Retrospective Post-market Hearing Performance Outcome in a Cohort of CI532 Recipients
Conditions: Hearing Loss
Sponsor: Cochlear

Official Title: 
Retrospective post-market hearing performance outcome in a 
 
cohort of CI532 recipients 
 
NCT Number: 
 
NCT03039283 
 
Document Date: 
16 January 2018  
 

 
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Retrospective Study Plan (RSP)
 
 
Retrospective post-market hearing performance outcome in a cohort of CI532 recipients
 
Retrospective CI532 Hearing Performance 
 
CEL5661 
 
Date:  16 January 2018 
 
version number: 3 
 
Author: 
 
 
 
 
 

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Sponsor  
Cochlear AG 
European Headquarters 
 
Peter Merian-Weg 4 
4052 Basel 
Switzerland 
 
Manufacturer  
Cochlear Limited 
 
1 University Avenue, 
Macquarie University, 
NSW 2109 
Australia 
 
Principal Investigators 
Please refer to Appendix I 
Coordinating Investigator  
 
Universitätsklinikum Schleswig-Holstein – 
Campus Kiel  
Klinik für Hals, Nasen-, Ohrenheilkunde, 
Kopf und Halschirurgie  
 
  
24105 Kiel 
Germany 
 
Biostatistician: 
 
 
 
 
        
 
 
 
 

 
 
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Table of contents 
 
1
Clinical Investigation Synopsis .................................................................................... 6
2
Terms and Abbreviations ............................................................................................. 7
3
Introduction.................................................................................................................... 8
4
Identification and description of the commercially available CI532 ......................... 8
5
Justification for the design of the clinical investigation ........................................... 8
6
Risks and benefits of the commercially available CI532 and clinical investigation 8
6.1
Anticipated clinical benefits ........................................................................................ 8
6.2
Anticipated adverse device effects and risks related to the commercially available 
CI532, risks associated with participation in the clinical investigation and risk mitigation .... 9
6.3
Risks associated with data protection ........................................................................ 9
6.4
Risk-to-benefit rationale ............................................................................................. 9
7
Objectives, hypothesis and Endpoints ....................................................................... 9
7.1
Objectives .................................................................................................................. 9
7.1.1
Primary Objective .............................................................................................................9
7.1.2
Secondary Objective ........................................................................................................9
7.2
Endpoints ................................................................................................................... 9
7.2.1
Primary Endpoint ..............................................................................................................9
7.2.2
Secondary Endpoint .........................................................................................................9
7.3
Hypotheses .............................................................................................................. 10
7.3.1
Primary hypotheses of retrospective study ....................................................................10
8
Design of the clinical investigation ........................................................................... 10
8.1
General .................................................................................................................... 10
8.2
Datasets for the commercially available CI532 ........................................................ 10
8.3
Subjects ................................................................................................................... 11
8.3.1
Inclusion Criteria .............................................................................................................11
8.3.2
Exclusion Criteria ............................................................................................................11
8.3.3
Criteria and procedures for subject’s withdrawal or discontinuation ..............................11
8.3.4
Point of enrolment...........................................................................................................11
8.3.5
Total expected duration of the clinical investigation .......................................................11
8.3.6
Expected duration of each subject's participation ..........................................................11
8.3.7
Number of subjects required to be included in the clinical investigation ........................11
8.3.8
Estimated time needed to select this number (i.e. enrolment period) ............................11
8.4
Procedures ............................................................................................................... 11
8.5
Monitoring Plan ........................................................................................................ 12
9
Statistical Considerations .......................................................................................... 12
10
Data Management ........................................................................................................ 12

 
 
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11
Amendments to the RSP ............................................................................................. 13
12
Deviations from the RSP ............................................................................................. 13
13
Device accountability .................................................................................................. 13
14
Statements of compliance .......................................................................................... 13
14.1
Declaration of Helsinki and compliance with standards ........................................... 13
14.2
Ethics Committee Approval ...................................................................................... 13
14.3
Audits and Supervision ............................................................................................ 13
14.4
Study Records ......................................................................................................... 14
15
Informed consent process .......................................................................................... 14
15.1
Obtaining informed consent ..................................................................................... 14
15.2
Data Privacy ............................................................................................................. 14
16
Incident reporting ........................................................................................................ 15
16.1
Incident Reporting .................................................................................................... 15
16.2
Definition of Incident ................................................................................................ 15
16.3
Reporting process .................................................................................................... 15
17
Suspension or premature termination ...................................................................... 15
18
Publication Policy ........................................................................................................ 16
19
Bibliography................................................................................................................. 16
20
Revision History .......................................................................................................... 16
21
Appendix I: List of Investigators ................................................................................ 17
 
