Clinical Investigation of the Safety and Performance of HiRes Ultra Cl HiFocus MS Electrode (Cl-1600-04) and HiRes Ultra 3D Cl HiFocus MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss
Conditions: Cochlear Hearing Loss
Sponsor: Advanced Bionics AG

 
                   D000024175 Rev A 
        Laubisrütistrasse 28, 8712 Stäfa, Switzerland            +41.58.928.70.00 
            info.switzerland@advancedbionics.com 
STUDY PROTOCOL – COVER PAGE 
 
Title: Clinical Investigation of the safety and performance of HiRes T M 
Ultra Cl HiFocus T M MS Electrode (Cl-1600-04) and HiRes T M Ultra 3D Cl 
HiFocus T M MS Electrode (Cl-1601-04) (Ultra X) in adults with severe -to-
profound hearing loss  
 
Sponsor: Advanced Bionics AG 
 
Project ID: ABInt l-19-44 
 
ClinicalTrials.gov ID: NCT04610112 
 
Date of the document: 12 January 2022 
 
 
 

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A B Intl-19-44
CIP approval page
S tudy title : 
C linical Investigation o f the safety and perform ance o f H iR es™ U ltra C I
H iF ocus™ M S E lectrode (C l-1600-04) and H iR es™ U ltra 3D C I H iFocus™ M S 
E lectrode (C I-1601-04) (U ltra X ) in adults w ith severe-to-profound hearing loss
S tudy com pliance : 
IS O 14155:2011, 90/385/E E C
IC H -G C P and D eclaration o f H elsinki 
A B S tudy N um ber/ C IP N um ber: 
A B Intl-19-44
09/07/2020
S um m ary of the revision history in th e case o f am endm ents no am m endm ents
Protocol Commitment - Signatures
W e have read and understood this protocol and agree on its content. W e agree to conduct the 
study in accordance w ith the com pliance and com m itm ents as stated in this protocol. In 
addition, the signatories o f this protocol (below ) and delegates w ill assum e responsibility for 
protocol com pliance fo r persons to w hom  they delegate study related tasks. T his docum ent is 
the property o f A B A G . It is at confidential disposal to th e study participants. It m ay not be 
used, divulged, published or otherw ise disclosed w ith ou t the consent o f the C oordinating 
Investigator and the A dvanced B ionics S enior M anager o f C linical R esearch. (Please Use blue 
ink)
Centre: ZH G @ U nfallkrankenhaus B erlin
N am e o f Coordinating investigator: P rof. D r. E rnst
D ate: 
July, 9 th, 2020 
S ignature:
Centre II: U niversity M edical C entre M annheim
D ate: 
S ignature:
C entre IV:
S ervais_C R _A B Intl-19-44 U ltraX _ P M C F _ C IP _ 2 00 7 09 a _A n n ex2 _ E W .d ocx  
D000015927 CIP Template Form; Rev. F
P age 3 o f41
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ABIntl-19-44
CIP approval page
Study title: 
Clinical Investigation of the safety and performance of HiRes™ Ultra CI
HiFocus™ MS Electrode (Cl-1600-04) and HiRes™ Ultra 3D CI HiFocus™ MS 
Electrode (Cl-1601-04) (Ultra X) in adults with severe-to-profound Hearing loss
Study compliance: 
ISO 14155:2011, 90/385/EEC
ICH-GCP and Declaration of Helsinki 
AB Study Number/ CIP Number: 
ABIntl-19-44
09/07/2020
Summary of the revision history in the case of amendments no ammendments
Protocol Commitment-Signatures
We have read and understood this protocol and agree on its content. We agree to conduct the 
study in accordance with the compliance and commitments as stated in this protocol. In 
addition, the signatories of this protocol (below) and delegates will assume responsibility for 
protocol compliance for persons to whom they delegate study related tasks. This document is 
the property of AB AG. It is at confidential disposal to the study participants. It may not be 
used, divulged, published or otherwise disclosed without the consent of the Coordinating 
Investigator and the Advanced Bionics Senior Manager of Clinical Research. (Please Use blue 
ink)
Centre: ZHG @ Unfallkrankenhaus Berlin
Name of Coordinating investigator: Prof. Dr. Ernst
Date: 
July, 9th, 2020 
Signatare:
Centre II: University Medical Centre Mannheim
Name of Principal Investigator III:_____________
Date: 
Signatare:
Centre IV:____________________________________
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Table of Contents 
CIP APPROVAL PAGE ............................................................................................................................................. 3 
TABLE OF CONTENTS ............................................................................................................................................. 5 
LIST OF ABBREVIATIONS ........................................................................................................................................ 6 
1.0 CLINICAL INVESTIGATION SYNOPSIS.............................................................................................................. 7 
1.1 SYNOPSIS (DEUTSCH) .......................................................................................................................................... 9 
2.0 IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE .......................................................12 
3.0 JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION .............................................................15 
4.0 RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION..............................18 
5.0 OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION ................................................................20 
6.0 DESIGN OF THE CLINICAL INVESTIGATION ....................................................................................................21 
6.1 GENERAL ........................................................................................................................................................ 21 
6.2 INVESTIGATIONAL DEVICE(S) AND COMPARATOR(S) ................................................................................................. 23 
6.3 SUBJECTS ....................................................................................................................................................... 24 
6.4 PROCEDURES .................................................................................................................................................. 25 
6.5 MONITORING PLAN .......................................................................................................................................... 28 
6.5.1 
Pre-Study Documentation Requirements ....................................................................................... 28 
6.5.2 
Study Documentation/Case Report Forms ..................................................................................... 29 
6.6 INTERIM MONITORING ACTIVITIES ....................................................................................................................... 29 
6.7 CLOSE-OUT MONITORING ACTIVITIES .................................................................................................................. 29 
6.8 MANAGEMENT OF SITE NONCOMPLIANCE ............................................................................................................ 30 
6.9 DOCUMENTATION AND RECORDS ........................................................................................................................ 30 
6.10 COMPENSATION .............................................................................................................................................. 30 
7.0 STATISTICAL CONSIDERATIONS ....................................................................................................................31 
8.0 DATA MANAGEMENT ...................................................................................................................................33 
9.0 AMENDMENTS TO THE CIP ...........................................................................................................................33 
10.0 DEVIATIONS FROM CLINICAL INVESTIGATION PLAN .....................................................................................34 
11.0 DEVICE ACCOUNTABILITY .............................................................................................................................34 
12.0 STATEMENTS OF COMPLIANCE ....................................................................................................................35 
13.0 INFORMED CONSENT PROCESS ....................................................................................................................35 
14.0 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES .....................................................36 
15.0 VULNERABLE POPULATION ..........................................................................................................................39 
16.0 SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION .........................................39 
17.0 PUBLICATION POLICY ...................................................................................................................................39 
18.0 BIBLIOGRAPHY .............................................................................................................................................39 
APENDIX:..............................................................................................................................................................41 
A 
MRI WARNING ............................................................................................................................................... 41 
B 
QUESTIONNAIRES ............................................................................................................................................. 41 
 
 
 

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List of Abbreviations 
 
AB AG 
Advanced Bionics, AG  
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CIP 
Clinical Investigation Plan  
CPM 
Clinical Project Manager 
CRF 
Case Report Forms  
eCRF 
electronic CRF 
ePTFE 
fluorocarbon polymer 
dB 
Decibel 
DMC 
Data Monitoring Committee 
E-Field [V/m] 
Electric field [volt per meter] 
FU 
Follow Up 
HA 
Hearing Aid 
HFMS 
HiFocus Mid Scala electrode array 
Hz  
Hertz 
ICF 
Informed Consent Form 
ICS  
implantable cochlear stimulator 
kV/m 
kilovolt per meter 
M-field [A/m] 
Magnetic Field [Ampère per meter] 
MHz 
Megahertz 
OlSa 
Oldenburger Satztest (Oldeburger sentence test) 
PMCF 
Post Marketing Clinical Follow up 
RF 
Radio Frequency 
RW 
Round Window 
QMS 
Quality Management System 
SADE 
Serious Adverse Device Effect 
SAE  
Serious Adverse Event 
SRT 
Speech Reception Threshold 
T 
Tesla 
TENS 
Transcutaneous Electrical Nerve Stimulation 
UADE 
Unanticipated Adverse Device Effect 

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1.0 Clinical Investigation Synopsis 
Study Title 
Clinical Investigation of the safety and performance of HiResTM Ultra Cl 
HiFocusTM MS Electrode (Cl-1600-04) and HiResTM Ultra 3D Cl HiFocusTM MS 
Electrode (Cl-1601-04) (Ultra X) in adults with severe-to-profound hearing loss 
Sponsor  
Advanced Bionics AG 
Device 
HiRes™ Ultra 3D CI HiFocus™ Mid-Scala Electrode (CI-1601-04) 
HiRes™ Ultra CI HiFocus™ Mid-Scala Electrode (CI-1600-04) 
Study Design 
Prospective within-subjects repeated-measures design where each subject 
serves as his/her own control 
Regulatory 
Objective 
Post Market Clinical Follow 
Study Population 
30 adult subjects with valid and useable data 
Inclusion Criteria 
• No previous experience with any auditory implant 
• 18 years of age or older 
• Postlingual onset of severe hearing loss (≥ 4 years of age) 
• Limited benefit from appropriately fitted hearing aids, defined as scoring 
60% or less in Freiburger Monosyllabic word test 
• German language proficiency 
• Willingness to participate in all scheduled procedures outlined in the 
protocol 
Exclusion Criteria 
• Cochlear malformation or obstruction that would preclude full insertion of 
electrode array.  
• Presence of additional disabilities that would prevent or interfere with 
participation in the required study procedures  
• Medical or psychological conditions that contraindicate surgery or impact 
the ability to manage an implanted device or the study related procedures 
• Evidence of central auditory lesion or compromised auditory nerve 
• Pregnancy at time of surgery. 
 
