Clinical Performance of a New Implant System for Bone Conduction Hearing
Phase: NA
Conditions: Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
Sponsor: Cochlear

 
 
 
 
 
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Clinical Investigation Plan (CIP) 
 
Investigation code  
CBAS5539 
Version  
Version date 
5 
14 Aug 2017 
 
Clinical performance of a new implant system for bone conduction 
hearing 
Open, two-armed prospective, multicentre clinical investigation. 3-month investigation 
(primary analysis) with an additional 9 months of follow-up. 
 
NCT03086135 
 
This CIP version 5 includes the following additions: 
 
CIP version 
Date 
Comments 
1 
25 September 2016 
Submitted in Australia 
2 
24 January 2017 
Including Amendment 1 
3 
05 March 2017 
Including Amendment 2 
4 
31 March 2017 
Including Amendment 3 
Will be submitted in US and EU 
 

 
 
 
 
 
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5 
14 August 2017 
Including Amendment 4: 
Update following Bfarm and 
FDA review 
Will be submitted in EU and 
Australia 
 

 
 
 
 
 
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SYNOPSIS 
Name of Sponsor  
 
Cochlear Bone Anchored Solutions AB 
Investigation code 
CBAS5539 
Investigational title 
Clinical performance of a new implant system for bone 
conduction hearing 
Design 
Open, two-armed, prospective, multicentre clinical investigation.  
Three-month investigation (primary efficacy analysis) with an additional 
9 months of follow-up. Primary safety analysis is based on an endpoint 
at 6 months. 
Investigational device(s)  
ATB System 
(Osseointegrated Steady State Implant System, commercially to be 
named Osia™ System) 
Comparator(s) 
No comparator will be used. 
Aim for conducting the 
investigation  
The aim of the investigation is to demonstrate that the ATB System 
provides an improvement in hearing outcomes and quality of life 
compared to unaided hearing in patients with a conductive or mixed 
hearing loss or single-sided sensorineural deafness (SSD). The aim is 
also to measure and present preoperative audiological test results with 
a Baha BP110 Power Sound Processor on a Baha Softband in relation 
to the Investigational device.Safety parameters will be collected. 
 
Inclusion criteria  
• 
Adult subjects (18 years or older) 
• 
Subject with conductive or mixed hearing loss in the ear to be 
implanted. Bone conduction thresholds with pure tone average 
(PTA4; mean of 0.5, 1, 2 and 4 kHz) of  55 dB. 
OR 
 
Subject with single-sided sensorineural deafness who is a 
candidate for Baha surgery. Air conduction thresholds with a pure 
tone average PTA4 of  20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in 
the good ear OR subject who is indicated for an AC CROS but—for 
some reason—cannot or will not use an AC CROS (Air 
Conduction-Contralateral Routing of Signal). 
• 
Signed informed consent. 
 
• 
Previous experience from amplified sound through properly fitted 
amplification . (For example but not limited to Hearing aid, CROS 
device, Bone conductional hearing device on headband/ softband) 
 
Exclusion criteria  
• 
Uncontrolled diabetes as judged by the investigator. 
• 
Condition that could jeopardise osseointegration and/or wound 
healing (e.g. osteoporosis, psoriasis, long-term systemic use of 

 
 
 
 
 
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corticosteroids) or condition that may have an impact on the 
outcome of the investigation as judged by the investigator. 
• 
Insufficient bone quality and quantity for implantation of a BI300 
Implant.  
• 
Use of ototoxic drugs that could be harmful to the hearing, as 
judged by the investigator 
• 
Unable to follow investigational procedures, e.g. to complete 
quality of life scales. 
• 
Participation in another clinical investigation with pharmaceutical 
and/or device. 
• 
Subject that has received radiotherapy in the area of implantation, 
or is planned for such radiotherapy during the study period. 
• 
The subject is pregnant or lactating  
• 
The subject suffers from psychiatric and/or psychosomatic 
disorder(s). 
Number of subjects  
• 
50 evaluable subjects (visit 2 performed successfully). 
Duration of subjects 
participation 
• 
One year in total (3 + 9 months) 
 
 
Objectives and outcome  measures 
Primary objective 
Outcome measure(s)  
To compare hearing performance with the 
Investigational device and the unaided hearing 
situation 
At 3 months 
• 
Thresholds audiometry, free-field [PTA4, 
Mean of 0.5, 1, 2 and 4 kHz]. Investigational 
device (at 3 months) vs. Unaided. 
• 
Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding]. 
Investigational Device vs. Unaided 
(preoperative). 
 
Secondary objective(s) 
Outcome measure(s) 
To compare hearing performance with the 
Investigational device and the unaided hearing 
situation 
• 
 Thresholds audiometry, free-field [PTA4, 
Mean of 0.5, 1, 2 and 4 kHz]. Investigational 
Device (4w, 6 and 12 months) vs. Unaided 
(preoperative). 
• 
Thresholds audiometry, free-field [0.25, 0.5, 
0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. 
Investigational Device (4w, 3, 6 and 12 

 
 
 
 
 
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months) vs. Unaided (preoperative). 
• 
Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding]. 
Investigational Device (4w, 6 and 12 months) 
vs. Unaided (preoperative). 
• 
Speech in quiet [% correctly perceived words 
at 50dB, 65dB and 80dB SPL]. Investigational 
Device (4w, 3, 6, and 12 months) vs. Unaided 
(preoperative). 
• Feedback measurements. Investigational 
Device (Visit 4 and onwards). 
To compare the self-reported assessments of 
hearing outcome with the Investigational device 
and in a preoperative hearing situation 
• Abbreviated Profile of Hearing Aid Benefit 
(APHAB). Investigational Device at 3 and 12 
months vs. preoperative hearing situation. 
• Health Utilities Index (HUI23S1EN.15Q) at 3 
and 12 months. Investigational device vs. 
preoperative hearing situation 
• Speech, Spatial and Qualities of Hearing 
Scale (SSQ) at 3 and 12 months. 
Investigational device vs. Unaided. 
To collect surgical information 
• Soft tissue thickness  
• Soft tissue reduction performed 
• Type of anaesthesia 
• Surgery time  
• Bone polishing/removal at the actuator site 
• BI300 Implant length  
• Location of BI300 Implant 
• Surgical incision type/location 
To collect information about the magnet choice 
and daily use of sound processor 
• Daily usage time 
• Comfort 
• Softpad use 
• Choice of magnet strength 
To measure hearing performance preoperatively 
with a Baha BP110 Power Sound Processor on a 
Baha Softband 
• Thresholds audiometry, free-field [PTA4, 
Mean of 0.5, 1, 2 and 4 kHz].  
• Thresholds audiometry, free-field [0.25, 0.5, 
0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].  
• Speech in quiet [% correctly perceived words 
at 50dB, 65dB and 80dB SPL] 
• Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding]. 
• BC Direct [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 

 
 
 
 
 
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4.0 and 6.0 kHz]. 
 
 
Tertiary objective 
Outcome measure(s) 
To measure hearing performance preoperatively 
with a current hearing aid (if used by the patient). 
• Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding]. 
 
 
Safety objective(s) 
Outcome measure(s) 
Primary safety analysis at 6 months. 
 
Implant site evaluations 
Numbness 
Adverse Events and concomitant 
medication/treatment 
Information will be collected from visit 2 and 
onwards. 
Device deficiency  
Information will be collected from Visit 2 and 
onwards. 
Audiogram 
Bone conduction thresholds preoperative and 
postoperative (3, 6, and 12 months). 
 

 
 
 
 
 
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Flowchart 
 
Visit 1 
Pre-op 
testing 
Visit 2 
Surgery 
 
Visit 3 
Suture 
removal 
Visit 4 
Fitting 
Visit 5 
Visit  6 
Visit 7 
Visit 8 
Visit time point 
 
0 
2W 
4W 
6W 
3M 
6M 
12M 
Visit window 
 
 
 5D 
 1W 
 1W 
 2W 
 3W 
 4W 
Demographics 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
Baseline characteristics 
X 
 
 
 
 
 
 
 
Audiogram 
X 
 
 
 
 
X6 
X6 
X6 
Eligibility criteria 
X 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
Soft tissue thickness 
X      or     X 
 
 
 
 
 
 
Surgery1 
 
X 
 
 
 
 
 
 
IOTS 
 
X 
 
 
 
 
 
 
Suture removal  
 
 
X 
 
 
 
 
 
Sound processor fitting 
X2 
 
 
X 
X 
X 
X 
X 
Magnet choice 
 
 
 
X 
X 
X 
X 
X 
BC Direct 
X2 
 
 
X 
X 
X 
X 
X 
Feedback measurements 
 
 
 
X 
X 
X 
X 
X 
 
Free field thresholds 
X2,3.4 
 
 
X 
 
X 
X 
X 
Speech recognition in quiet 
X2,3, 4 
 
 
X 
 
X 
X 
X 
Speech recognition in noise 
X2,3, 4 
 
 
X 
 
X 
X 
X 
APHAB  
X3 
 
 
 
 
X 
 
X 
HUI 
X4 
 
 
 
 
X 
 
X 
SSQ 
X3 
 
 
 
 
X 
 
X 
Daily use5 
 
 
 
 
X 
X 
X 
X 
Numbness 
 
 
X 
X 
X 
X 
X 
X 
 
Device deficiency  
 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medication/treatment 
 
X 
X 
X 
X 
X 
X 
X 
Extra visits as needed 
 
 
 
 
 
 
 
 
 
