A Prospective, Single-centre Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
Conditions: Hearing Impairment
Sponsor: Cochlear

CIP_CAMSEN_AI-5770 
D1673831 
Version: 5 
State: Approved (T+B) 
Approver: Kerrie Plant (kplant)
Date : 06 Feb 2020 
Document Control Note: Hardcopies of this document 
are non-controlled unless the relevant Transmittal Advice 
Notification (TAN) information is stamped in the box below. 
Number of pages (include Coversheet): 31

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
1 of 30 
 
 
 
Clinical Investigation Plan 
 
Investigation Title: A prospective, single-centre evaluation of Carina 
microphone sensitivity and maximum stable gain in adult recipients 
 
Short Tile: 
CAMSEN 
CIP Number: 
AI-5770 
Version Number: 
5.0 
Date:  
05-Feb-2020 
Sponsor 
Cochlear Limited 
1 University Avenue 
Macquarie University 
NSW 2109 
Australia 
 
 
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki, International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable. 
 
Confidential Information 
The information contained in this document is confidential and should not be copied or distributed to persons not involved 
in the conduct or oversight of the clinical investigation 
 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
2 of 30 
 
Manufacturer 
Cochlear Boulder LLC 
5445 Airport Boulevard,  
Boulder, CO 80301, USA 
EC Representative: 
Cochlear Deutschland GmbH & Co. KG 
Karl-Wiechert-Allee 76A 
30625 Hannover, Germany 
Sponsor Organisations 
 
Cochlear Limited 
1 University Avenue 
Macquarie University, NSW 2109 
Australia 
Principal Investigator 
 
Dr Victor Correia da Silva,  
Clinical Director, CUF Hospital, Porto 
Clinical Research Organisation  
 
Syneos Health 
Address: Stefan-George-Ring 6, 81929 
München, Germany 
Phone: +49 89 9939130 
Contract Services 
 
NA 
Safety Contact 
 
CLTD-SafetyMonitor@cochlear.com 
 
 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
3 of 30 
 
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 
Dr. Victor Correia da Silva 
Principal Investigator 
Signature 
Date 
 
 
 
 
 
 
 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
4 of 30 
 
TABLE OF CONTENTS 
1 
Definitions and Abbreviations ......................................................................................................... 6 
2 
Clinical Investigation Synopsis ........................................................................................................ 8 
3 
Schedule of Events ....................................................................................................................... 10 
4 
Background Information and Rationale ........................................................................................ 10 
4.1 
Introduction and Study Rationale ....................................................................................... 10 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 11 
4.2.1 
Nonclinical Data .................................................................................................... 11 
4.2.2 
Clinical Data .......................................................................................................... 11 
5 
Medical Device Information ........................................................................................................... 11 
5.1 
Identity and Description of the Approved Medical Device on Test (AMDT) ....................... 11 
5.2 
Identity and Description of the Comparator ........................................................................ 12 
5.3 
Accessory Device Requirements ........................................................................................ 12 
6 
Objectives ..................................................................................................................................... 12 
6.1 
Objectives ........................................................................................................................... 12 
6.2 
Exploratory Objective .......................................................................................................... 13 
7 
Design of the Clinical Investigation ............................................................................................... 13 
7.1 
General ............................................................................................................................... 13 
7.1.1 
Design Rationale ................................................................................................... 13 
7.2 
Subjects .............................................................................................................................. 13 
7.2.1 
Inclusion Criteria ................................................................................................... 13 
7.2.2 
Exclusion Criteria .................................................................................................. 13 
7.2.3 
Number of Subjects Required ............................................................................... 13 
7.2.4 
Vulnerable Populations ......................................................................................... 14 
7.2.5 
Enrolment & Study Duration ................................................................................. 14 
7.2.6 
Criteria for Subject Withdrawal ............................................................................. 14 
7.2.7 
Randomisation Procedures .................................................................................. 15 
7.2.8 
Post-investigation Medical Care ........................................................................... 15 
7.3 
Performance Evaluations and Procedures ......................................................................... 15 
7.3.1 
Microphone sensitivity and impulse response ...................................................... 15 
7.3.2 
Maximum stable gain ............................................................................................ 15 
7.3.3 
Audiometric thresholds ......................................................................................... 15 
7.4 
Safety Evaluations and Procedures ................................................................................... 15 
7.4.1 
Concomitant Medication and Therapies ............................................................... 15 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 15 
7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 15 
8 
Risks and Benefits of the Approved Medical Device on Test and Clinical Investigation .............. 16 
8.1 
Anticipated Clinical Benefits ............................................................................................... 16 
8.2 
Anticipated Adverse Device Effects .................................................................................... 16 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 16 
8.4 
Risk Mitigation .................................................................................................................... 16 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 16 
9 
Statistical Considerations .............................................................................................................. 17 
9.1 
General Considerations ...................................................................................................... 17 
9.2 
Endpoints ............................................................................................................................ 17 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
5 of 30 
 
