subject. 
Ample time will be provided for the subject to enquire about details of the clinical investigation and to decide 
whether to participate. 
All questions about the clinical investigation shall be answered to the satisfaction of the subject. Subjects shall 
not be coerced or unduly influenced to participate or to continue to participate in a clinical investigation. They 
shall not waive or appear to waive their legal rights. 
Each subject and the person who conducted the informed consent discussion, shall sign and personally date 
the ICF. Where required, an independent and impartial witness shall sign and personally date the ICF. A copy 
of the signed ICF shall be given to the subject. The original signed ICF shall be archived in the Investigator’s 
Site File or subject file at the investigational site. 
This process shall be documented in the subject’s source documents. 
The subject shall be informed in a timely manner if new information becomes available that may be relevant 
to the subject’s willingness to continue participation in the clinical investigation. The communication of this 
information must be documented as an update to the ICF and re-consent of the subject. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 Definitions 
11.1.1 Adverse Event  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons whether or not related to 
the research tool or the procedures required for implant or use, and whether anticipated or unanticipated. 
NOTE 1: This definition includes events related to the research tool or the comparator device. 
NOTE 2: This definition includes events related to the procedures involved. 

 
 
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NOTE 3: For users and other persons, this definition is restricted to events related to the use of research tools. 
11.1.2 Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of a research tool. 
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 research tool. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the research 
tool. 
NOTE 3: This includes ‘comparator’ if the comparator is a research tool. 
11.1.3 Serious Adverse Event 
A serious adverse event (SAE) is any AE that led to any of the following: 
1) death,  
2) serious deterioration in the health of the subject, users, or other persons as defined by one or more of the 
following: 
• 
a life-threatening illness or injury, or 
• 
a permanent impairment of, or damage to, a body structure or a body function including 
chronic diseases, or 
• 
in-patient hospitalisation or prolonged hospitalisation, or 
• 
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment or damage to a body structure or a body function, 
3) foetal distress, foetal death or a congenital physical or mental abnormality, or birth defect including 
physical or mental impairment. 
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, without serious 
deterioration in health, is not considered a SAE. 
11.1.4 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an ADE that has resulted in any of the consequences characteristic of 
a SAE. 
11.1.5 Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is a SADE, which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the hazard analysis, IB, IFU, CIP or ICF.  
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, severity, or 
outcome has been identified in the hazard analysis, IB, IFUs, CIP or ICF. 
11.1.6 Adverse Events of Special Interest 
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14 DATA MANAGEMENT 
The CRF will capture the datapoints necessary to determine the subject status according to the criteria 
described in section 7.2.5. 
14.1 Source Data 
Source data will be captured in clinic notes, paper-based source data worksheets, or printed directly from 
testing software. Data collected for specific tests as documented in the Origin of Source Data Form will be 
entered directly into the eCRF which shall be considered source data for these items. If electronic medical 
records do not permit read only access for monitoring purposes, a certified printout will be provided, 
indicated by a dated signature by a member of the site team or generated through a validated process. 
In addition, de-identified electronically generated data collected from the software tools used during the 
study visits will comprise measures such as impedance data, TIM data and map settings.  
 
 
 
The unamended data files shall be regarded as the source. 
An Origin of Source Data Form will be used to capture the location of source data kept at each site, outlining 
the individual site’s process for certification. 
14.2 Methods for Data Entry and Collection 
Data collection will be performed using Medidata Rave 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. 
Medidata Rave 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. 
In addition, de-identified electronically generated data collected from the software tools used during the 
study visits will be stored outside of Medidata Rave in a password protected secure sharefile location. Also, 
de-identified electronic collected data from the CI recipient for the 
 