1 Surgical variables: Soft tissue thickness (mm), Surgery time (time between first incision and last suture), Bone 
polishing/removal at the actuator site, BI300 Implant length (4mm, 3 mm), Location of BI300 Implant (mm), 
Type of anaesthesia (general, local), Soft tissue reduction performed (yes, no), Surgical incision type.  
2  BahaPower Sound Processor (BP110) on Baha Softband  
3 Unaided 
4 In a preoperative hearing situation 
5 Daily use: Usage time (hours/day), Comfort (visual analogue scale), Softpad use 
6 Only bone conduction 
 

 
 
 
 
 
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TABLE OF CONTENTS 
Synopsis .................................................................................................................................................. 3 
Table of Contents .................................................................................................................................... 8 
Abbreviations ........................................................................................................................................ 12 
1 
Introduction .................................................................................................................................... 13 
1.1 
Background ......................................................................................................................... 13 
1.1.1 
The Baha Systems ................................................................................................ 13 
1.1.2 
The ATB System ................................................................................................... 13 
1.2 
Aim ...................................................................................................................................... 14 
2 
Medical device(s) used during and after the investigation ............................................................ 15 
2.1 
Investigational device .......................................................................................................... 15 
2.1.1 
Description of the investigational device(s) ........................................................... 15 
2.1.2 
Description of comparator ..................................................................................... 17 
2.2 
Blinding................................................................................................................................ 18 
2.3 
Other devices used in the investigation, non-investigational .............................................. 18 
2.3.1 
Surgical instruments .............................................................................................. 18 
2.3.2 
Fitting Software (FS) ............................................................................................. 19 
2.3.3 
Programming pod .................................................................................................. 19 
2.3.4 
Intraoperative test system ..................................................................................... 19 
2.3.5 
Reference device .................................................................................................. 21 
2.4 
Treatment after the completion of the investigation ............................................................ 22 
3 
Subjects and subject protection .................................................................................................... 23 
3.1 
Selection of subjects ........................................................................................................... 23 
3.1.1 
Inclusion criteria .................................................................................................... 23 
3.1.2 
Exclusion criteria ................................................................................................... 23 
3.2 
Number of subjects ............................................................................................................. 23 
3.3 
Duration of subject participation .......................................................................................... 24 
3.4 
Subject enrolment and Informed consent ........................................................................... 24 
3.5 
Randomisation .................................................................................................................... 24 
3.6 
Discontinuation .................................................................................................................... 24 
3.7 
Replacement of subjects ..................................................................................................... 24 
3.8 
Insurance............................................................................................................................. 24 
4 
Design of the clinical investigation ................................................................................................ 25 
4.1 
Design of the clinical investigation ...................................................................................... 25 
4.2 
Justification for the design of the clinical investigation ....................................................... 25 

 
 
 
 
 
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4.3 
Objectives and outcome measures ..................................................................................... 25 
4.3.1 
Demographics and baseline variables .................................................................. 27 
5 
Procedures .................................................................................................................................... 28 
5.1 
Test equipment ................................................................................................................... 28 
5.2 
Demographics ..................................................................................................................... 28 
5.3 
Medical history .................................................................................................................... 28 
5.4 
Baseline characteristics ...................................................................................................... 28 
5.5 
Audiogram ........................................................................................................................... 29 
5.6 
Soft tissue thickness ........................................................................................................... 29 
5.7 
Surgery ................................................................................................................................ 29 
5.8 
Intraoperative Test system (IOTS) ...................................................................................... 30 
5.9 
Sound Processor fitting ....................................................................................................... 30 
5.10 Magnet choice ..................................................................................................................... 30 
5.11 Bone Conduction (BC) Direct .............................................................................................. 31 
5.12 Simultaneous bilateral ......................................................................................................... 31 
6 
Assessments ................................................................................................................................. 31 
6.1 
Postoperative audiometric assessment .............................................................................. 31 
6.2 
Free-field threshold ............................................................................................................. 31 
6.3 
Speech recognition in quiet ................................................................................................. 32 
6.4 
Adaptive Speech recognition in noise ................................................................................. 32 
6.5 
Abbreviated Profile of Hearing Aid Benefit (APHAB form A) .............................................. 33 
6.6 
Speech, Spatial, and Qualities of Hearing Scale (SSQ-12 version) ................................... 34 
6.7 
Health Utility Index (HUI23)................................................................................................. 34 
6.8 
Daily use.............................................................................................................................. 34 
6.9 
Numbness ........................................................................................................................... 36 
7 
Adverse event and device deficiencies ......................................................................................... 37 
7.1 
Device deficiency reporting ................................................................................................. 37 
7.2 
Adverse Event (AE) and Serious Adverse Event (SAE) ..................................................... 37 
7.2.1 
Definitions .............................................................................................................. 37 
7.2.2 
Handling and reporting of AEs and ADEs ............................................................. 38 
7.2.3 
Definition of AESI in this clinical investigation ....................................................... 38 
7.2.4 
Clinically significant threshold shifts ...................................................................... 38 
7.2.5 
Handling and reporting of AESIs, SAEs and device deficiency that could have led 
to a SAE .............................................................................................................................. 38 
7.3 
Reporting to ethical committees and regulatory authorities ................................................ 38 
7.4 
Foreseeable Adverse Events .............................................................................................. 40 
7.5 
Concomitant medication(s) and treatment(s) ...................................................................... 41 

 
 
 
 
 
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8 
Flow chart ...................................................................................................................................... 42 
9 
Risk and benefits of the investigational device(s) and the clinical investigation ........................... 43 
9.1 
Anticipated clinical benefits ................................................................................................. 43 
9.2 
Anticipated adverse device effects ..................................................................................... 43 
9.2.1 
ATB Sound Processor (Osia Sound Processor) ................................................... 44 
9.2.2 
Receiver-stimulator (CI24RE) ............................................................................... 44 
9.2.3 
Codacs .................................................................................................................. 44 
9.2.4 
BI300 Implant with the Baha Connect System ...................................................... 44 
9.2.5 
BI300 Implant with the Baha Attract System ......................................................... 44 
9.3 
Risks associated with participation in the clinical investigation .......................................... 45 
9.4 
Control and mitigation of risks ............................................................................................. 45 
9.5 
Risk-to-benefit assessment ................................................................................................. 45 
10 Statistical consideration ................................................................................................................. 46 
10.1 Statistical Design and Objectives ........................................................................................ 46 
10.1.1 
Primary statistical objectives ................................................................................. 46 
10.1.2 
Secondary statistical objectives ............................................................................ 46 
10.1.3 
Tertiary statistical objective ................................................................................... 46 
10.2 Efficacy variables/endpoints................................................................................................ 46 
10.2.1 
Primary variables/endpoints .................................................................................. 46 
10.2.2 
Secondary variables/endpoints ............................................................................. 47 
10.2.3 
Safety variables/endpoints .................................................................................... 47 
10.3 Sample size calculation ....................................................................................................... 48 
10.3.1 
Sample size calculation for the primary efficacy analysis ..................................... 48 
10.3.2 
Sample size calculation for the secondary analysis ............................................. 48 
10.3.3 
Sample size estimation for the primary safety analysis at 6 months .................... 48 
10.3.4 
Overall sample size considerations ...................................................................... 48 
10.4 General statistical methodology .......................................................................................... 48 
10.5 Efficacy analysis .................................................................................................................. 49 
10.5.1 
Primary efficacy analysis....................................................................................... 49 
10.5.2 
Secondary efficacy analyses ................................................................................ 49 
10.5.3 
Tertiary efficacy analyses...................................................................................... 49 
10.6 Safety analyses ................................................................................................................... 49 
10.6.1 
Implant site evaluation .......................................................................................... 49 
10.6.2 
Adverse Events ..................................................................................................... 49 
10.6.3 
Device deficiency .................................................................................................. 50 
10.7 Analyses of concomitant medications and treatments ........................................................ 50 
10.8 Demographics and baseline characteristics ....................................................................... 50 

 
 
 
 
 
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10.9 Interim analysis ................................................................................................................... 50 
10.10 Statistical Analysis Plan ...................................................................................................... 50 
11 Statement of compliance ............................................................................................................... 51 
11.1 Ethical requirements for the conduct of the investigation ................................................... 51 
11.2 Regulatory requirements for the conduct of the investigation ............................................. 51 
11.3 Updates ............................................................................................................................... 51 
11.4 Quality standards ................................................................................................................ 52 
12 Administrative Aspects .................................................................................................................. 53 
12.1 Training ............................................................................................................................... 53 
12.2 Investigational data ............................................................................................................. 53 
12.2.1 
Case report form ................................................................................................... 53 
12.2.2 
Source data ........................................................................................................... 53 
12.2.3 
Data management ................................................................................................. 53 
12.3 Archiving.............................................................................................................................. 53 
12.4 Device accountability .......................................................................................................... 53 
12.5 Quality control ..................................................................................................................... 54 
12.5.1 
Monitoring ............................................................................................................. 54 
12.5.2 
Audit ...................................................................................................................... 54 
12.5.3 
Sponsor expertise ................................................................................................. 54 
12.6 Clinical Investigation Plan ................................................................................................... 54 
12.6.1 
CIP amendment .................................................................................................... 54 
12.6.2 
Deviations from Clinical Investigation Plan ........................................................... 54 
12.7 Suspension or premature termination ................................................................................. 55 
12.8 Publication policy ................................................................................................................ 55 
12.9 Timetable............................................................................................................................. 55 
12.10 Definition of end of investigation ......................................................................................... 55 
13 Bibliography ................................................................................................................................... 56 
Appendix 1 - New ATB specific instruments and template ................................................................... 57 
14 Appendix 2 -  supportive and surgical non-  investigational devices used in the investigation ..... 59 
 