9.2.1 
Exploratory Endpoints ........................................................................................... 17 
9.3 
Hypotheses ......................................................................................................................... 17 
9.4 
Sample Size Determination ................................................................................................ 17 
9.5 
Analysis Populations ........................................................................................................... 17 
9.6 
Primary Endpoint Analyses ................................................................................................. 17 
9.7 
Secondary Endpoint Analyses ............................................................................................ 18 
9.8 
Exploratory Endpoint Analyses ........................................................................................... 18 
9.9 
Safety Analyses .................................................................................................................. 18 
9.10 Interim Analyses ................................................................................................................. 18 
10 Informed Consent Process ........................................................................................................... 18 
11 Adverse Events and Device Deficiencies ..................................................................................... 18 
11.1 Definitions ........................................................................................................................... 18 
11.1.1 
Adverse Event ...................................................................................................... 18 
11.1.2 
Adverse Device Effect .......................................................................................... 19 
11.1.3 
Serious Adverse Event ......................................................................................... 19 
11.1.4 
Serious Adverse Device Effect ............................................................................. 19 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 19 
11.1.6 
Device Deficiency ................................................................................................. 20 
11.2 Recording and Handling of Adverse Events ....................................................................... 20 
11.2.1 
Assessment of Severity ........................................................................................ 20 
11.2.2 
Assessment of Causality ...................................................................................... 20 
11.2.3 
Assessment of Seriousness ................................................................................. 22 
11.2.4 
Assessment of Expectedness .............................................................................. 22 
11.3 Recording and Handling of Device Deficiencies................................................................. 22 
11.4 Reporting Responsibilities .................................................................................................. 22 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 22 
11.4.2 
Sponsor Notification of Events ............................................................................. 23 
11.5 Independent Data Monitoring Committee ........................................................................... 23 
12 Device Accountability .................................................................................................................... 23 
13 Deviations from the Clinical Investigation Plan ............................................................................. 23 
14 Data Management ........................................................................................................................ 24 
15 Confidentiality ................................................................................................................................ 25 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 25 
17 Suspension or Premature Termination ......................................................................................... 25 
18 Amendments to the Clinical Investigation Plan ............................................................................. 26 
19 Record Keeping and Retention ..................................................................................................... 26 
20 Publication Policy .......................................................................................................................... 26 
21 Statements of compliance ............................................................................................................. 27 
22 Quality Control and Assurance ..................................................................................................... 27 
22.1 Monitoring ........................................................................................................................... 27 
22.2 Audits .................................................................................................................................. 27 
23 Trademarks and Copyright ........................................................................................................... 27 
24 References .................................................................................................................................... 27 
25 Change History ............................................................................................................................. 28 
26 Appendices ................................................................................................................................... 29 
26.1 Appendix 1: Certificates of Conformity ............................................................................... 29 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
6 of 30 
 
1 DEFINITIONS AND ABBREVIATIONS 
Term 
Description 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AMDT 
Approved Medical Device on Test 
AMEI 
Active Middle Ear Implant 
CER 
Clinical Evaluation Report 
CIP 
Clinical Investigation Plan 
CIR 
Clinical Investigation Report 
CRF 
Case Report Form 
CRO 
Contract Research Organisation 
CT 
Computed tomography 
DCF 
Data Clarification Form 
DD 
Device Deficiency 
EC 
Ethics Committee 
Synonymous abbreviations/terms include: 
IRB (Institutional Review Board) 
IEC (Institutional Ethics Committee or Independent Ethics Committee) 
HREC (Human Research Ethics Committee) 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practices 
HL 
Hearing loss 
HP 
Hearing Preservation  
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
IDMC 
Independent Data Monitoring Committee 
IMD 
Investigational Medical Device 
NCA 
National Competent Authority 
PI 
Principal Investigator 
PIL 
Principal Investigator List 
PMS 
Post-Market Surveillance 
RW 
Round window 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
7 of 30 
 
Term 
Description 
SNR 
Signal-to-noise ratio 
SOP 
Standard Operating Procedure 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
8 of 30 
 
2 CLINICAL INVESTIGATION SYNOPSIS 
Investigation title 
A prospective, single-centre evaluation of Carina microphone sensitivity and 
maximum stable gain in adult recipients 
Short title 
CAMSEN  
Investigation number 
AI-5770 
Name of Approved 
Medical Device on 
Test  
Cochlear™ Carina® 2 System MET-7000 
Intended use of 
investigational 
medical device(s) 
AMDTs for adults 
The Carina Fully Implantable Middle Ear Implant System MET-7000 with the 
MET-7500 actuator is intended to compensate auditory deficits in individuals 
aged 14 or older with moderate to severe sensorineural hearing loss, and for 
moderate to severe conductive or mixed hearing loss when used with one of 
the actuator extensions. The system provides amplification via direct 
mechanical stimulation of the auditory system. 
Name and description 
of comparator 
device/product(s) 
Not applicable 
Expected start date 
(first subject consented) 
January 2020 
Expected enrolment 
period 
2 months 
Expected duration per 
subject 
1 day 
Expected total 
duration of the clinical 
investigation 
2 months 
Number of subjects 
planned 
Up to 20 subjects will be enrolled.  
Number of 
investigational sites 
planned 
Single site 
Inclusion criteria 
1. Eighteen years of age or older at the time of enrolment in the study 
2. Current recipient of a Cochlear Carina System. 
Exclusion criteria 
1. Unwillingness or inability of the candidate to comply with all 
investigational requirements as determined by the Investigator 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
9 of 30 
 