Primary 
Efficacy 
Objective 
The primary efficacy objective is to demonstrate that mean monosyllabic word 
recognition score with the Ultra X used in combination with a sound processor 
programmed with the latest fitting software is at least 20% better than the 
mean monosyllabic word score at baseline with conventional amplification in 
the same ear. 
Secondary 
Efficacy Objective 
The secondary efficacy objective is to demonstrate that mean sentence score 
in noise with the Ultra X are equal or better than sentence scores in noise at 
baseline with conventional amplification in the same ear. 
Primary 
Safety 
Objective 
The primary safety objective is to document any adverse events related to 
Ultra X that require device replacement.  
Primary 
Efficacy 
Endpoint 
The primary efficacy endpoint is the Freiburger monosyllabic word recognition 
score in the implanted ear six months after device activation compared to the 
baseline score with a hearing aid in the same ear. 
Secondary 
Efficacy Endpoint 
50% speech reception threshold in the Oldenburger Sentence Test (OlSa) in 
noise  in the implanted ear six months after device activation compared to 

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baseline performance with conventional amplification in the same ear. 
Primary 
Safety 
Endpoint 
A maximum of one device failure that require device replacement during the 
first six months following device activation (activation approximately one to 
eight weeks after surgery). 
PMCF objective  
(if required) 
Primary and secondary efficacy objectives and safety objectives are the PMCF 
objective. 
Additional 
Interest 
• Device fitting data, especially M-level and impedances 
• Feedback of the audiologist using the latest fitting software to program 
the latest processor  
• Feedback from the surgeon on handling of the device and tools during 
implantation 
• Using habits of participants as summarized in the logging of the 
processor and assessed in a patient questionnaire 
• Monitoring of potential adverse events 
Additional 
Evaluation 
• Descriptive statistics for questionnaire rating of the surgeons, 
audiologists and patients; categorizing and trending of comments 
• Descriptive statistics and further statistical analysis of fitting and logged 
data, e. g. on duration of use and classified environment 
Study Schedule 
• Consent:  
Subject will sign ICF prior to conduct of any study procedures. 
• Baseline: 
Assessment of auditory perception abilities aided with conventional 
amplification (standard of care, aided and unaided hearing thresholds, 
word score in quiet, sentences in noise with OlSa), patient 
questionnaire 
• Surgery: 
Following standard of care 
Surgical questionnaire after each implantation 
• Device activation (approximately one to eight weeks after surgery) 
Auditory perception abilities aided with CI (standard of care, hearing 
thresholds), questionnaire for the audiologist 
• 3 months post device activation: 
Auditory perception abilities aided with CI (standard of care, hearing 
thresholds, word score in quiet, sentences in noise with OlSa), patient 
questionnaire, questionnaire for the audiologist 
• 6 month post device activation: 
Auditory perception abilities aided with CI (standard of care, hearing 
thresholds, word score in quiet, sentences in noise with OlSa), patient 
questionnaire, questionnaire for the audiologist 
Follow-up 
Schedule 
6 months after initial device activation subjects will continue to receive their CI 
after-care in clinical routine 
Study Monitoring 
According to ISO 14155 
Statistical 
Analyses 
Three and six months speech perception scores will be compared to baseline 
scores using applicable parametric or nonparametric statistical analyses. 
Questionnaire data will be summarized using frequency and relative 
frequency. 

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1.1 
Synopsis (deutsch) 
Studientitel 
Klinische Untersuchung der Sicherheit und der Leistungsfähigkeit von 
HiResTM Ultra Cl (Cl-1600-04) und HiResTM Ultra 3D Cl (Cl-1601-04) mit 
der HiFocusTM MS Elektrode (Ultra X Implantate) in hochgradig ertaubten 
Erwachsenen 
Sponsor  
Advanced Bionics AG 
Produkt 
HiRes™ Ultra 3D CI HiFocus™ Mid-Scala Elektrode (CI-1601-04) 
HiRes™ Ultra CI HiFocus™ Mid-Scala Elektrode (CI-1600-04) 
Studiendesign 
Prospektive Studie mit wiederholten Messungen beim gleichen 
Patienten, die miteinander verglichen werden; die Ausgangsdaten bei 
Studienaufnahme dienen jeweils als Kontrolle 
Regulatorische 
Zielsetzung 
Post Market Clinical Follow 
Studien-Population 
30 Erwachsene mit gültigen und verwertbaren Datensätzen 
Einschluss-Kriterien 
• Bisher keine Erfahrung mit einem auditorischen Implantat-System 
• 18 Jahre oder älter 
• Postlingualer Beginn einer starken Hörstörung (≥ 4 Jahre) 
• Nur begrenzter Nutzen von Hörgeräten, definiert als ein 
Sprachverständnis von 60% oder weniger im Freiburger Einsilber-
Test 
• Deutschkenntnisse 
• Bereitschaft, 
an 
allen 
im 
Studienprotokoll 
beschriebenen 
Maßnahmen teilzunehmen 
Ausschluss-Kriterien • Cochleäre Missbildung oder Obstruktion, die eine vollständige 
Insertion des Elektrodenträgers verhindern würde 
• Zusätzliche Einschränkungen, die eine Teilnahme an den Studien-
Maßnahmen beeinträchtigen würden 
• Medizinische oder psychologische Voraussetzungen, bei denen eine 
Operation kontraindiziert ist, die die Fähigkeit der Implantat-
Handhabung oder die Teilnahme an den Studienprozeduren 
einschränken würden 
• Hinweise auf zentral-auditorische Läsionen oder Beeinträchtigungen 
des Hörnervs 
• Schwangerschaft zum Zeitpunkt der Operation. 
Primäres 
Wirksamkeitsziel 
Das primäre Wirksamkeitsziel ist zu zeigen, dass das mittlere Verstehen 
im Freiburger Einsilbertest mit dem Ultra X in Kombination mit dem 
aktuellen Prozessor und Anpasssoftware mindestens 20% besser ist als 
das 
mittlere 
Einsilber-Verstehen 
zu 
Beginn 
der 
Studie 
mit 
konventioneller Versorgung auf der gleichen Seite.  
Sekundäres 
Wirksamkeitsziel 
Das sekundäre Wirksamkeitsziel ist zu zeigen, dass das mittlere 
Sprachverstehen in Geräusch mit dem Ultra X gleich oder besser ist wie 
das mittlere Sprachverstehen zu Beginn der Studie mit konventioneller 
Versorgung auf der gleichen Seite. 
Primäres 
Sicherheitsziel 
Das primäre Sicherheitsziel ist, alle Vorkommnisse mit dem Ultra X zu 
dokumentieren, die eine Re-implantation erforderlich machen. 
Primärer 
Verstehen im Freiburger Einsilber-Test auf der implantieren Seite sechs 

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Wirksamkeits-
Endpunkt 
Monate nach der Erstanpassung verglichen mit dem Einsilber-Verstehen 
zu Studienbeginn mit konventioneller Hörversorgung auf der gleichen 
Seite 
Sekundärer 
Wirksamkeits-
Endpunkt 
50%-Verständlichkeitsschwelle im Oldenburger Satztest in Geräusch auf 
der implantierten Seite verglichen mit der Schwelle zu Beginn der Studie 
mit konventioneller Hörversorgung auf der gleichen Seite 
Primärer 
Sicherheitsendpunkt 
Maximal ein Implantat-Ausfall in den ersten 6 Monaten nach 
Erstanpassung, der eine Re-Implantation erforderlich macht. 
PMCF Zielsetzung  
Primäres und sekundäres Wirksamkeitsziel sowie das Sicherheitsziel sind 
PMCF-Zielsetzung. 
Zusätzliche 
Interessen 
• Anpassdaten, insbesondere M-Level und Impedanzen 
• Rückmeldung der Audiologen zur aktuellen Anpass-Software 
• Rückmeldung der Operateure zur Handhabung der Implantates 
und der zugehörigen chirurgischen Instrumente während der 
Operation 
• Gewohnheiten 
der 
Studienteilnehmer, 
erfaßt 
über 
die 
Aufzeichnung der Prozessors sowie Patienten-Fragebogen 
• Verfolgen möglicher Vorkommnisse 
Zusätzliche 
Auswertungen 
• Beschreibende Statistik der Fragebogen-Einschätzungen der 
Operateure, Audiologen und Patienten; Kategorisierung und 
Trendanalyse von Kommentaren 
• Beschreibende und weitere Statistik der Anpassdaten und 
Prozessor-Aufzeichnungen, zum Beispiel zur Tragedauer oder der 
klassifizierten Umgebung 
Ablauf der Studie 
• Einwilligung: 
Jeder Patient unterschreibt vor Beginn der Studienmaßnahmen 
eine Studieneinwilligung 
• Ausgangsbasis: 
Feststellung der Hörfähigkeit mit konventioneller Versorgung 
(entspricht 
dem 
Behandlungsstandard, 
Hörschwelle, 
Aufblähkurve, Einsilber in Ruhe, Oldenburger Satztest in 
Geräusch), Patientenfragebogen 
• Operation: 
Erfolgt nach Behandlungsstandard 
Operateur-Fragebogen nach jeder Implantation 
• Erstanpassung (ungefähr eine bis acht Wochen nach 
Implantation) 
Feststellung 
der 
Hörfähigkeit 
mit 
CI 
(entspricht 
dem 
Behandlungsstandard, Hörschwelle), Audiologen-Fragebogen 
• 3 Monate nach Erstanpassung 
Feststellung 
der 
Hörfähigkeit 
mit 
CI 
(entspricht 
dem 
Behandlungsstandard, 
Aufblähkurve, 
Einsilber 
in 
Ruhe, 
Oldenburger 
Satztest 
in 
Geräusch), 
Patientenfragebogen, 
Audiologen-Fragebogen 
• 6 Monate nach Erstanpassung 
Feststellung 
der 
Hörfähigkeit 
mit 
CI 
(entspricht 
dem 

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Behandlungsstandard, 
Aufblähkurve, 
Einsilber 
in 
Ruhe, 
Oldenburger 
Satztest 
in 
Geräusch), 
Patientenfragebogen, 
Audiologen-Fragebogen 
Ablauf 
der 
Nachsorge 
Sechs Monate nach der Erstanpassung erhalten die Studienteilnehmer 
die CI-Nachsorge in der klinischen Routine 
Studien Monitoring 
Entsprechend ISO 14155 
Statistische 
Auswertung 
Entsprechende parametrische und nicht-parametrische statistische 
Tests werden herangezogen, das Verstehen drei und sechs Monate nach 
der Erstanpassung mit den Ausgangsdaten zu vergleichen. Die 
Fragebögen werden nach Häufigkeit und relativer Häufigkeit 
ausgewertet. 
 
 

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2.0 Identification and description of the investigational device 
• Investigational/study Device Description 
The HiResolution Bionic Ear System is a CE approved cochlear implant designed to provide 
useful hearing to individuals with severe-to-profound hearing loss via electrical stimulation of 
the auditory nerve. The HiResolution Bionic Ear System is intended to restore a level of auditory 
sensation. 
The HiResolution Bionic Ear System consists of internal and external components. 
 
The internal  components are either the HiResTM Ultra Cl HiFocusTM MS Electrode or the HiResTM 
Ultra 3D Cl HiFocusTM MS Electrode that are implanted surgically under the skin behind the ear. 
Throughout this protocol the term “Ultra X” will be used to refer to either of the implants. The 
electrode array has 16 contacts which are connected to the implant through the electrode lead. 
The receiver stimulator encapsulates the electronics into a titanium casing, the antenna coil 
allows for forward and backward telemetry between the implant and the external parts. The 
antenna coil also includes a magnet in order to retain the external headpiece. This magnet is 
the only significant difference between the Ultra and Ultra 3D implant. The HiResTM Ultra Cl 
HiFocusTM MS electrode uses a conventional static magnet, while the magnet of the HiResTM 
Ultra 3D Cl HiFocusTM MS electrode contains individually movable single magnets in a sealed 
housing. The movability of the individual magnets allows adjustments of the magnet in an 
external magnetic field, e. g. in an MRI machine. 
 
The external components include a sound processor (body-worn or ear-level), a headpiece, and 
a cable. The system converts sound into electrical energy that activates the auditory nerve. The 
auditory nerve then sends information to the brain, where it is interpreted as sound. 
 
