An Actual Use, Prospective, Adaptive Design, Single Centre, Non-randomised, Open-label Study, Assessing Usability of Remote Assist When Used to Program Cochlear Implant Recipients
Phase: NA
Conditions: Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Sponsor: Cochlear

 
 
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Clinical Investigation Plan 
 
Investigation Title: An actual use, prospective, adaptive design, single 
centre, non-randomised, open-label study, assessing usability of Remote 
Assist when used to program cochlear implant recipients. 
Short Tile: 
RAL 
CIP Number: 
CLTD5809  
Date:  
09 Aug 2021 
Sponsor 
Cochlear Limited 
1 University Avenue,  
Macquarie University 
NSW   2109 
Phone:  02 9428 6555 
 
 
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki (World Medical Association, 2013), International Standard ISO 
14155 Clinical investigation of medical devices for human subjects - Good Clinical Practice, and any 
regional or national regulations, as applicable. 
 
Confidential Information 
The information contained in this document is confidential and should not be copied or distributed to persons not involved 
in the conduct or oversight of the clinical investigation 
 
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Manufacturer 
Cochlear Limited 
1 University Avenue,  
Macquarie University 
NSW   2109 
Phone:  
 
Principal Investigator 
 
 
Principal Research Audiologist 
Cochlear Limited 
1 University Avenue,  
Macquarie University 
NSW   2109 
Phone:  
 
Safety Contact 
 
 
 
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INVESTIGATOR AGREEMENT 
Principal Investigator Approval and Declaration 
By my signature below, I confirm my review and approval of this Clinical Investigational Plan (CIP). 
I also confirm that I will strictly adhere to the requirements therein and undertake to ensure that all 
staff with delegated responsibilities in the conduct of this CIP have read, understood and will strictly 
adhere to the requirements therein. This CIP will not be implemented without prior written approval 
from the Ethics Committee, any applicable National Competent Authorities, and the Sponsor. If 
amendments to this plan become necessary, written approval by the Ethics Committee and any 
applicable National Competent Authorities will be obtained before the changes are clinically 
implemented per the amendment, except under emergency circumstances to protect the rights, 
safety, and well-being of subjects. 
Name 
Title 
 
Principal Investigator 
Signature 
Date 
 
 
 
 
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TABLE OF CONTENTS 
1 
Definitions and Abbreviations ......................................................................................................... 7 
2 
Clinical Investigation Synopsis ........................................................................................................ 9 
3 
Schedule of Events ....................................................................................................................... 11 
4 
Background Information and Rationale ........................................................................................ 12 
4.1 
Introduction ......................................................................................................................... 12 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 12 
4.2.1 
Nonclinical Data .................................................................................................... 12 
4.2.2 
Clinical Data .......................................................................................................... 13 
4.3 
Study Rationale .................................................................................................................. 14 
5 
Medical Device Information ........................................................................................................... 15 
5.1 
Identity and Description of the Investigational Medical Device (IMD) ................................ 15 
5.2 
Identity and Description of the Comparator ........................................................................ 17 
5.3 
Accessory Device Requirements ........................................................................................ 18 
6 
Objectives ..................................................................................................................................... 18 
6.1 
Primary Objective ............................................................................................................... 18 
6.2 
Secondary Objective ........................................................................................................... 18 
6.3 
Exploratory Objectives ........................................................................................................ 18 
7 
Design of the Clinical Investigation ............................................................................................... 18 
7.1 
General ............................................................................................................................... 18 
7.1.1 
Design Rationale ................................................................................................... 19 
7.2 
Subjects .............................................................................................................................. 21 
7.2.1 
Inclusion Criteria ................................................................................................... 22 
7.2.2 
Exclusion Criteria .................................................................................................. 22 
7.2.3 
Number of Subjects Required ............................................................................... 22 
7.2.4 
Vulnerable Populations ......................................................................................... 22 
7.2.5 
Enrolment & Study Duration ................................................................................. 22 
7.2.6 
Criteria for Subject Withdrawal ............................................................................. 23 
7.2.7 
Randomisation Procedures .................................................................................. 23 
7.2.8 
Post-investigation Medical Care ........................................................................... 24 
7.3 
Performance Evaluations and Procedures ......................................................................... 24 
7.4 
Safety Evaluations and Procedures ................................................................................... 28 
7.4.1 
Concomitant Medication and Therapies ............................................................... 28 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 28 
7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 28 
8 
Risks and Benefits of the Investigational medical device and Clinical Investigation .................... 29 
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8.1 
Anticipated Clinical Benefits ............................................................................................... 29 
8.2 
Anticipated Adverse Device Effects .................................................................................... 30 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 30 
8.4 
Risk Mitigation .................................................................................................................... 30 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 31 
9 
Statistical Considerations .............................................................................................................. 31 
9.1 
General Considerations ...................................................................................................... 31 
9.2 
Outcome measures ............................................................................................................ 32 
9.2.1 
Primary Outcome measure ................................................................................... 32 
9.2.2 
Secondary Outcome measures ............................................................................ 32 
9.2.3 
Exploratory Outcome measures ........................................................................... 32 
9.3 
Hypotheses ......................................................................................................................... 32 
9.3.1 
Primary Hypothesis ............................................................................................... 32 
9.3.2 
Secondary Hypothesis .......................................................................................... 32 
9.3.3 
Exploratory Hypothesis ......................................................................................... 32 
9.4 
Sample Size Determination ................................................................................................ 32 
9.5 
Analysis Populations ........................................................................................................... 33 
9.6 
Primary Outcome measure Analyses ................................................................................. 33 
9.7 
Secondary Outcome measure Analyses ............................................................................ 33 
9.8 
Exploratory Outcome measure Analyses ........................................................................... 33 
9.9 
Safety Analyses .................................................................................................................. 33 
9.10 Interim Analyses ................................................................................................................. 33 
10 Informed Consent Process ........................................................................................................... 33 
11 Adverse Events and Device Deficiencies ..................................................................................... 34 
11.1 Definitions ........................................................................................................................... 34 
11.1.1 
Adverse Event ...................................................................................................... 34 
11.1.2 
Adverse Device Effect .......................................................................................... 34 
11.1.3 
Serious Adverse Event ......................................................................................... 34 
11.1.4 
Serious Adverse Device Effect ............................................................................. 35 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 35 
11.1.6 
Adverse Events of Special Interest ....................................................................... 35 
11.1.7 
Device Deficiency ................................................................................................. 35 
11.2 Recording and Handling of Adverse Events ....................................................................... 35 
11.2.1 
Assessment of Severity ........................................................................................ 36 
11.2.2 
Assessment of Causality ...................................................................................... 36 
11.2.3 
Assessment of Seriousness ................................................................................. 37 
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11.2.4 
Assessment of Expectedness .............................................................................. 37 
11.3 Recording and Handling of Device Deficiencies................................................................. 38 
11.4 Reporting Responsibilities .................................................................................................. 38 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 38 
11.4.2 
Sponsor Notification of Events ............................................................................. 38 
11.5 Independent Data Monitoring Committee ........................................................................... 39 
12 Device Accountability .................................................................................................................... 39 
13 Deviations from the Clinical Investigation Plan ............................................................................. 40 
14 Data Management ........................................................................................................................ 40 
15 Confidentiality ................................................................................................................................ 41 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 41 
17 Suspension or Premature Termination ......................................................................................... 42 
18 Amendments to the Clinical Investigation Plan ............................................................................. 42 
19 Record Keeping and Retention ..................................................................................................... 42 
20 Publication Policy .......................................................................................................................... 42 
21 Statements of compliance ............................................................................................................. 43 
22 Quality Control and Assurance ..................................................................................................... 43 
22.1 Monitoring ........................................................................................................................... 43 
22.2 Audits .................................................................................................................................. 43 
23 Trademarks and Copyright ........................................................................................................... 43 
24 References .................................................................................................................................... 44 
24.1 Internal References ............................................................................................................ 44 
24.2 External References ........................................................................................................... 44 
25 Change History ............................................................................................................................. 45 
 