 
Objectives and Endpoints 
Objectives 
Endpoints 
1. To characterize Carina microphone 
sensitivity 
Acoustic sensitivity of implanted microphone [dB 
FS for 0.1 Pa], in-situ, for audiometric 
frequencies 250-6000 Hz, median and 
percentiles 
2. To characterize Carina microphone : 
accelerometer ratio for acoustic stimulation 
Ratio [dB] of response of implanted microphone 
to response of implanted accelerometer, in-situ, 
for audiometric frequencies 250-6000 Hz, 
median and percentiles 
3. To characterize Carina microphone impulse 
response for acoustic and actuator 
stimulation 
Identification of the system’s acoustic and 
vibration transfer functions including non-linear 
components. 
4. To characterize Carina maximum stable 
gain. 
Transfer function from Carina output to actuator 
[dB FS] to Carina input from implanted 
microphone [dB FS], for audiometric frequencies 
250-6000 Hz, with and without plugged ear canal 
   
 
  

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
10 of 30 
 
3 SCHEDULE OF EVENTS 
Visit Type 
Screening 
Visit 
Timing of Investigation 
 
 
Visit window () 
 
 
Procedures 
 
 
Written informed consent 
X 
 
Eligibility 
X 
 
Audiogram (bone conduction) 
 
X 
Direct thresholds 
 
X 
Microphone sensitivity  
 
X 
Microphone impulse response 
 
X 
Maximum stable gain  
 
X 
Adverse Events  
 
X 
4 BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction and Study Rationale   
The totally implanted Carina System is an active middle ear implant where all components 
(microphone, signal processing electronics, power source, and middle ear actuator) are implanted 
under the skin, making the system invisible and compatible with occupations and lifestyles that 
involve exposure to humidity or dust. 
Placing a microphone under the skin affects its acoustic sensitivity and vibration sensitivity. With 
higher vibration sensitivity of the microphone, it may pick up small vibrations of the skull caused by 
the actuator coupled to a middle ear ossicles, which may lead to feedback squealing, similar to a 
conventional hearing where an acoustic feedback pathway from speaker to microphone may led to 
feedback squealing. 
So far, acoustic sensitivity of an implanted microphone has been measured in bench and cadaver 
studies, and in a very small number of subjects implanted with a percutaneous access to the 
microphone (Gérard et al., 2017). Now, software is available to enable non-intrusive microphone 
measurements in existing patients with the Carina device, through a wireless link to the implant. 
Detailed knowledge of the acoustic sensitivity of the implanted microphone, and its inter-individual 
variability, will allow more accurate calculation of overall system performance, and thereby more 
accurate prediction of clinical outcomes. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
11 of 30 
 
Detailed knowledge of the vibration sensitivity and the ratio of acoustic to vibration sensitivity will help 
to optimize future signal processing strategies intended to reduce the perception of body sounds, and 
the to reduce feedback. 
Clinical studies on device performance typically report speech intelligibility scores and aided 
thresholds or functional gain, but it cannot be inferred to what extend the observed functional gain is 
determined by audiological needs, or the subject’s preferences, or device limitations. With the 
research software available now, an objective measurement of the feedback transfer function and 
thereby of maximum stable gain can be made, which is independent of the audiological profile of the 
individual study subject, and their listening preferences.  
Detailed knowledge of objectively measured maximum stable gain, and its inter-individual variability, 
will allow more accurate calculation of overall system performance, and thereby more accurate 
prediction of clinical outcomes. 
4.2 
Findings of Previous Nonclinical and Clinical Studies  
4.2.1 
Nonclinical Data 
n/a 
4.2.2 
Clinical Data 
The performance with an implanted microphone was compared to a standard external sound 
processor, in one patient fitted with temporary percutaneous access to the microphone (Jenkins & 
Uhler, 2012). A similar study on 4 subjects, also fitted with temporary percutaneous access to the 
microphone, was reported by (Gérard et al., 2017). Neither study investigated the sensitivity of the 
acceleration sensor. Maximum stable gain could also not be measured, because those were cochlear 
implant recipients, not recipients of an active middle ear implant. 
5 MEDICAL DEVICE INFORMATION 
5.1 
Identity and Description of the Approved Medical Device on Test 
(AMDT) 
The intended purpose of the Carina System for adults is to compensate auditory deficits in individuals 
aged 14 or older with moderate to severe sensorineural hearing loss, and for moderate to severe 
conductive or mixed hearing loss when used with one of the actuator extensions. The system 
provides amplification via direct mechanical stimulation of the auditory system.  
As shown in Figure 1, the Carina System consists of a main implant body, containing the signal 
processing electronics and rechargeable battery, the pendent with the implantable microphone, and 
an output actuator intended to be coupled to a middle ear ossicles or the cochlea.  