 
 
Manufacturer 
Advanced Bionics LLC 
 
  
 
25815 Westinghouse Place 
 
  
 
Valencia, CA  91355 
 
 

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• Investigational Device Model 
 
Product Description 
Model 
Number  
Product 
Name 
Brief Product description  
Sterile? 
Single use? 
Contact / 
Duration 
Photo/Drawing 
CI-1601-
04 
HiRes™ Ultra
 3D CI 
HiFocus™ MS 
Electrode 
Implantable part of the 
HiResolution Bionic Ear 
System. Includes the 
HiRes™ Ultra 3D receiver 
and the HFMS electrode 
array.  
Yes 
Yes 
Permanent 
contact  
 
CI-1600-
04 
HiResTM Ultra 
Cl HiFocusTM 
MS electrode 
Implantable part of the 
HiResolution Bionic Ear 
System. Includes the 
HiRes™ Ultra 3 receiver 
and the MS electrode 
array.  
Yes 
Yes 
Permanent 
contact  
 
Table 1 
• Description of traceability 
As all the products that are used in this study are commercially available on the CE market no 
study specific accountability will be performed. Data on which subject was implanted with 
which implant will be tracked according to standard clinical care. Devices are not labeled 
differently than those that will be used for subjects who do not participate in the study. 
 
• Intended purpose of the investigational device 
The HiResolution Bionic Ear System is a CE approved cochlear implant designed to provide 
useful hearing to individuals with severe-to-profound hearing loss via electrical stimulation of 
the auditory nerve. The HiResolution Bionic Ear System is intended to restore a level of auditory 
sensation. 
 
• Description of the intended population and indication 
The HiResolution Bionic Ear System is intended to restore a level of auditory sensation to 
individuals with severe-to-profound sensorineural hearing loss via electrical stimulation of the 
auditory nerve.  
 
• Description of the investigational device including any materials that will be in 
contact with tissues or body fluids 
The internal component or implantable cochlear stimulator (ICS) includes a receiver and an 
electrode which are implanted surgically under the skin behind the ear. 
The implant electronics are contained within a hermetically sealed titanium case with a 
removable magnet and telemetry (RF antenna) coil attached and encased in silicone. The 
antenna coil assembly receives power and data over an inductively coupled link from the 
external sound processor system. The electrode consists of a fantail, electrode lead, and 

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electrode array. The electrode array (distal) is connected to the implant through the electrode 
lead. The lead, which extends from the fantail to the electrode array, refers to the silicone 
carrier in which the electrode wires are enclosed. The fantail is directly connected to the 
electronics in the implant. The antenna coil assembly and the electrode lead assembly connect 
to the electronics inside the hermetic electronics housing. 
The HiFocus Mid Scala (HFMS or HiFocus MS) electrode consists of 16 platinum contacts each 
connected individually to sixteen insulated platinum/iridium contact wires insulated with a 
fluorocarbon polymer (ePTFE) in a silicone carrier. The ePTFE (higher stretch resistance) 
produces a more abrasion-resistant wire. The ePTFE insulation material was tested to ensure 
biocompatibility for chronic human implantation. The contact wire diameter allows 
conductivity to small amounts of stimulation pulse energy and delivers stimulation energy. The 
HFMS electrode is designed with materials and construction techniques to reduce the 
occurrence of electrode shorts and opens during manufacturing and to improve manufacturing 
yields. 
It is also designed to give surgeons flexibility to choose among contemporary standard insertion 
techniques and surgical approaches (tool or off-stylet). The design of the HFMS electrode lends 
itself to either a small cochleostomy or round window (RW) surgical approach, which is 
determined by the surgeon, based upon the anatomy of the individual implant recipient and/or 
surgeon preference. 
It also has two blue markers that are designed to facilitate visualization and consistency of 
insertion. The distal marker indicates the depth to which the surgeon should insert the 
electrode before beginning to advance the electrode off the stylet. The proximal marker 
indicates that full insertion has been reached. A radiopaque marker is situated under the 
proximal blue marker. The surgeon has the flexibility to employ either a tool or free-hand 
insertion. 
 
• Summary of the necessary training 
All required surgical and audiological training will be the same as what is required for standard 
clinical care.  
A Surgeon’s Manual and a video describing the surgical procedure and insertion of the 
electrode are provided to all physicians prior to implantation. Physicians must be well versed in 
mastoid surgery and the facial recess approach to the round window. Advanced Bionics 
conducts periodic training courses on the recommended surgical procedure to implant the 
Ultra X. Failure to obtain the appropriate training will result in a higher incidence of surgical and 
medical complications. Surgeons should work with an audiology professional who has been 
trained fully on the proper fitting and adjustment of the system. 
Device and Fitting Manuals are provided to all clinical centers with the Clinician’s Programming 
System. Audiologists must be highly skilled in administering test procedures used to determine 
cochlear implant candidacy according to the inclusion criteria of this PMCF. They should be 
knowledgeable about state-of-the-art hearing aid technology, fitting procedures as well as 
experience in Good Clinical Practice according to ISO 14155. In addition, at least one audiologist 
from a clinical center should be fully trained and qualified in the fitting of the Advanced Bionics 
cochlear implant. Advanced Bionics conducts periodic training courses for audiologists and 
strongly recommends that audiologists attend a training course. Failure to obtain the 
appropriate training will result in less-than-optimal patient performance. 
Instructions for use for external components of the HiResolution Bionics Ear System are 
provided to the recipient upon delivery of the components. Patient counseling materials are 

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made available to all implant centers upon request. These materials provide detailed 
information about the system, indications for use, benefits, risks, and what is involved in 
patient selection, surgery, and follow-up procedures. 
Further, the center will receive a training on the objective of this study, data to be obtained, 
any study specific procedures and the electronic data capturing system. 
 
• Description of the specific medical or surgical procedures 
For the implantation of the Ultra X the patient has to undergo a surgical intervention where the 
surgeon deploys the implant by an insertion through a skin incision (e.g. conventional incision 
approach; minimal incision approach) located behind the ear. The length of the incision, as well 
as the location of the incision itself, are decisions each implanting surgeon must consider. The 
titanium housing of the implant then rests in a small depression (recessed well) located in the 
osseous structure called the mastoid bone. A small hole in the cochlea is created at or adjacent 
to the round window (e.g. conventional cochleostomy, round window or a modified (extended) 
round window approach) and the surgeon threads the electrode array of the internal device 
through this hole into the cochlea. The incision behind the ear is closed so that the internal 
device remains beneath the skin. 
Additional surgical intervention might be required if a patient must have the internal implant 
magnet removed to undergo an MRI scan, then the magnet replaced following MRI. For both 
the surgical interventions mentioned above, Advanced Bionics provides a set of surgical tools to 
assist the surgeon. There are two types of tools: single use sterile tools and reusable tools. The 
tools are optional and common OR tools can be used instead. A detailed description of the 
implantation methods and surgical tools is provided in the Surgeon Manuals, 029-M647-02 and 
029-M725-02 for Ultra and Ultra 3D respectively. The technique used for the removal and 
replacement of the magnet of the Ultra 3D implant is described in the Ultra 3D Replacement 
Magnet and Temporary Non-Magnetic Plug Guide, 029-M785-49 
3.0 Justification for the design of the clinical investigation 
• Justification for the design of the clinical investigation 
This is a prospective study designed to evaluate the safety and performance of the Ultra X 
under normal conditions of use as it is approved for this device. This study is set up to 
document any adverse events and comparing pre- to post-implant benefit to subjects. Any 
adverse events associated with the device will be documented via Advanced Bionics complaint 
handling system for the lifetime of the device. A within-subjects repeated-measures design will 
be employed. Speech perception will be evaluated preoperatively with conventional 
amplification to determine candidacy and to establish baseline performance. Efficacy 
parameters are speech perception data which will be collected according to clinical routine 
with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X 
according to standard clinical care. 
 
The primary efficacy objective is to demonstrate that mean monosyllabic word recognition 
score with the Ultra X used in combination with a sound processor programmed with the latest 
fitting software six months after activation is at least 20% better than the mean word score at 
baseline with conventional amplification in the same ear. 
The primary efficacy endpoint is reached six months after device activation. This interval was 
judged to be sufficient to confirm post-implant benefit with the CI, as the majority of the 

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speech-perception benefit experienced by cochlear implant recipients occurs during the first 
few months after device activation (Koch et al., 2004; Parkinson et al., 2002; Zwolan et al., 
2001, Lenarz et al. 2012). Inclusion criteria as well as the primary endpoint were derived from 
the “White Book for Cochlear Implantation” of the German Society of Oto-Rhino-Laryngology, 
Head and Neck Surgery (Weißbuch Cochlea-Implantat(CI)-Versorgung, DGHNO, 2018). The 
White Book requires that a clinic implanting CIs shall in average achieve an improvement in 
monosyllabic word recognition of 20% at the end of the consecutive therapy, which is typically 
one year after implantation. As this study focusses on subjects without further handicap we 
assume to reach the 20% improvement already 6 months after first fitting. To assess further 
outcome parameters speech perception tests in noise (OlSa sentence test) will be conducted 
and subjective feedback will be collected via a questionnaire. 
 
The primary safety objective is to document any adverse events related to Ultra X, with focus 
on those adverse events that require device replacement.  
Primary Safety Endpoint is the maximum of one  device failures that require device 
replacement during the first six months following device activation. Most medical/surgical 
complications, which are rare and have not changed significantly since the beginning of 
cochlear implantation, occur during surgery or shortly thereafter (Arnoldner et al., 2005; Cohen 
and Hoffman, 1991; Dutt et al., 2005; Green et al., 2004; Roland, 1989, Venail et al., 2008). 
Historical device tracking data from Advanced Bionics demonstrate that failures attributable to 
the implant are extremely rare. Six months after device activation is a sufficient time to 
document device failures that require device replacement. Thus, the success of this clinical 
study is contingent upon observing not more than one implant-related failure.  
The inclusion criteria for the study reflects the majority of the clinical population. Subjects, 
which fall into the indication criteria from the IFU but from whom we do not expect reliable 
data or data which we can pool with other subjects will not be included. For example subjects 
who cannot perform a speech perception test due to additional handicaps or language 
proficiency will be excluded from the study, but may still fall into the indication criteria of the 
implant. These subjects will not deliver reliable data to support the first and second objective of 
this study. For market surveillance purposes these parts of the population will not be covered 
by this study but by other activities, like vigilance reports and surveys. 
 
• Evaluation of the results of the relevant pre-clinical testing 
The cochlear implant itself was qualified for long-term use in/on the human body through 
extensive preclinical testing using industry standards and specialized testing targeted just for 
cochlear implants. This testing takes into account anticipated use case stresses which could 
affect the stability and reliability of the device, such as: impact, flexure and tensile stresses; 
body fluid/tissue contact; anticipated medical procedures for the patient and environmental 
elements, e.g., EMI. The Ultra and Ultra 3D families and accessories are suitable and stable in 
the human body for at least 10 years. 
 
The stability of the Advanced Bionics implants is assured by the materials and processes used in 
the manufacture of the devices. The implants, including magnets, are carefully designed using 
materials and processing methods that have a track record of safe, long-term use in 
implantable devices. 
 

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Platinum, used in all Advanced Bionics implants for the stimulation contacts, has been used and 
accepted as a contact material for long-term stimulation in active implantable devices for over 
40 years. For example, Advanced Bionics has used this material in previous implants, some of 
which have remained implanted in patients since 1994. 
Silicone rubber is used to encapsulate the device. The medical device industry has been using 
silicone rubber in implantable devices since the late 1940s and with a surge in applications 
starting in the 1960s. The silicone materials used in the manufacture of the currently marketed 
Advanced Bionics implants are provided by a supplier that specializes in the formulation and 
manufacture of implantable silicones. Advanced Bionics has used this material in multiple 
implant products, with no issues related to the stability of this material. 
 