 
 

 
 
 
 
 
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ABBREVIATIONS  
 
 
APHAB 
Abbreviated Profile of Hearing Aid Benefit 
AC-CROS 
Air Conduction-Contralateral Routing of Signal 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest  
AIMD 
Active Implantable Medical Device 
ATB-System 
Active Transcutaneous Bone conduction System 
CBAS 
Cochlear Bone Anchored Solutions AB 
CE 
Conformité Européenne 
CI 
Cochlear Implants 
CIP 
Clinical Investigation Plan 
CRO 
Contract Research Organisation 
EC 
Ethic Committee 
eCRF 
Electronic Case Report Form  
FDA 
Food and Drug Administration  
FS 
Fitting Software 
HARL 
Hearing Aid Research Lab 
HRQL 
Health Related Quality of Life 
HUI23S1EN.15Q 
Health Utility Index 23 Self-Administered English 15 Questions  
IFU 
Instruction For Use 
IOTS 
Intraoperative Test System 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intention To Treat 
OFS 
Osia Fitting Software 
PTA4 
Pure Tone Average 4 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event   
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SNHL 
Sensorineural hearing loss 
SNR 
Signal to Noise Ratio 
SP 
Sound Processor 
SPL 
Sound Pressure Level 
SSD 
Single-sided sensorineural deafness 
SSQ 
Speech, Spatial, and Qualities of Hearing Scale 
WHO 
World Health Organisation 
PP 
Per Protocol 
USADE 
Unanticipated Serious Adverse Device Effect 
 

 
 
 
 
 
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1 
INTRODUCTION 
1.1 
Background 
1.1.1 
The Baha Systems 
The Cochlear Baha bone conduction systems offers two alternative ways to transmit vibrations from 
the external sound processor to the osseointegrated implant: The Baha Connect System uses a skin-
penetrating abutment and allows direct bone conduction. The passive Baha Attract System uses a 
magnetic connection through intact skin. Magnetic conduction have the advantage over skin-
penetrating systems of eliminating the daily cleaning, reduction in reported adverse skin reactions of 
the implant site and are perceived as more cosmetically appealing by many subjects. The skin-
penetrating abutment of the traditional Baha System is seen as a barrier for many candidates. The 
passive Baha Attract System was developed in consideration of all these features and incorporates 
implantable and external parts as illustrated in Figure 1. 
 
Figure 1: The passive Baha Attract System  
The sound processor (1) is connected (via a snap coupling) to the sound processor magnet (2), 
which, together with the implant magnet (3), constitute the transcutaneous coupling. The implant 
magnet is fixated to the titanium implant (4).  
Both Baha Systems make use of the same external sound processors and are built on the same 
implantable platform, the osseointegrated BI300 Implant. Both systems have been proven to be safe 
and effective through years of clinical use and data from clinical investigations1, 2, 3. While the Baha 
Connect System enables direct bone conduction through the percutaneous implant, the passive 
transcutaneous Baha Attract System offers less efficient bone conduction (especially at high 
frequencies) due to attenuation of sound vibrations through the intact skin that separates the external 
transducer from the osseointegrated implant. 
 
1.1.2 
The ATB System 
The ATB System (Osseointegrated Steady State Implant System) is developed to provide the benefits 
of a non-skin-penetrating system combined with the benefits of a skin-penetrating system. Compared 
to the passive transcutaneous Baha Attract System, the ATB System will provide a more efficient 
transmission of sound, especially in the high frequency range, as the implantable transducer 
eliminates the attenuation of sound vibrations through the soft tissue that is inherent to the passive 
system. With the ATB System it will also be possible to position the transducer closer to the ear canal, 
which may further improve audiological outcomes.  
 
 
 

 
 
 
 
 
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The ATB System is a bone-conduction hearing device that allows direct bone-conduction through an 
implanted actuator on the osseointegrated BI300 Implant (Figure 2). 
 
 
 
 
 
 
Figure 2: The ATB System  
The ATB System function as follows: 
• 
The external sound processor - SP (1) captures and digitally processes sound 
• 
The SP transmits power and digital information to the internal implant (2)  
• 
The implant converts the digital information into a an electric analogue implant (3) 
• 
This electric signal is transmitted to the actuator (4) 
• 
The actuator converts the electric signal to vibrations that are transmitted to the mastoid bone 
trough the osseointegrated BI300 Implant (5) 
 
With the ATB System the following transition paths have been established: 
• From a traditional percutaneous solution – the Baha Connect System 
• Via a magnetic connection solution (Baha Attract System) with better aesthetics but limited 
performance due to skin attenuation, especially in the high frequency area 
• To the ATB System which combines aesthetics with higher performance to meet the needs of 
subjects with mixed hearing loss. The target fitting range is 55dB Sensorineural hearing loss 
(SNHL). In addition, since the actuator creating the vibration is connected directly to the 
BI300 Implant, the attenuation of higher frequencies that occurs when using the Baha Attract 
System, could be avoided.  
1.2 
Aim 
The aim of the investigation is to demonstrate that the ATB System provides an improvement in 
hearing outcomes and quality of life compared to unaided hearing in patients with a conductive or 
mixed hearing loss or single-sided sensorineural deafness (SSD).  
The aim is also to measure and present preoperative audiological test results with a Baha BP110 
Power Sound Processor on a Baha Softband in relation to the Investigational device. Safety 
parameters will be collected. 
. 
 

 
 
 
 
 
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2 
MEDICAL DEVICE(S) USED DURING AND AFTER THE 
INVESTIGATION 
2.1 
Investigational device 
2.1.1 
Description of the investigational device(s) 
The ATB System is intended for patients with conductive or mixed hearing loss, or single-sided 
sensorineural deafness (SSD). Patients should have sufficient bone quality and quantity to support 
successful implant placement. This system should only be used by trained, qualified professionals. 
The ATB System has a fitting range of up to 55 dB SNHL bone conduction threshold in mixed 
hearing loss. 
The regulatory classification of the system is expected to be Class III active implantable medical 
device (AIMD) in the EU and Class II or III in the US1. The instruments of the ATB System that have 
previously been CE marked and FDA cleared for the current Baha or Cochlear Implant (CI) systems 
maintain their current classification. The BI300 Implant will also maintain its classification in the EU 
(Class IIb) and in the US (Class II). 
Figure 3: The ATB System parts:1 Sound Processor, 2 Receiver, 3 Stimulator, 4 
Actuator, 5 BI300 Implant, 6 Lead  
 
 
 
 
 
The ATB System (Figure 3) consists of the following components: 
Button sound processor (1):  
The ATB Sound Processor (SP) consists of an all-in-one off-the-ear button processor: processing unit 
with active coil, magnet (with seven possible strengths), and two battery cells. The ATB SP has 
identical hardware as the CP950 Sound Processor for Cochlear Implants, but with ATB specific 
firmware. The ATB SP will commercially be referred to Osia™ Sound Processor. 
The sound is picked up by the microphone and processed by the processing unit. It is sent to the 
active coil which transmits the signal to the implant coil. The processing unit also contains light 
emitting diodes (LED) and one command button, which allows the patient to control the processing 
unit e.g. switching the sound processor on/off. Power to the sound processor is provided by two 675 
Zinc-Air batteries which are accessed by removal of the battery cover. A SoftWear Pad (also used 
with the Baha Attract Sound Processor Magnet) will be available, which distributes the force imposed 
by the magnets and reduces point pressures on the skin (Figure 4). Complete information for the ATB 
SP is found in the user manual 4. 
                                                          
1 To be confirmed. 

 
 
 
 
 
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Figure 4. Left: Osia Sound Processor, external view (upper surface). Middle: Osia Sound Processor, partially 
exploded view. Right: SoftWear™ Pad, showing removal of protective film to expose self-adhesive surface. 
 
ATB-Implant (OSI100 Implant) consist of:  
Receiver- stimulator (2 and 3) 
The coil, magnet and case in the receiver-stimulator is reused from the Freedom Cochlear Implant 
platform (CI24RE), which has been used in Cochlear implantable systems since 2005. The Codacs® 
system also use identical coil, magnet and case. A magnet located at the centre of the implant coil 
allows the coil of the external sound processor to be placed in the correct position, over the receiver-
stimulator coil. The receiver-stimulator contains ATB specific electronics, which is powered by two 
batteries in the external sound processor. The receiver-stimulator is completely over-moulded by a 
silicone coating. 
Actuator (4) 
Actuator is a piezoelectric transducer which converts the signal into corresponding vibrations. The 
actuator design concept is conceived of a piezo-bender connected to two identical tungsten moving 
masses. When the piezo-element is electrically driven by the stimulator electronics, a vibration is 
generated at the central fixation clamp, the location where the actuator is fixed to the BI300 Implant. 
All external weld seams of the ATB Actuator are over-moulded by a silicone coating. See figure 5. 
Figure 5. : The ATB Actuator 
The design of the Actuator reuses critical design features from the BIM400 Implant magnet of the 
Baha Attract System. The size of the actuator, including the silicone coating, measures 31.4  22.6 x 
4.9 mm. The Actuator will come pre-mounted on the Isolator inside the sterile blister packaging, being 
prepared for the IOTS testing, see section 2.3.4. 
Lead (6) 
Actuator is connected to the receiver-stimulator via a standard Cochlear lead (currently used in the CE 
marked Codacs® System). The lead is over-moulded by a silicone coating. 

 
 
 
 
 
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CP950 Magnets 
The CP950 magnets come in 6 various strengths; ½ (weakest) to 6 (strongest). The CP950 magnets 
are identical as the magnet used in the CP950 Sound Processor for Cochlear implants and are 
therefore regulatory approved and bear CE marking. They are used according to their intended use. 
 
