Front-End Processing 3.0 - Noise Reduction, Transient Reduction, Scene Classifier
Conditions: Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Sponsor: MED-EL Elektromedizinische Geräte GesmbH

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CLINICAL INVESTIGATION PLAN 
Front-End Processing 3.0 - Noise reduction, Transient 
Reduction, Scene Classifier 
Study ID: 
  
Version: 1.2 
Date: 09 May 2019 
 
MED-EL contact: 
Clinical Research Department 
MED-EL Elektromedizinische Geräte GmbH 
Fürstenweg 77a 
6020 Innsbruck, Austria 
E-mail studies@medel.com 
Fax +43577885591 
 
Confidentiality 
This document is for confidential purposes only and shall not be reproduced, divulged or 
published without the consent of MED-EL. All the information contained in this document, 
especially unpublished data, is the intellectual property of MED-EL and thus meant for the 
exclusive use by the individual or entity to whom it has been sent or to whom it has been 
given by an authorized member of MED-EL staff. The information is being provided for the 
purpose of designing, conducting, evaluating and/or advising activities related to the clinical 
trial of MED-EL only. 
If the reader of this document is not the intended recipient, he/she is hereby notified that any 
dissemination, distribution or copying of this item is strictly prohibited. If you have received 
this document by mistake, please notify promptly the error to MED-EL by telephone, mail or 
fax and return immediately the original and all enclosures. 

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SIGNATURE PAGE 
MED-EL representative 
 
Company 
MED-EL Elektromedizinische Geräte GmbH 
Address 
Fürstenweg 77a 
Postal Code, City 
6020 Innsbruck 
Country 
Austria 
 
 
 
Date  
0 1 J A N 2 0 0 0 
Signature 
Place 
Day 
Month 
Year 
 
Study Manager 
 
Company 
MED-EL Elektromedizinische Geräte GmbH 
Address 
Fürstenweg 77a 
Postal Code, City 
6020 Innsbruck 
Country 
Austria 
 
 
 
Date  
0 1 J A N 2 0 0 0 
Signature 
Place 
Day 
Month 
Year 
 
 

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SIGNATURE OF THE PRINCIPAL INVESTIGATOR 
Principal Investigator 
 
Site 
Universitätsklinikum Würzburg  
Klinik und Poliklinik für Hals-, Nasen- und 
Ohrenkrankheiten, 
plastische 
und 
ästhetische Operationen 
Address 
Josef-Schneider-Str. 11  
Postal Code, City 
97080 Würzburg  
Country 
Germany 
Phone 
 
Fax 
 
E-mail 
 
Emergency Contact 
  
 
 
Investigator’s Statement 
The signature below constitutes the approval of this Clinical Investigation Plan and its 
attachments and provides the necessary assurances that this clinical investigation will be 
conducted according to all stipulations of this CIP, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements as applicable 
according to the most recent version of the Declaration of Helsinki and all relevant national 
and international regulations. 
By signing below, I accept that any amendment to this study and relative documentation will 
be implemented only upon mutual agreement with MED-EL and upon official approval by the 
relevant Ethics Committees. 
 
 
Date  
0 1 J A N 2 0 0 0 
Principal Investigator´s 
signature 
Place 
Day 
Month 
Year 
 
 
 

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TABLE OF CONTENTS 
SIGNATURE PAGE .............................................................................................................. 2 
SIGNATURE OF THE PRINCIPAL INVESTIGATOR............................................................. 3 
TABLE OF CONTENTS ........................................................................................................ 4 
1 
ABBREVIATIONS AND GLOSSARY .............................................................................. 9 
 
Abbreviations .......................................................................................................... 9 
 
 
3 
INTRODUCTION ...........................................................................................................17 
 
Literature Review ...................................................................................................17 
 
Previous Clinical Experience ..................................................................................18 
 
Rationale ................................................................................................................18 
4 
INVESTIGATIONAL DEVICE DESCRIPTION ...............................................................20 
 
Storage ..................................................................................................................22 
 
Accountability Procedures ......................................................................................22 
 
Study population ....................................................................................................24 
 
Study Procedures ...................................................................................................24 
 
Fitting .....................................................................................................................24 
 
Permitted Concomitant Treatments ........................................................................25 

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5 
STUDY OBJECTIVES ...................................................................................................26 
 
Primary Objectives .................................................................................................26 
 
Secondary Objectives ............................................................................................26 
 
Study Outcome Measures ......................................................................................26 
 
Primary outcome measures .............................................................................26 
 
Secondary outcome measures ........................................................................26 
6 
HYPOTHESES ..............................................................................................................28 
 
Hypotheses for the Primary Objectives ...................................................................28 
 
Hypotheses for the Secondary Objectives ..............................................................28 
7 
STUDY DESIGN ...........................................................................................................29 
 
Type of Study .........................................................................................................29 
 
Study Population ....................................................................................................29 
 
Sample Size Calculation ........................................................................................29 
 
Duration of the Study ..............................................................................................30 
 
Management of Deviations from the CIP ................................................................30 
 
Protocol Amendments ............................................................................................30 
8 
STUDY ENROLMENT AND WITHDRAWAL .................................................................31 
 
Selection Criteria ....................................................................................................31 
 
Inclusion criteria ..............................................................................................31 
 
Exclusion criteria .............................................................................................31 
 
Strategies for Recruitment and Retention ...............................................................32 
 
Treatment Assignment Procedures ........................................................................32 
 
Subject Identification ..............................................................................................32 
 
Early Withdrawal ....................................................................................................33 
 
Reason for Early Withdrawal ...........................................................................33 
 
Handling of Early Withdrawal ..........................................................................33 
 
Early Termination or Suspension of the Study ........................................................33 
 
Reason for early termination or suspension of the study .................................33 
 
Handling of Early Termination or Suspension of the Study ..............................34 
 
Replacement Policy ................................................................................................34 
 
Follow-Up Strategy .................................................................................................34 
 
Premature Discontinuation ..............................................................................34 
9 
STUDY SCHEDULE ......................................................................................................35 

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Screening and Upgrade Visit (1st study visit) .........................................................36 
 
Testing with the current audio processor (SONNET): ......................................36 
 
Testing with the SONNET 2: ...........................................................................36 
 
Follow-up Visit 1 (2nd study visit) .............................................................................37 
 
Testing with the current audio processor (SONNET): ......................................37 
 
Testing with the SONNET 2: ...........................................................................37 
 
Follow-up Visit 2 (3rd study visit) ............................................................................37 
 
Testing with the current audio processor (SONNET): ......................................38 
 
Testing with the SONNET 2: ...........................................................................38 
 
Follow-up Visit 3 (4th study visit) ............................................................................38 
 
Testing with the SONNET 2: ...........................................................................38 
 
Follow-up Visit 4 (5th study visit) ............................................................................39 
 
Testing with the SONNET 2: ...........................................................................39 
 
Early Termination Visit ...........................................................................................39 
 
Unscheduled Visit(s) ..............................................................................................39 
10 
EQUIPMENT AND TEST METHODOLOGIES ...........................................................40 
 
Equipment ..............................................................................................................40 
 
MAESTRO Software .......................................................................................40 
 
Tests/Material .........................................................................................................40 
 
Impedance Field Telemetry (IFT) ....................................................................40 
 
Speech testing in quiet ....................................................................................41 
 
Speech testing in noise ...................................................................................41 
 
Subjective user ratings ....................................................................................41 
11 
STUDY PROCEDURES ............................................................................................44 
 
Demographics and Medical Data ............................................................................44 
 
Medical History .......................................................................................................44 
 
Medication ..............................................................................................................44 
 
Compliance with the Selection Criteria ...................................................................44 
 
Special Tests/Procedures.......................................................................................45 
 
Fitting procedure .............................................................................................45 
 
Speech testing ................................................................................................45 
 
Subjective user ratings ....................................................................................46 
 
Scientific data export .......................................................................................48 

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........................48 
 
Randomization .......................................................................................................48 
13 
STUDY MONITORING ..............................................................................................59 
14 
DATA HANDLING AND RECORD KEEPING ............................................................60 
 
Source Data ...........................................................................................................60 
 
Study Records ........................................................................................................60 
 
Case Report Forms (CRFs) ....................................................................................60 
 
Record Retention ...................................................................................................61 
 
Data Management ..................................................................................................61 
15 
STATISTICAL ANALYSIS ..........................................................................................63 
 
Statistical Analysis Methods ...................................................................................63 
 
Primary Objectives ..........................................................................................63 
 
Secondary Objectives .....................................................................................63 

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Plan for Interim Analyses........................................................................................64 
 
Handling of Missing Data........................................................................................64 
 
Reporting Conventions ...........................................................................................64 
 
Presentation of Data ...............................................................................................64 
 
Computer Systems and Packages .........................................................................64 
16 
STUDY CLOSE-OUT .................................................................................................65 
18 
ETHICS AND PROTECTION OF HUMAN SUBJECTS ..............................................69 
 
Ethical and Regulatory Considerations ...................................................................69 
 
Informed Consent Process .....................................................................................69 
 
Subjects needing legally authorized representatives .......................................70 
 