Titanium is used for the electronics housing and the magnet case because of its 
biocompatibility. Titanium is non-toxic even in large doses and does not play any natural role 
inside the human body. Titanium is used in a gamut of medical implants, such as hip joint 
replacement and dental implants that can stay in place for over 30 years. Among metals, 
titanium benefits from a lower stiffness to more closely match that of the bone, and can more 
evenly distribute mechanical load. Titanium's chemical resistance stems from its tendency to 
form a very stable oxide (Ti02) on the surface. Titanium oxide is a common white pigment used 
in sunscreens, toothpaste, paints, and plastics. 
 
• Evaluation of clinical data 
Cumulative Survival Rate analysis reporting shows survival rates of over 99% for the currently 
marketed Ultra implant and Ultra 3D implant. 
The post market data including reliability, complaint, adverse events and CAPA data indicated 
that performance is consistently monitored using the various monitoring tools. Once identified 
the events are thoroughly investigated, analyzed for root causes and the necessary actions 
taken to mitigate any risks.  
The literature reviews performed examined general, indication, MRI consolidated and 
headpiece factors. These were conducted according to the state of the art methodology and 
identified a large amount of published literature. The benefits underline the substantial 
benefits of cochlear implantation when applied to selected candidates having severe to 
profound sensorineural hearing loss.  
These considerations indicate that the Ultra and Ultra 3D implant systems have a positive 
risk/benefit profile and hence are suitable for clinical application. The data available from the 
risk analysis, the literature reviews, standards compliance, and data on long-term reliability all 
indicate that the products perform well in comparison to other cochlear implant and 
accessories that are already on the market. 
Results of the weighted evaluation of clinical data confirms the continued clinical safety and 
clinical performance of the products under evaluation. The literature assessments also 
demonstrate a well characterized safety profile among all products in the Ultra X families. 
Cumulatively, the above cited evidence supports the clinical safety and performance of the 
Ultra X systems for restoring a level of auditory sensation in individuals with sensorineural 
hearing loss. 

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4.0 Risks and benefits of the investigational device and clinical investigation 
• Anticipated clinical benefits 
The HiResolution Bionic Ear System is intended to restore a level of auditory sensation to 
individuals with severe-to-profound sensorineural hearing loss via electrical stimulation of the 
auditory nerve. 
 
• Anticipated adverse device effects 
Implant recipients incur the normal risks of surgery and general anesthesia. Major ear surgery 
may result in numbness, swelling or discomfort about the ear, disturbance of taste or balance, 
or neck pain. If these events occur, they are usually temporary and subside within a few weeks 
of surgery. Rarely, cochlear implantation may cause a leak of the inner ear fluid, which 
increases the risk for meningitis. During the surgery, it is a rare possibility that the facial nerve 
could be injured resulting in a temporary or permanent weakening or full paralysis on the same 
side of the face as the implant. During the surgery, there is a rare possibility that cerebrospinal 
fluid leakage or perilymph fluid leakage could occur. As a result of the surgery, it is possible that 
dizziness, tinnitus, or vertigo may result. If these events occur, they are usually temporary and 
subside over time. The presence of a foreign body may cause irritation, inflammation, or skin 
breakdown and may require additional medical treatment or removal of the internal device. 
Skin infection in the area of the implant may require additional medical treatment or removal 
of the internal device. There is a possibility that the electrode or device may migrate requiring 
additional medical treatment or removal of the internal device to address any resulting injury. 
 
• Residual risks 
Adults who are considering a cochlear implant should be advised of the risk of meningitis. They 
should also be informed of the availability of vaccines that have been shown to substantially 
reduce the incidence of meningitis in the general population resulting from the organisms that 
commonly cause bacterial meningitis (Streptococcus pneumoniae, Haemophilus influenzae). 
Extreme direct pressure on the implanted device, up, down, left or right may cause the implant 
to move and possibly dislodge the electrode array. 
A direct impact to the implant site may damage the implant and result in its failure to function. 
In all cases, the failed device was explanted and a new device reimplanted with no further 
complications. 
The long term effects of chronic electrical stimulation are unknown. Clinical experience with the 
system has shown no adverse effects of chronic electrical stimulation on recipient performance, 
electrical thresholds, or dynamic range for almost 30 years. 
Electrode displacement can occur if the electrode is not inserted properly. Surgeons should be 
proficient in the use of the electrode insertion tool. Failure to follow the recommended surgical 
procedure for placement and stabilization of the Ultra X increases the risk of device migration 
or extrusion, and of damage resulting from impact trauma, including breakage of the electrode 
lead wires. Creating a recessed bed for the implant and securely stabilizing the device in place 
are critical elements of the surgical procedure. 
Insertion of a cochlear implant electrode will likely result in a decrease of any residual hearing 
in the implanted ear. 
 
• Risks associated with participation in the clinical investigation 

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There are no additional risks associated with the participation in this clinical studies than the 
already known anticipated adverse device effects and residual risks as described above. 
 
• Possible interactions with concomitant medical treatments 
In general, external components (e.g. sound processor and headpiece) should be removed or 
deactivated before undergoing the following medical procedures, where the implant may be 
exposed to electric fields or electrical current.  If unexpected sounds or interruptions are 
experienced during or after medical procedures notify the physician.  
• Electrosurgical instruments and RF Ablation instruments are capable of producing radio-
frequency voltages of such magnitude that a direct coupling might occur between the 
cautery tip and the electrode.  Induced currents may cause damage to the cochlear 
tissues or permanent damage to implants. Monopolar electrosurgery and RF Ablation 
must only be used outside the head or neck region.  For the use of bipolar 
electrosurgical equipment, the probe tips must not contact the implant and should be 
kept more than 1 mm (.04 in) from the implant. 
• Extracorporeal Electrical Stimulation: Electrodes or probe tips used in extracorporeal 
electrical stimulation instruments such as TENS, TEMS, etc. must not be placed over the 
implant. 
• Neurostimulation: Do not use neurostimulation directly over the implant.  High currents 
induced into the electrode lead can cause tissue damage or permanent damage to the 
implant. 
• Therapeutic Diathermy: Therapeutic diathermy may induce currents in the electrode, 
which could cause injury to cochlear tissues. The HiRes Ultra X cochlear implants is safe 
to use during exposure to shortwave (f = 27.12 MHz and E-field = 1.16 kV/m; M-field = 
8.5 A/m) and longwave (f = 1 MHz and E-field = 750 V/m; M-field = 2.0 A/m) diathermy. 
• Ultrasound: Diagnostic ultrasound can be used anywhere within the following 
parameters: Power: 1500 mW/cm2, Frequency Range: 3.325 - 3.675 MHz, Duty Cycle: 
20%. Therapeutic ultrasound energy must not be used over the implant since it may 
cause permanent damage to the implant by inadvertently concentrating the ultrasonic 
field and may cause injury in tissue surrounding the implant. 
• Electroconvulsive Therapy: Electroconvulsive therapy must never be used on a cochlear 
implant patient. Electroconvulsive therapy may cause tissue damage to the cochlea or 
permanent damage to the implant. 
• Ionizing Radiation Therapy: The implant remained functional after being exposed to a 
total dosage of 250 Gray using a 15 MeV beam strength and 3 cm depth.  Ionizing 
radiation therapy may damage the device.  Long term effects of ionizing radiation on the 
implant may not be immediately detectable.  The implant should not be placed directly 
in the ionizing radiation beam to minimize the risk of tissue necrosis. Diagnostic 
radiation imaging such as, CT, X-Ray, Mammography, etc. are safe to use. 
• MRI Warning:  
For information regarding the use of an MRI scanner with a HiRes Ultra or a HiRes Ultra 
3D device, please see the two MRI Safety Information in the appendix. 
 
• Risk mitigation 
Following the risk analysis risks are mitigated by design, inspections and tests of each specific 
implant and training. All risks have been reduced to the greatest extent possible. Economic 

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factors were not considered when determining whether to reduce any risk to the greatest 
extent possible. 
 
• Risk-to-benefit rationale 
An overall risk benefit analysis was performed on the Ultra X. There are no unacceptable 
residual risks associated with the implant. 
The overall residual risk remains acceptable when weighed against the benefit of providing 
sound and speech perception to patients with severe to profound sensorineural hearing loss. 
5.0 Objectives and hypotheses of the clinical investigation 
• Primary and secondary Objective 
The primary efficacy objective is to demonstrate that mean  Freiburger monosyllabic word 
score with the Ultra X used in combination with a sound processor (e.g Naida CI) programmed 
with the latest fitting software (e.g SoundWave 3.2) is at least 20% better than the mean word 
score at baseline with conventional amplification in the same ear. 
The secondary efficacy objective is to demonstrate that mean sentence score (OlSa test) in 
noise with the Ultra X used in combination with a sound processor (e.g Naida CI) programmed 
with the latest fitting software (e.g SoundWave 3.2) is equal or higher than sentence score at 
baseline with conventional amplification in the same ear. 
 
• Hypotheses 
The primary efficacy hypothesis is  
 
∑
𝑤𝑜𝑟𝑑 𝑠𝑐𝑜𝑟𝑒6 𝑚𝑜𝑛𝑡ℎ𝑠
𝑛
𝐼𝐷=1
−𝑤𝑜𝑟𝑑 𝑠𝑐𝑜𝑟𝑒𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒
𝑛
 ≥20% 
 
with the total number of subject n, score (percentage of words correctly understood) in the 
Freiburger monosyllabic word test with conventional amplification at baseline 
𝑤𝑜𝑟𝑑 𝑠𝑐𝑜𝑟𝑒𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒, score in the Freiburger monosyllabic word test 6 months after device 
activation 𝑤𝑜𝑟𝑑 𝑠𝑐𝑜𝑟𝑒6 𝑚𝑜𝑛𝑡ℎ𝑠. 
 
The secondary efficacy hypothesis is  
 
∑
𝑠𝑒𝑛𝑡𝑒𝑛𝑐𝑒 𝑠𝑐𝑜𝑟𝑒6 𝑚𝑜𝑛𝑡ℎ𝑠
𝑛
𝐼𝐷=1
−𝑠𝑒𝑛𝑡𝑒𝑛𝑐𝑒 𝑠𝑐𝑜𝑟𝑒𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒
𝑛
 ≥0% 
 
with the total number of subject n, score (percentage of words correctly understood) in the 
Oldenburger sentence test with conventional amplification at baseline 
𝑠𝑒𝑛𝑒𝑛𝑡𝑒𝑛𝑐𝑒 𝑠𝑐𝑜𝑟𝑒𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒, score in the Oldenburger sentence test 6 months after device 
activation 𝑠𝑒𝑛𝑡𝑒𝑛𝑐𝑒 𝑠𝑐𝑜𝑟𝑒6 𝑚𝑜𝑛𝑡ℎ𝑠. 
 
The primary safety hypothesis is that until the appointment six months after device activation 
not more than one adverse event will occur which require device replacement. 
 
• Description of the Claims and intended performance of the investigational device 

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The HiResolution Bionic Ear System is intended to restore a level of auditory sensation to 
individuals with severe-to-profound sensorineural hearing loss via electrical stimulation of the 
auditory nerve. 
6.0 Design of the clinical investigation 
6.1 
General 
• Description of the type of clinical investigation to be performed 
This is a prospective study designed to evaluated the safety and performance of the Ultra X 
with respective sound processor programmed with the related fitting software under normal 
conditions of use as it is approved for these devices. 
 