BI300 Implant (5) 
The ATB System uses the same osseointegrated BI300 Implant for anchorage in the bone as in 
existing Baha Connect and Baha Attract systems and is identical to the Cochlear Vistafix VXI300 
Implant which all are regulatory approved. The BI300 Implant bears CE marking and comes in two 
different lengths, 4mm and 3 mm and is made of titanium. The surface is moderately roughened 
(TiOblast™) on its intraosseous parts. The BI300 Implant is used according to their intended use. 
 
Table 1 lists the investigational device used in this clinical investigation.  
 
Table 1. List of Investigational device. 
Name 
Description  
Part Number 
Osia Sound Processor 
Sandy Blonde 
Chocolate Brown 
Slate Grey 
Black 
P798664 – P798667 
OSI100 Implant 
- Receiver-Stimulator (coil, 
magnet, case) 
- Actuator (including isolator) 
- Lead 
Z398787 
CP950 Magnets 
Strength from 0.5 – 6 
Z566412, Z502922, Z502923, 
Z502924, Z502925, Z566414, 
Z566415 
BI300 Implant 
4mm, 3 mm 
92129, 92128 
 
Complete information for the ATB implant is found in the professional user guides 5, 6. 
 
2.1.1.1 Manufacturer of investigational device(s) 
Cochlear Limited, Sydney, Australia 
Osia Sound Processor 
ATB Implant 
CP950 Magnets 
Cochlear Bone Anchored Solutions AB 
BI300 Implant 
 
2.1.2 
Description of comparator 
No comparator will be used in this clinical investigation. All patients will be their own control. 
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2.2 
Blinding 
No blinding will be used in this clinical investigation. 
 
2.3 
Other devices used in the investigation, non-investigational 
 
2.3.1 
Surgical instruments 
The surgical procedure for the ATB System combines steps of the recommended surgical procedure 
for implantation of the BI300 Implant, the BIM400 Implant Magnet of the Baha Attract System, and the 
receiver-stimulator assembly of CI24RE. Hence, ATB surgery reuses existing surgical tools and 
templates for Baha and CI surgery. There are only 4 new surgical tools and 1 new template (sterile 
and non-sterile versions) specific to the ATB System. Table 2 lists the recommended surgical 
instruments for ATB surgery. The ATB specific surgical instruments used to prepare the bone bed for 
the ATB Actuator reuse design features of the instruments that are used to prepare the bone bed for 
Baha Attract surgery; different instrument design is required due to the different shape of the ATB 
Actuator compared to Baha Attract implant magnet (rectangular versus circular).  
 
Table 2. ATB surgical instruments  
Instrument 
Description  
Part 
Number 
New surgical instruments 
ATB specific Reusable 
Instruments 
Actuator Template 
P772551 
Clearance indicator 
P772552 
OSI100 Recess checking gauge 
P795943 
ATB specific Single Use 
Instruments 
OSI100 Single use kit (Sterile, single use) 
Includes: Guide Pin, OSI100 template 
Z496667 
 
OSI100 template (Non sterile, single use) 
P794316 
Existing surgical instruments 
Cochlear Baha Reusable 
Instruments 
Screwdriver Unigrip 95mm  
90469 
Multi wrench with ISO adapter 
92143 
Machine Screwdriver Unigrip 25mm 
90381 
Implant inserter   
92142 
Drill indicator 
91116 
Soft tissue gauge 6 mm 
95070 
 
Raspatorium 
90944 
 
Dissector 
90943 
 
Baha ruler 
93339 
Cochlear Baha Single Use 
Instruments 
Conical guide drill 3+4 mm 
93363 
Widening drill 3mm 
92140 
Widening drill 4mm 
92141 
Cochlear Nucleus 
Reusable Instruments 
Bone Recess Template 
Z60479 
Array Exit Marking Template 
Z33017 
 

 
 
 
 
 
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More information about the new ATB specific instruments and template are found in Appendix 1. 
Complete information for the ATB surgical instruments is found in the professional guides 5, 6.  
 
2.3.2 
Fitting Software (FS) 
Two different fitting software platforms will be used for fitting of sound processors during this clinical 
investigation, the Baha Fitting Software (BFS) (currently released version) for the reference device 
Baha Power Sound Processor, and the Osia™ Fitting Software (OFS) CSDS Clin Trial version 1.02 
for evaluation of the ATB Sound Processor. 
The investigator shall use the BFS to configure the Baha BP110 Power Sound Processor for each 
subject/user at visit 1. Communication between the fitting software and the sound processor shall be 
achieved using a Hi-Pro 2 programming interface from GN Otometrics (GNO) and a Programming 
Cable Long Blue/Red (Figure 6).  
The investigator shall use the OFS to configure the operational features of the Osia Sound Processor 
for each subject/user at visit 4. Communication between the fitting software and the sound processor 
is achieved using a Freedom Programming Pod, Cochlear Nucleus Programming Shoe with Cable as 
well as CP950 Programming Shoe Adaptor Cable Kit and two Battery ZN Air P675 Implant Plus. 
This fitting software for the Osia Sound Processor version 1.02 is built on and has equivalent 
graphical user interface and features as the current regulatory approved Baha Fitting Software (BFS). 
Complete information is found in the Instruction For Use (IFU) 7, 8. 
 
Figure 6. Programming set-up for a BP110, Hi-Pro2 and computer 
 
2.3.3 
Programming pod  
The Freedom Programming Pod, approved and used for Cochlear’s CI products, will be used as it is 
with the ATB System. The programming pod provides a connection between the programming 
computer and the ATB Sound Processor via a USB cable and a programming shoe with cable as well 
as an adaptor cable kit and two batteries. 
 
2.3.4 
Intraoperative test system 
An intraoperative test system Osia ™ Intraoperative Test System (IOTS) CSDS Clin Trial version 1.01 
will be available to confirm device integrity at the time of implantation. An intraoperative test system is 
available and in use for Cochlear Implants and Codacs to verify the functionality. For ATB System, the 
IOTS will evaluate any potential damages to the piezo-element and to the lead before surgical 
closure. The integrity test will be a mandatory step of the surgical procedure, and will be performed 
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current consumed by the implant's audio circuitry (including the actuator). The measured frequency 
response provides an indication of the state of the actuator and of the actuator lead.  
 
The test system concept is similar to the existing intraoperative tests available for CI and Codacs, and 
uses a number of similar and/or identical components (including a computer with dedicated software, 
Osia Sound Processor, Freedom Programming Pod, Cochlear Nucleus Programming Shoe with 
Cable as well as CP950 Programming Shoe Adaptor Cable Kit and two Battery ZN Air P675 Implant 
Plus (Figure 7). The test also relies on the use of a custom silicone Isolator to provide mechanical 
isolation for the actuator during the test (Figure 8). The Isolator will come pre-mounted on the actuator 
inside the sterile blister packaging. During the test the receiver-stimulator will already be in place 
under the patient's skin and the actuator will be mounted in the Isolator (which is secured to the BI300 
Implant using the Guide pin). The test takes approximately two minutes to perform, and the software 
provides the user with an unambiguous test result regarding device integrity prior to closing and 
suturing the surgical site. A Signal Check wand (currently available for CI and Codacs) is also 
available to check the radio-frequency (RF) link between the transmitting coil of the sound processor 
and the internal coil in case of no response from the implant is received during the intraoperative test. 
The sound processor should be switched on and the Signal Check wand held to the coil. If the signal 
check lights up the coil is working. 
 
 
 
 
 
1. 
Adapter cable 
2. 
Battery retention clip 
3. 
Clothing clip 
Figure 7. Intraoperative Test System (IOTS) concept 
 

 
 
 
 
 
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Figure 8. ATB Implant, with actuator pre-mounted onto the Isolator.  
 
2.3.5 
Reference device 
The ATB System will provide similar output and audiological performance as the Cochlear Baha 
BP110 Power Sound Processor. The BP110 Power Sound Process will be used as reference device 
in this clinical investigation. The BP110 Sound Processor on a Softband will be used at the first visit 
for the subject, before the surgery visit, to measure preoperative Sound Processor performance and 
to prepare the subject for the postoperative hearing situation. The BP110 Sound Processor is a fully 
programmable, head-worn sound processor, with automatic signal processing, which is regulatory 
approved for use together with Baha systems (Baha Connect and Baha Attract) and together with a 
Baha Softband (Figure 9). This sound processor is secured to the Baha Softband by means of a 
snap coupling. The sound processor has several automatic systems, including active feedback 
cancellation through phase cancellation, automatic adaptive multi-band directional microphones, 
wide dynamic range compression and automatic noise management. The transducer is driven by a 
size 675 battery. 
 
                           
 
Figure 9. Cochlear Baha BP110 Power Sound Processor and Baha Softband 
 
All other non-investigational devices, are listed in Appendix 2. 
 