Subjects unable to read or write ......................................................................70 
 
Subject Confidentiality ............................................................................................71 
20 
REFERENCES ..........................................................................................................73 
21 
Appendices ................................................................................................................75 
 
Appendix 1 .............................................................................................................75 
 
 
 
 
 

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1 
ABBREVIATIONS AND GLOSSARY 
 
Abbreviations 
Abbreviation 
Definition 
ACALES 
Adaptive Categorical Listening Effort Scaling 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ASC 
Automatic Scene Classifier 
ASM 
Automatic Sound Management 
APSQ 
Audio Processor Satisfaction Questionnaire 
CI 
Cochlear Implant 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
DD 
Device Deficiency 
FEP 
Front-end Processing 
HISQUI 
Hearing Implant Sound Quality Index 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
IEC 
Independent Ethics Committee 
ISF 
Investigator Site File 

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OLSA 
Oldenburger Sentence Test 
(Oldenburger Satztest) 
NR 
Noise Reduction  
PI 
Principal Investigator 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SNR 
Signal-to-Noise Ratio 
SOP 
Standard Operating Procedure 
SRT 
Speech Reception Threshold 
SSQ12 
The Speech, Spatial and Qualities of Hearing 
Scale (short version with 12 questions) 
TMF 
Trial Master File 
TR 
Transient Noise Reduction 
USADE 
Unanticipated Serious Adverse Device Effect 
WNR 
Wind Noise Reduction 

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Test interval Test Condition 
Test performed 
First 
visit 
(upgrade) 
SONNET (must be the 
current audio processor) 
Speech tests in quiet (Freiburg Monosyllables) 
Questionnaires  
SONNET 2 
• 
Fitting of all audio processor configurations 
• 
Speech test in quiet in all 6 configurations 
• 
Subject sent home with two configurations 
(randomised across subjects)  
Note: the subjects' SONNET stays at the clinic 
until the study is completed (or subject is 
withdrawn) 
Second visit 
SONNET  
Speech tests in noise (S0N0) 
SONNET 2 
• 
Readout and save data logging  

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• 
Questionnaires 
• 
Speech tests in noise (S0N0) in all 6 
configurations 
• 
Speech tests in noise (S0N0T0) in the 
SONNET 
configuration 
and 
SONNET 
2 
configuration 1 and 2 
• 
Subject send home with two configurations 
(randomised across subjects)  
Third visit 
SONNET  
Speech tests in noise with 5 loudspeakers (S0,  
±N45, ± N135) 
SONNET 2 
• 
Readout and save data logging 
• 
Questionnaires  
• 
Speech tests in noise 5 loudspeakers (S0,  
±N45, ±N135) in all 6 configurations 
• 
Subject send home with two configurations 
(randomised across subjects)  
Fourth visit 
SONNET 2 
• 
Readout and save datalogging 
• 
Questionnaires  
• 
Subjective ratings  
• 
Subject send home with two configurations 
(randomized across subjects)  
Fifth visit 
SONNET 2 
Readout and save datalogging ( 
Subjective ratings  
Give back the subject's SONNET 
Table 1. Study overview  

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3 
INTRODUCTION 
 
Literature Review 
Cochlear implant (CI) users have experienced a steady improvement in their speech 
perception scores through the last decades (Zeng, 2004; Zeng, Rebscher, Harrison, Sun, & 
Feng, 2008). Nowadays, many CI users perform at ceiling in sentence tests in quiet (i.e. > 
90%), and many CI users successfully converse over the telephone (Zeng, 2004; Zeng et al., 
2008). Although the introduction of fine structure coding strategies and bi-directional 
microphones have improved the hearing performance in more challenging listening 
conditions, CI users still face considerable challenges when listening in background noise, 
reverberating surroundings (Cacace, Kleine, Holt, & Dijk, 2016; Finke, Strauss-Schier, Kludt, 
Buchner, & Illg, 2017). 
In contrast to normal hearing people, cochlear implant users typically need a signal-to-noise 
ratio (SNR) of at least +5 dB, but often up to +20 dB to reach a 50% speech reception 
threshold (SRT) (Nelson, Jin, Carney, & Nelson, 2003; Stickney, Zeng, Litovsky, & Assmann, 
2004; Zeng et al., 2008). Importantly, CI users' speech reception scores in noise often drop 
remarkable compared their scores in quiet (Finke et al., 2017; Schafer & Thibodeau, 2004; 
Wolfe & Schafer, 2008) which may lead to a considerable increase in listening effort and a 
loss in quality of hearing. CI users tend to have even more difficulties speech understanding 
if exposed to fluctuating noise (e.g. slamming doors, clattering dishes) than in stationary 
noise or noise with relatively low temporal variations (e.g. car engine) (Fu & Shannon, 1999; 
Nelson et al., 2003; Stickney et al., 2004; Zeng & Galvin, 1999). Therefore, the improvement 
of speech understanding in noise is still a very important topic in the CI field. 
Early CI development aiming at enhancing speech recognition, have focused on increasing 
number of channels and the stimulation rate and improving the signal-processing strategies 
and the electrode design. Considerable improvements were also reached by improved front-
end processing methods. MED-EL cochlear implants incorporate the Automatic Sound 
Management (ASM). This technology provides a wide input dynamic range and to some 
extent protection from sudden loud sound to cochlear implant users which is achieved by a 
dual loop automatic volume control and automatic gain control. Additionally, dual, omni-
directional or adaptive directional microphones, and remote microphone technologies can 
improve signal quality by optimizing the acoustic signal. In combination with pre-processing 
algorithms, the signal can be enhanced for different environments, for instance by 
automatically identifying sounds, and thus customized for the individual user. A common 
approach is to use two omni-directional microphones to form fixed or adaptive directional 
microphones, also known as beamforming. With the SONNET, MED-EL introduced ASM 2.0 
including wind-noise reduction and microphone directionality and significant improvements in 
speech performance could be shown (Hagen et al., In submission). With the most recent 
audio processor, SONNET 2, ASM 3.0 including new front-end features were incorporated: 
the noise reduction, the transient noise reduction and an automatic scene classifier. 

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Previous Clinical Experience 
The SONNET 2 is an approved medical device indicated for individuals suffering severe to 
profound hearing loss. This study is designed to test speech perception quiet and in noise 
using different front-end processing features and collect subjective feedback on these new 
features by the use of different questionnaires (details are described in Section 10.2). 
Detailed information on the device can be found in Section 4.  
 
Rationale 
Similar to previous studies on audio processor and software development, this study 
investigates the new front-end features incorporated in the most recent audio processor 
SONNET 2.  
This study is planned as an active post-market follow-up with an approved product bearing a 
CE mark, within its intended use. 
Subjects will undergo the study-specific speech in quiet and speech in noise test and will 
complete questionnaires. This design will allow to a direct comparison of objective and 
subjective measures to test the new front-end features. 

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4 
INVESTIGATIONAL DEVICE DESCRIPTION 

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Storage 
SONNET 2 audio-processor will be stored at the clinic according to the provision of the User 
Manual (see Section 21.1, Appendix 1 for details). The previous SONNET audio-processor 
will be stored at the clinics under the responsibility of the Investigator. An accountability log 
will be set-up to track the subjects' devices.  
 
Accountability Procedures 
Subjects will receive a SONNET 2 for the duration of the study. The audio processor will be 
handed over at the first study visit. To control for the SONNET 2 use during the study, the 
subject's audio processor will remain in the centre during active study participation and and 
will be given back after completing the study (see section 4.2 for details regarding the 
SONNET audio-processor retaining and storage procedure). If the subject discontinuous the 
study for any reasons, the subject will get back their own audio processor in the original 
setting (I.e. SONNET) without unnecessary delay. Might re-fitting be required the procedure 

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will be implemented according to the centre clinical routine procedures for follow up fitting. 
The details of the procedure will not be recorded as part of the study.  
After study completion (all visits attended) the participants have the choice to keep the 
SONNET 2 processor or return it. The choice will be recorded during the last visit and will be 
descriptively analysed as study outcome. 

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Study population 
This study aims to enrol experienced adult users of the MED-EL cochlear implant system.  
• 
Target population: adults of both sexes suffering from sensorineural hearing loss as 
specified in the SONNET 2 Intended Use (IU) in the User Manual (See Section 21.1, 
Appendix 1 for details) 
• 
Accessible population: target population matching all inclusion and exclusion criteria as 
defined in section 8.1 
• 
Intended population: accessible population that can be recruited by the study site 
appointed for this study 
• 
Actual population: intended population enrolled in the study without considering drop-
out or withdrawal 
• 
Analytic population: actual population meeting all criteria for analysis  
the study population is identified with the analytic population.  
 
Study Procedures 
This study is performed in experienced adult users of the MED-EL Cochlear Implant System 
and involves an upgrade of the audio processor. Additionally, speech tests and 
questionnaires outside the clinical routine will be implemented.  
For a detailed description of all study procedures, see Section 11. 
 
Fitting 
This study will involve fitting sessions in order to set the maps with the various configurations 
of front-end processing available for the SONNET 2.  
Fitting will generally follow the clinical practice at the centre. Particular front-end features will 
be enabled/disabled for the four configurations.  
 