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
12 of 30 
 
   
Figure 1: Carina implant, composed of the main implant body with electronics and battery (top), the implantable 
microphone pendent (middle), and the MicroDrive™ actuator (bottom). 
 
5.2 
Identity and Description of the Comparator 
There is no comparator in this study.  
5.3 
Accessory Device Requirements 
The AMDT is used in conjunction with the Carina Charging System (composed of the Carina Charger 
Base AUD-5112, the Carina Charger Body AUD-5111 and the Carina Charging Coil AUD-5120), the 
Carina Remote Control AUD-5900, and optionally the Carina Button Processor BAP-11x0. 
During the measurements, the implant will be controlled using Carina 2 Surgical & Fitting Software (CE 
marked) via the Carina Interface SUR-2300 and the Carina Interface Coil SUR-2320.  
6 OBJECTIVES 
6.1 
Objectives  
Since this study is a pilot investigation without powering to reject specific null hypotheses, objectives 
and associated endpoints in section 9.2 are listed without differentiation between primary and 
secondary objectives.   
1. To characterize Carina microphone sensitivity, in-situ, and its variability 
2. To characterize the ratio of (a) microphone response to sound to (b) accelerometer response 
to sound, in-situ, and its variability 
3. To characterize Carina microphone impulse response for acoustic and actuator stimulation 
4. To objectively measure maximum stable gain, i.e. gain before feedback squealing would 
occur 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
13 of 30 
 
6.2 
Exploratory Objective 
There are no exploratory objectives.  
7 DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
The investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot 
clinical investigation in adults previously implanted with the Carina system.   
The subjects will include men and women aged 18 years and over.  
Subjects will attend one scheduled study visit to be assessed as described in the CIP Schedule of 
Events (section 3).  At the study visit, several objective acoustic measurements will be performed that 
do not require active participation from the subject. No data monitoring committee will be used for this 
clinical investigation.  
7.1.1 
Design Rationale 
The single-subject repeated measures, pilot design will enable an estimation of microphone 
sensitivity and maximum stable gain.  
7.2 
Subjects 
Written, informed consent must be obtained from subject before initiating any study procedures which 
are not part of clinical routine.  
Other than meeting the inclusion criteria stated below, subjects will be recruited into the study; with 
no pre-selection based on age (other than being an adult, 18 years-of-age or older), ethnicity or 
gender.  
7.2.1 
Inclusion Criteria 
Subjects must meet all of the inclusion criteria described below to be eligible for this clinical 
investigation. 
1. Eighteen years of age or older at the time of enrolment in the study 
2. Current recipient of a Cochlear Carina System. 
7.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical 
investigation. 
1. Unwillingness or inability of the candidate to comply with all investigational requirements as 
determined by the Investigator. 
7.2.3 
Number of Subjects Required 
Up to 20 subjects will be enrolled, which is the total number of patients implanted at the 
investigational site at the time of writing of this document. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
14 of 30 
 
Since the study is a pilot investigation, sample size calculations have not been conducted.  
7.2.4 
Vulnerable Populations 
Not applicable.  
7.2.5 
Enrolment & Study Duration 
The preoperative assessment will be composed of one evaluation. The ICF must be signed prior to 
any study related evaluation taking place.  
The enrolment period for the clinical investigation is anticipated to be 1 month from the time of first 
subject consent to enrolment of the last subject. 
The expected duration of each subject’s participation in the clinical investigation, is 1 month, from the 
time of informed consent through to the only study visit. 
The anticipated total duration of the clinical investigation is therefore 2 months.  
Clinical Investigation completion is last subject visit completed. In the event of an ongoing 
SAEs/SADEs at the time of this last visit, the clinical investigation completion will be extended for a 
further 30 days, or until resolution or stabilisation of the event, whichever comes first. 
7.2.6 
Criteria for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the 
reason(s), although the subject does not have to give a reason. If a reason for withdrawal is offered, 
it 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 their best interests. 
Subject withdrawal may be for any of the following reasons: 
 
Adverse Event (AE) 
 
Device Deficiency (DD) 
 
CIP or GCP deviation 
 
Subject lost to follow-up 
 
Subject withdrew consent 
 
Subject death 
 
Sponsor decision 
 
Investigator decision 
 
Other (specify) 
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. It must be remembered however 
that the subject does not need to provide a reason/s. At least 3 separate attempts taken to contact 
the subject must be documented.  