• Description of the measures to be taken to minimize or avoid bias, including 
randomization and blinding/masking. 
To minimize the effect of subject-specific factors such as age, cognitive capabilities or etiology 
of hearing impairment on the investigation outcomes, a study design with within-subject 
comparisons was chosen. Factors such as gender or lifestyle are not expected to have an effect 
on study outcomes. 
 
• Description of the primary and secondary endpoints 
Primary endpoint is the mean Freiburger monosyllabic word score with the Ultra X six months 
following device activation. It is the aim to demonstrate that six months post activation the 
group mean Freiburger monosyllabic word score is at least 20% higher than the group mean 
score at baseline with conventional amplification in the same ear.  
 
The secondary efficacy endpoint is the group mean score in the Oldenburger sentence test in 
noise six months after device activation compared to the group mean score at baseline in the 
same ear. Only subjects who achieve less than 75% in the OlSa in quiet will be taken into 
account, as subjects with poorer performance may not be able to conduct the OlSa in noise 
with meaningful result (Hey et al., 2014)The group mean score six months after device 
activation is expected to be at least as good as at baseline.  
 
Testing of both primary and secondary endpoints is described under section 7.0 Statistical 
considerations. 
 
The primary safety endpoint is a maximum of one device failure that require device 
replacement during the first six months following device activation (approximately one to eight 
weeks after surgery). 

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• Methods and timing for assessing, recording, and analysing variables 
   Visit 
Standard Procedure 
Study-Related Procedure 
Baseline 
• 
Audiological history 
• 
Possibly*radiological scan 
• 
Freiburger monosyllabic word test 
• 
Pure tone audiogram 
Depending on center`s standard practice following evaluations may be additionally: 
• 
Oldenburger sentence test in noise 
• 
Tinnitus and vertigo assessment 
Clinic admission with surgery  
• 
Standard surgical and post-surgical 
procedures 
• 
Possibly* radiological scan 
• 
Surgical questionnaire after implantation  
 
Initial device activation 
(approximately 1-8 weeks after 
surgery) with rehabilitation1  
• 
Initial device activation 
• 
Further program optimization 
• 
Hearing training 
• 
Questionnaire for the audiologist assessing her/his experience during patient 
counselling and programming 
• 
Audiogram 
• 
Tinnitus and vertigo assessment 
3 months after device activation 
(window + ≤ 14 working days) 
• 
Program optimization 
• 
Freiburger monosyllabic word test 
 
• 
Questionnaire for the audiologist assessing her/his experience during patient 
counselling and programming 
• 
Questionnaire for the patient assessing her/his experience at home 
Depending on center`s standard practice following evaluations may be additionally: 
• 
Audiogram 
• 
Oldenburger sentence test in noise  
• 
Tinnitus and vertigo assessment 
6 months after device activation 
(primary efficacy endpoint) 
(window + ≤ 14 working days) 
• 
Program optimization 
• 
Freiburger monosyllabic word test 
• 
Questionnaire for the audiologist assessing her/his experience during patient 
counselling and programming 
• 
Questionnaire for the patient assessing her/his experience at home 
Depending on center`s standard practice following evaluations may be additionally: 
• 
Audiogram 
• 
Oldenburger sentence test in noise  
• 
Tinnitus and vertigo assessment 
Other 
• 
Unscheduled visits at subject´s or 
physician´s initiative 
• 
Documentation as unscheduled visit in the respective CRF 
Table 2 Summary of standard of care and study related visits and procedures. 
* if part of standard hospital practice, not specifically requested in the CIP; sponsor will not receive any scans unless required for AE tracking

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• Equipment to be used for assessing the clinical investigation variables 
For assessment of feedback from the surgeons or patients questionnaires will be used which 
were developed specifically for this study. Ratings will be assessed using a 10 point rating scale 
where 5.5 indicates a neutral rating. 
To obtain hearing thresholds and speech perception scores in the Freiburger monosyllabic word 
test or the Oldenburger sentence test clinics will be using a standard audiometer where the 
respective tests will be implemented. 
• Description of procedures for the replacement of subjects 
Subjects who withdraw or who are discontinued prior to the completion of the six-months 
follow-up visit will be replaced. Unless withdrawal of consent all data as per protocol will be 
gathered and used in the analysis. Thus the total enrollment may exceed 30 so that a total of 30 
subjects will provide valid and complete data sets. Subjects who withdraw or who are 
discontinued from the study will be reported on the appropriate Case Report Form. These 
subjects will continue to receive standard clinical care and keep the implant. 
 
The Investigator (or authorized delegate) in cooperation with the trial monitor will complete a 
log to document the disposition of each enrolled subject (completed study, withdrew, 
discontinued). 
6.2 
Investigational device(s) and comparator(s) 
• Description of the exposure to the investigational device(s) or comparator(s) 
The investigational device is implanted surgically under the skin behind the ear. The internal 
receiver includes of HiResTM Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM 
MS Electrode that are implanted surgically under the skin behind the ear. The electrode array 
has 16 contacts which are connected to the implant through the electrode lead. The receiver 
stimulator encapsulates the electronics into a titanium casing, the antenna coil allows for 
forward and backward telemetry between the implant and the external parts. The antenna coil 
also includes a magnet in order to retain the external headpiece. 
 
The external components include a sound processor (body-worn or ear-level), a headpiece, and 
a cable. The system converts sound into electrical energy that activates the auditory nerve. The 
auditory nerve then sends information to the brain, where it is interpreted as sound. 
 
• Justification of the choice of comparator(s) 
There is no comparator device in this study; data will be analyzed as within-subject comparison, 
therefore a comparator is not needed. 
 
• List of any other medical device or medication to be used during the clinical 
investigation 
This study protocol follows very closely the standard clinical care. There is no additional medical 
device or medication needed which would not be needed in standard clinical care. 
 
• Number of investigational devices to be used, together with a justification  

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Each subject will receive one implant; therefore we plan 30 implants for this study, but it may 
be more if a subject needs to be replaced (see above Description of procedures for the 
replacement of subjects) 
 
6.3 
Subjects 
• Inclusion criteria for subject selection 
▪ No previous experience with any auditory implant 
▪ 18 years of age or older 
▪ Postlingual onset of severe hearing loss (≥ 4 years of age) 
▪ Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or 
less in Freiburger Monosyllabic word test (either assessed by a previous hearing aid 
experience or the audiologist`s judgment based on pure tone thresholds in case of 
profound deafness) 
▪ German language proficiency 
▪ Willingness to participate in all scheduled procedures outlined in the protocol 
 
• Exclusion criteria for subject selection 
▪ Cochlear malformation or obstruction that would preclude full insertion of 
electrode array.  
▪ Presence of disabilities other than deafness that would prevent or interfere with 
participation in the required study procedures  
▪ Medical or psychological conditions that contraindicate surgery or impact the 
ability to manage an implanted device or the study related procedures 
▪ Evidence of central auditory lesion or compromised auditory nerve 
▪ Pregnancy at time of surgery. 
 
• Criteria and procedures for subject withdrawal or discontinuation 
Subjects may withdraw from the study at any time, with or without reason, and without 
affecting continued standard of medical care they would receive. Subjects can be discontinued 
from the study for the following reasons:  
▪ Withdrawal of consent 
▪ A safety concern noted by a clinician that endangers the subject or cannot be 
tolerated for medical and/or ethical reasons 
▪ Inability of the subject to perform the tasks necessary to provide usable data for 
the study. 
▪ Failure to attend a follow-up visit after three documented attempts to contact the 
subject and reschedule the visit. 
 
• Point of enrolment 
An individual is considered to be enrolled as a study subject only after the Informed Consent 
Form (ICF) has been signed. Each subject will get ample time to consider participation in the 
trial. Once enrolled, the subject will be assigned a unique identifier. The identifier will consist of 
an alphanumeric sequence that will consist of the investigational site identifier and the 
sequential subject number. 
 

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• Total expected duration of the clinical investigation 
In total, the clinical investigation will run for 24 months. 
 
• Expected duration of each subject's participation 
Each subject’s participation in the clinical investigation will last approximately 10 months 
(consent, baseline data, surgery up to 10 weeks later, initial device activation 4 to 8 weeks after 
surgery, 6 months follow-up period). 
 
• Number of subjects required to be included in the clinical investigation 
Complete data sets of 30 subjects will be required. The total number of subjects enrolled may 
be higher in case a subject needs to be replaced due to withdrawal or discontinued follow up. 
 
• Estimated time needed to select this number (i.e. enrolment period) 
It is planned to enroll three to five centers in Germany. Selection and enrolment of the clinics 
may take up to 6 months. Once a clinic is prepared to start the study and has all required 
approvals in place we estimate an additional 10 months for enrollment of a minimum of 5 
subjects. This results in an overall estimated time for enrolment of 12 months. 
6.4 
Procedures 
• Description of all the clinical-investigation-related procedures for the subjects 
No investigational procedures outside of the clinical routine are used to screen subjects for 
study eligibility. Subjects eligible to participate in this study already will have been evaluated 
and considered to have met the surgical and audiological criteria for cochlear implantation. 
Cochlear implant eligibility will be determined using standard-of-care tests and procedures. 
These tests may include radiographic imaging to assess cochlear patency, audiometric hearing 
thresholds, and speech/auditory perception tests. 
All study visits are summarized in table 2. The time window for the post-operative visits is + ≤ 
14 working days. This time window is chosen because it allows a sufficient amount of time for 
subjects to find a date that fits their agenda for the follow ups to be performed. The medical 
history will include demographic information (gender, date of birth, etiology of hearing loss and 
hearing aid use) and otology history that might impact study outcomes (chronic ear infections, 
ear surgeries, history of tinnitus or vestibular disturbances).  
Hearing test results obtained prior to enrollment may be used as baseline data if the results 
were obtained no more than 10 weeks prior to surgery. 
Unscheduled visits to the implant center may be made at any time for evaluation of possible 
adverse events or to address any questions or concerns expressed by the subject that cannot 
be managed adequately by telephone or e-mail.  
After the study visits are completed, subjects will continue to receive standard medical routine 
treatment. 
The participating surgeons will be asked after each surgery about details of their surgical 
technique, for example how the access to the middle ear was configured and how the implant 
was secured. These details allow to assess how the fantail area of the implant was treated 
during the surgery and how it is supported once positioned in its final position. 
Further the audiologist will receive a questionnaire to assess his experience when using the 
fitting software and when explaining the system to the patient.  
 

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Measurement procedures:  
Pure Tone Audiogram  
For the pure tone audiogram thresholds will be measured with a clinical audiometer.  
Conditions: At baseline thresholds will be measured unaided with headphones or insert 
earphones for each side separately as well as with bone conduction. Further the aided 
thresholds shall be determined for each side separately. After surgery threshold will be 
measured in free field using the processor in its normally used setting.  
For acoustic stimulation thresholds shall be determined at the frequencies 125, 250, 500, 1000, 
2000, 4000 and 8000 Hz; for bone conduction the frequencies 250, 500, 1000, 2000 and 4000Hz 
shall be measured. 
 