 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction 
Clinical management of cochlear implant (CI) recipients involve programming, counselling, 
performance evaluation and habilitation. The standard practice for this management involves 
frequent clinical visits in the first year after implantation and annual visits for the rest of the recipient’s 
life (Müller & Raine, 2013). The need to travel to the clinic for follow up appointments can pose 
significant challenges for recipients, particularly those who live far away from the clinic. There have 
been reports of recipients being lost to follow up due to the difficulties in travelling to the clinic (Rooth 
et al 2017). The inconvenience of scheduling a session and travelling to the clinic might deter 
recipients from seeking help for some seemingly small / less troubling issues and increase their 
tendency to somehow bear and live with the issues. Sometimes clinicians schedule follow-up 
sessions with the primary purpose of following-up on progress with strategies provided earlier to 
overcome real world problems. Such follow-up on progress can easily be completed via a video call 
as well. 
Remote programming is one telehealth solution known to be successful in addressing the challenges 
of travelling to the clinic for appointments. During the Covid-19 pandemic there was a demonstrated 
increase in the uptake of remote programming when traveling to the clinic posed a health and safety 
risk (Kim et al 2021). Current methods of remote programming of CI requires the use of special 
computer and programming hardware as well as proprietary programming software to be installed on 
a personal computer (PC) at the remote location. Although remote programming potentially reduces 
the travel burden for some recipients, it involves substantial administrative effort and cost by clinics to 
prepare, send, retrieve back, and clean remote programming hardware and software. This also 
reduces the frequency with which remote programming appointments can be scheduled due to time 
delays in sending and retrieving equipment.  
Remote Assist (RA) is a new solution that allows the clinician to make MAP and sound processor 
adjustments via the recipient’s Nucleus Smart app (NSA) installed on their smart phone. With RA the 
clinician can also perform counselling using a video call directly via the NSA. As RA uses no 
specialised hardware and software that needs to be sent and retrieved back from the recipient, it has 
the potential to further improve the remote programming experience and convenience for both the 
recipient and the clinician. 
The current study aims to assess recipients ease and experience with using Remote Assist to 
receive remote programming of their CI. 
  
4.2 
Findings of Previous Nonclinical and Clinical Studies 
4.2.1 
Nonclinical Data 
The investigational device in this study is the NSA and Custom Sound Pro (CSPro) 6.3 software 
when used with CP1000 or CP1150 sound processors. This application is assessed for their effect on 
the safety and efficacy as per the Cochlear’s Product Risk Management Procedure [1] and in 
accordance with ISO 14971, “Medical devices – Application of risk management to medical devices”.  
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Bench verification and validation [2] and [3] has demonstrated that commercially available versions of 
NSA and CSPro are safe and effective and does not contribute to an unacceptable risk. The RA 
hazard analysis [4] concludes that the overall risks for RA fall within the low and medium regions of 
risk acceptability. 
4.2.2 
Clinical Data 
RA uses Master Volume, Bass and Treble (MVBT) adjustments for fitting. Botros, Banna and 
Maruthurkkara (2013) showed that new MAPs created by adjusting the threshold of NRT profile using 
MVBT adjustments provided speech perception benefits that were not different from MAPs created 
using conventional fitting methods. Vroegop et al (2017) showed that when MAPs were adjusted by 
recipients in real world environments using MVBT, the patients’ SSQ-C scores showed significant 
improvement in perceived auditory functioning, while no significant changes in speech perception or 
acceptable noise measures (on average) were shown. 
Remote programming for CI recipients has been reported in several studies in the last decade. A 
literature review [5] on remote programming identified 13 high quality studies (in English) where the 
CI fitting software on a PC was controlled remotely via the internet in order to conduct fitting 
procedures similar to those carried out in a typical CI clinic.  
The literature review concluded that the range of networking software packages used to control the 
CI fitting software remotely and the audio-visual software used for communication have proved to be 
reasonably reliable with only occasional loss of connection or delays encountered. The studies report 
that remote programming provides equivalent listening benefits as compared with in-clinic 
appointments. Both clinicians and recipients have provided highly positive feedback on the 
experience of remote programming. Twelve out of 13 studies were conducted with a local facilitator in 
the same room as the patient to assist the patient during the session. Only one study (Slager et al. 
2019) reported remote sessions with and without use of a local facilitator.  
Remote Assist however is intended for conducting remote programming sessions without the help of 
a local facilitator and using the patient’s smartphone rather than via the software on a PC.  
A second literature review [6] was completed on Remote programming where patients were not 
accompanied by a clinician in the same room. Seven high or medium quality publications which 
reported on remote services where patients were not accompanied by a clinician in the same room 
were identified. The seven studies reported on remote services for a total of 210 adult patients, 33 
teenage patients and 13 health care professionals. Majority of the studies (6 out of 7) reported on 
hearing aid fitting. Only one article explicitly reported on the safety of the remote service: no device-
related nor procedure-related adverse events were encountered. Six out of seven studies reported on 
CI or hearing aid fitting via the patient’s computer, tablet or smartphone.  
Venkatesan and Carr (2019) and Schnittker (2019) connected the hearing aid to a tablet PC at the 
patient’s home to complete remote programming. They reported that the remote programming 
sessions could be completed successfully. Froehlich et al. (2020), Miller et al. (2020) and Sonne et 
al. (2019) reported that remote hearing aid fitting could be successfully conducted by connecting to 
the app on the patient’s smartphone. Slager et al. (2019) reported on the successful use of a tablet 
PC connected to the recipient’s sound processor for remote CI fitting. 
The second literature review showed that when remote programming was conducted without a local 
facilitator, patients’ subjective hearing abilities and the objectively measured speech perception 
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performance are similar between patients receiving remote versus in-office follow-up appointments. 
Overall, patients as well as clinicians were satisfied with remote services and feel comfortable using 
them. The publications highlight the importance of direct, face-to-face interaction to achieve high 
patient satisfaction and, in turn, successful fittings. The patient’s preference of remote over in-clinic 
appointments is highly driven by time savings (i.e., large distances to clinic). Similarly, clinicians 
believe that remote services would save time for themselves (i.e., scheduling efficiency). In addition, 
one publication demonstrated that remote services are attractive for teenagers and might increase 
their engagement in audiological services. 
No study was identified in both literature reviews where remote CI fitting was conducted via a 
smartphone App.  
 
4.3 
Study Rationale 
RA allows the clinician to perform select remote fitting activities including MVBT adjustments via the 
Nucleus Smart app running on a compatible smartphone. Previous studies detailed above have 
demonstrated that remote programming is effective and convenient, remote fitting of hearing aids 
using an app via the smart phone is feasible and effective. Other studies have demonstrated that 
MVBT is effective for making MAP adjustments. The combination of remote fitting via an app for CI 
fitting as offered by RA has not been evaluated before. The present study aims to evaluate the ease 
of use of Remote Assist for remote programming in real world environments.  
Actual use testing: RA allows the clinician to make select MAP and sound processor adjustments 
using CSPro over the internet via the NSA installed on the recipient’s smart phone. Both the clinician 
and the recipient are users of the system. One of the users, the clinician, makes MVBT changes to a 
MAP based on the response from the other user, the recipient. Thus, the use of RA is a unique 
situation where the interaction between the users affects how the product is used. Usability testing of 
a recipient using the app under simulated conditions alone does not expose the complexity involved 
when one user adaptively changes the next step based on the other user’s response. Actual use 
testing is particularly suited for the usability testing of systems where more than one user is involved 
in obtaining the desired outcome for example, programming hearing aids or cochlear implant 
systems. Additionally, RA is intended to be used by the clinician in the clinical environment while the 
recipient is in their home environment. Thus, in this case the effects of the environment add an 
additional layer of complexity that affects how the product would function. This study will be using an 
actual use testing process for usability testing of RA in real world environments. 
RA will be evaluated with recipients for the first time in this clinical study, and evaluations will be 
undertaken on developmental versions of the app, with features and updates progressively made 
available throughout the study period. This study aims to investigate the ease of use of these 
developmental versions as per (AAMI HE75, 2018).  
 