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
15 of 30 
 
Enrolled subjects who are withdrawn/discontinued will not be replaced.  
7.2.7 
Randomisation Procedures 
Not applicable 
7.2.7.1 
Blinding Procedures 
Not applicable in this pilot study with no comparator.  
7.2.8 
Post-investigation Medical Care 
Not applicable 
7.3 
Performance Evaluations and Procedures 
7.3.1 
Microphone sensitivity and impulse response 
Measurement of microphone and accelerometer signal (spectrum and impulse response) in response 
to an external sound, as defined in D1673818. 
7.3.2 
Maximum stable gain 
Measurement of microphone and accelerometer signal (spectrum and impulse response) in response 
to a stimulus generated by the implanted actuator, as defined in D1673818. 
7.3.3 
Audiometric thresholds 
Bone conduction thresholds at audiometric frequencies from 250 to 6000 Hz, measured in 
accordance with clinical practice. 
Direct thresholds (using the implant as a test signal generator), at audiometric frequencies from 250 
to 6000 Hz, measured in accordance with clinical practice. 
7.4 
Safety Evaluations and Procedures 
There will be a data safety monitor who will review all AEs, ADEs and DDs. 
 
Safety endpoints will be a summary of AEs/ADEs and DDs from the screening to end of the last 
subject last visit.  
7.4.1 
Concomitant Medication and Therapies 
Not applicable 
7.5 
Equipment Used for Evaluation of Performance and Safety 
The annual calibration certificates of the audiometer, tympanometer and sound treated room for 
audiometric testing will be kept in the site resources file.  
7.6 
Sponsor Role in Conduct of the Clinical Investigation 
Subject matter experts employed by the sponsor will perform the acoustic measurements on-site. 
 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
16 of 30 
 
8 RISKS AND BENEFITS OF THE APPROVED MEDICAL DEVICE ON TEST 
AND CLINICAL INVESTIGATION 
8.1 
Anticipated Clinical Benefits  
The anticipated clinical benefits of implantation of the AMDT prior to the start of the study are 
described in the Physician’s Guides and not affected by the study.  
The anticipated future clinical benefit of the data collection and analysis of the study is to provide 
optimized clinical guidance for patient selection based on level of hearing loss. 
The study endpoints are expected to inform future designs of active middle ear implants with an 
implantable microphone. 
8.2 
Anticipated Adverse Device Effects 
There are no anticipated adverse device effects related solely to this investigation.  
8.3 
Risks Associated with Participation in the Clinical Investigation 
The clinical trial does not prescribe medical treatments. No interaction with medication that may be 
given as part of clinical routine is anticipated. 
Theoretically, the stimulation of the patient’s cochlea with the white noise signal used to measure 
maximum stable gain could damage residual hearing, if it was dangerously loud. The maximum 
stimulation level that can be set in the software is 85 dB MET (broadband), which is a -35 dBV drive 
level to the actuator (Jenkins, Pergola, & Kasic, 2007). Actuator efficiency as measured in temporal 
bone studies and clinically (Grossöhmichen et al., 2017) is below 120 dB SPLeq @ 1V median, so 
the -35 dBV corresponds to 85 dB SPLeq loudness perceived by the patient. Even at exceptionally 
good actuator efficiency of 125 dB SPLeq @ 1V, equivalent loudness will be below (125-35) = 90 dB 
SPLeq. 
A stimulation level of 91 dB SPL is deemed safe for a maximum of 2 hours per day continuous 
exposure, it is the maximum acceptable loudness dosage for workplace noise hazards (NIOSH, 
1998), below which an employer is not even required to offer hearing protection. The planned 
measurement duration (see below) is 2 conditions x 3 repetitions x 10s = 60s, far below the 2h limit. 
8.4 
Risk Mitigation 
 
The risk of acoustic overstimulation will be mitigated by limiting the stimulus level by design, 
as described above 
 
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. 
8.5 
Risk-to-Benefit Rationale 
The software and hardware that will be used is CE marked, ensuring conformity with the relevant 
Medical Device Directive essential requirements.  The clinical safety (risks) and benefit relevant to 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
17 of 30 
 