 
 

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Signature Page 
 
By signing this page the Sponsor, Coordinating Investigator and Principal Investigator agree 
to conduct this investigation in accordance with the current investigational plan. No changes 
to this clinical investigation plan will be permitted without the written approval of both parties. 
If substantial amendments to this plan become necessary, written approval by the Ethics 
Committee will be obtained before the changes are clinically implemented, except under 
emergency circumstances to protect the rights, safety and well-being of the subjects. 
Sponsor Signature 
 
 
 
PRINT NAME 
 
DATE  
 
SIGNATURE 
 
TITLE 
 
Coordinating Investigator Signature 
 
 
 
PRINT NAME 
 
DATE  
 
 
Coordinating Investigator 
SIGNATURE 
 
TITLE 
Principal Investigator Signature 
 
 
 
PRINT NAME 
 
DATE  
 
 
Principal Investigator 
SIGNATURE 
 
TITLE 

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1 Clinical Investigation Synopsis 
Name of device 
Commercially available Cochlear™ 
Nucleus® Profile with Slim Modiolar 
Electrode (CI532) 
Short study title and study number: 
CEL5661: Retrospective CI532 Hearing 
Performance 
Principal Investigator (s)  
Please refer to Appendix I 
Coordinating Investigator  
 
 
 
Start date 
March 2017 
End date 
November 2018 
Total expected duration of the retrospective 
study: 
21 months  
Study design: 
Multicenter retrospective data collection of 
already available routine clinical data. 
Number of datasets: 
 150 datasets  
Inclusion criteria: 
1. Ability to conduct adult hearing 
performance test material 
2. Good German language skills to assess 
clinical hearing performance  
3. All CI532 recipients assessed via routine 
clinical measurements at pre implant, 
and post implant intervals with available 
data records in hospital files. 
4. Patients that have read understood and 
signed the PIC.   
Exclusion criteria: 
1. Recipients that have participated in the 
CLTD5446 study. 
 
Primary objectives: 
1. To assess available speech 
understanding in quiet and in noise pre-
operative (daily listening condition) and 
at 6 months post CI532 implantation 
(best aided conditions) 
Secondary objectives: 
1. To compare available aided (daily 
listening condition) and unaided pure 
tone audiometric thresholds obtained 
before surgery and at 6 months after 
CI532 surgery  
2. To get insight for available CI532 device 
characteristics (electrode impedances, 
NRT, MAP T and C levels) and patient 
characteristics (datalogging) (cdx files) 
3. To assess subjective surgeon’s opinion 
and clinical experience with CI532 via a 
questionnaire  

 
 
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Primary endpoints: 
1. Change from pre-op (daily listening 
condition) baseline speech 
understanding in quiet and in noise at 6 
months post-op (best aided conditions)  
2. The proportion of the recipient cohort in 
percent examined showing post-
operative improvement per test and 
listening condition. 
Secondary endpoints: 
1. Change from pre-op baseline aided 
(daily listening condition) and unaided 
thresholds at 6 months post-operative  
2. Defined normative CI532 device 
characteristics (electrode impedances, 
NRT, MAP T and C levels) and patient 
characteristics (datalogging) 
3. Combined subjective clinical experience 
and opinion about CI532 from surgeons  
 
 
 
2 Terms and Abbreviations 
Abbreviation 
Definition 
CI532 
Cochlear™ Nucleus® Profile with Slim Modiolar Electrode 
RSP 
Retrospective Study Plan 
NRT 
Neural Response Telemetry 
MAP T&C levels 
Subjective threshold (T) or comfortable (C) level for an 
electrode measured in current level units. 
cdx 
computer record files 
CRF 
Case Report Form 
PIC 
Patient Informed Consent 
CI 
Cochlear implants 
PMS 
Post-market Surveillance 
ENT 
Ear Nose Throat 
OLSA 
Oldenburger Sentence Test 
HSM 
Hochmayer Schulz Moser Sentence Test 
SNR 
Signal to Noise Ratio 
SRT 
Speech Reception Threshold 
EC 
Ethic committee 
NCA 
National Competent Authority 
CE 
Conformité Européene = European Conformity 
ID 
Identification 