 

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Table 2 Overview of the different SONNET 2 fitting configurations 
Audio 
Processor 
Configuration ASC 
WNR 
Beam- 
former 
AGC 
Compression 
AGC 
Sensitivity 
NR 
TR 
SONNET 
Default 
N/A 
Mild 
NAT 
3:1 
75% 
N/A 
N/A 
SONNET 
2 
OPUS 2 
Off 
Off 
OMNI 
3:1 
75% 
N/A 
N/A 
SONNET 
2 
SONNET 
(default) 
Off 
Mild 
NAT 
3:1 
75% 
N/A 
N/A 
SONNET 
2 
SONNET 2/1 
Off 
Mild 
NAT 
3:1 
75% 
Mild 
Mild 
SONNET 
2 
SONNET 2/2 
Off 
Mild 
NAT 
3:1 
75% 
Strong 
Strong 
SONNET 
2 
SONNET 2/3 
Mild 
Mild 
Auto 
(NAT) 
3:1 
75% 
Auto 
(Off-
Mild) 
Auto 
(Off-
Mild) 
SONNET 
2 
SONNET 2/4 
Strong Strong Auto  
(OMNI-
ABF) 
3:1 
75% 
Auto 
(Off-
Strong) 
Auto 
(Off-
Strong) 
 
Permitted Concomitant Treatments 
Medications that are considered necessary for the subject’s welfare and are not specifically 
prohibited may be given at the discretion of the Investigator.  

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5 
STUDY OBJECTIVES 
 
Primary Objectives 
Comparison between the speech reception thresholds in the OLSA test in noise (S0N0) of 
the SONNET 2 programmed as a SONNET and the SONNET 2 (setting 1; ASC off, mild 
WNR, mild NR, mild TR). 
 
Secondary Objectives 
• 
Comparison between the speech reception thresholds in the OLSA test in noise across 
all audio processors and audio processor settings. 
• 
Comparison between the speech reception in quiet (Freiburg Monosyllables Test) across 
all audio processors and audio processor settings. 
• 
Comparison of subjective user satisfaction, sound quality, quality of hearing, and listening 
effort across audio processors and audio processor settings 
 
Study Outcome Measures 
 
Primary outcome measures 
The primary outcome measure is speech intelligibility in the S0N0 set-up in the OLSA speech 
test in noise. For a description of the test setup see Section 10.2.3 
 
Secondary outcome measures 
Performance of the SONNET 2 will be assess with different combinations of frontend 
processing features under different environmental test conditions using the following tests: 
• 
Speech performance 
❖ Freiburg Monosyllabic test in quiet; speech presented from the front 
❖ Oldenburg Sentence Test in noise in the set-ups 
➢ S0N0 
➢ S0N0T0 
➢ S0, ±N45, ± N135 
• 
Quality of hearing in real life 
❖ HISQUI19 

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❖ SSQ12 
• 
Device handling 
❖ Data Logging 
❖ APSQ 
• 
Subjective Rating 
❖ ACALES 
❖ Subjective Sound Quality Rating 
❖ Product Specific questionnaire 

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6 
HYPOTHESES 
 
Hypotheses for the Primary Objectives 
The primary objective of this study is to show non-inferiority of SONNET2 in a OLSA in noise 
speech test (S0N0) compared to the SONNET. The margin of non-inferiority is set to 2 dB 
SNR (Hey, Hocke, Hedderich, & Müller-Deile, 2014; Nogueira, Rode, & Buchner, 2016). 
• 
Verbal formulation 
Hypothesis H0 (Null Hypothesis): 
Speech perception with the SONNET 2 in its default setting in the OLSA in noise (S0N0) is 
inferior to the speech perception in the same test condition with the SONNET. 
Hypothesis H1 (Alternative Hypothesis): 
Speech perception with the SONNET 2 in its default setting in the OLSA in noise (S0N0) is 
non-inferior to the speech perception in the same test condition with the SONNET. 
• 
Mathematical formulation 
H0:  µ1 - µ2 ≥ ∆ (2 dB SNR) 
H1:  µ1 - µ2 < ∆ (2 dB SNR) 
Where: 
µ1 = SONNET mean OLSA in noise (S0N0) results for the study population expressed in dB 
SNR 
µ2 = SONNET2 mean OLSA in noise (S0N0) results for the study population expressed in dB 
SNR 
 
Hypotheses for the Secondary Objectives 
The secondary objectives of this study are to provide additional evidence on the performance 
of SONNET 2-specific front-end features. Thus, the analyses are of an explorative nature 
and will not influence the results of the primary outcome of the study.  Due to the exploratory 
nature of the secondary objectives, no hypothesis is formulated a priori. 

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7 
STUDY DESIGN 
 
Type of Study 
This study has been planned as a mono-centric, open label, prospective longitudinal study 
where each subject acts as his/her own control. 
The SONNET 2 is an incremental innovation to the SONNET audio processor with additional 
front-end processing features which are designed to improve patient performance in specific 
auditory environments. The study is designed to prospectively follow-up experienced 
SONNET users who received the SONNET 2. As intra-individual control, subjects will be 
acutely tested with the SONNET in the same test conditions as with the SONNET 2. 
 
Study Population 
This study will be performed with experienced users of MED-EL cochlear implants (defined 
as a minimum experience of 6 months with a MED-EL cochlear implant and their current 
audio processor) who will be followed-up for fife study specific visits to the test centre.  
 
Sample Size Calculation 
The primary objective of this study is to show non-inferiority of SONNET2 in a OLSA in noise 
speech test (S0N0) compared to the SONNET. The margin of non-inferiority is set to 2 dB 
SNR (Hey et al., 2014; Nogueira et al., 2016). 
Comparable data of the final report "Performance of Cochlear Implant Patients with 
Microphone Directionality and Wind Noise Reduction with the "SONNET" of the OLSA in 
noise speech test (S0N0) were used as basis for the sample size calculation (Hagen et al., In 
submission): 
OPUS2  
 
 
mean:  0.589 dB;  
± SD: 1.586 dB vs. 
SONNET natural-MILD  
mean: -0.088 dB;  
± SD: 1.463 dB 
The sample size was estimated using the formula on noninferiority (Chow, Shao, & Wang, 
2008): 
𝑁= (1 +
1
r)(σ
Zcrit+Zpwr
(µA− µB)−Δ) ² 
 
Assuming a non-inferiority margin of 2 dB (∆), with an alpha-level of 0.025 (noninferiority, 
one-sided) and a power of 90%, a minimum sample size of 13 subjects was calculated (Zcrit 
is the normal quantile for the 0.025 alpha level, and Zpwr is the normal quantile for the 90% 

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power). To allow for possible dropouts (approximately 20%) and to provide additional safety 
and efficacy data, a maximum of 30 subjects will be included in this study. 
 
Duration of the Study 
Subject enrolment is scheduled to last for 15 months. If the minimum number of subjects is 
not achieved, enrolment may continue until the minimum number of subjects is reached or 
for an additional 9 months. 
 
Management of Deviations from the CIP 
Investigational sites shall inform the Monitor immediately about any deviations as they 
become aware of them. In addition, compliance to the CIP is verified by the Sponsor through 
monitoring sessions according to the study Monitoring Plan provisions.  
Deviations that potentially affect the study outcome are recorded and listed in the final 
Clinical Investigation Report. 
 
Protocol Amendments 
Major Amendments shall be submitted to the relevant IEC(s) and NCA(s). Amendments may 
be implemented only after IEC(s) and, if required, NCA(s) approval has been obtained.  
Amendments that are intended to eliminate an apparent immediate hazard for the subjects 
enrolled in the study may be implemented prior to receiving the relevant IEC(s) approval. 
However, in this case, approval shall be obtained as soon as possible after implementation. 
No changes in the study procedures shall be affected without the mutual agreement of MED-
EL, the Investigator and the Coordinating Investigator (if applicable). All changes shall be 
documented in the form of signed protocol amendments, or as a revised protocol. Changes 
to the protocol may require notification to or approval by the relevant IEC(s) before 
implementation. Local regulatory requirements shall be followed. 
The Monitor is responsible for the distribution of protocol amendment(s) to the Investigator(s) 
and those concerned within the conduct of the study. The Investigator is responsible for the 
distribution of all amendments to the staff involved at his centre. 

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8 
STUDY ENROLMENT AND WITHDRAWAL 
 
Selection Criteria 
 
Inclusion criteria 
• 
A minimum of 18 years old 
• 
Experienced user (≥ 6 months) of a MED-EL cochlear implant (C40+ and later model)  
• 
Experienced user of a MED-EL SONNET audio processor (≥ 6 months) 
• 
Post-lingual onset of bilateral severe to profound sensory-neural hearing loss 
• 
Unilateral CI user 
• 
A minimum of 10 active electrodes 
• 
A minimum of 40% speech recognition in the Freiburg Monosyllables test in quiet at 65 
dB SPL (at the last time tested) 
• 
Fluent in German (the language of the test centre) 
• 
Signed and dated ICF before the start of any study-specific procedure. 
 