the anticipated performance of the Carina system are documented in the respective Physician’s 
Guides for these devices.  
The findings from this clinical investigation will be important to providing optimized clinical guidance 
for patient selection based on level of hearing loss, and it will inform the design of future active 
middle ear implants with an implantable microphone. 
9 STATISTICAL CONSIDERATIONS 
9.1 
General Considerations 
There will be no formal statistical analyses given the absence of statistical null hypotheses in this 
pilot investigation.  
Descriptive statistics will used to summarise the endpoints; such as means, medians, standard 
deviations, confidence intervals and interquartile ranges.  
9.2 
Endpoints 
1. Acoustic sensitivity of implanted microphone [dB FS for 0.1 Pa], in-situ, for audiometric 
frequencies 250-6000 Hz, median and percentiles 
2. Ratio [dB] of response of implanted microphone to response of implanted accelerometer, in-
situ, for audiometric frequencies 250-6000 Hz, median and percentiles 
3. Transfer function from Carina output to actuator [dB FS] to Carina input from implanted 
microphone [dB FS], for audiometric frequencies 250-6000 Hz, with ear canal open and ear 
canal plugged 
4. Identification of the system’s acoustic and vibration transfer functions including non-linear 
components. 
9.2.1 
Exploratory Endpoints 
Not applicable 
9.3 
Hypotheses 
No formal testable hypotheses are applicable in this pilot study. 
9.4 
Sample Size Determination 
No sample size has been calculated given the pilot nature of the investigation (see section 7.23). Up 
to 20 subjects will be enrolled in this study. 
9.5 
Analysis Populations 
Given that the study is single arm with no formal statistical analyses, there is no clear need to impute 
missing data.  The descriptive statistical analyses will be computed with the per protocol data set.  
9.6 
Primary Endpoint Analyses 
See section 9.1. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
18 of 30 
 
9.7 
Secondary Endpoint Analyses 
See section 9.1. 
9.8 
Exploratory Endpoint Analyses 
Not applicable  
9.9 
Safety Analyses 
The number and percent of patients with adverse events will be reported and tabulated. Adverse 
events will be summarized by event type, severity, seriousness, as well as relatedness to the device 
and implant procedure 
9.10 Interim Analyses 
There will be no planned interim analyses 
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 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 this clinical investigation. 
Each subject (or their legally authorised representative) and the person who conducted the informed 
consent discussion, shall sign and date the ICF. Where required, a witness shall sign and personally 
date the ICF. A copy of the signed ICF shall be given to the subject. The original signed ICF shall be 
archived in the Investigator’s Site File or subject file at the investigational site. 
The subject, or the subject’s legally authorised representative, shall be informed in a timely manner if 
new information becomes available that may be relevant to the subject’s willingness to continue 
participation in the clinical investigation. The communication of this information must be documented 
as an update to the ICF and re-consent of the subject. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 Definitions 
11.1.1 Adverse Event  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons 
whether or not related to the medical device or the procedures required for implant or use. 
NOTE 1: This definition includes events related to the medical device or the comparator device. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
19 of 30 
 
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: 
a) led to a death,  
b) 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. 
c) led to foetal distress, foetal death or a congenital physical or mental abnormality, or birth 
defect 
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a SAE. 
11.1.4 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an ADE that has resulted in any of the consequences 
characteristic of a SAE. 
11.1.5 Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is a SADE, which by its nature, incidence, 
severity, or outcome has not been identified in the CI500 Series Implant Hazards Analysis (Internal 
document 389012). 
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, 
severity, or outcome has been identified in the risk analysis report. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
20 of 30 
 
11.1.6 Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. 
NOTE: Device Deficiencies include malfunctions, use errors, and inadequate labelling or information 
supplied by the manufacturer. 
11.2 Recording and Handling of Adverse Events 
Subjects shall be carefully monitored during the clinical investigation and the investigator should 
enquire about AEs at investigation visits.  
All AEs will be recorded from the time of screening. AE recording will continue for each subject until 
completion of their End of Study visit. Ongoing SAEs, 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 AMDT 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: 
Mild 
An event that is easily tolerated by the subject, causing minimal discomfort and not 
interfering with everyday activities. 
Moderate 
An event that is sufficiently discomforting to interfere with normal activities 
Severe 
An event which is incapacitating and prevents normal everyday activities 
 
11.2.2 Assessment of Causality 
The Investigator will assess the potential causal relationship of each event, using clinical judgement.  
Alternative causes, such as natural history of underlying diseases, other risk factors and the temporal 
relationship of the event to the AMDT will be considered and investigated.  The causal relationship to 
the AMDT is to be assessed by the Investigator (or medically qualified delegate) and should be 
assessed using the following classifications: 
Not related 
Relationship to the medical device or procedures can be excluded when:  
 the event is not a known side effect of the product category the device 
belongs to or of similar devices and procedures;  
 
the event has no temporal relationship with the use of the device or the 
procedures;  