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A clinician will determine the eligibility of the recipient for RA based on their implant type, Sound 
Processor and MAP characteristics listed below. If a recipient is eligible, they can be enrolled for an 
RA Session in MCP. 
The RA feature will only be available within the Nucleus Smart App for those Cochlear recipients that 
have been enrolled by their clinician. 
The RA system is indicated for use for Cochlear™ recipients of the following compatible Cochlear™ 
implants using a CP1000 or CP1150 Sound Processor for   
• 
CI600 series (CI612, CI622 and CI632) 
• 
CI500 series (CI512, CI513, CI522 and CI532) 
• 
Freedom series (CI24RE (ST), CI24RE (CA), CI24RE (CS), CI24RE Hybrid L24 and CI422)  
• 
Nucleus 24 series (CI24M, CI24R (CA), CI24R (ST) and CI24R (CS)) 
• 
Nucleus 22 series 
• 
Double array (CI24M Double Array) 
• 
Auditory Brainstem implants (ABI24M) 
MVBT adjustment (a feature contained within RA)  is not supported for N22, N24, ABI or Double Array 
implants or for incompatible MAPs that have the following characteristics. 
• 
Non-monopolar MAPs (bipolar, common ground, variable mode) 
• 
No recent compliance measurement  
• 
One or more electrodes out of compliance. 
• 
Dynamic range of <10 CL 
• 
Hybrid mode enabled 
• 
Mixed pulse widths  
• 
Double channel MAPping 
• 
Pulse widths >100 usecs 
• 
10 or more electrodes turned off 
• 
Channel or electrode reordering 
The download page for the Nucleus Smart app and Custom Sound Pro 6.3 will state that the 
app/software is exclusively for use in a clinical investigation. The smartphones provided to the 
participants will be labelled with “exclusively for use in a clinical investigation”.  
The instructions for use of Remote Assist on iOS devices is provided in the Nucleus Smart App User 
Guide. 
 
 
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5.3 
Accessory Device Requirements 
Table 3: List of accessory devices that will be used in this investigation 
Device name 
Purpose 
Regulatory 
Approval status 
CP1000 programming cable  Cable needed to program the CP1000 sound 
processor 
Approved 
CP1150 programming cable  Cable needed to program the CP1150 sound 
processor 
Approved 
Cochlear™ Wired 
Programming pod  
Interface needed to program the sound processors 
Approved 
Cochlear™ Wireless 
Programming pod 
Interface needed to program the sound processors 
Approved 
CP1000 (Nucleus 7) Sound 
processor  
Used by recipient to hear the clinician and to receive 
select updates to their MAP or processor settings 
Approved hardware 
and firmware 
CP1150 (Kanso 2) Sound 
processor  
Used by recipient to hear the clinician and to receive 
select updates to their MAP or processor settings 
Approved hardware 
and firmware 
Android / iOS smart phones 
To run the Nucleus Smart app  
Not a medical device 
 
6 OBJECTIVES 
6.1 
Primary Objective  
To confirm the ease of use and user experience of Remote Assist when used in real world 
conditions. 
6.2 
Secondary Objective 
There are no secondary objectives. 
6.3 
Exploratory Objectives 
• 
Characterise the ability of the subject to understand the clinician via the video call. 
• 
Characterise the time taken for RA to make changes to the MAP over the internet in real 
world conditions. 
7 DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
This is an actual use usability, prospective, adaptive design, single-centre, non-randomised, open-
label, single arm, non-controlled, pre-market clinical investigation in adults using Nucleus cochlear 
implants.  
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The subjects include adults aged 18 years or above who are currently using a Nucleus cochlear 
implant. Subjects will be screened, and 15 eligible subjects will be enrolled in the clinical 
investigation. Eligible subjects will be asked to use the IMD with the help of the inbuilt instructions in 
the IMD.   
After the first visit, subjects will attend scheduled study visits over a six-month study period to be 
assessed as described in the CIP Schedule of Events (Section 3). At study visits, subjects will 
undergo usability assessments and safety assessments. Participants will use the IMD only during the 
study sessions and will be asked to use their own devices at other times.  
The primary outcome measure is to determine the proportion of subjects who, while using the final 
version of Remote Assist, can complete the primary tasks, as assessed by the investigator / observer 
using a usability rating scale. Safety will be assessed by recording and summarising all AEs/ADEs 
and DDs. No data monitoring committee will be used for this clinical investigation. 
 
7.1.1 
Design Rationale 
• 
An actual use study design is used so that the end to end workflow and user acceptance of 
the product can be further evaluated in a variety of internet / device configurations under real 
world conditions. 
• 
The study includes only adults so that they can provide reliable feedback as to the ease of 
use of the RA system.  
• 
Only Cochlear implant recipients implanted with the CI500 series, CI600 series or Freedom 
series cochlear implants in one or both ears are included as the RA system only supports 
these cochlear implants for MVBT adjustments. 
• 
The hearing ability and the MAPs undergo significant changes in the first three months after 
implantation. Thus, cochlear implants recipients with at least 3 months experience with their 
cochlear implant will be enrolled so that any changes in their hearing function do not act as 
confounding variables. 
• 
Only subjects willing and able to provide written informed consent will be enrolled to be 
compliant with ISO 14155. 
• 
Investigator site personnel directly affiliated with this study and/or their immediate families; 
immediate family is defined as a spouse, parent, child, or sibling or Cochlear employees or 
employees of Contract Research Organizations or contractors engaged by Cochlear for the 
purposes of this investigation will be excluded to avoid enrollment of a vulnerable population. 
• 
Since the study involves only acute testing and does not require continued use of the IDE 
during take home use, participation in previous acute testing studies may not impact its 
results. 
 