Exclusion criteria 
• 
Lack of compliance with any inclusion criteria  
• 
CI user with contralateral hearing equal to or better than 60 dB (PTA measured at 500, 
1000, and 2000Hz) 
• 
EAS user (user of an EAS audio processor) 
• 
Implanted with C40X and C40C 
• 
Implanted with an ABI or Split electrode array 
• 
Known allergic reactions to components of the investigational medical device   
• 
Unstable psychological status  
• 
Anything that, in the opinion of the Investigator, would place the subject at increased risk 
or preclude the subject’s full compliance with or completion of the study 
 

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Strategies for Recruitment and Retention 
The pro-active recruitment can be performed by identification of potential study participants 
from the clinic database and invitation of such patients.  
Subjects will be enrolled into the study by signing the informed consent upon being properly 
informed by the investigator. Subjects will retain a copy of the Informed consent form (ICF). 
These recruitment activities will be conducted by the PI or delegated site staff. 
 
Treatment Assignment Procedures 
All subjects participating in this study will receive an upgrade to the SONNET 2 and undergo 
the same test regime (including tests with the SONNET 2 and SONNET audio processor). 
 
Subject Identification 
A subject willing to sign the ICF voluntarily at the screening visit will be considered enrolled 
into the study. 
Thus, each subject will receive a code, which identifies them uniquely on all study related 
documents. This code constitutes the subject identification number according to the following 
scheme: 
The subject will receive a subject identification number according to the scheme depicted in 
Table 3. The subject identification number shall be used henceforth to identify the subject on 
all study related documents. 
Table 3: Coding of subjects entered into the study after signing and dating the ICF  
The subjects of this study won’t be replaced unless they are found not compliant with the 
inclusion/exclusion criteria prior to the first study specific tests. In this case, a non-compliant 
subject can be withdrawn and replaced. The replacing subject selected in place of a non-
compliant one, will undergo the same approval procedure performed for the replaced subject 
and will receive a new unique identifier code (see section 8.2 for details about the enrolment 
procedure). 

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Early Withdrawal 
 
Reason for Early Withdrawal  
The Investigator may decide to withdraw a subject from the study for one of the following 
reasons upon agreement with MED-EL: 
• 
Health issues (e.g. occurrence of SAEs, subject’s death, etc.) 
• 
Further participation would cause an unacceptable risk to the subject 
• 
The subject moved away 
• 
The subject does not comply with the CIP (e.g. s/he does not attend the visits on 
schedule; she/he does not communicate relevant medical issues to the Investigator, etc.) 
In accordance with the Declaration of Helsinki (Fortaleza, 2013), subjects are free to 
terminate their participation in the study at any time for any or for no reason, without 
prejudicing their basic right to receive the best treatment available for them. 
If a subject decides to withdraw early, he/she must return the SONNET 2 audio processor. 
 
Handling of Early Withdrawal 
Withdrawal of any subjects shall be recorded by the Investigator in the appropriate CRF 
“Early Withdrawal”. If a subject decides to withdraw from the study, every effort should be 
made to contact him/her and to obtain information about the reason(s) for discontinuation 
and/or any AEs experienced. Subjects withdrawing prematurely won’t be followed-up actively 
unless they suffer from an ongoing AE. In the case of an ongoing AE, the procedure 
described in section 8.8 of this CIP shall be followed. 
 
Early Termination or Suspension of the Study 
 
Reason for early termination or suspension of the study 
The study may be suspended or early terminated by MED-EL for any of the following rea-
sons: 
• 
Suspicion or recognition of unexpected, significant and/or unacceptable risks for the 
subjects 
• 
Insufficient adherence to protocol requirements   
• 
Data that are not sufficiently complete and/or evaluable 

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• 
Plans to modify, suspend or discontinue the development of the investigational medical 
device 
 
Handling of Early Termination or Suspension of the Study 
The study may be suspended or early terminated either in all or in specific study sites, de-
pending on the circumstances. 
If the study is prematurely terminated or suspended, MED-EL will promptly inform the 
Investigators/institutions, the relevant IEC(s) and NCA(s) of the termination or suspension 
and state the reason(s) for the termination or suspension. 
 
Replacement Policy 
Subjects withdrawn from the study won’t be replaced. Might the minimal sample size to 
evaluate the primary objective not be reached due to study drop-out or withdrawal, the 
enrolment is allowed to continue upon reaching the minimum number of subjects needed for 
such purpose in the analytical population as define in section 7.2. 
 
Follow-Up Strategy 
 
Premature Discontinuation 
This study is designed to be conducted with a CE-marked investigational medical device 
which will be used solely within the approved indication. 
Upon regular conclusion or premature discontinuation of the study, subjects won’t be actively 
monitored unless a subject suffers from an ongoing AE. 
Non-device or -procedure-related AEs that are ongoing at the time of a subject’s end of 
active participation in the study will not be followed-up. Ongoing AEs will be recorded as 
ongoing and lost-to-follow-up at the time of a subject’s end of active participation in the study. 
Device- or procedure- related (ADEs, SADEs, and USADEs) or SAEs that are ongoing at the 
time of a subject’s end of active participation in the study will be followed-up for a maximum 
of eight weeks. The PI will schedule a follow-up visit with the subject within the 8 weeks after 
the end of active participation. The subject may however decline to be followed-up. If the 
subject declines a follow-up visit, the unresolved AEs will be recorded as ongoing and lost-to-
follow-up. Additionally, any unresolved AEs at the time of the follow-up visit will be recorded 
as ongoing and lost-to-follow-up. 

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9 
STUDY SCHEDULE 
Audio 
Processor 
Configuration 
Visit 1 
Take home 2 programs  
Visit 2 
Take home 2 programs  
Visit 3 
Take home 2 programs  
Visit 4 
Take home 2 programs 
Visit 5 
Speech in 
quiet (S0) 
Speech in noise 
(S0N0 & 
S0N0T0) 
Speech in noise  
Subjective Ratings 
Subjective Ratings 
SONNET 
Default SONNET 

 
 
x 
x 
SONNET 2 
OPUS 2 
 
 
 
 
 
SONNET 2 
Default SONNET 
 
 
 
 
 
SONNET 2 
SONNET 2/ 
Configuration 11  
 
 
 
 
 
SONNET 2 
SONNET 2 
Configuration 21 
 
 
 
 
 
SONNET 2 
SONNET 2 
Configuration 31 
 
 
 
x 
x 
SONNET 2 
SONNET 2/ 
Configuration 41 
 
 
 
x 
x 
Questionnaires   
SONNET: 
APSQ 
HISQUI 
SSQ 
SONNET 2: 
SONNET 22 
Questionnaire 
HISQUI 
SSQ 
SONNET 2: 
SONNET 22 
Questionnaire 
APSQ 
HISQUI 
SSQ 
SONNET 2: 
SONNET 22 Questionnaire 
HISQUI 
SSQ 
SONNET 2: 
SONNET 22 
Questionnaire 
HISQUI 
SSQ 
                                               
1 Details on all SONNET 2 configurations are described in Table 2 
2 The questionnaire will be completed for the SONNET 2 in the SONNET default configuration and one of the four SONNET 2 configurations 
(which will be randomised across subjects). 

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Screening and Upgrade Visit (1st study visit) 
Potential subjects will be approached and asked for their willingness to participate in the 
study. If they indicate interest, they will be informed about the study in detail, receive the 
information and consent form. The investigator will perform a chart review to determine 
suitability of the subject. 
If the subject voluntarily signs the consent and all inclusion/exclusion criteria are fulfilled the 
subject will be enrolled in the study. Appropriate fitting for the subject's SONNET will be 
confirmed according to clinical routine and then receive the upgrade to the SONNET 2. The 
SONNET 2 will be fitted based on the most current clinical map of the subject. Adjustments 
to the fitting map imported can be made if deemed necessary according to the clinical routine 
procedures.  Adjustments to the fitting maps across the study visits are possible if deemed 
necessary according to the clinical routine procedures. Clinical maps will be recorded as part 
of the study. 
For the duration of the study, the subject's own audio processor will be stored at the study 
site, and only be used at the follow-up test intervals by the subjects. 
 
Testing with the current audio processor (SONNET): 
• 
Speech test in quiet 
• 
User satisfaction and subjective rating via questionnaires 
 
Testing with the SONNET 2: 
• 
Speech test in quiet 
❖ Set-up as an OPUS 2 
❖ Set-up as an SONNET (without new front-end features) 
❖ Setting 1: ASC off, mild WNR, mild NR, mild TR 
❖ Setting 2: ASC off, mild WNR, strong NR, strong TR 
❖ Setting 3: ASC mild, mild WNR, auto NR, auto TR 
❖ Setting 4: ASC strong, strong WNR, auto NR, auto TR 
• 
Set the data logging in all configurations to zero  
• 
MAESTRO Export of all SONNET 2 configurations  
• 
Send subject home with two SONNET 2 configurations (randomized across subjects) and 
make sure data logging is on when the subject is send home 
• 
 

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Follow-up Visit 1 (2nd study visit) 
The first follow-up visit will be scheduled 2 weeks (±1 week) after the first study visit. 
During this visit, fittings of the SONNET and the SONNET 2 sor will be confirmed prior to any 
study test and only adjusted if needed. 
 