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
21 of 30 
 
 
the event does not follow a known response pattern to the medical 
device (if the response pattern is previously known) and is biologically 
implausible;  
 
the discontinuation of medical device application or the reduction of the 
level of activation/exposure - when clinically feasible - and reintroduction 
of its use (or increase of the level of activation/exposure), do not impact 
on the event;  
 
the event involves a body-site or an organ not expected to be affected 
by the device or procedure;  
 
the event can be attributed to another cause (e.g. an underlying or 
concurrent illness/ clinical condition, an effect of another device, drug, 
treatment or other risk factors);  
 
the event does not depend on a false result given by the investigational 
medical device used for diagnosis, when applicable;  
 
harms to the subject are not clearly due to use error;  
In order to establish the non-relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of device/procedures 
and the event. 
Unlikely related 
The relationship with the use of the medical device seems not relevant 
and/or the event can be reasonably explained by another cause, but 
additional information may be obtained. 
Possibly related 
The relationship with the use of the medical device is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g., an 
underlying or concurrent illness/ clinical condition or/and an effect of another 
device, drug or treatment). Cases where relatedness cannot be assessed or 
no information has been obtained should also be classified as possibly 
related. 
Probably related 
The relationship with the use of the medical device seems relevant and/or 
the event cannot be reasonably explained by another cause, but additional 
information may be obtained. 
Definitely related 
The event is associated with the medical device or with procedures beyond 
reasonable doubt when:  
 
the event is a known side effect of the product category the device 
belongs to or of similar devices and procedures;  
 
the event has a temporal relationship with the medical device 
use/application or procedures;  
 
the event involves a body-site or organ that 
 
the medical device or procedures are applied to  
 
the medical device or procedures have an effect on;  
 
the event follows a known response pattern to the medical device (if the 
response pattern is previously known);  
 
the discontinuation of medical device application (or reduction of the 
level of activation/exposure) and reintroduction of its use (or increase of 
the level of activation/exposure), impact on the event (when clinically 
feasible);  
 
other possible causes (e.g., an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment) have 
been adequately ruled out;  
 
harm to the subject is due to error in use;  

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
22 of 30 
 
 
the event depends on a false result given by the medical device used for 
diagnosis, when applicable;  
In order to establish the relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the 
event.  
 
11.2.3 Assessment of Seriousness 
The Investigator will assess the seriousness of each event according to clinical judgement and the 
definition provided in section 11.1.3. 
11.2.4 Assessment of Expectedness 
An event should be considered unanticipated if the nature, severity, or frequency of that event is not 
consistent with the applicable safety reference information, such as the risk analysis report, hazards 
analysis, IB, or Product Information/IFU if the product is approved for marketing. 
For this clinical investigation the listed items in Section 8.2 and 8.3 of this CIP and/or the Product 
Information/IFU are anticipated ADEs. 
Anticipated 
An adverse device effect (ADE) which by its nature, incidence, severity, or outcome 
is consistent with the applicable safety reference information (e.g., IB, IFU). 
Unanticipated 
An adverse device effect (ADE) which by its nature, incidence, severity, or outcome 
is not consistent with, or has not been identified in the applicable safety reference 
information (e.g., IB, IFU). 
 
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 immediately. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
23 of 30 
 
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 contact for the Safety Monitor for AE/DD assessment and any AE/DD related queries is: CLTD-
SafetyMonitor@cochlear.com 
 
11.5 Independent Data Monitoring Committee 
Not applicable  
12 DEVICE ACCOUNTABILITY 
The device used within the clinical investigation is the commercially released CI622/CI522 electrode 
array. The device shall therefore be registered following the standard product registration process. 
13 DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
The Investigator(s) must not deviate from the CIP, except in case of an emergency to protect the 
safety and well-being of the subject(s). Such deviations will be documented by the site personnel in 
the source documentation for the subject and reported to the relevant EC as per institutional 
requirements and to the Sponsor as soon as possible from the date of the emergency. 
If there is a deviation from CIP-defined assessments or parts thereof are omitted or completed 
incorrectly, the deviation will also be documented by the site personnel in the source documentation 
for the subject. Depending on the type or severity of the deviation the Investigator may be required to 
notify the EC, particularly if the deviation potentially impacts subject safety, performance of AMDT, 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. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
24 of 30 
 
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 subject status according to the following criteria: 
 
Consented: Signed consent and eligibility evaluations underway 
 
Screen Fail: Subject determined not to be eligible to proceed for participation 
 
Enrolled: Completion of screening activities and confirmation of eligibility after the signing of the 
consent. 
 
Withdrawn: Enrolled subjects who withdraw or are 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. 
 
Complete: Enrolled subjects who complete the planned follow up schedule and End of Study 
visit.  
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 verified printout must be provided. 
Data collection for demographics, medical history, 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 the source data for audiometric tests, speech perception tests, 
surgical and self-reported questionnaires and x-rays and entered into a password controlled 
managed document on the Windchill database that has restricted access or a restricted access folder 
on a dedicated server set up by Cochlear Ltd Information Technology employees and located in 
Hannover. Unamended data files shall be regarded as the source. A privacy assessment was 
undertaken to ensure a secure, acceptable process for managing the non-safety data.  
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. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
25 of 30 
 
The Principal Investigator will affirm that the data for each subject at the site is accurate and 
complete by way of an electronic signature. 
15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance 
with governing data privacy regulations such as the EU GDPR regulations. 
Data will be reported to the Sponsor on CRFs or related documents (for example, questionnaires). 
Subjects will be identified on CRFs and other related documents only by a unique subject 
identification code and shall not include the subject’s name or other personal identifiable information. 
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: 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
26 of 30 
 