 
 
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3 Introduction 
Cochlear implants (CI) restore auditory sensitivity in the case of moderate to profound levels 
of sensorineural hearing loss. Typically patients implanted with cochlear implants can achieve 
a relatively high level of speech understanding in quiet and to a lesser degree in background 
noise. In general performance is sufficiently high that currently for cochlear implantation in 
many countries the criterion is for pre-operative speech recognition scores, measured in quiet, 
to be inferior or equal to 50% correct using well fitted acoustic hearing aids. 
The CE marked Cochlear™ Nucleus® Profile with Slim Modiolar Electrode (CI532) has a 
perimodiolar (pre-curved) design and is designed to bring electrode contacts closer to the 
medial wall of the cochlea and so therefore closer to the spiral ganglion. This could potentially 
improve the hearing performance. 
This investigation aims to retrospectively collect hearing performance data that have been 
measured by five clinics in Germany as part of their clinical routine in CI532 recipients. This 
will allow the combination of post market follow-up hearing performance data within the same 
language group to be used as bench mark data.  
4 Identification and description of the commercially available CI532  
The CE marked CI532 is manufactured at Cochlear Limited in Australia. The CI532 is 
commercially available as a state of the art treatment for moderately severe to profound levels 
of sensorineural hearing loss within the clinical routine.  
Please refer to the commercially available brochures; manuals and labelling in German 
language for identification and description of the commercially available CI532: 
x 
Nucleus® Cochlea-Implantate - Wichtige Informationen für Cochlea-Implantatträger 
x 
Nucleus® CI532 Cochlea-Implantat mit Slim-Modiolar-Elektrode - Handbuch für Ärzte 
x 
Nucleus® CI532 Cochlea-Implantat mit Slim-Modiolar-Elektrode – Dokumentation 
x 
Cochlear™ Nucleus® Weltweit eingeschränkte Garantiebestimmungen 
The unique serial numbers of the CE marked CI532 device are collected to facilitate follow-up 
with the clinics if required.  
5 Justification for the design of the clinical investigation 
An extended review of clinical performance data for CI532 device (Section 19) has identified 
limited hearing performance outcome data. Cochlear is already collecting post market clinical 
data with the ongoing CLTD5446, but is aiming to collect additional data from a wider subject 
population with this retrospective evaluation. Therefore the aim of this study is to establish 
more post-market hearing performance outcomes with CI532 to establish bench mark speech 
data for German hearing performance material for CI532 recipients. 
6 Risks and benefits of the commercially available CI532 and 
clinical investigation 
6.1 Anticipated clinical benefits 
Within the scope of this study neither treatment nor special clinical interventions are planned. 
Therefore no anticipated clinical benefits for the patients are expected other than that this 
study will provide more insight in the benefits of CI treatment with CI532 as post-market 
follow-up. The CI532 Hazards Analysis and Routine post-market surveillance (PMS) will be 
updated with any new identified risks from this study. 

 
 
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6.2 Anticipated adverse device effects and risks related to the commercially 
available CI532, risks associated with participation in the clinical 
investigation and risk mitigation 
Not applicable, because of this retrospective nature of this study. Patients are not exposed to 
any additional clinical investigational measurements beyond the clinical routine measures.  
6.3 Risks associated with data protection 
As precaution to avoid any risks associated with data protection the patient’s identity and all 
information collected during the investigation will be kept strictly confidential and in accordance 
with EU data protection laws. Each participant’s data will be given a unique code and the list 
of codes will be kept by the investigator as described in the data privacy section. 
6.4 Risk-to-benefit rationale 
In conclusion taking part in the study does not incur any risks for the participating patients. 
The study aims to give insight in speech perception benefit at 6 months after switch on of CI532 
and this will help clinicians in their routine clinical practice. 
Given the above the potential benefits will outweigh the risks. 
7 Objectives, hypothesis and Endpoints 
7.1 Objectives 
7.1.1 
Primary Objective 
To assess available speech understanding in quiet and in noise pre-operative (daily listening 
condition) and at 6 months post CI532 implantation (best aided conditions). 
7.1.2 
Secondary Objective 
1. To compare available aided (daily listening condition) and unaided pure tone audiometric 
thresholds obtained before surgery and at 6 months after CI532 surgery  
2. To get insight for available CI532 device characteristics (electrode impedances, NRT, 
MAP T and C levels) and patient characteristics (datalogging) (cdx files) 
3. To assess subjective surgeon’s opinion and clinical experience with CI532 via a 
questionnaire 
7.2 Endpoints 
7.2.1 
Primary Endpoint 
1. Change from pre-op (daily listening condition) baseline speech understanding in quiet 
and in noise at 6 months post-op (best aided conditions).  
2. The proportion of the recipient cohort in percent examined showing post-operative 
improvement per test and listening condition. 
7.2.2 
Secondary Endpoint 
1. Change from pre-op baseline aided (daily listening condition) and unaided thresholds at 6 
months post-operative  
2. Defined normative CI532 device characteristics (electrode impedances, NRT, MAP T and 
C levels) and patient characteristics (datalogging) 
3. Combined subjective clinical experience and opinion about CI532 from surgeons 