Testing with the current audio processor (SONNET): 
• 
Speech test in noise (S0N0) 
 
Testing with the SONNET 2: 
• 
User satisfaction and sound quality rating via questionnaires 
• 
MAESTRO Export of all SONNET 2 configurations including the data logging information 
• 
Speech test in noise (S0N0) 
❖ Set-up as an OPUS 2 
❖ Set-up as an SONNET (without new front-end features) 
❖ Setting 1: ASC off, mild WNR, mild NR, mild TR 
❖ Setting 2: ASC off, mild WNR, strong NR, strong TR 
❖ Setting 3: ASC mild, mild WNR, auto NR, auto TR 
❖ Setting 4: ASC strong, strong WNR, auto NR, auto TR 
• 
Speech test in noise (S0N0T0) 
❖ Set-up as an SONNET (without new front-end features) 
❖ Setting 1: ASC off, mild WNR, mild NR, mild TR 
❖ Setting 2: ASC off, mild WNR, strong NR, strong TR 
 
• 
Reset the data logging in all configurations 
• 
Send subject home with two SONNET 2 configurations (randomized across subjects) 
with data logging set to zero 
 
Follow-up Visit 2 (3rd study visit) 
The first follow-up visit will be scheduled 2 weeks (±1 week) after the second study visit. 
During this visit, fittings of the SONNET and the SONNET 2 or will be confirmed prior to any 
study test and only adjusted if needed. 

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Testing with the current audio processor (SONNET): 
• 
Speech test in noise (S0,  ±N45, ± N135) 
 
Testing with the SONNET 2: 
• 
User satisfaction and sound quality rating via questionnaires 
• 
MAESTRO Export of all SONNET 2 configurations including the data logging information 
• 
Speech test in noise (S0,  ±N45, ± N135)  
❖ Set-up as an OPUS 2 
❖ Set-up as an SONNET (without new front-end features) 
❖ Configuration 1: ASC off, mild WNR, mild NR, mild TR 
❖ Configuration 2: ASC off, mild WNR, strong NR, strong TR 
❖ Configuration 3: ASC mild, mild WNR, auto NR, auto TR 
❖ Configuration 4: ASC strong, strong WNR, auto NR, auto TR 
• 
Reset the data logging in all configurations 
• 
Send subject home with two SONNET 2 configurations (randomised across subjects) 
with data logging set to zero 
 
Follow-up Visit 3 (4th study visit) 
The first follow-up visit will be scheduled 2 weeks (±1 week) after the third study visit. 
During this visit, fittings of the SONNET 2 will be confirmed prior to any study test and only 
adjusted if needed. 
 
Testing with the SONNET 2: 
• 
User satisfaction and sound quality rating via questionnaires 
• 
MAESTRO Export of all SONNET 2 configurations including the data logging information 
• 
Subjective sound quality ratings (S0N0T0) and the ACALES test in noise (S0N0) to 
evaluate the NR and TR for the following audio processor configurations 
❖ Set-up as an OPUS 2 
❖ Set-up as an SONNET (without new front-end features) 
❖ Configuration1: ASC off, mild WNR, mild NR, mild TR 
❖ Configuration 2: ASC off, mild WNR, strong NR, strong TR 
• 
Reset the data logging in all configurations 

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• 
Send subject home with two SONNET 2 configurations (randomised across subjects) 
with data logging set to zero 
 
Follow-up Visit 4 (5th study visit) 
The first follow-up visit will be scheduled 2 weeks (±1 week) after the fourth study visit. 
During this visit, fittings of the SONNET 2 will be confirmed prior to any study test and only 
adjusted if needed. 
 
Testing with the SONNET 2: 
• 
User satisfaction and sound quality rating via questionnaires 
• 
MAESTRO Export of all SONNET 2 configurations including the data logging information 
• 
Subjective sound quality ratings (S0,  ±N45, ± N135, T135 ipsilateral to the CI) and the 
ACALES test in noise (S0, ±N45, ± N135) to evaluate the NR and TR for the following 
audio processor configurations 
❖ Set-up as an OPUS 2 
❖ Set-up as an SONNET (without new front-end features) 
❖ Configuration 1: ASC off, mild WNR, mild NR, mild TR 
❖ Configuration 2: ASC off, mild WNR, strong NR, strong TR 
 
Early Termination Visit 
If a subject withdraws from the study, he or she can do so during a regular study visit. In this 
case, the subject gives back the SONNET 2 audio processor and the centre gives him/her 
back their own SONNET audio processor and ensures that fitting is appropriate. In case a 
subject withdraws from the study outside of a study visits, an early termination visit shall be 
scheduled to follow-up on any potential open issues and document reasons for the 
withdrawal. During this visit, the subject gives back the SONNET 2 audio processor and the 
centre gives him/her back their own SONNET audio processor and ensures that fitting is 
appropriate. In any case, the case report form "Early Withdrawal Form" will be completed.  
 
Unscheduled Visit(s) 
In the case of any unexpected events, subjects may present at the clinic in-between regular 
study visits. During unscheduled visits the CRF "Unscheduled visit" shall be completed. 

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10 EQUIPMENT AND TEST METHODOLOGIES 
 Equipment 
 
MAESTRO Software 
Within the MED-EL Cochlear Implant System, MAESTRO 8 is used to program system 
components in order to achieve an optimal benefit for each individual implant patient. 
MAESTRO 8 consists of the software application, the installation program, and the 
accompanying labelling (instructions for use and CD labelling). Like its predecessor 
MAESTRO 7, MAESTRO 8 is designed and developed via the Microsoft .NET Framework 
and intended to be run on a personal computer that has a Microsoft Windows™ operating 
system installed. To communicate with implants and audio processors MAESTRO 8 uses the 
MAX Programming Interface which is connected via the standard USB 2.0 interface to the 
personal computer on which the software is running. 
With MAESTRO 8 it is possible to program the new SONNET 2 audio processor and the new 
front-end processing features can be activated. The SONNET 2 audio processor comes 
equipped with various new ASM features (e.g. noise reduction, transient reduction, and 
automatic scene classification).  
As MAESTRO 8 is a component of the MED-EL Cochlear Implant System, all indications 
stated for the MED-EL Cochlear Implant System are applicable. 
MAESTRO 8 is intended to be used: 
• 
In a clinical or office environment by persons adequately skilled and trained to perform all 
intended tasks 
• 
With patients who received one of the intended MED-EL cochlear implants 
• 
Installed on a Personal Computer running a version of the supported Microsoft Windows 
operating system 
• 
All tasks which can be performed are described in the MAESTRO 8 manual.  
 Tests/Material 
 
Impedance Field Telemetry (IFT) 
A telemetry recording will be performed according to the procedures explained in the MED-
EL Fitting Guide. The impedance field telemetry (IFT) recording ensures the proper function 
of the implant and measures impedances on all electrodes as well as the ground path.  

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These data form the basis of every clinical map and are necessary to interpret differences 
between fitting maps.  
 
Speech testing in quiet 
The Freiburg Monosyllabic test is an open-set monosyllabic word test and is widely used to 
test adults in German-speaking countries (K.-H. Hahlbrock & Zöllner, 1970; K. H. Hahlbrock, 
1970). It consists in total of 20 lists with 20 words each. Each patient shall perform a training 
starting the actual testing. The results scored in this training session will not be analysed. 
The test lists will be allocated according to a randomization procedure. The analysis 
evaluates the number of correctly repeated words in % correct at a fixed presentation level. 
Speech is presented at 65dB SPL. The test shall be performed in quiet. 
 
Speech testing in noise 
In this study speech audiometry in noise will be performed using Oldenburger matrix 
sentence tests (Wagener, Brand, & Kollmeier, 1999a, 1999b; Wagener, Kühnel, & Kollmeier, 
1999). 
Oldenburger matrix sentence tests are available as measurement modules of the Olden-
burger Measurement Application (OMA) (Hörtech GmbH). Matrix sentence tests will be used 
in the study, due to the sensitivity and applicability in a two-language study. Speech au-
diometry with the Oldenburger matrix sentence test using speech test material in the national 
language of the study site.  
The test is used to assess the 50% speech-recognition threshold (SRT50 in dB SNR), which 
is a measure of the level difference at which speech can be identified at half the time in 
presence of simultaneous masking noise.  
The sentences of matrix tests all are composed with the same structure. Test lists with 20 or 
30 items are generated from several such sentences. The words are taken in a seemingly 
random fashion from an inventory (a matrix) of 50 words (10 words per category).  
 
Subjective user ratings 
 
Audio Processor Satisfaction Questionnaire (APSQ) 
The APSQ is a validated general questionnaire which is designed to assess the handling of 
MED-EL devices. It assesses the wearing comfort, sound quality, and other device-specific 
factors related to the audio processor. The APSQ will be filled out by the patients at the first 
visit for the OPUS 2 before they get the SONNET and at the third visit for the SONNET.A 
copy of the completed questionnaire shall be sent to the study monitor. A copy of the 
completed questionnaire shall be sent to the study monitor. 