Adaptive procedure: 
The IMD used in the study has been fully verified by bench testing to ensure safe and effective use 
with cochlear implant recipients. Any new versions of the IMD will be fully verified by bench testing 
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7.2.1 
Inclusion Criteria 
Subjects must meet all the inclusion criteria described below to be eligible for this clinical 
investigation. 
1) Adults (≥18 years). 
2) Implanted with the CI500 series (CI512, CI513, CI522, CI532,), CI600 series (CI612, 
CI622, CI632), Freedom series cochlear implants (CI24RE (ST), CI24RE (CA), CI24RE 
(CS), CI422) in one or both ears. 
3) At least 3 months experience with the cochlear implant. 
4) Willing and able to provide written informed consent. 
7.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical 
investigation. 
1) Unable or unwilling to comply with the requirements of the clinical investigation as 
determined by the Investigator. 
2) Investigator site personnel directly affiliated with this study and/or their immediate 
families; immediate family is defined as a spouse, parent, child, or sibling. 
3) Cochlear employees or employees of Contract Research Organizations or contractors 
engaged by Cochlear for the purposes of this investigation.  
4) Currently participating or participated in another interventional clinical study/trial in the 
past 30 days, or if less than 30 days the prior investigation was Cochlear sponsored and 
determined by the investigator to not impact clinical findings of this investigation. 
5) Prior exposure to Remote Assist concept during previous usability testing. 
7.2.3 
Number of Subjects Required 
Fifteen subjects will be enrolled in the study to meet sample size calculation requirements stated in 
section 9.4 with the expected dropout rate (10%). 
7.2.4 
Vulnerable Populations 
Not applicable for the current clinical investigation. 
7.2.5 
Recruitment & Study Duration 
The following subject status definitions apply: 
• 
Enrolled: A subject that has a signed the Informed Consent form for the study.  
• 
Screen Fail: An Enrolled subject that has been determined to not meet one or more eligibility 
criteria. 
• 
Participated: Subjects who have met eligibility criteria and have commenced visit 1 procedures. 
• 
Withdrawn: An Enrolled subject who withdrew or was withdrawn by the Investigator or Sponsor 
before the expected End of Study visit. Withdrawn subjects may still continue in safety follow up 
until their scheduled End of Study visit, for reasons described in section 7.2.6. 
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• 
Completed: Enrolled subjects who complete the required treatment and visit schedule.  
The recruitment period for the clinical investigation is estimated to be up to 8 months from the time of 
first subject consent to recruitment of the last subject. This is to allow the replacement of any subjects 
who withdraw from the study. 
The expected duration of each subject’s participation in the clinical investigation is up to 6 months 
from the time of informed consent through to the End of Study when devices are returned. This is to 
allow testing of new device iterations as per the adaptive procedure described in section 7.1.1. 
The anticipated total duration of the clinical investigation is therefore 8 months. 
Clinical Investigation completion is last subject last visit (a take-home session is also considered as a 
visit).  
7.2.6 
Criteria for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the 
reason(s), however the subject is under no obligation to give a reason for wanting to withdraw. The 
reason for withdrawal should be documented in the subject’s source files and the case report form 
(CRF). 
The Investigator or Sponsor may also decide to withdraw a subject from the clinical investigation if it 
is considered to be in the subject’s best interests. 
Subject withdrawal may be for any of the following reasons: 
• 
Adverse Event (AE) 
• 
Device Deficiency (DD) 
• 
CIP or GCP deviation 
• 
Subject withdrew consent 
• 
Subject lost to follow-up 
• 
Subject death 
• 
Sponsor decision 
• 
Investigator decision 
• 
Other (specify) 
If subject withdrawal is due to problems related to the IMD safety or performance, the Investigator 
shall ask for the subject's permission to continue in safety follow up (i.e., adverse events) until their 
scheduled End-of-Study visit. 
If a subject is lost to follow-up, every possible effort must be made by the study site personnel to 
contact the subject and determine the reason for discontinuation. At least 3 separate attempts taken 
to contact the subject must be documented. 
Participating subjects who are withdrawn/discontinued will be replaced.  
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7.2.7 
Randomisation Procedures 
Not applicable 
7.2.7.1 
Blinding Procedures 
As the objective of this study is to evaluate the ease of use of the IMD, blinding is not feasible for the 
clinical investigation and this is unlikely to affect the study results. 
7.2.8 
Post-investigation Medical Care 
As this clinical investigation is non-surgical in nature, no specific medical care will be provided for the 
subjects after the clinical investigation has been completed. Subjects will return to their routine 
clinical management at their local Cochlear Implant clinic after the final study visit. Subjects will use a 
loan CP1000 or CP1150 sound processor for the duration of the study.  All clinical study devices will 
be returned at the end of the study. Subjects will return to use of their own sound processor and 
smartphone at the end of the clinical investigation.  
7.3 
Performance Evaluations and Procedures 
The following procedures will be followed in this study. Table 1 in section 3 shows the schedule of 
events planned in the study.  
Recruitment: Cochlear implant recipients will be identified by review of clinic records based on the 
eligibility criteria in section 7.2. The potential participants will be invited to the study and will be 
provided the informed consent form (ICF). Potential participants who are willing to participate in the 
study based on reading the ICF will be invited to attend a session at the study site. 
Written informed consent: Prior to enrolment, potential study participant will be issued an ICF and 
the study information will be explained in full by the investigator, after which the recipient-participant 
can decide whether they consent to inclusion in the study or not. Informed consent will be obtained 
as per section 10 in this document. 
Eligibility: After the consent form has been signed the investigator will record the eligibility of the 
potential participant to confirm their enrolment to the study. 
Demographics, hearing history, device history and medical history: After the participant has 
been enrolled into the study, participant demographic information, hearing history, device history will 
be collected from the participant. Any additional information that cannot be obtained from the 
participant will be obtained from the participant’s CI clinic as necessary. The participants’ own 
processor will be connected to the commercially available Custom Sound fitting software and the 
participants’ MAP will be saved to the site’s database. 
CP1000 / CP1150 fitting: The participant will be fitted with a loaner CP1000 or CP1150 sound 
processor using the MAP, program and processor settings used in their own processor. Where 
necessary update to the MAP, programs or processor settings will be made based on feedback from 
the recipient. CSPro software will be used by the investigator for creating a ‘soft’ MAP with 
perceivable sound quality issues, for example, reduced overall loudness or with low or high 
frequency sounds. The soft MAP along with the participant’s own MAPs will be loaded to a loaner 
sound processor prior to each remote programming session.  
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Usability evaluation: RA is designed to be easy to use for a cochlear implant recipient even if they 
have no prior experience in using the Nucleus Smart App. Since RA is a new feature, participants are 
expected to have no prior experience of using RA. No training will be provided to the participants on 
the use of the app; however, they will have the ability to access the guidance inbuilt in the app and 
user guide. The participants will be asked to complete the tasks within RA. The investigator will 
facilitate the session and observer(s) will record any use problems as per summative usability test 
methods. The observer will rate the participant’s ability to complete the primary tasks in Table 6 using 
the rating scale in Figure 3. The participant will be interviewed at the end of the session to assess 
their satisfaction. The usability ratings, observations and the log files will be analysed across to 
assess the learnability, efficiency, memorability, use errors and satisfaction as described in Table 5.  
 
1 
2 
3 
4 
5 
Unable to complete 
Completed after 
using help 
document 
Completed after 
trying an incorrect 
option 
Completed after 
some exploration 
Completed in first 
attempt 
Figure 3: Usability ranking scale 
In-clinic remote programming session: Within the clinic, the investigator will be in one room and 
the participant will be in another room. An Observer may be present with the participant to make 
observations. The investigator will present live speech using the participants own MAP through the 
video call function of RA to assess the ease with which participants can understand speech via the 
video call. The investigator will use the MVBT controls in RA to adjust the soft MAP to resolve sound 
quality issues. The investigator will assess the adjusted soft MAP using speech sounds and a range 
of real-world noise sources in the participant’s environment to test the acceptability of changes to the 
soft MAP. The participant will be asked to provide feedback on the sound quality of the adjusted soft 
MAP. Video recording of the session will be done to measure the response times and any use 
problems. 
Custom Sound Pro: After the in-clinic remote programming the adjusted soft MAP from the sound 
processor will be read and saved in CSPro. Feedback on the adjusted MAPs will be gathered. 
Table 5: Usability dimensions to be assessed 
Dimension 
Definition 
Metric 
Learnability 
How easy is it for users to accomplish 
basic tasks the first time they encounter 
the design? 
Task completion will be ranked, and the use 
errors/issues observed will be recorded when 
software is used by participants with no prior 
experience in using the app. 
Efficiency 
Once users have learned the design, 
how quickly can they perform tasks? 
Time taken to complete the tasks in the app will 
be recorded when app is used by participants for 
the second time. 
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Dimension 
Definition 
Metric 
Memorability 
When users return to the design after a 
period of not using it, how easily can 
they re-establish proficiency? 
Task completion will be ranked, and the use 
errors/issues observed will be recorded when 
app is used by participants for the second time. 
Errors 
How many errors do users make, how 
severe are these errors, and how easily 
can they recover from the errors? 
Observation and video analysis of participants 
using the app. 
Close Calls 
How many cases in which a user almost 
commits an error, or does commit an 
error, but detects it and corrects it? 
Observation and video analysis of participants 
using the app. 
Difficulty 
How many cases in which a user 
struggles to perform a task? 
Observation and video analysis of participants 
using the app. 
Satisfaction 
How satisfied are users with the design? 
The participant’s satisfaction rating will be 
obtained in an interview with the participant. 
 