 
 
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7.3 Hypotheses 
7.3.1 
Primary hypotheses of retrospective study 
1. H0: Speech understanding in quiet and in noise at the 6 months post-operative visit are 
equal with speech understanding in quiet and noise at the pre-operative evaluation visit 
H1: Speech understanding in quiet and in noise at the 6 months post-operative visit is 
better than speech understanding in quiet and noise at the pre-operative evaluation 
visit    
2. H0: The proportion of the recipient’s cohort examined showing post-operative 
improvement per test and listening condition is below 80% for the 6 months post-
operative visit. 
H1: The proportion of the recipient’s cohort examined showing post-operative 
improvement per test and listening condition is  80% (Dowell, Hollow & Winton, 2004) 
for the 6 months post-operative visit. 
 
8 Design of the clinical investigation 
8.1 General 
The aim of this study is to assess hearing performance based on clinically available routine 
hearing measures to demonstrate changes from pre- to post-CI treatment for patients 
implanted with the CI532 cochlear implant in a German speaking cohort. 
The study is multi-centric including five centres in Germany (Kiel, Erlangen, Frankfurt am Main, 
Freiburg, Hannover) to retrospectively gather bench mark hearing performance data of CI532 
recipients. The centres have been chosen due to their experience with CI532 and the 
availability of hearing performance data with CI532.  
The hearing performance data located in patient’s hospital file will be pseudo-anonymized by 
the clinician and entered into the study database. Therefore no bias is expected and no 
corrective action on a potential bias is required. 
The hearing performance data has been gathered as part of the routine clinical measurements 
pre-operatively and at 3 and 6 months post-operatively for speech understanding in quiet and 
in noise and for unaided and aided thresholds. In addition medical history, anomalies in terms 
of electrode placement and recipient’s device characteristics will be collected. Surgeons with 
CI532 experience will be asked to retrospectively evaluate the handling and usability of CI532 
during conducted surgeries.   
A first data export will be conducted after 50 datasets have been entered to informally view the 
datasets per centre. Over the study period clinicians are asked to gradually enrol the CI532 
recipient’s based on available datasets. It is expected to enrol  150 datasets until end of the 
study. 
8.2 Datasets for the commercially available CI532  
The pre-operative datasets are dependent on the recipient’s daily device use. This is 
dependent on the advice of the recipient’s ENT practitioner or clinical routine and could consist 
of either: a) an unaided condition, b) hearing aid unilateral/bilateral, or c) unilateral CI. 
Preoperative device use and hearing performance will be collected and considered for analysis 
as the comparator to the postoperative hearing performance.   
The post-operative best aided conditions are dependent on the clinical routine advice and 
could consist of: a) a contralateral hearing aid, b) unaided contralateral ear, or c) contralateral 

 
 
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CI. Evaluation of electrode placement and location in the scala, by e.g. imaging data, will be 
considered during postoperative hearing performance analysis.   
8.3 Subjects  
8.3.1 
Inclusion Criteria 
1. Ability to conduct adult hearing performance test material 
2. Good German language skills to assess clinical hearing performance  
3. All CI532 recipients assessed via routine clinical measurements at pre implant, and post 
implant intervals with available data records in hospital files. 
4. Patients that have read understood and signed the PIC.     
 