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Hearing Implant Sound Quality Index 19 (HISQUI19) 
The Hearing Implant Sound Quality Index 19 (HISQUI19) is a self-administered 
questionnaire to quantify the individual perceived sound quality of hearing implanted patients 
in daily life (Amann & Anderson, 2014). The questionnaire consists of 19 seven-level Likert 
items ranging from “always (99%)” to “never (1%)”. Added percentage values shall support 
the answering. Eight additional items assess the current sound sensation of the patients 
implanted. The HISQUI19 takes about 15 minutes to complete. It will be filled out by the 
patients at the first visit for the OPUS 2 before they get the SONNET and at the third visit 
(final visit) for the SONNET. Documentation of the results shall be recorded in the 
appropriate sections of the case report forms. A copy of the completed questionnaire shall be 
sent to the study monitor. 
 
SSQ12 (Speech Spatial Qualities) in German 
The speech, spatial, and qualities of hearing (SSQ) questionnaire is used in its shorter 12-
question version (Noble, Jensen, Naylor, Bhullar, & Akeroyd, 2013). The short version of the 
SSQ questionnaire provides similar results to the full version comprising 49 questions. A 
conversion formula between the abbreviated and full versions has been provided previously 
(Noble et al., 2013). The SSQ questionnaire is a sensitive and specific measure to assess 
the impact of hearing loss on speech perception, sound localization, and QoL. The SSQ12 
covers: 
• 
Hearing speech in a variety of competing contexts; 
• 
The directional, distance and movement components of spatial hearing 
• 
Segregation of sounds and attending to simultaneous speech streams; 
• 
Ease of listening; 
• 
The naturalness, clarity and identifiability of different speakers, different musical pieces 
and instruments, and different everyday sounds. 
SSQ12 has a scale from 0 (not at all) to 10 (perfectly) and allows to rate every answer 
everywhere inside that scoring frame. 
The SSQ12 will be filled out by the patients at the first visit for the OPUS 2 before they get 
the SONNET and at the third visit for the SONNET. A copy of the completed questionnaire 
shall be sent to the study monitor. 
 
SONNET 2 questionnaire 
A study specific questionnaire was developed to investigate how the four new SONNET 2 
fitting configuration compare to the previous SONNET settings. The questionnaire covers 
different everyday situations (e.g. conversations in a cocktail party setting, speech different 
background noise situations, music etc.). The subjects are asked to state which fitting 

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configuration is preferred and give a reason why. Additionally, there are blank spaces which 
each subject can state situations which are important to each individual, state their preferred 
fitting and also tick why a particular fitting was preferred.  
 
Subjective sound quality rating 
In addition to questionnaires, subjects are asked to subjectively rate the sound quality of the 
different fitting configuration. The subjective sound quality of the different SONNET 2 
configurations will be assessed on a visual analogue scale (VAS) for a range of signals 
comprising different samples of speech, music, and background noises. The subject will 
have to rate the perceived quality on different scales, compared to a reference condition.  
 
ACALES Test  
To evaluate the listening effort induced by different configurations, the ACALES test will be 
performed (Krueger & Schulte, 2017). In this test, the subject will listen to speech in noise 
and rate the subjectively perceived listening effort on a scale from “effortless” to “extremely 
effortful”. Depending on the rating of the subject, the level of the speaker will be varied 
adaptively while the noise level is kept constant.  This test will be performed in different fitting 
configurations. 
 

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11 STUDY PROCEDURES 
 Demographics and Medical Data 
The Investigator will record age and gender of the subject. Demographic data will be 
recorded in the appropriate section of the CRF at the screening visit and confirmed at every 
subsequent visit by the Investigator, as applicable 
 Medical History 
Generally, the Investigator will record the medication history according to clinical standards in 
order to evaluate whether the subjects fulfils indication and inclusion criteria and does not 
fulfil any contraindications or exclusion criteria for CI surgery in general and for the study 
participation in particular. Results from the examination will be reported in the respective 
CRFs as applicable. 
 Medication 
The Investigator will record the medication history according to clinical standards in order to 
evaluate whether the subject fulfils indication and inclusion criteria of the study. Results from 
the examination will be reported in the respective CRFs as applicable. 
 Compliance with the Selection Criteria 
During the screening visit the Investigator thoroughly evaluates whether a subject meets the 
selection criteria and can be enrolled into the study. This does not imply that the subject 
needs to perform any kind of study specific testing. In case a subject meets the criteria and is 
willing to participate, the Investigator will explain all the involved procedures, risks and 
benefits of the clinical investigation understandably and will answer all upcoming questions. 
The subject will read the ICF, sign and date it. A written copy of the ICF will be given to the 
subject and can be taken home.  The compliance of the subject with the study inclusion and 
exclusion criteria will be documented in the appropriate section of the CRF at each visit by 
the Investigator. 

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 Special Tests/Procedures 
 
Fitting procedure 
Appropriate fitting for the subject's SONNET will be confirmed according to clinical routine 
and then receive the upgrade to the SONNET 2. The SONNET 2 will be fitted based on the 
most current clinical map of the subject. Adjustments to the fitting map imported can be 
made if deemed necessary according to the clinical routine procedures.  Adjustments to the 
fitting maps across the study visits are possible if deemed necessary according to the clinical 
routine procedures. Clinical maps will be recorded as part of the study. 
 
Telemetry (IFT) recording 
Perform a routine telemetry recording as explained in the MAESTRO user guide. There are 
no parameters to be adjusted. Save the telemetry recording in MAESTRO and rename it 
according to the following scheme: “SubjectID_IFT_visit name”.  
 
MCL and THR recording 
The standard fitting procedure as implemented at the study centre as per clinical routine will 
be used to determine MCL and THR levels. Briefly, THR and MCL levels are measured using 
verbal feedback from the patient. THR levels may be obtained using an ascending 
presentation, followed by a standard bracketing procedure. MCLs are obtained through a 
method referred to as loudness scaling. The level of current is gradually increased, while the 
patient reports on the level of loudness and comfort. Ideally, MCL levels should also be 
balanced across the electrode array. Loudness balancing requires comparison on at least 
two electrodes at a time until all MCLs are perceived as equally loud. After adjusting the 
parameters according to the subject's needs, save the THR and MCL recording in 
MAESTRO and rename it according to the following scheme: “SubjectID_THRs_visit name” 
and “SubjectID_MCLs_visit name”. 
 
Speech testing 
 
Freiburg Monosyllables 
The Freiburg Monosyllables in quiet will be implemented according to the routine testing 
approach at the study centre. The results are recorded and expressed in % correct and 
reported in the CRFs. 

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OLSA 
The Oldenburger Matrix Sentence Test will be performed according to the specification in the 
case report form (e.g. order of configuration etc.). Prior to the test lists, a training round will 
be performed at each visit. Noise level will be fixed to 60 dB SPL and the speech level will be 
adaptive. 
The OLSA will be performed indifferent set-ups (also see Figure 1): 
• 
S0N0 
Speech and noise signal are both presented from the front of the subject (0° angle). 
• 
S0N0T0 
Speech, noise and transient noise are presented from the front of the subject (0° angle). 
 
• 
S0,  ±N45N, ± N135 
Speech in presented from the loudspeaker in front of the subject (0°angle). Stationary noise 
presented from +45° and -45° angle and +135° and -135° angle.  
 
 
Figure 1 Loudspeaker set-up 
 
Subjective user ratings 
 
Audio Processor Satisfaction Questionnaire (APSQ) 
The APSQ will be completed by the subject. An instruction is given in the questionnaire 
document. These data are considered source data. 
45°
135°
-45°
-135°

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Hearing Implant Sound Quality Index 19 (HISQUI19) 
The HISQUI will be completed by the subject. An instruction is given in the questionnaire 
document. These data are considered source data. 
 
SSQ12 (Speech Spatial Qualities) in German 
The SSQ12 will be completed by the subject. An instruction is given in the questionnaire 
document. These data are considered source data. 
 
SONNET 2 questionnaire 
The SONNET 2 Questionnaire will be completed by the subject. An instruction is given in the 
questionnaire document. These data are considered source data. 
 
Subjective rating 
 
ACALES Test  
To evaluate the listening effort induced by different configurations, the ACALES test will be 
performed. In this test, the subject will listen different sound files and rate the subjectively 
perceived listening effort on a scale from “effortless” to “extremely effortful”. Depending on 
the rating of the subject, the level of the signal will be varied adaptively while the noise level 
is kept constant, 
The ACALES will be performed in different set-ups (also see Figure 1): 
• 
S0N0 
Speech and noise are both presented from one loudspeaker being in front of the subject (0° 
angle). 
S0,  ±N45, ± N135 ±Speech is presented from the loudspeaker in front of the subject 
(0°angle). Stationary noise is presented from +45° and -45° angle and +135° and -135° 
angle.  
 