 
Freiburger Monosyllabic Word Test 
The Freiburger Monosyllabic Word Test will be conducted with a clinical audiometer. The signal 
will be presented at 65dB from a loudspeaker in front of the subject. The score will be obtained 
as the percentage of words correctly understood. 
In each condition two lists shall be tested. During the study lists shall not be repeated. 
Conditions: At baseline the monosyllabic word test will be conducted in free field on the ear to 
be implanted. The patient shall use the hearing aid setting with which he obtains best results. 
The score obtain is the baseline monosyllabic word score. With the CI system the monosyllabic 
word test will be measured in free field using the processor in its normally used setting.  
 
 
Oldenburger Sentence Test (OlSa) 
The Oldenburger Sentence Test will be performed in an adaptive way using a clinical 
audiometer. Both, signal and noise, shall be presented from the loudspeaker in front of the 
subject. The noise will be presented at 65dB in a continuous way. The signal will be varied to 
obtain the signal-to-noise ratio at which the patient will correctly understand 50% of the words. 
This is called speech reception threshold (SRT) measured in dB. 
Prior to collecting results for the study subjects shall pass a training. Typically the training 
consists of four lists of the OlSa in quiet. The training may be adapted based on the individual 
needs to be shorter or longer. For the study relevant data in each condition two lists shall be 
tested and each list shall have 30 sentences. During the study lists shall not be repeated. 
Some subjects may not be able to pass the OlSa in noise successfully. The OlSa does not 
converge for subjects with too poor performance. In order to avoid frustration and spending 
time inappropriately only subjects with a certain speech understanding in quiet will be required 
to conduct the OlSa in noise. Therefore the OlSa in quiet shall be conducted first. The signal 
shall be presented from the front at 65dB and words understood correctly shall be counted. 
Subjects who achieve less than 60% do not need to conduct the OlSa in noise as clinical 
experience shows that these subjects are not able at all to pass the OlSa in noise. 
Hey et al., 2014 set the criteria at 75% in the OlSa in quiet. Therefore the secondary objective 
will only respect subject with 75% or more. But as a test in quiet reflects different abilities than 
a test in noise the test in quiet is only a rough estimator. Hey at al. did not investigate subjects 
below 75%. Therefore subjects between 60% and 75% in quiet shall pass the OlSa in noise as 
supportive data. In case the audiologists estimates that the whole test session may be too 
exhausting for the subject and may therefore not give valuable results she or he may decide to 
use either two OlSa lists with 20 sentences, or only one list with 30 sentences. She or he will 

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select the option which seems more appropriate in the specific situation. The decision will be 
documented in the CRF. 
 
 
Conditions: At baseline the Olsa will be conducted in free field on the ear to be implanted. The 
patient shall use the hearing aid setting with which he obtains best results. The SRT obtained in 
this condition is the baseline SRT. With the CI system the OlSa will be measured in free field 
using the processor in its normally used setting .  
 
 
Surgeon`s questionnaire: 
The surgeon will receive a paper based questionnaire in which she/he will be asked to report 
her/his experiences during the surgery. For questions requiring a rating a 10 point scale will be 
used. The data will then be entered to the eCRF data base and monitored. 
 
Audiologist`s questionnaire: 
The audiologist will receive a questionnaire in which she/he will be asked to report her/his 
experiences during the fitting an counselling. This questionnaire will be realized in the eCRF 
data base. For questions requiring a rating a 10 point scale will be used.  
 
Patient`s questionnaire: 
The patient will receive a questionnaire in which she/he will be asked to report her/his 
experiences with the CI system. This questionnaire will be realized with an ePRO module in the 
eCRF data base. For questions requiring a rating a 10 point scale will be used. In case the 
patient needs any help to fill in the questionnaire, the audiologist may support him. 
 
Data obtained in the fitting process: 
When starting the fitting the fitting software will at first measure the impedances of intra-
cochlear electrode contacts. Further the audiologist will determine several parameters in the 
fitting process. Especially the M-level will be of interest. 
During standalone operation of the CI system the processor logs the duration of use in classified 
environments. When connected next time to the fitting software these data will be 
downloaded and are available for further evaluation.  
 
• Description of those activities performed by sponsor representatives 
The sponsor will provide the general training required for using the medical devices (Ultra X 
with all accessories and tools, processor and fitting software) in standard clinical care. Further 
the sponsor will take care of all study specific training, such as training on the study schedule 
and study specific procedures. Data management, data evaluation and potentially a draft for a 
scientific publication will be provided by the sponsor. 
 
• Any known or foreseeable factors that may compromise the outcome of the clinical 
investigation or the interpretation of results 
In the study design each subject serves as his own control. This carries the risk of changes in the 
general condition of a subject which cannot be reflected in the baseline measurements. Even 
though the duration of the study is relatively short other factors may influence the results, such 
as any additional illness. Still this seems to be the best study design and the risk is mitigated by 

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the fact that only approximately 10 months will be observed and the sample size is higher than 
required for the efficacy objective. 
6.5 
Monitoring plan 
A clinical research monitor will supervise conduct of the study at each site. The monitor will 
visit the Investigator and the study facility at periodic intervals in addition to maintaining 
ongoing telephone, e-mail, and/or letter contact. The monitor will maintain up-to-date 
personal knowledge of the study through observation, review of study records and source 
documentation, and discussion of the study with the Investigator and study personnel.  
The Sponsor’s internal auditors or contract auditors may evaluate the conduct of the study at a 
site. These parties will have access to all study-related documents. The Sponsor audit reports 
are confidential and proprietary. 
All investigators and investigational sites will be monitored on a continuing basis through the 
course of the clinical study to oversee compliance with the regulatory and clinical aspects of the 
study. A Clinical Monitor will maintain current personal knowledge of the study through 
observation, review of study records and source documentation, and discuss and update study 
related issued with the investigators and study site staff. 
The following information is reviewed and discussed during site initiation training: 
• Good Clinical Practice, including investigator responsibilities and purpose of 
monitoring activities 
• Requirements for EC approval (initial application and continuing reviews)  
• Informed consent procedures, including requirements for inclusion of all 
foreseeable risks in the ICF   
• Study protocol and procedures  
• Processes for recording and reporting adverse events  
• Device accountability procedures  
• Data collection and correction procedures, source documentation, and record 
retention requirements 
 
NOTE A detailed plan for monitoring arrangements will be prepared separately from the CIP.  
 
6.5.1 Pre-Study Documentation Requirements 
Prior to obtaining consent from any subjects, the following documents must be provided to 
Advanced Bionics: 
• A copy of the protocol signature page and investigator agreement, signed and 
dated by the Principal Investigator and Co-Principal Investigator(s), if 
applicable 
• A signed and dated copy of the Clinical Study Agreement 
• A copy of the written EC approval of the protocol 
• A copy of the approved ICF and written EC approval of the form  
• A copy of the curriculum vitae of the Principal Investigator and Co-
Investigator(s), if applicable 

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• Financial disclosure forms  
6.5.2 Study Documentation/Case Report Forms 
Data must be submitted according to protocol requirements for all enrolled subjects. CRFs 
provided for this study must be used to submit data to the Sponsor. Each subject will be 
assigned a unique identifier at the time of enrollment (as described above), which will be used 
on all CRFs.  
Study records are comprised of monitored CRFs, and all other administrative documents 
including, for example, EC correspondence, clinical trial materials and supplies shipment 
manifests, monitoring logs, and correspondence with the Sponsor. A study-specific binder will 
be provided with instructions for maintenance of study records. 
Source documentation is defined as any hand-written or computer-generated document that 
contains medical information or test results that have been collected for or are in support of 
the protocol specifications. For example, these documents may include audiograms, results 
from CT scans and x-rays, lab reports, clinic notes, subject questionnaires, and telephone logs. 
All draft, preliminary, and pre-final versions of a report also are considered source documents, 
including faxed reports or data and hard copies of test results. 
6.6 
Interim Monitoring Activities 
The Clinical Monitor will perform at least the following activities during on-site 
visits: 
• Confirm that the facilities continue to be appropriate and that the study 
records are stored in a secure location 
• Conduct review and collection of regulatory documents 
• Review subject ICFs for completeness and accuracy 
• Confirm that the study protocol is being followed and that any changes in the 
protocol have been reported to the EC and Advanced Bionics, as applicable 
• Review CRFs and source documents for completeness, accuracy, and timely 
submission to the Sponsor 
• Verify that all adverse events have been reported to the Sponsor within the 
appropriate timeframe. If an event is discovered that requires reporting, the 
Clinical Monitor will instruct the investigators to document the event on the 
appropriate CRF and submit to the Sponsor within the required timeframe 
• Review and resolve data clarification requests, if appropriate 
• Review device accountability records 
• Follow up on outstanding monitoring visit action items 
 
At the end of the visit, the Clinical Monitor will meet with the investigators to review site 
compliance with the protocol, investigator responsibilities, and applicable regulations. 
6.7 
Close-Out Monitoring Activities 
The Clinical Monitor performs at least the following activities during study close 
out: 
• Conduct review and collection of regulatory documents 
• Resolve open data clarification requests 

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• Review study file retention and storage requirements 
• Collect outstanding CRFs 
• Review investigator responsibilities including EC notification of study closure 
• Follow up on any outstanding issues, including unresolved adverse events.  
• Review post-study financial disclosure requirements 
• Review the potential of regulatory or Sponsor audits. 
 
At the end of the visit, the Clinical Monitor will meet with the investigators to review site 
compliance with the protocol, investigator responsibilities, and applicable regulations. 
6.8 
Management of Site Noncompliance  
Noncompliance with the signed agreement, the CIP, regulatory requirements, or any conditions 
of approval imposed by the EC will be addressed by re-training the investigators on the 
appropriate study procedures and documenting the re-training. Continued noncompliance may 
result in termination of study participation.  
In the event of site termination and the use of investigational product, the Sponsor will stop 
shipping investigational product and request that any investigational product at the site be 
returned. 
6.9 
Documentation and Records 
The Sponsor and investigators maintain files with Ethical committee and regulatory documents. 
CRFs are completed for each study subject. The Sponsor maintains the original CRFs and the 
study site retains copies of all CRFs. The Clinical Monitor documents monitoring activities and 
prepares a report after each monitoring visit.  
 
All study records (e.g., protocol, correspondence with the Sponsor and the EC, EC approvals, 
CRFs, subject records, consent forms, reports) must be maintained by the Investigator until 
notified by the Sponsor and at least as long as local document retention regulations require. If 
an Investigator opts to discontinue participation in the study, all records will be transferred to a 
mutually agreed designee (i.e., another Investigator).  
This transfer is subject to the Sponsor’s approval and will be documented in writing with copies 
sent to the sponsor. If an Investigator leaves the site at which the study was conducted, the 
Sponsor should be contacted regarding the disposition of documents. 
In the event of an audit, the Investigator agrees to allow representatives of the Sponsor or other 
regulatory authorities to access all study records. The Investigator will notify the Sponsor 
promptly of all audit requests from government or other regulatory agencies and will promptly 
forward a copy of all audit findings to the Sponsor. 
 
6.10 
Compensation 
The clinical site will be compensated for their time and effort to fulfil the obligations of this 
clinical study. Study subjects will be compensated for their travel expenses in case they need to 
visit the site due to a study visit outside of the clinical routine.  