2.3.5.1 Manufacturer of the non-investigational devices 
Cochlear Limited, Sydney, Australia 
• 
ATB specific Reusable Instruments 
• 
ATB specific Single Use Instruments 
• 
Cochlear Nucleus Reusable Instruments 
• 
Osia™ Fitting Software CSDS Clin Trial 
version 1.02 
• 
Freedom Programming Pod 
• 
Osia™ Intraoperative Test Software CSDS 

 
 
 
 
 
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Clin Trial version  1.01 
• 
Cochlear Nucleus Programming Shoe with 
Cable  CP950 Programming Shoe Adaptor 
Cable Kit Battery ZN Air P675 Implant Plus 
• 
Signal Check (Wand) 
Cochlear Bone Anchored Solutions AB 
• 
Cochlear Baha Reusable Instruments 
• 
Cochlear Baha Single Use Instruments 
• 
Baha BP110 Power Sound Processor 
• 
Baha Fitting Software (currently released 
version) 
• 
Baha Softband (Unilateral) 
 
2.4 
Treatment after the completion of the investigation 
After the clinical investigation the subjects will be able to continue with their investigational device 
(ATB System). Routine controls with audiological checks will follow local routines according to 
the standard treatment program for similar devices (e.g. active, non-skin penetrating, bone-
conduction hearing devices). 
The ATB Implant is expected to have a lifetime of at least 10 years. Any changes to the ATB 
Implant during or after this time-period should be performed according to the ATB Implant 
revision/replacement procedure described in the professional guide 5.  
After this clinical investigation, it will be possible to use future upgrades of the ATB Sound 
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3 
 SUBJECTS AND SUBJECT PROTECTION 
3.1 
Selection of subjects 
3.1.1 
Inclusion criteria 
A subject will be eligible for inclusion in the investigation if he/she meets all of the criteria below: 
• 
Adult subjects (18 years or older) 
• 
Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction 
thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of  55 dB HL. 
OR 
 
Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air 
conduction thresholds with a pure tone average PTA4 of  20 dB HL (mean of 0.5, 1, 2 and 3 
kHz) in the good ear OR subject who is indicated for an AC CROS but—for some reason—
cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).  
• 
Signed informed consent 
• 
Previous experience from amplified sound through properly fitted amplification. (For example 
but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ 
softband). 
 
3.1.2 
Exclusion criteria 
A subject will be excluded from participation in the investigation if he/she meets any of the criteria 
below: 
• 
Uncontrolled diabetes as judged by the investigator. 
• 
Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, 
psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on 
the outcome of the investigation as judged by the investigator. 
• 
Insufficient bone quality and quantity for implantation of a BI300 Implant. 
• 
Subject that has received radiotherapy in the area of implantation, or is planned for such 
radiotherapy during the study period  
• 
Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator 
• 
Unable to follow investigational procedures, e.g. to complete quality of life scales. 
• 
Participation in another clinical investigation with pharmaceutical and/or device. 
• 
The subject is pregnant or lactating  
• 
The subject suffers from psychiatric and/or psychosomatic disorder(s). 
 
3.2 
Number of subjects 
Fifty (50) evaluable subjects (visit 2 performed successfully) will be recruited at five international 
clinics in order to meet the requirement for recruitment in the investigation. The number of subjects to 
be included for each centre will be approximately 10. The sponsor will be able to control the inclusion 
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3.3 
Duration of subject participation 
Subjects will participate during a 12-month period in total. 
3.4 
Subject enrolment and Informed consent 
Before a subject is asked to sign an informed consent form, an investigator must explain the following 
to the potential investigational subject: 
• 
The rationale, aims and objectives of the investigation 
• 
Risks and benefits 
• 
Alternative treatments 
• 
Extent of the subject’s involvement  
• 
That the subject can withdraw his/her consent at any time  
• 
That the confidentiality of patient data will be maintained at all time 
• 
That the subject will be informed if new information becomes available that may be relevant to 
the subject's willingness to continue participation in the trial 
The subject must have the opportunity to ask any questions. Signed and dated informed consent from 
potential subjects must be obtained before any investigational procedure can be performed. The 
investigator will, after informed consent has been obtained, assign a consecutive enrolment number 
to the subject according to given instructions, e.g. centre 1, subject 101, 102, 103 etc. Centre 2, 
subject 201, 202, 203 etc. 
3.5 
Randomisation 
This is an open study with no comparator device. Randomisation is not possible. 
3.6 
Discontinuation 
• 
Subjects are free to discontinue their participation in the investigation at any time 
• 
Subjects may be discontinued from the investigation at any time at the discretion of the 
investigator 
• 
Other reason for subject withdrawal or discontinuation, e.g. implant loss 
Subjects who themselves discontinue from the investigation should always be asked about the 
reason(s) for the discontinuation and the presence of any adverse events. If possible, the subject 
should always be seen and assessed by an investigator. Any adverse event should be followed up. 
3.7 
Replacement of subjects 
If a subject discontinues his/her participation in the investigation, he/she will not be replaced if this 
discontinuation occurs after surgery is performed. If this discontinuation occurs before surgery the 
subject will be replaced in order to reach 50 evaluable subjects. 
3.8 
Insurance  
In case of any damage or injury occurring during the participation in the investigation, the Sponsor 
has contracted an insurance company, Willis Australia Limited, which will cover the liability of the 
Sponsor, the investigators and other persons involved in the investigation. The Sponsor may use a 
local insurance company, where applicable, according to national legislation. 

 
 
 
 
 
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4 
DESIGN OF THE CLINICAL INVESTIGATION 
4.1 
Design of the clinical investigation 
This clinical investigation is an open, two armed, prospective, multicentre clinical investigation and is 
divided into a 3-month period (primary efficacy analysis) followed by an additional 9 months of follow-
up for the complete 12 months period. The primary safety endpoint is 6 months. One arm is selected 
for conductive and mixed hearing loss subjects, the other arm is selected for single-sided 
sensorineural deafness subjects. Each subject will be compared to his/her own preoperative unaided 
hearing situation, with the Baha BP110 Power Sound Processor on a softband preoperatively and 
with the Investigational device at 3 months. If applicable subjects with a current hearing amplification 
will also be tested preoperatively. 
4.2 
Justification for the design of the clinical investigation 
The design where the primary assessment consist of a comparison of the post-operative aided 
performance with the preoperative unaided performance is considered relevant for this purpose. The 
primary efficacy assessment of the investigation, i.e. threshold, free-field, pure tone average PTA4, is 
a relevant and objective method used by clinics internationally as a way to assess hearing 
performance. The test is not language specific (no words used), thus rendering comparative data in 
an international, multilingual setting.  
The self-reported assessment of hearing outcome using the APHAB questionnaire was chosen as an 
important secondary efficacy assessment; hence, the APHAB scale was used for determination of the 
sample size in the investigation9. The APHAB has been used in investigations previously and has 
shown to be a good tool for measuring changes in patient benefits. 
The rationale for measuring and collect data  with Baha BP110 Power Sound Processor on a 
Softband as a secondary assessment is based on the fact that the FDA guideline for middle ear 
implants suggests that a comparative non-inferiority or superiority study design (using within-patient 
comparison) may be required.  
The Baha BP110 Power Sound processor on a Softband was chosen for a secondary assessment, 
since the ATB System mimics the performance of a Baha Power Sound Processor (with the same 55 
dB fitting range) on the passive transcutaneous Baha Attract System1. Therefore it is also a relevant 
choice to present as a postoperative hearing situation for the subject. 
This investigation is limited to adult subjects. The paediatric population constitutes an inhomogeneous 
patient group (age-related), and currently there are no audiological tests that are suitable for 
comparisons across age ranges and across multiple countries/languages. 
The follow-up period of 12 weeks post-surgery, 8 weeks post fitting for the primary analysis is chosen 
as it is judged as long enough for the subjects to adapt and get used to the hearing performance with 
this investigational device. The total length of the investigation is judged long enough to collect 
hearing performance and safety data as long term data. 
4.3 
Objectives and outcome measures  
Primary objective 
Outcome measure(s)  
To compare hearing performance with the 
Investigational device and the unaided hearing 
situation 
At 3 months 
• 
Thresholds audiometry, free-field [PTA4, 
Mean of 0.5, 1, 2 and 4 kHz]. Investigational 

 
 
 
 
 
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device (at 3 months) vs. Unaided. 
• 
Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding]. 
Investigational Device vs. Unaided 
(preoperative). 
 
 
Secondary objective(s) 
Outcome measure(s) 
To compare hearing performance with the 
Investigational device and the unaided hearing 
situation 
• Thresholds audiometry, free-field [PTA4, 
Mean of 0.5, 1, 2 and 4 kHz]. Investigational 
Device (4w, 6 and 12 months) vs. Unaided 
(preoperative). 
• Thresholds audiometry, free-field [0.25, 0.5, 
0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. 
Investigational Device (4w, 3, 6 and 12 
months) vs. Unaided (preoperative). 
• Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding]. 
Investigational Device (4w, 6 and 12 months) 
vs. Unaided (preoperative). 
• Speech in quiet [% correctly perceived words 
at 50dB, 65dB and 80dB SPL]. Investigational 
Device (4w, 3, 6, and 12 months) vs. Unaided 
(preoperative). 
• Feedback measurements. Investigational 
Device (Visit 4 and onwards). 
To compare the self-reported assessments of 
hearing outcome with the Investigational device 
and in a preoperative hearing situation 
• Abbreviated Profile of Hearing Aid Benefit 
(APHAB). Investigational Device at 3 and 12 
months vs. preoperative hearing situation 
• Health Utilities Index (HUI23S1EN.15Q) at 3 
and 12 months. Investigational device vs. 
preoperative hearing situation. 
• Speech, Spatial and Qualities of Hearing 
Scale (SSQ) at 3 and 12 months. 
Investigational device vs. Unaided. 
To collect surgical information 
• Soft tissue thickness  
• Soft tissue reduction performed 
• Type of anaesthesia 
• Surgery time  
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• BI300 Implant length  
• Location of BI300 Implant 
• Surgical incision type/location 
To collect information about the magnet choice 
and daily use of sound processor 
• Daily usage time 
• Comfort 
• Softpad use 
• Choice of magnet strength 
To measure hearing performance preoperatively 
with a Baha BP110 Power sound processor on a 
Baha Softband  
• Thresholds audiometry, free-field [PTA4, 
Mean of 0.5, 1, 2 and 4 kHz].  
• Thresholds audiometry, free-field [0.25, 0.5, 
0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].  
• Speech in quiet [% correctly perceived words 
at 50dB, 65dB and 80dB SPL].  
• Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding].  
• BC Direct [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 
4.0 and 6.0 kHz].  
Tertiary Objective 
Outcome measure(s) 
To measure hearing performance preoperatively 
with a current hearing aid (if used by the patient). 
• Adaptive speech in noise [speech-to-noise 
ratio, 50% speech understanding]. 
 