8.3.2 
Exclusion Criteria 
1. Recipients that have participated in the CLTD5446 study. 
 
8.3.3 
Criteria and procedures for subject’s withdrawal or discontinuation 
Subjects can decide to withdraw from the investigation without indicating any reasons at any 
stage. Recipient’s datasets will then be excluded from the CI532 retrospective evaluation.  
8.3.4 
Point of enrolment 
Subjects are enrolled into the clinical investigation when they have signed the Informed 
Consent Form. 
8.3.5 
Total expected duration of the clinical investigation 
It is expected to retrospectively collect CI532 hearing performance data between March 2017 
to November 2018.  
8.3.6 
Expected duration of each subject's participation 
Not applicable due to the retrospective data collection. 
8.3.7 
Number of subjects required to be included in the clinical investigation 
The anticipated number of datasets is  150.     
8.3.8 
Estimated time needed to select this number (i.e. enrolment period) 
The estimated time to collect  150 datasets are 21 months.   
8.4 Procedures 
No product or procedure related training is required since we will collect pseudo-anonymised 
clinical follow-up data hearing performance data and device characteristic data exported from 
clinical software provided with this CE marked product. The clinics will be trained by the Clinical 
Project Manager how to pseudo-anonymise the clinical data.  
The clinic will recruit patients by phone and or mail. Based on their clinical database they select 
patients that fulfil the inclusion criteria and will provide the Patient Informed Consent to these 
patients by mail. Potentially a follow-up call will be conducted by the clinic to answer open 

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questions from the recipient. After patients have signed the Patient Informed Consent they will 
send it back to the clinic.  
After the clinic has received the signed Informed Consent the clinician enters the available 
hearing performance data from the recipient’s hospital file into the electronic data capturing 
system in a pseudo-anonymized way (See section 15.2).  
The device/patient characteristics will be collected through anonymized computer record files 
(“cdx”) produced by the CustomSound software which is routinely used to fit the CI532 
recipients. The cdx files will be pseudo-anonymized with a unique patient code and sent to 
Cochlear. 
Study subjects did follow clinical routine treatment practices and this retrospective approach 
does not impact routine clinical treatment at the implanting centre.   
The surgeon’s questionnaire will be filled by at least one surgeon per site once that surgeon 
has achieved a minimum experience of ten (10) CI532 surgeries. This could be in the beginning 
or close to the end of the study based on the surgeon’s experience with CI532. Completed 
paper surgeon’s questionnaire will be shipped to the clinical project manager by regular mail 
for further handling and analysis.   
8.5 Monitoring Plan 
Please refer to the Monitoring Plan. 
9 Statistical Considerations 
Please refer to the Statistical Plan. 
Depending on the clinic different types of speech understanding measurements in noise will 
be measured. For example the OLSA is an adaptive test in which the 50% point of the 
discrimination function is measured. This point of the discrimination function has the maximal 
steepness and is most sensitive to changes in hearing function. On the other hand, HSM is a 
test with a fixed SNR. In this test different points along the discrimination function are being 
measured. The steepness changes at these different points of the discrimination function. 
Therefore, there is no linear relation between the test results for the OLSA and HSM sentence 
materials and it is not possible to calculate a linear relation like "a change of x dB SNR in OLSA 
corresponds to y% change in HSM". Therefore the type of speech test material in noise has to 
be considered as dependent variables for analysis of group performance. 
10 Data Management 
Data collection is performed through 
, a web-based system for electronic data 
capturing. Site personnel will be trained to use this system. Data validity has to be confirmed 
by the investigator through an electronic signature. An audit trail is kept by this system and 
data clarifications may be generated by the system and sponsor personnel after review of data. 
 is a system that has been verified and validated by the vendor. Installation of the 
system within Cochlear has been validated as well. Study-specific implementations are 
validated by Data Management and consist of verification that all required items are included, 
validity of edit checks and appropriate functionality of conditional fields. The study-specific data 
in 
 can only be accessed by those that have been allocated their individual account, 
which are personnel of the investigational sites, Clinical Project Manager, Study Monitors and 
Data Management staff.  