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7.0 Statistical considerations  
• Statistical design, method and analytical procedures 
The hypothesis is that the mean Freiburger Monosyllabic words score will be at least 20% 
better six months after device activation compared to baseline with conventional amplification 
in the same ear. 
The secondary efficacy endpoint is the mean Oldenburger sentence test score six months after 
device activation compared to conventional amplification baseline performance in the same 
ear. If the primary efficacy analysis proves statistically significant, then the results will be 
analyzed for the secondary endpoints using a non-inferiority hypothesis.  
 
• Sample size, level of significance and power of the investigation 
A total sample size of 30 subjects is planned for this study based on efficacy and safety 
considerations.  
 
In order to estimate the required sample size to demonstrate safety and efficacy of the device, 
both the primary efficacy endpoint as well as the primary safety endpoint were taken into 
account.  
 
In order to estimate the standard deviation of Freiburger Monosyllabics 6 months after first 
fitting the following sources were considered:   
1) 
the “Safety and efficacy trial of the HiFocusTM mid-scala electrode array” (sponsored by 
AB in 2012/13): In that study speech perception was measured with a word test in quiet a) with 
a hearing aid on the ear to be implanted prior surgery as well as b) with the CI on the same ear 
three months after device activation. A mean improvement of 49.5% with a standard deviation 
of 22% was found. 
2) 
Data from an evaluation of postoperative speech performance conducted by the 
Unfallkrankenhaus Berlin (Battmer et al., in press): the evaluation included only subjects with a 
pre-operative score in Monosyllabics of 0%. At three months after device activation subjects 
reached a score of 54% with a standard deviation of 24%.  
3) 
The publication from Helbig et al. (2014): this publication analyses preservation of 
residual hearing after cochlear implantation. Prior surgery subjects had a mean score in the 
Monosyllabic word test of 16% and six months after device activation the group reached 61% 
with a standard deviation of 24% (derived from fig. 4B).  
4) 
The publication from Lenarz et al. (2011): in a retrospective analysis the effect of 
technological advances in the past 20 years on the hearing performance was determined. For 
subjects with recent CI systems a three months word score of 48.3% with a standard deviation 
of 29.0% was reported. Mean score at six months after device activation can only be estimated 
from the diagram, it is about 54% with no standard deviation mentioned in the paper.   
 
Supposedly the standard deviation is not significantly different three or six months after 
activation; we therefore assume a standard deviation ϭ=25% for the sample size calculation. 
Sample size calculation was performed using G*Power 3.1.9.4 (Faul et al., 2007). The expected 
difference Δμ=20% was derived from the “White Book for Cochlear Implantation” of the 
German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (Weißbuch Cochlea-
Implantat(CI)-Versorgung, DGHNO, 2018).  This yields to a standardized difference in means of 
dz = Δμ/ ϭ = 0.8. The number of subjects required to demonstrate an equivalent improvement 
at a type-1 error rate of α=0.025 and a power 95% was determined to be 24. 

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The sample size was expanded to 30 in order to provide sufficient data for determining the 
safety and reliability of the electrode. AB internal data reveal a cumulative survival rate of 
99.93% for the Ultra 3D, 99.98% for the Ultra and 99.92% for the Advantage (the predecessor 
of the Ultra). This survival rate included all types of failures needing device replacement. So the 
probability of experiencing a device failure during the first 3 months is <0.08 %. The probability 
of observing at least one failure requiring device replacement in a sample size of 30 is 2.4%, and 
accordingly, one event may occur in a sample of 30. 
Based on these considerations we concluded that a target number of 30 subjects enrolled in 
the study will be sufficient to allow the conclusion that the confirmatory data represents valid 
information. 
 
• Expected drop-out rates 
Experience so far has shown that the drop-out rate in this kind of investigation is very low, as 
the appointment coincide with the regular clinical follow-up intervals. We expect that 
maximally two subjects drop out from the investigation. Any drop-out will be replaced. 
 
• Pass/fail criteria to be applied to the results of the clinical investigation 
Primary efficacy and safety objectives need to be fulfilled in order to successfully close the 
study.  
 
• The provision for an interim analysis, where applicable 
Results will be analyzed on an annual basis. 
 
• Criteria for the termination of the clinical investigation on statistical grounds 
It is not planned to terminate the investigation on statistical grounds. 
 
• Procedures for reporting any deviation(s) from the original statistical plan 
In case of an deviation from the statistical plan, the annual report will highlight and justify the 
deviations. 
 
• Specification of subgroups for analysis 
No sub-group analysis is planned. 
 
• Procedures that take into account all the data 
The annual analysis will take all data into account. 
 
• Treatment of missing, unused or spurious data, including drop-outs and withdrawals 
Subject who withdraw from the study will be replaced. Therefore we do not expect any missing 
data for the primary endpoint. If still any data are missing, an analysis will be conducted using 
the observed results. A further analysis also will be completed that imputes 0 for the change 
from baseline for non-completers. In that case, the imputation analysis would become the 
primary efficacy evaluation. 
 
• Exclusion of particular information from the testing of the hypothesis, if relevant 
This is not planned. 
 

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• Minimum and maximum number of subjects to be included for each centre in 
multicentre clinical investigations  
It is expected that each participating center enrolls 3 to 8 subjects. 
8.0 Data management 
• Procedures used for data review, database cleaning, and issuing and resolving data 
queries 
An electronic Case Report Form (eCRF) data base will be used. The system allows to track all 
entries, queries and changes. Data will be verified according to the monitoring plan. Further, in 
case of outliers source data will be checked. Data will be exported for further analysis, e. g. in 
Excel or Statistica. 
 
• Procedures for verification, validation and securing of electronic clinical data systems, 
if applicable 
The eCRF data base will be validated following AB´s QMS procedures. The eCRF system is 
provided by IBM, who takes care of securing the data system. 
 
• Procedures for data retention 
eCRFs will be used to collect all subject data during the study. eCRFs must be fully completed 
for each subject and electronically signed. They will be available for the Clinical Monitor who 
will work under ICH-GCP rule.  
The investigators or the authorized study personnel are required to electronically sign the eCRF 
pages where needed to validate they have read and are in agreement with the reported data. 
• 
The investigator or designated individual is responsible for recording all 
data from the trial on the eCRFs supplied by the Sponsor. The data 
reported in the eCRF must be unambiguous. 
• 
Implementation of the eCRF data base will be performed by the 
Sponsor. 
By signing the study protocol, the investigator agrees to keep all information made available to 
him/her in strict confidence and ensures the same level of confidentiality from his/her staff.  
The information made available to study hospital personnel must not be passed on to others 
without written authorization of the Sponsor. 
 
• Specified retention period 
Study documents (study protocol, CRFs and other materials) made available by/to the principal 
investigators need to be stored adequately in order to assure their confidentiality in the 
hospital for a duration of 15 years. 
 
• Other aspects of clinical quality assurance, as appropriate 
The Investigator will assure proper implementation and conduct of the study including those 
study-related duties delegated to other appropriately qualified individuals and designated in 
the study documentation. The Investigator will assure that study personnel cooperate with 
monitoring and audits, and will demonstrate due diligence in recruiting and retaining study 
subjects. 
9.0 Amendments to the CIP  

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• Description of the procedures to amend the CIP 
The protocol must be followed exactly. Any changes to the protocol must be implemented 
through a formal protocol amendment. Amendments to the protocol must be initiated by the 
Sponsor or at the request of other parties. In either case, a formal amendment cannot be 
initiated until it has been approved by the Sponsor, the Investigator, regulatory agencies (if 
applicable), and the EC. It can only be altered by written approved amendments by the Clinical 
Project Manager (CPM). Administrative changes that do not affect the subject risk ratio may be 
made after consulting AB AG. 
10.0 Deviations from clinical investigation plan 
• Statement specifying that the investigator is not allowed to deviate from the CIP, 
except as specified in ISO 14155:2011 4.5.4 
The Investigator must agree that the study will be conducted according to this CIP, the 
principles of ISO 14155:2011, 90/385/EEC, ICH-GCP, Declaration of Helsinki and internal 
Standard Operating Procedures (SOPs) and local regulations. 
 
• Procedures for recording, reporting and analysing CIP deviations 
Deviations from the clinical protocol and protocol requirements including GCP and 
ISO14155:2011  guidelines will be reviewed and evaluated at each monitoring visit.  
A very serious deviation that affects the scientific soundness of the study or any aspect of the 
subject’s safety, rights or wellbeing may be a cause to close the study at an investigational 
center. In addition, these very serious deviations will require urgent reporting to ECs and data 
management.  
 
• Notification requirements and time frames 
The requests for deviations, and reports of deviations, if the deviation affects subject's rights, 
safety and wellbeing, or the scientific integrity of the clinical investigation shall be provided to 
the EC. 
Under emergency circumstances, deviations from the CIP to protect the rights, safety and well-
being of human subjects may proceed without prior approval of the sponsor and the EC. Such 
deviations shall be documented and reported to the sponsor and the EC as soon as possible.  
 
• Corrective and preventive actions and principal investigator disqualification criteria 
Appropriate corrective actions will be implemented as necessary. Each and every deviation 
from the protocol requirements and European standard ISO 14155:2011 ‘clinical investigation 
of medical devices’ will have to be reported as ‘Protocol Deviation’.  
 
Advanced Bionics AG may disqualify a clinical investigator if the clinical investigator has 
repeatedly or deliberately failed to comply with applicable regulatory requirements or the 
clinical investigator has repeatedly or deliberately submitted false information to Advanced 
Bionics or, if applicable, to any ethics committee in any required report. A disqualified clinical 
investigator is not eligible to receive investigational devices, and is not eligible to conduct any 
clinical investigation that supports an application for a research or marketing permit for 
products. 
11.0 Device accountability 

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• Description of the procedures for the accountability of investigational devices 
As all the products that are used in this study are commercially available on the CE market no 
study specific accountability will be performed. Data on which subject was implanted with 
which implant will be tracked according to standard clinical care. Devices are not labeled 
differently than those that will be used for subjects who do not participate in the study. 
12.0 Statements of compliance 
• Statement specifying that the clinical investigation shall be conducted in accordance 
with the ethical principles 
This clinical investigation is conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki. 
 
• Statement specifying compliance with this International Standard and any regional or 
national regulations, as appropriate. 
This clinical investigation is conducted in compliance with ISO 14155:2011. 
 
• Statement specifying that the clinical investigation shall not begin until the required 
approval/favourable opinion from the EC or regulatory authority have been obtained, 
if appropriate. 
This clinical investigation will not begin until the required approval/favourable opinion from the 
center specific EC have been obtained. 
 
• Statement specifying that any additional requirements imposed by the EC or 
regulatory authority shall be followed, if appropriate. 
Any additional requirements imposed by the EC or regulatory authority will be followed. 
 
• Statement specifying the type of insurance that shall be provided for subjects, if 
appropriate. 
Due to the fact that all devices are market approved and used according to the approved 
indication there is no study specific insurance required according to local regulation. 
 