Take-home remote programming session: The investigator will be remote and the participant will 
be outside the clinic environment, such as their home environment. The investigator will present live 
speech using the participants own MAP through the video call function of RA to assess the ease with 
which participants can understand speech via the video call. The participant will be asked to use their 
own processor during the take home period outside the programming session. During the take home 
session, the study devices will be used. The investigator will use the MVBT controls in RA to adjust 
the soft MAP to resolve sound quality issues in the participant’s soft MAP. The investigator will 
assess the adjusted soft MAP using speech sounds and a range of real-world noise sources in the 
participant’s environment to test the acceptability of changes to the soft MAP. The participant will be 
asked to provide feedback on the sound quality of the adjusted soft MAP. Video recording of the 
session will be done to measure the response times and any use errors. 
Questionnaire: Feedback will be gathered from participants about their experience of the RA 
session with a questionnaire.  
Troubleshooting / issues analysis: If the participant experiences issues with the app during take 
home use, they will be asked to attend a follow up visit to troubleshoot issues or gather greater 
details of the issues.  
Adaptive Procedure: The study will use an adaptive procedure Section 7.1.1 provides details of the 
adaptive procedure used. 
Return devices: After take home RA session if no issues are identified then the study subject will be 
asked to return the IMD to the study site either by courier or visiting the site. The data generated in 
the app during take home RA session will be collected from the returned devices. 
 
 
 
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Table 6: Primary tasks in a Remote Assist session 
Screen 
Primary Tasks 
Acceptance criteria 
Additional areas of 
interest 
Burger menu 
Start Remote Assist 
User can start Remote 
Assist session 
- 
Remote Assist 
Start Screen 
Grant Remote Assist 
Permissions 
User successfully grants 
Remote Assist permissions 
- 
Connection 
screen 
Connect to clinician 
User successfully enables 
audio/visual connection 
- 
Video call 
Position phone camera 
User positions the phone 
optimally for the video call  
Types of positions 
phone held during the 
session 
Video call 
Use reverse camera 
User successfully uses 
reverse camera 
Ability to show the 
sound processor using 
reverse camera 
Video call 
Mute microphone 
User successfully mutes 
microphone 
- 
Video call 
Turn off camera 
User successfully turns off 
camera 
Ability to understand 
with camera turned off 
Chat 
Use Chat 
User successfully uses the 
chat function 
Number of errors made 
in the chat 
Interruption 
Resume session after an 
interruption by a phone 
call 
User successfully resumes 
session after an interruption 
by a phone call 
- 
Interruption 
Resume session after an 
interruption due to 
processor disconnection 
User successfully resumes 
session after an interruption 
due to processor 
disconnection 
- 
Interruption 
Resume session after an 
interruption due to 
internet disconnection 
User successfully resumes 
session after an interruption 
due to internet 
disconnection 
Ability to evaluate 
internet connection 
and/or quality of internet 
connection 
Fitting 
Provide feedback for 
fitting 
User is able to provide 
feedback to clinician for 
fitting.  
- 
Fitting 
Test the sound with real 
world sounds 
User is able to test the 
hearing with real world 
sounds. 
- 
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Screen 
Primary Tasks 
Acceptance criteria 
Additional areas of 
interest 
Disconnect 
Disconnect from Remote 
Assist Session  
User successfully 
disconnects from Remote 
Assist session 
- 
 
Procedural mitigation relating to COVID-19 
Due to the physical distancing restrictions in place during the COVID-19 pandemic, optional device 
programming and procedural provisions may be introduced. These measures are to support the 
continuation of this project, while ensuring the safety of subjects and study staff. 
• 
Screening and consent: See section 10 for the consent process. If COVID-19 restrictions also 
restrict research candidates from attending the study site, screening and consent may be 
performed via phone call or video conference. Paper copies of the consent form will be 
provided via mail/courier and subjects will be asked to use a prepaid envelope to return 
original signed copies. 
• 
Study devices: Subjects may be asked to commence take-home testing through remote 
management. Devices, accessories, questionnaires, and instructions may be sent to subjects 
via courier, so that they do not need to attend the clinic. Prior to shipping, the loaner study 
sound processor(s) will be prepared as per the steps detailed above in “CP1000 / CP1150 
fitting” section. If a subject’s most recent MAP(s) are not retrievable either from the site’s 
database or the subject’s clinical audiologist, remote management will not be possible until 
they are able to attend the site to have their own processor(s) connected to the software.  
• 
Study procedures: Only the procedures listed under “take-home remote programming 
session” will be conducted. For subjects who do not wish to participate in remote study and 
device management, the device programming and fitting will be performed in clinic once 
restrictions in New South Wales allow in-clinic visits. 
7.4 
Safety Evaluations and Procedures 
The risks and anticipated ADEs for the IMD, as identified in Section 8.3 of the CIP, will be assessed 
in the clinical investigation via reporting of all AEs/ADEs from the time of first subject first visit until 
last subject last visit. 
Safety data adjudication may be conducted by the Sponsor’s Medical Officer in accordance with the 
Sponsor’s standard operating procedures. 
7.4.1 
Concomitant Medication and Therapies 
Not applicable for this clinical investigation. 
7.5 
Equipment Used for Evaluation of Performance and Safety 
No additional equipment apart from IMD and the accessory devices described in Section 5 will be 
used in this clinical investigation. 
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7.6 
Sponsor Role in Conduct of the Clinical Investigation 
Prior to commercially launching new technology, Cochlear conduct both pre-clinical and clinical 
testing to ensure the products meet quality and performance specifications. New product technology 
may include the implanted device, the external sound processor, fitting software, or other devices 
such as smart phone applications or wireless accessories that enable remote control and streaming 
of the sound directly to the cochlear implant. Clinical Investigations are planned when performance 
and/or safety evidence requirements require human use. This clinical investigation will be conducted 
by an internal site. Internal sites are clinical research facilities owned and operated by Cochlear. 
Cochlear has the following processes to mitigate the potential conflicts of interest that may arise with 
the use of internal sites: 
 
• 
Standard Operating Procedures to manage the separation of Investigator and Sponsor 
activities as well as ensuring compliance with Good Clinical Practice and all applicable 
regulations. 
• 
Secure separation of Investigators’ trial materials and testing rooms (Audiology Suite) from 
Sponsor facilities and other employees. The research facility is restricted to limited personnel.  
• 
Electronic data capture is restricted by user roles to control access to data entry/correction, 
source data verification, data sign off, and reporting functionalities. 
• 
Centralised review of safety events to provide independence in oversight. 
• 
Cochlear Investigators are qualified by education and experience in cochlear implant 
technology and clinical programming. 
• 
Monitoring roles performed by individuals who are not also investigators or other delegated 
site personnel on the same clinical investigation. 
• 
Joint Cochlear Site and Sponsor roles not permitted if the clinical investigation design 
involves double-blinding of randomised treatment or testing assignment. 
 