Safety objective(s) 
Outcome measure(s) 
Primary safety analysis at 6 months. 
 
Implant site evaluations 
Numbness 
Adverse Events and concomitant 
medication/treatment 
Information will be collected from Visit 2 and 
onwards. 
Device deficiency  
Information will be collected from Visit 2 and 
onwards. 
Audiogram 
Bone conduction thresholds preoperative and 
postoperative (3, 6, and 12 months) 
 
4.3.1 
Demographics and baseline variables 
 
Demographics and baseline variables to be collected during visit 1 are the following: 
• 
Demographics  

 
 
 
 
 
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• 
Medical history 
• 
Baseline characteristics 
• 
Audiogram 
• 
Eligibility criteria (inclusion/exclusion criteria) 
• 
Informed consent  
5 PROCEDURES 
Procedures that will be performed during the clinical investigation is outlined in the flow chart, see 
section 6. 
5.1 
Test equipment 
 
The test set-up regarding speaker placement, sound room facility and software used at each clinic 
shall be checked and approved by the Sponsor at the latest during the Site initiation visit. All tests 
shall be performed in the sound isolated room. Equipment used for audiological testing shall be 
calibrated before initiation of the investigation. Calibration certificates will be asked for by the Sponsor 
as part of the study documentation. It is important to keep the same sound room and test equipment 
set-up during the entire clinical investigation. Changes are not allowed. 
If, for some exceptional reason, any significant changes would be needed with the test equipment 
during the investigation a new calibration needs to be performed together with a new unaided 
baseline measurement. Calibration documentation should be kept with the Investigator File. 
5.2 
Demographics 
The following demographic data will be recorded at Visit 1: 
• 
Age collected as date of birth (month and year)  
• 
Gender  
• 
Ethnicity  
• 
Nicotine use (Subjects does not smoke, ≤ 10 cigarettes/day, 11-20 cigarettes/day,  
21 40 cigarettes/day, > 40 cigarettes/day) 
5.3 
Medical history 
The following information will be recorded at Visit 1:  
• 
Relevant medical and surgical treatment during the past three years judged by the 
investigator  
• 
Current concomitant medication and treatments  
5.4 
Baseline characteristics 
During visit 1 a number of baseline characteristics will be recorded; 
• 
Treatment ear (indicate left or right or both. In case of both, indicate side for hearing tests) 
• 
Type of hearing loss: (Conductive, Mixed or SSD) 
• 
Aetiology: (chronic) infection, tumour, trauma, malfunction, otosclerosis, other 

 
 
 
 
 
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• 
Current hearing aid (yes/no, specify model, side and years of hearing aid use, reason for 
change) 
• 
Previous experience from amplified sound through properly fitted amplification  (yes/no, 
specify type, years of aid in use, when stopped use, reasons stop using) 
• 
Has the subject previously been suggested a bone conduction hearing implant (BCHI) 
solution (yes/no, reason for rejection) 
5.5 
Audiogram 
Unaided audiometric threshold measures (including both air- and bone conduction thresholds) should 
demonstrate that the subject has a conductive, mixed hearing loss or single-sided sensorineural 
deafness and meets the audiological inclusion criteria.  
 
An existing audiogram may be used as long as it has been completed during the last six months, and 
contains all the required relevant frequencies (250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 
and 8000Hz). The subject’s pre-operative Pure Tone Average PTA4 (mean of 500, 1000, 2000 and 
4000Hz) should be computed and recorded to ensure the subject meets the inclusion criteria. 
 
If an audiogram is older than 6 months or does not contain the required frequencies, a new will be 
performed at Visit 1. Frequencies required for air conduction thresholds are 250, 500, 750, 1000, 
1500, 2000, 3000, 4000, 6000 and 8000Hz. Bone conduction thresholds are 250, 500, 750, 1000, 
1500, 2000, 3000, 4000 and 6000Hz. Contralateral masking should be used if needed, and according 
to local practice. The hearing care professional shall always record the unmasked threshold and 
record the masked if applicable. 
 
Audiograms for bone conduction thresholds will also be performed at Visits 6, 7, and visit 8 to monitor 
hearing thresholds postoperatively. 
5.6 
Soft tissue thickness 
At visit 1 or visit 2 (start of surgery), depending on local practice and requirements, soft tissue 
thickness should be measured. For the ATB System, the skin thickness should not exceed 6 mm to 
ensure optimal retention and system performance. The measurement should be performed in the 
centre of the marked coil position. For complete instruction see the surgery guide 5.  
5.7 
Surgery 
The surgery, performed at visit 2, does not take account for any particular circumstances or factors 
relevant to an individual patient or case. Other surgical approaches and variations are practiced and 
may be more appropriate in certain patient cases. After considering all relevant circumstances, factors 
and information in each case, the appropriate surgical procedure is determined by the responsible 
investigator exercising independent medical judgment. Complete information is found in the surgery 
guide5. 
 
During surgery the following variables should be collected: 
 
• 
Surgery time (time between first incision to last suture) 
• 
Bone polishing/removal at the actuator site (yes/no) 
• 
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• 
Location of BI300 Implant (mm from the ear channel), measured horizontally and vertically). 
Distance from BI300 to receiver/coil (centre to centre). An alternative option to preoperative 
measurements with a ruler, is to take a lateral skull radiography postoperatively and 
measure the distance between the implant receiver magnet and the BI300. 
• 
Type of anaesthesia (general/local) 
• 
Soft tissue reduction (yes/no) 
• 
Surgical incision type (C-shaped flap is anterior based for an anterior actuator position or 
posterior based flap is considered for a more posterior actuator position or other incision type) 
 
At visit 3, approximately 2 weeks after surgery sutures should be removed. 
5.8 
Intraoperative Test system (IOTS) 
At visit 2, in the end of the surgery procedure, the IOTS test should be performed. The test takes 
approximately two minutes to perform, and the software provides the user with an unambiguous test 
result regarding device integrity prior to closing and suturing the surgical site. It is crucial that the staff 
during surgery follow the instruction for use10. The software used for the IOTS is installed on a lap-top 
provided by the Sponsor. The software collects data from transducer of the implant and will make the 
Sponsor gain understanding of the behaviour and performance of the transducer once implanted on a 
recipient. IOTS data will be saved on the lap-top until study is ended when it will be transferred to the 
Sponsor in a coded way. 
5.9 
Sound Processor fitting 
The Baha Fitting Software 4.0 SR28 will be used at visit 1 when the fitting procedure should be 
performed for the Baha BP110 Power Sound Processor as a reference device.  
 
The Osia Fitting Software 1.027 will be used to adjust the investigational device sound processor 
settings for a specific subject. This will happen during Visit 4 when tests will be performed, and 
throughout the study. The fitting software will be installed on a lap-top provided by the Sponsor, and 
the fitting-data will be saved on the lap-top until study is ended when it will be transferred to the 
Sponsor in a coded way. 
 
The Digital Link Calibration (e.g. coil-to-coil measurement) that is a step in the connection step in the 
Osia Fitting Software, should be performed at each occasion that the software is being used to fit or 
fine tune the device to optimize the performance of the device throughout the study. This will also 
provide an indication of the soft tissue thickness. 
 
For the sound processors Individual Stable Gain (e.g. feedback measurements as part of the Fitting 
Software) the Feedback Analyser should be performed at each occasion that the software is being 
used to fit or fine tune the device to optimize the performance of the device throughout the study. For 
the Investigational device this data will be collected, saved and eventually transferred to the Sponsor 
for analysis. 
5.10 
Magnet choice 
At visit 4 (sound processor fitting) the most suitable magnet should be selected for the sound 
processor to be tested, and the instruction for use5 should be followed. It is important that the strength 
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visits the choice of sound processor magnet should be checked. There may be a need to decrease or 
increase the strength depending on the subject’s preference. 
5.11 
Bone Conduction (BC) Direct 
BC Direct is a tool in the Baha Fitting Software (current version) to establish the unmasked bone 
condition threshold with tones presented through the sound processor. At Visit 1, BC Direct data shall 
be collected with the Baha BP110 Power Sound Processor on a Softband and shall be used to 
calculate the fitting (settings) of the sound processor for the Softband test. BC Direct measurements 
(as part of the Osia Fitting Software) will also be performed at visit 4 to visit 8 when the subject is 
using the investigational device. BC thresholds obtained at the following frequencies will be recorded; 
250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 Hz. 
5.12 Simultaneous bilateral 
In the case of a subject receiving simultaneous bilateral ATB systems one of the treatment ears will 
be selected as the investigational ear for efficacy purposes. Speech in noise performance will be 
documented for the second ear alone and bilaterally. However, efficacy outcomes for the 
investigational ear only will be pooled with the outcomes measures made for the unilaterally implanted 
subjects. Investigational ear choice will be as judged by the responsible investigator prior to surgery. 
Patient-reported outcomes (APHAB, SSQ and HUI), will be collected post-surgery in a bilateral 
situation. Safety-related information, including adverse events, will be collected and reported for each 
ear receiving the ATB system. 
6 
ASSESSMENTS 
Assessments that will be performed during the clinical investigation is outlined in the flow chart, see 
section 8. 
During the assessments, the signal processing of the sound processors will be harmonised according 
to given instructions given in the eCRF. This will also be included in the staff training at each 
participating centre during the site initiations.  
6.1 
Postoperative audiometric assessment 
Bone conduction thresholds for the study ear will be monitored postoperatively, to characterize 
observed unaided thresholds postoperatively. These measures will occur at visit 6 (3 months 
postoperative) and 7 (6 months postoperative), once healing and swelling is most likely to be resolved 
and repeated at visit 8 (12 months postoperative). Bone conduction thresholds are 250, 500, 750, 
1000, 1500, 2000, 3000, 4000 and 6000Hz. Contralateral masking should be used if needed, and 
according to local practice. The hearing care professional shall always record the unmasked threshold 
and record the masked if applicable.  
6.2 
Free-field threshold 
The purpose of this test is to establish the hearing thresholds in free field through a speaker in front 
position (0 degrees azimuth) according to the so-called ascending or modified Hughson-Westlake 
method (Figure 10). The test shall be performed with the non-test ear blocked (in case of normal or 
near-normal hearing or a large asymmetry with the non-test ear having significantly better hearing 
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At Visit 1, free-field thresholds shall be measured for the unaided situation and with the BP110 Power 
Sound Processor on a Baha Softband.  
At Visit 4, 6, 7 and 8 this measurement should be performed with the investigational device. 
 