Subjective sound quality rating 
The subjective sound quality of the different configurations will be assessed on a visual 
analogue scale (VAS) for a range of signals. The subject will have to rate the perceived 
quality on different scales, compared to the reference condition (Set-up as an SONNET 
(without new front-end features). 
• 
Overall quality: Scale ranging from ‘Much better’ to ‘Much worse’ 

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• 
Listening effort: Scale ranging from ‘Much less effortful’ to ‘Much more effortful’ 
• 
Listening comfort: Scale ranging from ’Much more comfortable’ to ’Much less 
comfortable’ 
• 
Annoyance of background signal: Scale ranging from ‘Much less annoying’ to ‘Much 
more annoying’ 
• 
Acceptability of the program (no reference necessary): ‘Not acceptable’ to ‘Very 
acceptable’ 
 
Scientific data export 
After each take home period, the data of all configurations is exported and saved using the 
scientific export of MEASTRO. This data contains, among others, the logging data 
information (e.g., the processor usage, exposure time in the different audio environments, 
etc.) and enables to draw a relation between subjective ratings (questionnaires) and 
exposure to various audio environments during the take home periods. 
 Randomization 
The order of the audio processor testing (see Section 9 for details) will be randomised for 
each subject and study visit. Additionally, it will be randomised, which audio processor 
configurations will be taken home after a particular visit. These randomizations will be 
performed to avoid any sequence-effects (e.g. training effect, fatigue effect). The particular 
fitting configuration and the order of the test procedures is verbally stated in the respective 
CRFs for each subject and each study visit. Hence, no de-randomisation procedure is 
necessary. 
 

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13 STUDY MONITORING 
The Monitor is appointed by MED-EL and is responsible for monitoring this investigation in 
accordance with the relevant MED-EL SOPs (SOPs), the principles of ISO 14155:2011, the 
most recent version of the Declaration of Helsinki and all national and international 
requirements. 
A detailed description of the Monitoring activities can be found in the “Monitoring Plan”. 

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14 DATA HANDLING AND RECORD KEEPING 
The study site is responsible to ensure the accuracy, completeness, legibility, and timeliness 
of the data reported. All source documents should be completed in a neat, legible manner to 
ensure accurate interpretation of data. Dark ink (preferentially BLUE INK) is required to 
ensure clarity of reproduced copies. When making changes or corrections, cross out the 
original entry with a single line, and initial (or sign) and date the change. DO NOT ERASE, 
WRITE OVER, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 Source Data 
The participating study centres will store all source data acquired during the study according 
to routine procedures. If source data is recorded directly on a CRF, this shall be stated. 
 Study Records 
During the study, the Investigator will maintain complete and accurate documentation of the 
study procedures, including medical records, records detailing the progress of the study for 
each subject, test reports, CRFs, signed ICFs, correspondence with the relevant IEC(s) and 
NCA(s), the Monitor, the Clinical Support Staff, the Clinical Research Manager or MED-EL in 
general, serious adverse reports and information regarding subject screening, enrolment, 
discontinuation, and completion of the study.  
Data on subjects collected on CRFs will be documented in an anonymous fashion in such a 
way that a subject will not be identifiable from the information recorded on the CRF. The 
confidentiality of those documents, which could identify the subjects, shall respect the 
subjects’ privacy and the standard of confidentiality in accordance with the applicable 
regulatory requirements. The study site will maintain a subject identification code list. 
 Case Report Forms (CRFs) 
In compliance with the principles of ISO 14155:2011, the Declaration of Helsinki as amended 
in Fortaleza (2013) and all national and international requirements, the medical records, 
medical notes and other source documents have to be clearly marked and permit easy 
identification of participation by an individual in the specified clinical trial. 
All study data will be documented by the Investigator directly into the CRF provided by MED-
EL. 
The PI may designate authority to complete the CRF to appropriately qualified staff. This has 
to be documented by completing and signing the “Delegation of Responsibility Log”. At study 
closure, if not present already, hardcopies of the finalized CRFs are generated and signed to 

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confirm the accuracy and completeness of all the data. A full audit trail of all changes to CRF 
data shall be available. 
 Record Retention 
Upon completion of the study, the Investigator shall maintain all study records in a safe and 
secure location. 
All study related documents shall be kept by the Investigator for the maximum period of time 
required by local regulations. No study document shall be destroyed without prior written 
agreement between the Investigator and MED-EL. Should the Investigator decide to assign 
the study documents to another party, or move them to another location, MED-EL and the 
Coordinating Investigator (if applicable) shall be notified. 
The Investigator is responsible for archiving all source documents and the study 
documentation (including copies of the CRFs) as required by national laws and regulations. 
The Investigator will retain all study records according to the Clinical Investigation 
Agreement.  
If the Investigator is withdrawn or decides to leave the study (for any reason), the records 
shall be transferred to another person whose designation has been mutually agreed. The 
written notification of this transfer shall be sent to MED-EL and the Coordinating Investigator 
(if applicable). 
All data archived during the clinical study will be completely accessible for medical purposes 
to the staff of the associated study centres. The publication policy concerning the results of 
the clinical study is described in section 19. 
 Data Management 
A detailed description of the data management designed for this study, including methods 
and data cleaning can be found in the “Data Management Plan”. 
• 
Quality Control and Quality Assurance 
Quality assurance and quality control principles in full accordance with ISO 13485 will be 
applied to all the processes of this clinical study.  
MED-EL will implement and maintain written clinical quality procedures to ensure that the 
clinical investigation is designed, conducted and monitored, and that data are generated, 
documented, recorded and reported in compliance with the relevant MED-EL SOPs, the 
principles of ISO 14155:2011, the Declaration of Helsinki as amended in Fortaleza (2013) 
and all national and international requirements.  
Furthermore, MED-EL will maintain records to document the compliance of all parties 
involved in this clinical study and ensure that the auditing requirements in accordance with 

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the relevant MED-EL SOPs and ISO 14155:2011 are met. Significant exceptions will be 
documented and justify as appropriate. 

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15 STATISTICAL ANALYSIS 
 Statistical Analysis Methods 
Descriptive statistics will be calculated to report patients’ baseline characteristics (e.g. age, 
gender) and to describe test outcomes. The mean, standard deviation (SD) and/or median 
with range (minimum and maximum) will be used to describe quantitative data; absolute and 
relative frequencies will be used to present qualitative data. 
Inferential statistics: Data will be analysed based on the objectives and the formulated 
hypotheses described in sections 5 and 6. To choose whether a parametric or a non-
parametric test shall be applied, the Kolmogorov-Smirnov test and a graphical examination 
will be used before to check the data distribution.  
 
Primary Objectives  
A difference between SONNET2 in a OLSA in noise speech test (S0N0) and the SONNET 
shorter than 2 dB SNR (∆) is not seen as a clinically relevant difference (Hey et al., 2014; 
Nogueira et al., 2016). A statistical significant difference will be examined applying Student’s 
t-test or Wilcoxon signed-rank test. 
 
Secondary Objectives  
 
Speech performance 
Speech performance of the SONNET2 will be assessed with different combinations of 
frontend processing features under different environmental test conditions using the following 
tests: 
• 
Freiburg Monosyllabic test in quiet; speech presented from the front 
• 
Oldenburg Sentence Test in noise in the set-ups: 
❖ S0N0 
❖ S0, N0, ±N45, ± N135 
A statistical significant difference will be examined applying Student’s t-test or Wilcoxon 
signed-rank test. 
 
Subjective feedback 
• 
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❖ HISQUI19 
❖ SSQ12 
• 
Device handling 
❖ Data Logging 
❖ APSQ 
• 
Sound Quality 
❖ ACALES 
❖ SONNET 2questionnaire 
The secondary objectives are exploratory and will be analysed descriptively. If applicable (i.e. 
if total score and/or subscales are existing), a statistical significant difference between the 
different test intervals will be examined applying Student’s t-test or Wilcoxon signed-rank 
test. 
 Plan for Interim Analyses  
No interim analysis is planned. 
 Handling of Missing Data 
Missing data will be treated as missing values.  
 Reporting Conventions 
Statistical significance is set to p≤0.05. The corresponding confidence level is 95%. 
 Presentation of Data 
The results of the data analyses may be presented in tables and/or displayed in graphs 
depending on their nature and meaning. 
 Computer Systems and Packages  
IBM SPSS Statistics 24 (IBM, Armonik, New York) and STATISTICA 13 will be used for the 
analyses. Graphs will be created in Microsoft Office Excel (http//www.microsoft.com). 
A more detailed description of the statistical analysis planned for this study, including 
methods and sampling are described in the “Statistical Analysis Plan”. 

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16 STUDY CLOSE-OUT 
The study close-out comprises the following activities. Ensuring that:  
• 
All essential documents are complete and up-to-date  
• 
All Case Report Forms are completed  
• 
All outstanding queries are resolved  
• 
The current status of all on-going Adverse Events is documented  
• 
Arrangements are made for archiving and record retention  
• 
All materials are appropriately disposed of  
• 
Notification to the relevant Independent Ethics Committee (IECs)  
The Monitor will notify the Investigator when the entire study is complete. A letter to the 
Investigator will be sent notifying them of a “closed status” following completion of all 
requirements of the Study Plan and regulatory bodies. 
 