Activities to be performed by sponsor representative excluding monitoring include: 
1. Application of clinical quality assurance and quality control principles to the processes of the 
clinical investigation  
a. Implement and maintain written clinical quality procedures to ensure the clinical 
investigation is designed, conducted and that data generated is compliant with the ISO 
14155:2011 Standard(ISO, 2011).  
b. Clinical quality assurance and quality control will be implemented according to 
sponsors quality system (Cochlear Quality Manual reference [7]) 
2. Clinical investigation planning and conduct 
a. Selection of clinical personnel for project management of the clinical investigation 
b. Preparation of documents and materials for the clinical investigation 
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c. Project management for the clinical investigation. i.e. accountability of investigational 
devices, clinical trial insurance coverage, submission of application(s) and 
investigation updates to the appropriate regulatory authority(ies). 
3. Safety evaluation and reporting of adverse events (AE) to the TGA and ethics committee  
4. Clinical investigation close-out, statistical analyses, and final report 
 
8 RISKS AND BENEFITS OF THE INVESTIGATIONAL MEDICAL DEVICE AND 
CLINICAL INVESTIGATION 
8.1 
Anticipated Clinical Benefits  
There are no additional anticipated clinical benefits to using the IMD. 
This study provides subjects with the opportunity to trial a new cochlear implant CP1000 or CP1150 
sound processor and related components (Nucleus 7 system) if they don’t already own these 
features, and the new RA prior to the commercial release date. Subjects may benefit from improved 
usability and performance of the different components of the Nucleus 7 system, there is no expected 
benefit of using RA in the study environment. 
8.2 
Anticipated Adverse Device Effects 
The CP1000 and CP1150 Sound Processors and Nucleus Smart App are approved products. 
Product specific warnings can be found in the CP1000 and CP1150 Sound Processor User Guides 
[8] and [9].   
The Nucleus Smart app with the addition of RA allows MVBT adjustments to be done remotely. 
There is a low risk that participants may hear a sound that is uncomfortably loud during programming 
with RA. 
8.3 
Risks Associated with Participation in the Clinical Investigation 
• 
Exposure to soft MAP temporarily during the adjustments 
• 
Possible exposure to sound that is uncomfortable or loud during fitting of the sound processor 
or streaming from the smartphone. 
• 
Possible interactions with concomitant medications and residual risks for the device are not 
anticipated in this clinical investigation. 
• 
Possible increased risk of exposure to infectious diseases, for example COVID-19, due to 
need to visit the study site that is outside their normal routine.  
8.4 
Risk Mitigation 
• 
The fitting and use of the sound processor will be supervised by the investigator at the start of 
the study. In addition, recipients will be encouraged to inform the investigator whether the 
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sound processor provides any physical discomfort or produces sounds that are 
uncomfortable. Stimulation will be immediately ceased. 
• 
Recipients will be counselled to remove the sound processor off their head if any 
uncomfortable sound occurs. Subjects will maintain access to their own sound processors 
and programs during the course of the study.  
• 
All reported ADEs and DDs will be regularly reviewed by the Sponsor’s Clinical review Board 
for the duration of the study to facilitate early detection and appropriate intervention if events 
are unanticipated with respect to incidence, severity, or outcome. 
 
It is expected that study participants will be taking steps to limit exposure to infectious diseases, for 
example, COVID-19. The site will actively follow the advice of official health authorities and 
governments to ensure the health and wellbeing of site employees and research subjects. These 
include but are not limited to:  
• 
Cochlear headquarters has implemented procedures to enable contact tracing for all 
employees and visitors, as well as processes to scale up, scale down and/or deep clean 
should there be a confirmed positive case of coronavirus on the premises. 
• 
The research site is separated physically, enabling separation of study participants from other 
employees working in the building during study sessions.  
• 
Increased hygiene etiquette including cleaning of high-touch surfaces before and after each 
study visit, disinfection of any shared study devices or equipment and investigators are 
equipped to use gloves or wear a face mask upon request. Hygiene resources such as 
handwashing/rubbing stations are readily available throughout the building and research site. 
• 
There is adequate signage to communicate onsite hygiene requirements throughout 
the building. 
• 
Where possible, study participants will be encouraged to drive to Cochlear and utilize 
the free on-site parking instead of travelling via public transport. 
• 
All visitors to Cochlear headquarters are to declare their health status via a written 
declaration on arrival at the site. The declaration must state the subject is well and 
COVID-19 symptom free and have not been in contact with a known or suspected 
case of COVID-19 in the 14 days prior to access to the building. 
• 
Subjects will be provided with any necessary resources required to return study devices to the 
site, should they be unable to attend any of the scheduled visits. For example, couriers or 
postage may be arranged as necessary. 
8.5 
Risk-to-Benefit Rationale 
The Nucleus 7 sound processor Clinical Evaluation Report (CER) [10] states that all hazards 
associated with the Nucleus Smart App have been classified as having “Low” or “Medium” residual 
risk of harm. The CER concludes that the clinical safety (risks) and performance benefit of devices 
relevant to anticipated performance of the Nucleus 7 sound processor including the Remote Assist 
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functionality on iOS devices have been evaluated, and the data demonstrate that the device has a 
favourable safety profile and is effective.  The Cochlear-Sponsored clinical investigations and 
systematic literature review, coupled with the design verification/validation and post-market 
surveillance data, establish that the benefits of the device outweigh the risks. 
Participants will only use the IMD only during the study sessions and will be asked to use their own 
devices at other times. 
The Remote Assist system Hazards Analysis report [4] concludes that the overall risks for RA fall 
within the low and medium regions of risk acceptability. The post market surveillance monitoring will 
continue throughout the lifecycle of Remote Assist in accordance with the Product Risk Management 
Procedure [1]. Any new or increased risks will be managed in accordance Product Risk Management 
Procedure [1]. 
9 STATISTICAL CONSIDERATIONS 
9.1 
General Considerations 
The summary of primary and exploratory outcome measures will be descriptive providing summary 
statistics reflecting the outcome measures as appropriate. Means, standard deviations, ranges will be 
reported for continuous variables. Numbers, percentages, and totals will be reported for binary or 
ordinal variables. Missing data will not be imputed. Demographic and safety data will be summarised 
descriptively.  
Pass / fail criteria: The investigator or observer will rate the participant’s ability to complete the 
primary tasks listed in Table 6 using the rating scale in Figure 3. If the participant is unable to 
complete the task (rating 1, unable to complete) in the final version of Remote Assist then it will be 
considered as a fail.  
9.2 
Outcome measures 
9.2.1 
Primary Outcome measure 
Proportion of subjects who, while using the final version of Remote Assist, are able to complete the 
primary tasks determined by an observer using a rating scale.  
9.2.2 
Secondary Outcome measures 
There is no secondary outcome measure. 
9.2.3 
Exploratory Outcome measures 
• 
The median rating on the ability to understand the clinician via the RA video call. 
• 
The median time taken for RA to make changes to the MAP over the internet. 
9.3 
Hypotheses 
No formal testable hypotheses are applicable. 
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9.3.1 
Primary Hypothesis 
No formal testable hypotheses are applicable. 
9.3.2 
Secondary Hypothesis 
No formal testable hypotheses are applicable. 
9.3.3 
Exploratory Hypothesis 
No formal testable hypotheses are applicable. 
 
9.4 
Sample Size Determination 
The primary outcome measure of this study is the proportion of subjects who, while using the final 
version of Remote Assist, are able to complete the primary tasks.  
Observations will be used to determine the participant’s ability to complete the tasks. Different 
versions of the IMD will be used in an adaptive procedure to assess the usability and to make 
incremental changes in the IMD.  This actual use study will be conducted as per summative usability 
test standards. 
A minimum of 15 test participants will be used for this study. As per standard HE75:2009(R2018) 
Human Factors Engineering – Design of Medical Devices (AAMI HE75, 2018) and Applying Human 
Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug 
Administration Staff (UCM259760, 2016), a minimum of 15 test participants per user group is 
recommended for summative evaluation testing.  
9.5 
Analysis Populations 
Full analysis set is generally recommended over per protocol set analysis for randomised controlled 
studies with multiple arms (Ranganathan, Pramesh, & Aggarwal, 2016) As this study does not 
involve randomisation and any subjects who withdraw will be replaced, per protocol set analysis is 
appropriate for this study. Primary and exploratory analysis will be completed with per protocol set 
data. If a participant withdraws after completion of the primary outcome measure but not the 
exploratory outcome measure, their data will be included in the analysis. Safety analysis will be 
completed with the full analysis set data to ensure that all safety issues are taken into consideration. 
9.6 
Primary Outcome measure Analyses 
Proportion of subjects who, while using the final version of Remote Assist, are able to complete the 
primary tasks as per the pass/fail criteria will be described using descriptive statistics. 
9.7 
Secondary Outcome measure Analyses 
Not applicable for this clinical investigation 
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9.8 
Exploratory Outcome measure Analyses 
The rating on the ability to understand the clinician via the RA video call  will be described using 
descriptive statistics. 
The time taken for RA to make changes to the MAP over the internet will be described using descriptive 
statistics. 
 