 
BACK 
      
 
                        Signal 
 
             FRONT 
Figure 10. Free field front speaker position.  
 
6.3 
Speech recognition in quiet 
The purpose of this test is to establish the test subject’s word recognition score in quiet. The speech 
test in quiet shall be performed using phonetically balanced words presented in free field through a 
speaker from the front (0 degrees azimuth) (figure 10). The test material shall be monosyllabic words 
and presented at 50, 65 and 80 dB sound pressure level (SPL) and scores shall be recorded as % 
correct words at each presentation level. The test shall be performed with the non-test ear blocked (in 
case of normal or near-normal hearing or a large asymmetry with the non-test ear having significantly 
better hearing thresholds). 
 
At Visit 1, the speech in quiet test shall be performed for the unaided situation and BP110 Power 
Sound Processor on a Baha Softband. 
At Visit 4, 6, 7 and 8 this measurement should be performed with the investigational device. 
6.4 
Adaptive Speech recognition in noise 
The purpose of this test is to establish the test subject’s ability to recognise speech in the presence of 
background noise. The adaptive speech test in noise shall be conducted using validated lists of 
phonetically balanced sentences, with speech presented in free field from the front (0 degrees 
azimuth) and noise from the back (180 degrees azimuth) (figure 11). The noise shall be kept constant 
at 65 dB SPL, and the speech shall be adapted stepwise according to the software used to establish 
the speech-to-noise ratio (SNR) providing a 50% level of understanding. Software and speech 
material to be used is the Matrix test in language specific versions as applicable.  
The test shall be performed with the non-test ear blocked (in case of normal or near-normal hearing or 
a large asymmetry with the non-test ear having significantly better hearing thresholds). 
The speakers should be at the height of the test subjects head and more than 1 metre away from the 
test subject. There should preferably be more than 1 metre of free space around the test subject in all 
directions. This is in accordance with the current standard11. 

 
 
 
 
 
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         BACK 
 
                    FRONT 
Figure 11. Speech in noise test speaker position 
At Visit 1, the speech in noise test will be performed for the unaided situation and BP110 Power 
sound processor on a Baha Softband. If the subject presents with hearing aids preoperatively, the 
measurement will also be completed in the subject’s test ear in the aided condition. 
At Visit 4, 6, 7 and 8 this measurement should be performed with the investigational device. 
 
IMPORTANT: When all audiological tests have been performed and the audiological team is pleased 
with the data collection, remember to reset the sound processor features according to the patient´s 
fitting. 
6.5 
Abbreviated Profile of Hearing Aid Benefit (APHAB form A) 
The APHAB form “A” questionnaire from HARL (Hearing Aid Research Lab, University of Memphis, 
USA) is a 24-item self-assessment inventory that evaluates the benefit experienced by the subject 
when using hearing amplification compared to the unaided situation. APHAB produces a global score 
and scores for four subscales: ease of communication, reverberation, background noise, and 
averseness.  
The subjects will complete the APHAB questionnaire at Visit 1, 6 and 8.  
• 
At Visit 1, the subjects shall complete the questionnaire prior to the Softband test, and the 
questionnaire shall be answered with respect to an unaided hearing situation, even for subjects 
with a previous hearing device.  
• 
At Visit 6 and 8, the subjects shall complete the questionnaire for the aided situation (with the 
Investigational device). 
 
The APHAB questionnaire is available for free and in a number of different translations on the HARL 
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6.6 
Speech, Spatial, and Qualities of Hearing Scale (SSQ-12 
version) 
The short form of Speech, Spatial, and Qualities of Hearing questionnaire (SSQ-12) from MRC 
Institute of Hearing Research, UK, is a scaled-down version of the 49 items SSQ questionnaire. It is 
designed to compile a sub-set of items from the longer original 49 version to represent the scale as a 
whole, measuring self-reported auditory disability, reflecting the reality of hearing in the everyday 
world. It has been shown to provide similar results to SSQ4912. It covers: 
• 
Hearing speech in a variety of competing contexts 
• 
The directional, distance and movement components of spatial hearing 
• 
Segregation of sounds and attending to simultaneous speech streams 
• 
Ease of listening 
• 
The naturalness, clarity and identifiability of different speakers, different musical pieces and 
instruments, and different everyday sounds 
 
The subjects will complete the SSQ questionnaire at Visit 1, 6 and 8. 
• 
At Visit 1, the subjects shall complete the SSQ questionnaire prior to the Softband test and the 
SSQ questionnaire shall be answered with respect to an unaided hearing situation, even for 
subjects with a previous hearing device. 
• 
At Visit 6 and 8, the subjects shall complete the questionnaire for the aided situation (with the 
Investigational device). 
 
The SSQ-12 questionnaires was approved for use in this clinical investigation for free by the MRC 
Institute of Hearing Research.  
 
6.7 
Health Utility Index (HUI23) 
The Health Utilities Index (HUI®) 23S15Q is a generic preference-based system for measuring 
comprehensive health status and health-related quality of life (HRQL). HUI provides descriptive 
evidence on multiple dimensions of health status, a score for each dimension of health, and a HRQL 
score for overall health. Health dimensions include vision, hearing, speech, ambulation/mobility, pain, 
dexterity, self-care, emotion and cognition. Each dimension has 3-6 levels. The version in this clinical 
investigation uses a recall time of 1 week. 
The subjects will complete the HUI at Visit 1, 6 and 8.  
• 
At Visit 1, the subjects shall complete the HUI questionnaire prior to the Softband test and with 
respect to their current hearing situation 
• 
At Visit 6 and 8, the subjects shall complete the questionnaire for the aided situation (with the 
Investigational device). 
 
The license to use the HUI questionnaire is purchased from Health Utilities Inc., 88 Sydenham Street, 
Dundas, ON, L9H 2V3 Canada.  
6.8 
Daily use 
During the clinical investigation at visit 5, 6, 7 and 8 data regarding daily use of the sound processor 
will be collected. 

 
 
 
 
 
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• 
Average hours of daily use (hours/day) during the last week before Visit 5, and during the last 
month before Visit 6-8. 
• 
Softpad use (Yes/No) and if yes, frequency of change; number of times the subject changed 
the Soft pad during the last week before Visit 5, and during the last month before Visit 6-8? 
• 
Comfort (by visual analogue scale 100 mm). Subject will be asked at Visit 5-8: 
 
With regard to your Sound processor, please rate the overall comfort by placing a single 
vertical line on the scale. 
 
 
Not comfortable  
 
 
                                         Most comfortable 
 
        at all 
 
 
 
 
 
                   imaginable 

 
 
 
 
 
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6.9 
Numbness 
Sensibility of the skin directly over the implant is an important outcome measurement to establish a 
possible difference between surgery with or without skin thinning. Two different sensibilities will be 
tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with 
broken, sharp wooden side) sensibility. The measurement locations and procedures need to be 
standardized (Figure12). ATB Implant site evaluations regarding numbness will be performed at Visits 
3-8.  
 
• 
30 and 60 mm along the lines from the centre of 
the coil/magnet 
• 
Cranial and caudal and 90 degrees anterior and 
posterior 
• 
No sampling on the incision line 
• 
The sequence of gnostic/vital stimuli randomly 
gently applied 
• 
Gnostic sensibility :0-100% 8 locations 
Vital sensibility: 0-100% 8 locations 
      Total sensibility: 0-100% 16 trials 
 
 
 
Figure 12. ATB Implant site evaluation. 

 
 
 
 
 
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7 
ADVERSE EVENT AND DEVICE DEFICIENCIES 
7.1 
Device deficiency reporting 
The definition of a device deficiency is ”an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance.” 
Any a device deficiency observed will be fully investigated by the investigator and documented in the 
case report form (CRF). 
A device deficiency that could have led to a Serious Adverse Event (SAE) should be reported 
immediately (see next section). 
 
7.2 
Adverse Event (AE) and Serious Adverse Event (SAE) 
7.2.1 
Definitions 
Term 
Definition  
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the medical 
device used in the investigation. 
 
NOTE 1 This definition includes events related to the investigational 
medical device or the comparator. 
 