1) major non-adherence to the CIP or GCP principles is occurring 
2) it is anticipated that the subject recruitment will not be adequate to meet the objectives of the 
clinical investigation 
An ongoing clinical investigation may be discontinued in case of: 
1) device failure 
2) serious or intolerable ADE, leading to the explant or discontinued use of the device 
3) subject’s death 
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 Investigator 
(and to the relevant regulatory authority(s) by the Sponsor, if applicable. 
19 RECORD KEEPING AND RETENTION 
Data generated from the clinical investigation will be stored in a limited-access file area and be 
accessible only to representatives of the study site, the Sponsor and its representatives, and relevant 
health authorities/regulatory agencies.  All reports and communications relating to study subjects will 
identify subjects only by subject unique identification code.  Complete subject identification will be 
maintained by the Investigator. This information will be treated with strict adherence to professional 
standards of confidentiality. 
The investigator must retain study-related records for a period of at least 10 years after completion of 
the investigation or after the last device was placed on the market, if the AMDT 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 
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 (e.g., 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. 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
27 of 30 
 
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 qualification, 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, Button, CareYourWay, Carina, 
Cochlear, 科利耳, コクレア, Cochlear SoftWear, Codacs, ConnectYourWay, Contour, Contour 
Advance, Custom Sound, ESPrit, Freedom, Hear now. And always, HearYourWay, Hugfit, Hybrid, 
Invisible Hearing, Kanso, MET, MicroDrive, MP3000, myCochlear, mySmartSound, NRT, Nucleus, 
Off-Stylet, Slimline, SmartSound, Softip, SPrint, True Wireless, the elliptical logo, WearYourWay and 
Whisper are either trademarks or registered trademarks of Cochlear Limited. Ardium, Baha, Baha 
SoftWear, BCDrive, DermaLock, EveryWear, Vistafix, and WindShield are either trademarks or 
registered trademarks of Cochlear Bone Anchored Solutions AB.  © Cochlear 2019. 
24 REFERENCES 
International Organization for Standardization.  ISO 14155:2011 Standard:  Clinical investigation of 
medical devices for human subjects – Good clinical practice. 2011.  Available at: 
https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-2:v1:en 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
28 of 30 
 
World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving 
Human Subjects. 2013.  Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-
ethical-principles-for-medical-research-involving-human-subjects/. 
Gérard, J.-M., Demanez, L., Salmon, C., Vanpoucke, F., Walraevens, J., Plasmans, A., … Levébvre, 
P. (2017). Feasibility of an implanted microphone for cochlear implant listening. Eur Arch 
Otorhinolaryngol, 274, 1383–1390. https://doi.org/10.1007/s00405-016-4410-x 
Grossöhmichen, M., Waldmann, B., Salcher, R., Prenzler, N., Lenarz, T., & Maier, H. (2017). 
Validation of methods for prediction of clinical output levels of active middle ear implants from 
measurements in human cadaveric ears. Nature Scientific Reports, 7(1), 1–10. 
https://doi.org/10.1038/s41598-017-16107-9 
Jenkins, H. A., Pergola, N., & Kasic, J. (2007). Intraoperative ossicular loading with the Otologics fully 
implantable hearing device. Acta Oto-Laryngologica, 127(4), 360–364. 
https://doi.org/10.1080/00016480601089424 
Jenkins, H. A., & Uhler, K. (2012). Speech perception comparisons using an implanted and an 
external microphone in existing cochlear implant users. Otology and Neurotology, 33(1), 13–19. 
https://doi.org/10.1097/MAO.0b013e31823c9335 
NIOSH. (1998). Occupational Noise Exposure Revised Criteria 1998 (No. DHHS (NIOSH) Publication 
No. 98–126). Retrieved from https://www.cdc.gov/niosh/docs/98-126/pdfs/98-126.pdf 
 
25 CHANGE HISTORY 
Version 
Change 
Rationale 
V1.0 
 
Introduction of document 
V2.0 
Study will not prospectively registered 
at a public clinical trial registry 
Prospective registration not required 
V3.0 
Section 21 added “With the exception 
of prospective registration on a public 
clinical trials registry” 
Content in Section 21 now matches approved 
Cochlear template 
V4.0 
Section 7.1 changed from interventional 
to non-interventional 
Incorrectly defined as an interventional trial. 
V5.0 
Study to be prospectively registered on 
a public clinical trial registry 
Post-market, non-interventional trial needs 
prospective registration 
 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
29 of 30 
 
26 APPENDICES 
26.1 Appendix 1: Certificates of Conformity  
 

 
CIP Number: GRIS 5770 
 
AI-5770 CAMSEN 
Windchill D1673831 V5 
 
Template 1278855 Version 1.0 
30 of 30