9.9 
Safety Analyses 
For AE/ADEs and DDs, the percentage of subjects who experienced at least one occurrence of each, 
will be summarised. Any subjects who discontinued an intervention due to an AE/ADEs, or who 
experienced a severe or an SAE/SADEs will be summarised separately. 
9.10 Interim Analyses 
The usability observations and feedback will be analysed on an ongoing basis and these will be used 
to improve the product.  No formal interim analysis is planned for the usability ratings. 
10 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject using an approved ICF prior 
to any clinical investigation-related examination or activity. The rationale of the clinical investigation, 
as well as the risks and benefits, what participation will involve, and alternatives to participation will 
be explained to the subject. Ample time will be provided for the subject to enquire about details of the 
clinical investigation and to decide whether to participate. 
All questions about the clinical investigation shall be answered to the satisfaction of the subject or the 
subject’s legally acceptable representative. Subjects shall not be coerced or unduly influenced to 
participate or to continue to participate in a clinical investigation. 
Each subject (or their legally authorised representative) and the person who conducted the informed 
consent discussion, shall sign and date the Informed Consent Form (ICF). Where required, a witness 
shall sign and personally date the ICF. A copy of the signed ICF shall be given to the subject. The 
original signed ICF shall be archived in the Investigator’s Site File or subject file at the investigational 
site. 
The subject, or the subject’s legally authorised representative, shall be informed in a timely manner if 
new information becomes available that may be relevant to the subject’s willingness to continue 
participation in the clinical investigation. The communication of this information must be documented 
as an update to the ICF and re-consent of the subject. 
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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 related to the medical device or the procedures required for implant or use. 
NOTE 1: This definition includes events related to the medical device or the comparator device. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users and other persons, this definition is restricted to events related to medical 
devices. 
11.1.2 Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of a medical device. 
NOTE 1: This includes any AE resulting from insufficiencies or inadequacies in the instructions for 
use, the deployment, the implantation, the installation, the operation, or any malfunction of the 
medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the 
medical device. 
11.1.3 Serious Adverse Event 
A serious adverse event (SAE) is any AE that: 
1) led to a death,  
2) led to a serious deterioration in the health of the subject that either resulted in: 
• a life-threatening illness or injury, or 
• a permanent impairment of, or damage to, a body structure or a body function, or 
• in-patient hospitalisation or prolonged hospitalisation, or 
• medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment or damage to a body structure or a body function, or 
• Chronic disease. 
3) led to foetal distress, foetal death or a congenital physical or mental abnormality, or birth 
defect 
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a SAE. 
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11.1.4 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an ADE that has resulted in any of the consequences 
characteristic of a SAE. 
11.1.5 Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is a SADE, which by its nature, incidence, 
severity, or outcome has not been identified in the current version of the hazards analysis [4].  
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, 
severity, or outcome has been identified in the hazards analysis [4]. 
11.1.6 Adverse Events of Special Interest 
Not applicable for the current clinical investigation. 
11.1.7 Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. 
NOTE: Device Deficiencies include malfunctions, use errors, and inadequate labelling or information 
supplied by the manufacturer. 
11.2 Recording and Handling of Adverse Events 
Subjects shall be carefully monitored during the clinical investigation and the investigator should 
enquire about AEs at investigation visits.  
All AEs will be recorded from the time of first use of the IMD. AE recording will continue for each 
subject until completion of their End of Study visit. Ongoing SAEs and SADEs will be followed for 30 
days, or until resolution or stabilisation of the event, whichever comes first. 
Source notes should indicate the evaluation for AEs, even if none to report. All required AEs will be 
reported if observed, even if anticipated and/or acknowledged as a risk factor in the consent. 
All AEs will have the following information documented: start and stop dates, action taken, outcome, 
severity, and investigators opinion on the potential relationship to the IMD and study procedures. If 
an AE changes in severity, the most severe (highest) grade will be captured for that event on the 
Adverse Events CRF. 
11.2.1 Assessment of Severity 
The Principal Investigator (or qualified delegate) will make an assessment of severity for each event 
based on clinical judgement.  The intensity of each event recorded in the CRF should be assigned to 
one of the following categories: 
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11.3 Recording and Handling of Device Deficiencies 
Subjects shall be carefully monitored during the clinical investigation and routinely questioned about 
DDs at investigation visits. Source notes should indicate the evaluation for DDs, even if none to 
report. 
The Investigator shall assess if the DD led to an AE or could have led to a serious medical 
occurrence (serious adverse device effect) if; 
a) suitable action had not been taken,  
b) intervention had not been made, or, 
c) circumstances had been less fortunate 
All DDs will be documented in the source notes and the DD page of the CRF.   
11.4 Reporting Responsibilities 
The Investigator is responsible for reporting all AEs and DDs in the CRF.   
11.4.1 Investigator Reporting of Serious Adverse Events 
All AEs meeting the criteria for an SAE, or DD that could have led to an SADE, must be reported to 
the Sponsor by five working days. 
Reporting is achieved through completion of the events details in the Adverse Event page of the 
eCRF 
The Investigator shall always provide an assessment of causality at the time of the initial report, as 
described in section 11.2.2 ‘Assessment of Causality’. If data obtained after reporting indicates that 
the assessment of causality is incorrect, then the SAE form may be appropriately amended, signed, 
dated, and resubmitted to the Sponsor. 
If the Investigator does not have all other information regarding an SAE, he/she will not wait to 
receive additional information before reporting the event.  The reporting forms shall be updated when 
additional information is received. 
The Investigator is responsible for reporting of safety events to their local EC using the applicable 
report form, in accordance with local regulations. 
11.4.2 Sponsor Notification of Events 
The Sponsor is responsible for reviewing all safety data to evaluate potential causality and 
anticipation of all ADEs. 
The Sponsor is also responsible for reporting all reportable events according to the requirements and 
timelines of the regulatory authorities relevant to this clinical investigation, and shall conduct an 
expedited assessment of all SAEs, unanticipated ADEs, DDs that could have led to an SADE. 
The Safety Monitor for AE/DD assessment and any AE/DD related queries is: 
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If there is a deviation from CIP-defined assessments or parts thereof are omitted or completed 
incorrectly, the deviation will also be documented by the site personnel in the source documentation 
for the subject. Depending on the type or severity of the deviation the Investigator may be required to 
notify the EC, particularly if the deviation potentially impacts subject safety, performance of IMD, or 
data integrity. 
All CIP deviations will be documented in the eCRF to enable analysis and reporting by the Sponsor in 
the Clinical Investigation Report (CIR), or to the relevant regulatory authority(s), if applicable. 
Gross misconduct on behalf of an Investigator, such as intentional non-compliance with CIP or GCP 
requirements or fraud, will result in disqualification of the Principal Investigator and/or Investigational 
Site from participation in the investigation. Data provided by the Principal Investigator or 
Investigational Site will be excluded from the per-protocol analysis group. 
14 DATA MANAGEMENT 
The CRF will capture the datapoints necessary to determine the subject status according to the 
criteria described in section 7.2.5. 
Source data will be captured in clinic notes, paper-based source data worksheets, or printed directly 
from testing software. If electronic medical records do not permit read only access for monitoring 
purposes, a certified printout must be provided. 
Data collection for demographics, device exposure, adverse events, device deficiencies, protocol 
deviations and completion will be performed using Medidata Rave for electronic data capture (EDC) 
on electronic Case Report Forms (Medidata Safety eCRF), to support safety analysis and reporting. 
All other data will be collected from clinical fitting software, and captured into Nucleus Smart App. 
Unamended data files shall be regarded as the source. 
Site personnel will be trained on the completion of the Medidata Safety eCRF 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. 
 