 
 
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11 Amendments to the RSP 
No changes in the study protocol shall be effected without mutual agreement of the 
investigator(s) and the Sponsor. All changes must be documented by signed RSP amendment. 
Substantial changes will require notification to the Ethics Committee. 
12 Deviations from the RSP 
The expected number of deviations is anticipated to be low due to the retrospective nature of 
the study. Only datasets of CI532 recipients that have signed the Patient Informed Consent 
will be part of this evaluation. Any deviations by the clinical investigator shall be documented 
and reported to the Sponsor and the EC as necessary.  
13 Device accountability 
Not applicable because of the retrospective approach in already implanted CI532 recipients. 
14 Statements of compliance 
14.1 Declaration of Helsinki and compliance with standards 
The clinical investigation shall be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki (2013), the EN ISO 14155:2011 and any regional or 
national regulations, as appropriate. This retrospective investigation will be registered on 
ClinicalTrials.gov. 
14.2 Ethics Committee Approval 
The clinical investigation shall not commence prior to the written favourable opinion or approval 
from the EC is obtained. 
The investigator shall submit the final version of the clinical investigation plan, the informed 
consent and all subsequently required documents to the Ethics Committee.  A copy of the 
Ethics Committee opinion/approval shall be provided to the sponsor.  
Sponsor and investigator shall continue the communication with the EC as required by national 
regulations, the clinical investigational plan or the responsible EC.  
Any additional requirements imposed by the EC shall be followed. 
The investigator shall submit the appropriate documentation if any extension or renewal of the 
EC approval is required. In particular substantial amendments to the clinical investigation plan, 
the informed consent, or other written information provided to subjects must be approved in 
writing by the EC. 
The investigator shall 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 requirement. 
The clinical investigation is covered by the Cochlear global cover insurance. No additional 
clinical trial insurance is required, because no exposure to recipients applies. 
14.3 Audits and Supervision 
Study sites and study documentation may be subject to Quality Assurance audits during the 
course of the clinical investigation. In addition, regulatory bodies at their discretion may conduct 
inspections, during and after study completion. 

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14.4 Study Records 
The investigational site will receive and has to maintain an Investigator’s File which does 
include without limitation at a minimum the signed Retrospective Study Plan, the EC approval 
letter, completed Informed Consent Forms, Investigator copies of all CRFs, correspondence 
with the Sponsor and third parties related to the study, a subject identification list, and a site 
delegation and signature sheet. All study records and source documents shall be archived at 
the investigational site, which aims to be the implanting centre for this study, for at least 15 
years after the end of the study. 
15 Informed consent process 
15.1 Obtaining informed consent 
The investigator must obtain written informed consent from the subject prior to any clinical 
investigation related activity, and after explaining the rationale for and the details, aims and 
objectives of the study and the extent of the subject’s involvement. Ample time must be 
provided for the subject to inquire about details of the investigation and to decide whether to 
participate. All questions about the investigation should be answered to the satisfaction of the 
subject or the subject’s legally acceptable representative. Subjects must not be coerced or 
unduly influenced to participate or to continue to participate in an investigation. 
Each subject and the person who conducted the informed consent discussion must sign and 
date the informed consent form. Where required, a witness must sign and personally date the 
consent form. 
A copy of the information leaflet and consent form must be given to the subject. All signed 
Informed Consent Forms must be archived in the Investigator’s File at the investigational site, 
according to the requirements of the country’s health regulations, but for a minimum of 15 
years after completion of the clinical investigation.  
The investigator shall forward any amendment made to the approved subject informed consent 
for review to the Sponsor or Study Monitor and any other written information to be provided to 
the subject, prior to submission to his EC.  
15.2 Data Privacy 
Subjects will be identified on CRFs or similar documents by a unique subject identification 
code. No personal identification of private information will be extracted.  Completed CRFs or 
similar documents are confidential documents and will only be available to the Sponsor and 
their representatives, the investigator, the investigational statistician, and if requested to the 
Ethics Committee and national regulatory authorities.  
The investigator and site staff will not include the name of any subject in any CRF or other 
forms, electronic files, publication, or submission to a regulatory authority; will not otherwise 
disclose the identity of any subject; and, in any CRF, will refer to each subject by his/her unique 
identification code. 
An identification code (pseudo-anonym) will be used 
  
 
 
 
 
 
 
 
 