13.0 Informed consent process 
• Description of the general process for obtaining informed consent 
The Informed Consent Form must be provided to the Sponsor for approval prior to submission 
to the EC. The Sponsor will provide an informed consent template and assistance in adapting 
that template to conform to local requirements. Before enrollment, the study will be explained 
to each prospective study candidate. Candidates will be asked to read the approved ICF and 
given the opportunity to ask questions. Once all questions have been answered and the 
Investigator is assured that the individual understands the implications of participating in the 
study, the subject will be asked to sign the ICF. Each subject must get ample time to consider 
participation in the trial. The Investigator will provide a copy of the signed ICF to each subject. 
If an amendment to the protocol changes the scope or activities associated with a subject’s 
participation, or increases the potential risk to the subject, the ICF must be revised and 
submitted to the EC for review and approval. The revised ICF must be used to obtain consent 

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from a subject currently enrolled in the study if he or she is affected by the amendment. The 
revised ICF must be used to obtain consent from any new subject who is enrolled in the study 
after the date of the approval of the amendment. Any modification of the consent, e.g. subject 
information made by an investigator has to be authorized by the Sponsor before it is sent to the 
EC. 
 
• Description of the informed consent process in circumstances where the subject is 
unable to give it; in the case of emergency treatment, the items specified in ISO 
14155:2011 4.7.3.4 shall be included 
Studies conducted by AB do not involve emergency treatment or any other situation where a 
subject in unable to give consent. 
14.0 Adverse events, adverse device effects and device deficiencies 
• Definitions of adverse events and adverse device effects 
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (incl. abnormal laboratory findings) in subjects, users or other 
persons whether or not related to the investigational device. 
A serious adverse event (SAE) is an event that leads to: 
• Death due to any cause 
• A life-threatening illness or injury 
• A permanent impairment of a body structure or a body function 
• In-subject hospitalization or prolongation of existing hospitalization 
• Medical or surgical intervention to prevent permanent impairment to body 
structure or body function 
• Fetal distress, fetal death, congenital abnormality or birth defect.  
An adverse device effect (ADE) is any untoward and unintended response to a medical device. 
NOTE 1 This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device. 
NOTE 2 This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. 
 
• Definition of device deficiencies 
A device deficiency is the occurrence of inadequacy of the medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
 
Device deficiencies include malfunctions, use errors, and inadequate labelling. 
 
• Definitions of serious adverse events and serious adverse device effects and, where 
appropriate, unanticipated serious adverse device effects 
A serious adverse device effect (SADE) is an event that resulted in any of the consequences 
characteristic of a serious adverse event (SAE) or that might have led to any of the 
consequences if suitable action had not been taken or interventions had not been made or if 
circumstances had been less opportune. 

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An unanticipated adverse device effect (UADE) Is any serious adverse effect on health or 
safety; any life threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application; or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects. 
All adverse events and adverse device effects, serious and non-serious and device deficiencies 
will be tracked during the course of the study using the appropriate case report form. Case 
report forms should include, but are not limited to: 
• Description of event, duration, and severity  
• Date that event was first detected (if after surgery) 
• Course of action taken 
• Status (resolved, improving, no change, worsening). The status of the event will be 
tracked throughout the study until it is resolved or the study is closed. 
• Subject and device identification 
 
The relationship between the study procedures and the incidence of an adverse event will be 
classified by the investigator in categories as divided in the CRF: 
• Not related 
• Related 
• Unknown 
 
• Time period in which the principal investigator shall report all adverse events and 
device deficiencies to the sponsor and, where appropriate, to ECs and the regulatory 
authority 
Adverse events classified as SAE according to the definition above have to be reported by the 
investigator to AB AG without unjustified delay but nevertheless within 48 hours after first 
knowledge of the event. Investigator – AB AG reporting should preferably be done by the eCRF 
in combination with an e-mail or fax to the address indicated in this CIP.  Initial reporting must 
be concluded within 48hrs of awareness, irrespective of missing data/information.  If additional 
information or documentation is needed, the study manager will be responsible to contact the 
study center in order to retrieve the necessary information. 
 
• Details of the process for reporting adverse events (date of the adverse event, 
treatment, resolution, assessment of both the seriousness and the relationship to the 
investigational device) 
Evaluation of any SAEs, SADEs, and UADEs will be conducted promptly. Confirmed SAEs, SADEs, 
and UADEs will be reported by the Sponsor to all ethics committees as soon as possible but in 
any case within 2 working days after receiving notice of the event. If it is determined that an 
event or effect presents an unreasonable risk to subjects, this study, or those parts of the study 
presenting that risk, will be terminated not later than 5 working days after the determination is 
made and not later than 15 working days after the Sponsor/Clinical Research first received 
notice of the effect (section 4.7). 
All other issues related to the device will be reported to Advanced Bionics AG, as indicated in 
the product manuals. 
 

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As Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) are treated 
identically with respect to the procedures given in this section, the term SAE will include the 
term SADE in this section. 
 
• Details of the process for reporting device deficiencies 
In this clinical investigation Adverse Events and device deficiencies will be collected using the 
applicable section in the Case Report Form based on Adverse Event Report  and registered into 
AB`s vigilance data base, if applicable. AE and ADE will be included in periodic safety reports 
and in the clinical study report. More immediate and direct reporting to EC and/or NCAs is 
required when AE or ADE are classified as SAE or USADE. 
 
• List of foreseeable adverse events and anticipated adverse device effects, together 
with their likely incidence, mitigation or treatment 
Anticipated adverse device effects and residual risks as well as possible interactions with 
concomitant medical treatments are described in 4.0 Risks and benefits of the investigational 
device and clinical investigation. 
 
• Emergency contact details for reporting serious adverse events and serious adverse 
device effects 
Emergency deviations or modifications must be reported to the Sponsor and the EC no later 
than 24 hours after the emergency.  
Study Management accepts the right of the investigator to deviate from protocol in a medical 
emergency when necessary to safeguard the life or physical wellbeing of the subject. The 
following conditions must apply for a situation to be considered a medical emergency: 
• The subject is in a life threatening situation and needs immediate treatment. 
• No generally acceptable alternative for treating the subject is available. 
• Time does not allow the investigator to notify the Sponsor to obtain regulatory 
approval. 
In these cases the investigator is obliged to notify the CPM immediately who will notify the EC 
and Regulatory agencies no later than 5 working days after the event was reported. 
 
Emergency Contact for reporting serious adverse events and serious adverse device effects: 
Name  
Cyrill Reber 
Address 
Advanced Bionics AG 
Clinical Research 
Laubisrütistrasse 28 
CH-8712 Stäfa, Switzerland 
Telephone 
+41 58 928 78 66  
e-mail 
Cyrill.reber@advancedbionics.com  
 
• Information regarding the DMC, if established 
Not applicable 
XXXXXXXXXXXX
XXXXXXXXXXXX
XXXXXXXXXXXX

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15.0 Vulnerable population 
In this PMCF study no vulnerable subjects will be recruited. 
16.0 Suspension or premature termination of the clinical investigation 
• Criteria and arrangements for suspension or premature termination of the whole 
clinical investigation or of the clinical investigation in one or more investigation sites 
AB AG reserves the right to terminate the study or enrolment at any center at any time. 
However, this right will be exercised only for valid scientific or business reasons (excluding as a 
reason the actual interim study results), or because of issues related to protection of research 
subjects.  
 
Possible reasons for suspending or terminating a center include: 
• Investigator non-compliance. 
• Repeated failure to complete or submit CRFs in a timely manner. 
• Failure to obtain written informed consent from each subject. 
• Failure to report an SAE or UADE to the Sponsor within the required 
timeframe. 
Investigators and EC s will be notified in writing in the event of termination. 
 
 
 
• Criteria for access to and breaking the blinding/masking code in the case of 
suspension or premature termination of the clinical investigation, if the clinical 
investigation involves a blinding/masking technique 
Not applicable for this study. 
 
• Requirements for subject follow-up after termination 
After termination of this study subjects will continue their standard clinical care. 
17.0 Publication policy 
• Statement indicating whether the results of the clinical investigation will be submitted 
for publication.  
The study may be published on conferences and in a peer reviewed journal. Please consider the 
details in the contract. 
 
• Statement indicating the conditions under which the results of the clinical 
investigation will be offered for publication 
It is planned to publish the study results at conferences as potentially in a peer reviewed 
journal. Once the evaluation of all data is finished, sponsor and investigator shall discuss the 
details of the publication (format, journal, authors etc.) The sponsor will not have a veto. 
 
18.0 Bibliography 

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Arnoldner C, Baumgartner WD, Gstoettner W, Hamzavi J. (2005) Surgical considerations in 
cochlear implantation in children and adults: a review of 342 cases in Vienna. Acta 
Otolaryngol. 2005 Mar;125(3):228-34. 
Battmer RD, Scholz S, Gazibegovic D, Ernst A (in press) Comparison of a Mid Scala and a 
Perimodiolar electrode in adults: Performance, Impedances and Psychophysics. Otol Neurotol, 
in press. 
Cohen and Hoffman (1991)  Complications of cochlear implant surgery in adults and children. 
Ann Otol Rhinol Laryngol. 1991 Sep;100(9 Pt 1):708-11 
DGHNO (2018) Weißbuch Cochlea-Implantat(CI)-Versorgung 
Dutt SN, Ray J, Hadjihannas E, Cooper H, Donaldson I, Proops DW. (2005)  Medical and surgical 
complications of the second 100 adult cochlear implant patients in Birmingham. J Laryngol Otol 
119:759-764. 
Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power 
analysis program for the social, behavioral, and biomedical sciences. Behavior Re-search 
Methods, 39, 175-191. 
Green KM, Bhatt YM, Saeed SR, Ramsden RT. (2004)  Complications following adult cochlear 
implantation: experience in Manchester. J Laryngol Otol 118:417-420. 
Helbig S, Helbig M, Leinung M, Stöver T, Baumann U, Tader T (2014) Hearing Preservation and 
Improved Speech Perception With a Flexible 28-mm Electrode. Otol Neurotol 36:34-42 
Hey M, Hocke T, Hedderich J, Müller-Deile J (2014) Investigation of a matrix sentence test in 
noise: Reproducibility and discrimination function in cochlear implant patients. Int J Audiol 
53(12):895-902 
Koch DB, Osberger MJ, Segel P, Kessler D. (2004)  HiResolution and conventional sound 
processing in the HiResolution Bionic Ear: Using appropriate outcome measures to assess 
speech recognition ability. Audiol Neurotol 9: 214-23. 
Lenarz M, Joseph G, Sönmez H, Büchner A, Lenarz T (2011) Effect of Technological Advances on 
Cochlear Implant Performance in Adults. Laryngoscope 121(12):2634-40. 
Parkinson A, Arcaroli J, Staller S, Arndt P, Kosgriff A, Ebinger K. (2002)  The NucleusTM 24 
Contour™ cochlear implant system: adult clinical trial results. Ear Hear 22: 41S-48S. 
Roland JT, Jr. (1989)  Complications of cochlear implant surgery. In Waltzman SB, Cohen NL, 
eds. Cochlear implants. New York: Thieme, pp. 171-177. 
Venail F, Sicard M, Piron JP, Levi A, Artieres F, Uziel A, Mondain M. (2008) Reliability and 
complications of 500 consecutive cochlear implantations. Arch Otolaryngol Head Neck Surg. 
Dec;134(12):1276-81 
Zwolan T, Kileny PR, Smith S, Mills D, Koch DB, Osberger MJ. (2001)  Adult cochlear implant 
patient performance with evolving electrode technology. Otol Neurotol 22:844-49. 
 

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Apendix: 
A 
MRI Warning 
MRI warning for Ultra  
MRI Warning for Ultra 3D 
 
B 
Questionnaires 
Questionnaire for the surgeon 
Questionnaire for the audiologist 
Questionnaire for the patient 
 
-End Of Document-