 complex impedances 
 
will be collected and stored by the sponsor password protected in the electronic 
trial master folder with limited access. Site staff and CI recipients will be trained in conducting and completing 
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Access to clinical study information will be based on an individual’s role and responsibilities. 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 maintains a comprehensive log for all data entered and documents 
the time that each entry occurred. 
14.3 Database Lock 
The Sponsor shall confirm that no further subject visits will be conducted, all required forms have been 
completed and required data have been entered into the EDC including resolution of ongoing Adverse Events 
in accordance with CIP requirements, study has been closed in MRA, all electronic data collected for specific 
tests by means of the MRA have been closed and stored on a password-protected secure file location, all 
electronically generated data collected from clinical fitting software, electrophysiology applications and the 
research MRA tools have been stored on a password-protected secure file location, all required monitoring 
has been performed according to the Monitoring Plan, all data queries have been closed, all completed CRFs 
have been signed off by the PI or delegate. The Sponsor shall lock clinical investigation database and generate 
raw datasets to enable analysis. Sites will be sent PDF representations of the data captured in Medidata Rave, 
including audit trail, to enable the site to archive the data for their subjects. Additionally, the study data of 
those subjects who consented may be used for other medical scientific research purposes in the field of 
hearing loss.  
15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance with 
governing data privacy regulations such as the EU GDPR regulations. 
Data will be reported to the Sponsor on CRFs or related documents (for example questionnaire). Subjects will 
be identified on CRFs and other related documents only by a unique subject identification code and shall not 
include the subject’s name or other personal identifiable information. Completed CRFs or related documents 
are confidential and will only be available to the Investigator and site staff, the Sponsor and their 
representatives, and if requested to the Ethics Committee and national regulatory authorities. Publications or 
submission to a regulatory authority shall not disclose the identity of any subject. 
16 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
This clinical investigation will be conducted under the following regulatory pathways: 
Country 
Pathway 
Australia 
CTN 
European Union* 
EU MDR Article 82 
*See Veeva VV-TMF-27244 for applicable Statement/Declaration of conformity 
The clinical investigation will not commence prior to the written favourable opinion or approval from the 
Ethics Committee (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 
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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/CA. 
The Sponsor and Principal Investigator will continue communications with the EC/CA, 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/sponsor shall submit the appropriate documentation if any extension or renewal of the 
EC/CA 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/CA. 
The Investigator/sponsor shall report to the EC/CA any new information that may affect the safety of the 
subjects or the conduct of the clinical investigation. The Investigator/sponsor will send written status 
summaries of the investigation to the EC/CA regularly, as per local EC/CA requirements.  
Upon completion of the clinical investigation, the Investigator shall provide the EC/CA with a brief report of 
the outcome of the clinical investigation, as per local EC/CA requirements. Local requirements are listed 
below. 
Australia:  
If a clinical investigation is prematurely terminated or suspended, the sponsor should promptly inform the 
investigator(s), institution(s), the EC, and the regulatory authorities. The sponsor should provide the reason(s) 
for the termination or suspension. 
European Union: 
Upon end of a clinical investigation, the sponsor shall notify the EC and 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 EC and regulatory authority within 15 days. Justification for the halt or termination shall be included. If 
either situation is on safety grounds, then the reporting timeframe is 24 hours. 
The clinical investigation report and summary needs to be submitted within one year of the end of the clinical 
investigation or within three months of the early termination or temporary halt to the EC and regulatory 
authorities. 
For Sweden, an approval from the Swedish regulatory authority is required to restart the clinical investigation 
if the temporary halt was due to safety reasons. 
 
The clinical investigation is covered by clinical trial insurance, meeting the requirements of the participating 
countries. 
17 SUSPENSION OR PREMATURE TERMINATION 
The Sponsor will discontinue the clinical investigation site if: 
1) major non-adherence to the CIP or GCP principles is occurring 

 
 
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2) it is anticipated that the subject recruitment will not be adequate to meet the objectives of the clinical 
investigation 
An ongoing clinical investigation may be discontinued in case of: 
1) device failure 
2) serious or intolerable ADE, leading to the explant or discontinued use of the device 
3) subject’s death 
18 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
No changes in the CIP or investigation procedures shall be made without mutual agreement of the Principal 
Investigator and the Sponsor. This agreement will be documented as a CIP amendment. Amendments will 
require notification to the Ethics Committees by the Principal Investigators (and to the relevant regulatory 
authority(s) by the Sponsor, if applicable). In Belgium and Sweden, the reporting of substantial modifications 
to the Ethics Committee is coincident with the reporting to the FAMHP/MPA. Only one submission is required 
through the national contact point (FAMHP/MPA). Substantial changes to the Clinical Investigation Plan may 
not be implemented until they have been notified and assessed in accordance with MDR Article 75. 
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 in accordance with the period required by local regulation, 
as follows: At least 15 years after completion of the investigation, or, in the event that the device is 
subsequently placed on the market, at least 15 years after the last device has been placed on the market. 
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. 
 
 
 
 

 
 
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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 14155:2020 Clinical investigation of medical devices for 
human subjects - Good Clinical Practice, and any regional or national regulations, as applicable. 
22 QUALITY CONTROL AND ASSURANCE 
In accordance with Cochlear’s Quality Management System, all clinical investigations shall be conducted 
according to internationally recognised ethical principles for the purposes of obtaining clinical safety and 
performance data about research tools. 
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, 
GCP, and applicable local regulations. 
22.1 Monitoring 
The Sponsor will perform on-site and remote monitoring visits as frequently as necessary to oversee conduct, 
data collection and record keeping by sites. The clinical investigation monitoring plan is a separate document 
for the sponsor to follow, describing all the activities performed during site qualification, initiation, 
monitoring, and close out. 
In accordance with applicable regulations, GCP, and sponsor’s/CRO’s procedures, monitors will contact the 
site prior to the start of the study to review with the site staff the CIP, study requirements, and their 
responsibilities to satisfy regulatory, ethical, and sponsor’s requirements. When reviewing data collection 
procedures, the discussion will also include identification and documentation of source data items. 
The sponsor/designee will monitor the site activity to verify that the: 
• 
Data are authentic, accurate and complete 
• 
Safety and rights of subjects are being protected 
• 
Study is conducted in accordance with the currently approved CIP 
• 
Any other study agreements, GCP, and all applicable regulatory requirements are met. 
The investigator and the head of the medical institution (where applicable) agrees to allow the monitor direct 
access to all relevant documents. 
22.2 Audits 
To ensure compliance with GCP, the CIP, study procedures and applicable regulatory and EC requirements, an 
independent audit of the study may be conducted. The investigator/institution will be informed of the 
outcome for audits involving their site.  

 
 
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