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18 ETHICS AND PROTECTION OF HUMAN SUBJECTS 
 Ethical and Regulatory Considerations 
The Coordinating Investigator (if applicable) and MED-EL or their designees will submit the 
protocol for review by the relevant IEC(s) and NCA(s), according to national legislation, and 
agree to provide the relevant IEC(s) and NCA(s) with all appropriate materials. No subject 
will be admitted to this study until appropriate relevant IEC(s) and NCA(s) approval of the 
protocol has been received and the Investigator has obtained the signed and dated ICF. 
Appropriate reports on the progress of this study will be made to the relevant IEC(s) and 
NCA(s) by MED-EL and the Coordinating Investigator (if applicable), in accordance with 
applicable local regulations and in agreement with the policy established by the relevant 
IEC(s) and NCA(s) as well as with MED-EL relevant SOPs. The Coordinating Investigator (if 
applicable) and MED-EL will inform the relevant IEC(s) and NCA(s), if appropriate, of 
subsequent protocol amendments and any AE occurring during the study as described in 
section 12. The Investigator shall ensure that the study will be carried out in compliance with 
the protocol, the principles of ISO 14155:2011, the Declaration of Helsinki as amended in 
Fortaleza (2013) and all national and international requirements. 
 Informed Consent Process 
Acquisition of consent is the step by which subjects are enrolled into the study. No study 
specific procedures shall be performed unless the information and consent process was 
conducted and fully documented by signing and dating the ICF. Only the PI or study 
personnel expressly acting on behalf of the PI (as reported in the relevant Delegation of 
Responsibilities Log) may administer consent. The person conducting the information 
conversation shall speak the native language of the subject. This person will thoroughly 
explain to the subject the purpose and methods of the study, the background and the present 
knowledge of the study treatment with special reference to known activity and side effects. 
The person conducting the information conversation shall also ensure that the following 
requirements are fulfilled: 
• 
The subject shall be provided with the ICF consistent with the protocol version used and 
approved by the relevant IEC(s) 
• 
The subject shall be thoroughly informed about risks, contraindications and expected 
benefit of the investigational treatment 
• 
The subject will be given sufficient time and opportunity to inquire about the details of the 
trial and to discuss and decide on their participation in the study with the Investigator. 
• 
The written consent shall be obtained before the enrolment in the study.  

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• 
The subject and the Investigator with whom they discussed the ICF will sign and date the 
ICF. A copy of the signed ICF will be kept by the subject and the original filed in the ISF 
unless otherwise agreed. 
• 
The subject may refuse treatment either before or at any time during the study. Refusal to 
participate will involve no penalty or loss of benefits to which the subject is otherwise 
entitled. Similarly, the Investigator and/or MED-EL will be free to withdraw the subject at 
any time for safety or administrative reasons. 
• 
Any other requirements necessary for the protection of the human rights of the subject 
will also be explained, according to the principles of ISO 14155:2011, the Declaration of 
Helsinki as amended in Fortaleza (2013) and all national and international requirements. 
• 
The subject shall be given information about whom to contact for answers to questions 
pertinent to the research and the research subject’s rights, and whom to contact in the 
event of a research-related injury. 
• 
If the ICF is updated to include protocol changes, all the subjects affected by such 
changes shall sign and date a new ICF mirroring such changes, with the following 
exceptions: 
❖ The subject is clearly not affected by the changes 
❖ The changes do not have any clinical and/or ethical relevance (reformulation of 
sentences maintaining the same meaning, spelling, etc.) 
❖ The subject has already completed the study 
The above requirements shall also apply with respect to informed consent obtained from a 
subject's legally authorized representative. 
 
Subjects needing legally authorized representatives 
Informed consent may be given by the legally authorized representative only if a subject is 
unable to make the decision to participate in a clinical investigation (e.g. infant, child and 
juvenile, seriously ill or unconscious subject, mentally ill person, mentally handicapped 
person). In such cases, the subject shall also be informed about the clinical investigation 
within his/her ability to understand. 
 
Subjects unable to read or write  
Informed consent shall be obtained through a supervised oral process if a subject or legally 
authorized representative is unable to read or write. An independent witness shall be present 
throughout the process. The written informed consent form and any other information shall 
be read aloud and explained to the prospective subject or his/her legally authorized 
representative and, whenever possible, either shall sign and personally date the informed 
consent form. The witness also signs and personally dates the informed consent form 

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attesting that the information was accurately explained and that informed consent was freely 
given. 
 Subject Confidentiality 
The study protocol, documentation, data, and all other information generated will be kept in 
strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party, without prior written approval of MED-EL.  
The Investigator will guarantee that all persons involved will respect the confidentiality of any 
information concerning the investigation subjects. 
All parties involved in a clinical investigation will maintain the strict confidentiality to assure 
the protection of privacy of a subject participating in the clinical investigation. Likewise, the 
appropriate measures shall be taken to avoid the access of non-authorized persons to the 
trial data. The processing of the personal data on the subjects taking part in this trial, shall 
comply with the local law on privacy.  
All information provided to the Investigator by MED-EL will be kept strictly confidential and 
confined to the clinical personnel involved in conducting the trial. Such personnel will be 
informed of the confidential nature of the information. It is recognized that this information 
may be communicated in confidence to the relevant IEC(s). In addition, no reports or 
information about the trial or its progress will be provided to anyone not involved in the trial 
other than MED-EL or in confidence to the relevant IEC(s), except if required by applicable 
law, regulation or court order. 
In the event the Investigator is requested or required by applicable law, regulation or court 
order to disclose any confidential information contained in this protocol, such Investigator 
shall give prompt notice to MED-EL, so that MED-EL may seek a protective order or take 
other measures reasonable in light of the circumstances. 
All data provided to MED-EL will be identified by a unique subject ID, thereby ensuring that 
the subject’s identity remains unknown. The subjects should be informed in writing, that their 
data will be stored and analysed in a computer, with confidentiality maintained in accordance 
with local regulations. 
The subjects should also be informed in the form of a written documentation that authorized 
representatives of MED-EL and/or regulatory authorities may require access to those parts of 
the site records (relevant to the study), including medical history, for data verification. 
The Investigator is responsible for keeping a subject identification list of all subjects screened 
and enrolled.  

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20 REFERENCES 
 
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134(9), 915-923. doi:10.3109/00016489.2014.909604 
Cacace, A. T., Kleine, E. d., Holt, A. G., & Dijk, P. v. (2016). Scientific foundations of 
audiology : perspectives from physics, biology, modeling, and medicine.  
Chow, S.-C., Shao, J., & Wang, H. (2008). Sample size calculations in clinical research. 
Boca Raton: Chapman & Hall/CRC. 
Finke, M., Strauss-Schier, A., Kludt, E., Buchner, A., & Illg, A. (2017). Speech intelligibility 
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Fu, Q. J., & Shannon, R. V. (1999). Effect of acoustic dynamic range on phoneme 
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Hagen, R., Stark, T., Radeloff, A., Anderson, I., Nopp, P., Aschbacher, E., . . . Rak, K. (In 
submission). Microphone directionality and wind noise reduction enhance speech 
perception in users of the MED-EL SONNET audio processor. Ear and Hearing.  
Hahlbrock, K.-H., & Zöllner, F. (1970). Sprachaudiometrie: Thieme. 
Hahlbrock, K. H. (1970). Sprachaudiometrie: Grundlagen und praktische Anwendung einer 
Sprachaudiometrie für das deutsche Sprachgebiet: Thieme Georg Verlag. 
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sentence test in noise: Reproducibility and discrimination function in cochlear implant 
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Krueger, M., & Schulte, M. (2017). Development of an adaptive scaling method for subjective 
listening effort. The Journal of the Acoustical Society of America, 141(6), 4680-4693. 
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Nelson, P. B., Jin, S. H., Carney, A. E., & Nelson, D. A. (2003). Understanding speech in 
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Acoust Soc Am, 113(2), 961-968.  
Noble, W., Jensen, N. S., Naylor, G., Bhullar, N., & Akeroyd, M. A. (2013). A short form of 
the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the 
SSQ12. Int J Audiol, 52(6), 409-412. doi:10.3109/14992027.2013.781278 
Nogueira, W., Rode, T., & Buchner, A. (2016). Spectral contrast enhancement improves 
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Schafer, E. C., & Thibodeau, L. M. (2004). Speech recognition abilities of adults using 
cochlear implants with FM systems. J Am Acad Audiol, 15(10), 678-691.  
Stickney, G. S., Zeng, F. G., Litovsky, R., & Assmann, P. (2004). Cochlear implant speech 
recognition with speech maskers. J Acoust Soc Am, 116(2), 1081-1091.  
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Wagener, K., Brand, T., & Kollmeier, B. (1999b). Development and evaluation of a German 
sentence test part III: Evaluation of the Oldenburg sentence test. Zeitschrift Fur 
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personal FM systems. J Am Acad Audiol, 19(8), 585-594.  
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doi:10.1177/108471380400800102 
Zeng, F. G., & Galvin, J. J., 3rd. (1999). Amplitude mapping and phoneme recognition in 
cochlear implant listeners. Ear Hear, 20(1), 60-74.  
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21 Appendices 
 Appendix 1 
User Manual for "SONNET 2 (Me1510) and SONNET 2 EAS (Me1520) audio processors"