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16 Incident reporting 
16.1 Incident Reporting 
This investigation is performed using CE marked devices thus requiring reporting of incidents 
under the MEDDEV 2.12-1 via Cochlear’s policy & procedures for complaints- and issues 
handling as implemented routinely for all products under postmarket surveillance as part of our 
mandated postmarket vigilance. Due to the retrospective approach, any incidents may have 
already been reported as part of the hospital’s routine via Cochlear’s policy & procedures for 
complaint and issue handling. To close any potential gaps, we will actively ask if all complaints 
and incidents have been reported to Cochlear via Cochlear’s policy & procedures for complaint 
and issues handling in the CRFs. 
16.2  Definition of Incident 
“Any malfunction or deterioration in the characteristics and/or performance of a device, as well 
as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might 
lead to or might have led to the death of a subject, or user or of other persons or to a serious 
deterioration in their state of health.”   
16.3 Reporting process 
As is routine, the investigator shall report all incidents without undue delay to the sponsor, EC 
and as applicable to the NCA:  
Name of contact person of the sponsor: 
  
Fax: 
 
 
E-mail: 
 
The Sponsor shall assess all reported incidents with the investigator, co-ordinate appropriate 
actions, if required, and provide the NCA with a final report.  
The investigator shall report all incidents to his/her EC using the applicable report form as per 
national requirement.  
17 Suspension or premature termination 
The Sponsor will withdraw from sponsorship of the clinical investigation if, 
1.) major non-adherence to the RSP is occurring 
2.) it is anticipated that the subject recruitment via patient informed consent signature 
will not be adequate to meet the objectives of the retrospective investigation 

 
 
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18 Publication Policy 
Investigators will be able to publish and/or present their own data. The publishing investigator 
will provide the sponsor with a manuscript copy of the abstract and paper at least 30 days in 
advance of publication or presentation. If the publication contains information that the sponsor 
at his discretion finds worth protecting in the form of a patent or trademark etc., the sponsor 
has the right to delay the publication or presentation for 90 days. 
After finishing the study it is planned to generate a joint publication by the clinical investigator(s) 
and the sponsor. The responsibility for writing the publication is with the Coordinating 
Investigator. In case of multi-centre investigation, the authorship will be based on contribution 
of complete datasets and contribution to paper preparation according to the rules of the journal 
chosen for publication. The joint publication must be reviewed by the sponsor at least 30 days 
in advance to any release of publication. If the publication contains information that the sponsor 
at his discretion finds worth protecting in the form of a patent or trademark etc., the sponsor 
has the right to delay the publication or presentation for 90 days.   
19 Bibliography  
Holden et al. (2013): Factors affecting open-set word recognition in adults with cochlear 
implants. Ear Hear. 34(3):342-60 
CI532 Clinical Evaluation Report, version: 4, date: 15.06.2015, pages 46-49 
CLTD5446 CIP version: 4, date: 18.06.2015 
Dowell, R.C., Hollow, R., & Winton, E. (2004).Outcomes for cochlear implant users with 
significant residual hearing: Implications for selection criteria in children. Archives of 
Otolaryngology, Head and Neck Surgery, 130, 575-581. 
 
20 Revision History 
 
Version Number 
Date 
Reason for Change 
2 
22.06.2017 
Updated study start and end date 
3 
16.01.2018 
Updated study end date and duration of study 
Updated phone numbers of Coordinating Investigator 
and Principal Investigator Kiel and name of sponsor 
representative  
 

Company confidential 
 
CEL5661 Retrospective Study Plan Clinical Study protocol template 
Version 3 
 
Page 17 of 17 
Template CTC-4-2-044, Issue 2
 
 
21 Appendix I: List of Investigators 
Site ID 
Name and professional 
position of Investigator 
Address 
Telephone, email 
  
 
 
 
Klinik für Hals-, Nasen-, 
Ohrenheilkunde, Kopf- und 
Halschirurgie 
 
D-24105 Kiel 
Germany 
 
  
  
  
 
 
 
Deutsches HörZentrum Hannover 
der HNO-Klinik der MHH  
  
D-30625 Hannover  
Germany 
 
 
 
 
 
  
  
Universitätsklinikum Erlangen  
Hals-Nasen-Ohren-Klinik  
  
D-91054 Erlangen,  
Germany 
 
 
 
 
 
 
Universitätsklinik für Hals-, Nasen- 
und Ohrenheilkunde 
 
D-79106 Freiburg i. Br.  
Germany 
 
 
 
Klinikum der J. W. Goethe-
Universität Frankfurt,  
  
D-60590 Frankfurt a. M.,  
Germany