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15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance 
with governing data privacy regulations. 
Data will be reported to the Sponsor on CRFs or related documents (for example, questionnaires). 
Subjects will be identified on CRFs and other related documents only by a unique subject 
identification code and shall not include the subject’s name or other personal identifiable information. 
Completed CRFs or related documents are confidential and will only be available to the Investigator 
and site staff, the Sponsor and their representatives, and if requested to the Ethics Committee and 
national regulatory authorities. Publications or submission to a regulatory authority shall not disclose 
the identity of any subject. 
16 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
The clinical investigation will not commence prior to the written favourable opinion or approval from 
the EC and or regulatory authority (if appropriate) is obtained. 
The final Sponsor-approved version of the CIP, Informed Consent Form, and other necessary 
documents shall be submitted to the EC. A copy of the EC opinion/approval shall be provided to the 
Sponsor. 
The Investigator shall forward to the Sponsor, for review and approval, any amendment made to the 
approved ICF and any other written information to be provided to the subject prior to submission to 
the EC. 
The Sponsor and Principal Investigator will continue communications with the EC, as required by 
national regulations, the clinical investigational plan, or the responsible regulatory authority. 
Any additional requirements imposed by the EC or regulatory authority will be implemented by the 
Sponsor. 
The Investigator shall submit the appropriate documentation if any extension or renewal of the EC 
approval is required.  In particular, substantial amendments to the CIP, the ICF, or other written 
information provided to subjects will be approved in writing by the EC. 
The Investigator shall report to the EC any new information that may affect the safety of the subjects 
or the conduct of the clinical investigation. The Investigator will send written status summaries of the 
investigation to the EC regularly, as per local EC requirements. 
Upon completion of the clinical investigation, the Investigator shall provide the EC with a brief report 
of the outcome of the clinical investigation, as per local EC requirements. 
The clinical investigation is covered by clinical trial insurance, meeting the requirements of the 
participating countries. 
17 SUSPENSION OR PREMATURE TERMINATION 
The Sponsor will discontinue the clinical investigation site if: 
1) major non-adherence to the CIP or GCP principles is occurring 
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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 (ECs) by the Principal Investigators 
(and to the relevant regulatory authority(s) by the Sponsor, if applicable). 
19 RECORD KEEPING AND RETENTION 
Data generated from the clinical investigation will be stored in a limited-access file area and be 
accessible only to representatives of the study site, the Sponsor and its representatives, and relevant 
health authorities/regulatory agencies.  All reports and communications relating to study subjects will 
identify subjects only by subject unique identification code.  Complete subject identification will be 
maintained by the Investigator. This information will be treated with strict adherence to professional 
standards of confidentiality. 
The investigator must retain study-related records for a period of at least 15 years after completion of 
the investigation or after the last device was placed on the market, if the IMD has market 
authorisation. 
The Sponsor will notify the Principal Investigator when records are no longer needed. The 
Investigator will not discard any records without notifying the Sponsor. If the Principal Investigator 
moves from the current investigational site, the Sponsor should be notified of the name of the person 
who will assume responsibility for maintenance of the records at the investigational site or the new 
address at which the records will be stored. The Investigator will notify the Sponsor as soon as 
possible in the event of accidental loss or destruction of any study documentation. 
20 PUBLICATION POLICY 
This clinical investigation will be prospectively registered at a public clinical trial registry 
ClinicalTrials.gov. 
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 
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. 
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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 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 clinical investigation monitoring plan is a 
separate document describing all the activities performed during site initiation, monitoring, and close 
out. 
22.2 Audits 
An Investigator must, in reasonable time, upon request from a relevant health authority or regulatory 
agency, permit access to requested records and reports, and copy and verify any records or reports 
made by the Investigator. Upon notification of a visit by a regulatory authority, the Investigator will 
contact the Sponsor immediately.   
The Investigator will grant the Sponsor representatives the same access privileges offered to relevant 
health authority or regulatory agents, officers, and employees. 
23 TRADEMARKS AND COPYRIGHT 
ACE, Advance Off-Stylet, AOS, AutoNRT, Autosensitivity, Beam, Bring Back the Beat, Button, 
Carina, Cochlear, 科利耳, コクレア, 코클리어, Cochlear SoftWear, Codacs, Contour, Contour 
Advance, Custom Sound, ESPrit, Freedom, Hear now. And always, Hugfit, Hybrid, Invisible Hearing, 
Kanso, MET, MicroDrive, MP3000, myCochlear, mySmartSound, NRT, Nucleus, Outcome Focused 
Fitting, Off-Stylet, Slimline, SmartSound, Softip, SPrint, True Wireless, the elliptical logo, and 
Whisper are either trademarks or registered trademarks of Cochlear Limited. Ardium, Baha, Baha 
SoftWear, BCDrive, DermaLock, EveryWear, SoundArc, Vistafix, and WindShield are either 
trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB. © Cochlear 2021 
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Botros A, Banna R, Maruthurkkara S. The next generation of Nucleus(®) fitting: a multiplatform approach 
towards universal cochlear implant management.  Int J Audiol. 2013 Jul;52(7):485-94. 
Cochlear Ltd. (2020). Nucleus Smart App User Guide (D1842663). 
Froehlich et al. (2020) User Engagement with Signia TeleCare: A Way to Facilitate Hearing Aid Acceptance. 
Audiol Online. 
ISO. (2011). Clinical investigation of medical devices for human subjects — Good clinical practice. 14155. 
Kim J, Jeon S, Kim D, Shin Y. A Review of Contemporary Teleaudiology: Literature Review, Technology, and 
Considerations for Practicing. J Audiol Otol. 2021 Dec;25(1):1-7. doi: 10.7874/jao.2020.00500. Epub 2021 
Jan 10. PMID: 33494551; PMCID: PMC7835434. 
Miller et al. (2020). Digital Service Delivery with AudiogramDirect : being there for your clients when you can’t 
be with.Phonak Field Study News 
Müller, J., & Raine, C. H. (2013, June). Quality standards for adult cochlear implantation. Cochlear Implants 
International, pp. 6–12. https://doi.org/10.1179/1467010013Z.00000000097 
Ranganathan, P., Pramesh, C., & Aggarwal, R. (2016). Common pitfalls in statistical analysis: Intention-to-treat 
versus per-protocol analysis. Perspectives in Clinical Research, 7(3), 144. https://doi.org/10.4103/2229-
3485.184823 
Rooth, M., King, E. R., Dillon, M., & Pillsbury, H. (2017). Management Considerations for Cochlear Implant 
Recipients in Their 80s and 90s. Hearing Review, (Aug). 
Schnittker (2019). Benefits and technical feasibility of providing remote hearing aid support for follow-up 
appointments. Phonak Field Study News. 
Slager et al. (2019) Remote Programming of Cochlear Implants.Otol Neurotol. 40(3):e260-e266. 
Sonne et al. (2019). Right at Home: Remote Care in Real Life. Hearing Review.   
Venkatesan et al. (2019). Could teleaudiology be the answer for teens? Phonak Field Study New. 
Vroegop JL, Dingemanse JG, van der Schroeff MP, Metselaar RM, Goedegebure A. Self-adjustment of upper 
electrical stimulation levels in CI programming and the effect on auditory functioning. Ear and Hearing. 
2017 Jul 1;38(4):e232-40. 
World Medical Association. (2013). World Medical Association Declaration of Helsinki: ethical principles for 
medical research involving human subjects. JAMA, 310(20), 2191–2194. 
https://doi.org/10.1001/jama.2013.281053 
 
 
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Signature Page for VV-TMF-06169 v2.0
Signature Page for VV-TMF-06169 v2.0
Reason for signing: Approved
Name: 
Role: A
Date of signature: 10-Aug-2021 02:02:25
GMT+0000
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