NOTE 2 This definition includes events related to the procedures 
involved. 
Adverse Event of Special 
Interest (AESI) 
 
 
An AESI is an AE of scientific and medical concern specific to the 
sponsor’s product(s).  
 
The reporting requirements from the investigator to CBAS for an AESI 
will be the same as the reporting requirements for an SAE 
Adverse Device Effect 
(ADE) 
Adverse event related to the use of an investigational medical device 
Serious Adverse Event 
(SAE) 
Adverse event that 
a) led to death 
 
b) led to serious deterioration in the health of the subject, that either 
resulted in 
• 
a life-threatening illness or injury 
• 
a permanent impairment of a body structure or a body 
function 
• 
in-patient or prolonged hospitalization 
• 
medical or surgical intervention to prevent life-threatening 
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c) led to foetal distress, foetal death or a congenital abnormality or birth 
defect 
 
Note - Planned hospitalization for a pre-existing condition, or a 
procedure required by the CIP, without serious deterioration in health, is 
not considered a serious adverse event. 
Serious Adverse Device 
Effect (SADE)  
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event 
Unanticipated Serious 
Adverse Device Effect 
USADE 
Serious adverse device effect which by its nature, incidence, severity or 
outcome has not been identified in the current version of the risk 
analysis report 
 
7.2.2 
Handling and reporting of AEs and ADEs 
Subjects will be carefully monitored during the investigation for possible adverse events and 
appropriate treatment of the subject will be initiated. 
Any adverse events observed will be fully investigated by the investigator and documented in the 
case report form (CRF) including assessment of seriousness, severity (mild, moderate or severe) and 
relationship to the medical device. 
7.2.3 
Definition of AESI in this clinical investigation 
The following AEs are defined as adverse events of special interest (AESIs) and should be reported 
within 24 hours, after being aware of an event (see section 7.4.2.4): 
• 
AE that interferes with the daily use of the medical device(s) 
• 
AE at the site of the implant that leads to 
o 
Revision surgery including explantation 
o 
Severe soft tissue complication 
o 
Prescription of antibiotics 
7.2.4 
Clinically significant threshold shifts 
Shifts in threshold, relative to the preoperative baseline, will be reported as an adverse event (AE) 
when a shift at any frequency exceeds 15 dB HL. 
 
7.2.5 
Handling and reporting of AESIs, SAEs and device deficiency that 
could have led to a SAE 
An investigator should report within 24 hours, after being aware of the event, an AESI, SAE or a 
device deficiency that could have led to a SAE. The report shall be sent as an email attachment to the 
safety inbox or faxed to Cochlear Bone Anchored Solutions AB. Contact information is available on 
the SAE form. 
7.3 
Reporting to ethical committees and regulatory authorities 
SAEs/SADEs/USADEs and device deficiencies that could have led to a SAE shall be reported to 
ethics committees/institutional review board and competent authorities in accordance with local 
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Safety Reporting in Germany  
In Germany, a serious adverse event is every unwanted event manifesting in a clinical trial or 
performance evaluation subject to authorization, which led, could have led or could lead directly or 
indirectly to the death or a severe worsening of the state of health of a study subject, a caregiver or 
another person, without considering whether the medical device was the cause of the event (§ 2 No. 5 
MPSV). According to the definition of SAEs (in § 2 No. 5 MPSV), every SAE in a clinical trial or 
performance evaluation subject to authorization must be reported. Therefore, in accordance with § 3 
(6) of the Ordinance on Medical Devices Vigilance, for SAEs that occur in Germany that may be 
device and/or procedure related, Cochlear Bone Anchored Solutions AB or its representatives will use 
the Report form for reporting of serious adverse events (SAEs) in clinical trials or performance 
evaluations (SAE Report Form). 
All SAE’s are reported on forms for reporting of serious adverse events (SAEs) in clinical trials or 
performance evaluations for use by sponsors according to § 3 (6) of the Ordinance on Medical 
Devices Vigilance. Timelines for reporting SAE’s to the BfArM as described under § 5 MPSV will be 
adhered to. The reports and messages pursuant to § 3 paragraph 2 to 5 and 6, sentence 3 of the 
MPSV will be made immediately. All other Serious Adverse events will be fully documented and 
reported by Cochlear in a summary form on a quarterly basis.  
Further according to MPSV §3(6) Cochlear will report Serious Adverse Events to BfArM, which have 
occurred outside of Germany. If a clinical trial carried out in other parties to the Agreement within the 
European Economic Area, Cochlear or its representative will report to those competent authorities 
about Serious Adverse Events that occurred in Germany. 
BfArM SAE reporting timelines as described under § 5 MPSV will be adhered to: 
Condition for 
reporting to BfArM 
Country of occurence 
Timeline for reporting 
to BfArM 
Form 
a causal relationship 
between the SAE and 
the investigational 
medical device, a 
comparator device, 
diagnostic or 
therapeutic procedures 
performed as part of 
the clinical trial or other 
conditions of the trial 
conduct cannot be 
excluded 
Germany 
immediately 
German SAE Report 
Form for single reports 
all other countries 
where the clinical trial 
is performed 
immediately 
MEDDEV 2.7.3 
Summary Table 
 
a causal relationship 
between the SAE and 
the investigational 
medical device, a 
comparator device, 
diagnostic or 
therapeutic procedures 
performed as part of 
the clinical trial or other 
conditions of the trial 
Germany 
quarterly 
MEDDEV 2.7.3 
Summary Table  
(sheet 2) 
all other countries 
where the clinical trial 
is performed 
quarterly 
MEDDEV 2.7.3 
Summary Table 
(sheet 1) 

 
 
 
 
 
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conduct can be 
excluded 
 
Safety Reporting in The Netherlands 
In the Netherlands serious adverse events will be reported by the sponsor (or its representative 
Factory CRO for Medical Devices) to the accredited Ethics Committee that approved the protocol and 
Competent Authorities. 
Reporting Timelines to the Ethics Committee: 
The Ethics committee requires that all SAEs occurring in all participating sites in the Netherlands and 
all foreign countries will be reported.  The timelines and reporting requirements are as follows: 
1. An SAE which indicates an imminent risk of death, serious injury, or serious illness and that 
requires prompt remedial action for other patients/subjects, users or other persons or a new 
finding to it: immediately, but not later than 7 calendar days after awareness by sponsor of a 
new reportable event or of new information in relation with an already reported event. 
2. All other SAEs will be reported within 15 calendar days. 
Reporting to the Ethics Committee will occur by completing the SAE form in the ToetsingOnline portal 
(https://toetstingonline.ccmo.nl). These SAEs are automatically forwarded to the Ethics Committee.  
Reporting Timelines to the Competent Authority in the Netherlands: 
IGZ requires that all SAEs (device-related and not device-related) occurring in all participating sites in 
all participating countries will be reported. 
The reporting timelines are as follows: 
1. An SAE which indicates an imminent risk of death, serious injury, or serious illness and that 
requires prompt remedial action for other patients/subjects, users or other persons or a new 
finding to it: Immediately, but not later than 2 calendar days after awareness by sponsor of a 
new reportable event or of new information in relation with an already reported event. 
2. All other SAEs will be reported quarterly using SAE line listing according the reporting table of 
MEDDEV 2.7/3 SAE reporting guidelines. 
All SAEs can be reported via email: meldpunt@igz.nl 
 
7.4 
Foreseeable Adverse Events 
Just like any surgical treatment, OSI100 Implant surgery is not free of risks. Prospective Osia System 
recipients should be advised of the following possible effects of receiving an implant: 
- Normal risks associated with surgery and general anaesthesia  
- Increased surgical and anaesthetic risks for certain populations  
- Osseointegration failure - Potential causes for failure of osseointegration include lack of adequate 
bone quantity/quality, trauma, infection, generalised diseases and surgical complications  
- Complications that may require additional medical treatment, surgery and/or removal of the device, 
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i. Acute Otitis Media (AOM)  
ii. Concurrent Cerebrospinal Fluid (CSF) leakage  
iii. subdural injury  
iv. subcutaneous haematoma  
v. irritation, inflammation or breakdown of the skin flap; infection; and in some cases, extrusion of the 
device caused by the presence of a foreign body under the skin. 
Failure of component parts (both external and internal) could result in the perception of an 
uncomfortably loud sound sensation, intermittent sound, or no sound.  
- Failure of various component parts of the implanted device could require removal or replacement of 
the implant. 
 
7.5 
Concomitant medication(s) and treatment(s) 
All medications and treatments given, whether or not to treat AEs/ADEs, must be recorded in the 
appropriate section of the case report form. Medication given as standard of care in connection with 
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8 FLOW CHART 
 
Visit 1 
Pre-op 
testing 
Visit 2 
Surgery 
 
Visit 3 
Suture 
removal 
Visit 4 
Fitting 
Visit 5 
Visit  6 
Visit 7 
Visit 8 
Visit time point 
 
0 
2W 
4W 
6W 
3M 
6M 
12M 
Visit window 
 
 
 5D 
 1W 
 1W 
 2W 
 3W 
 4W 
Demographics 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
Baseline characteristics 
X 
 
 
 
 
 
 
 
Audiogram 
X 
 
 
 
 
X6 
X6 
X6 
Eligibility criteria 
X 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
Soft tissue thickness 
X      or     X 
 
 
 
 
 
 
Surgery1 
 
X 
 
 
 
 
 
 
IOTS 
 
X 
 
 
 
 
 
 
Suture removal  
 
 
X 
 
 
 
 
 
Sound processor fitting 
X2 
 
 
X 
X 
X 
X 
X 
Magnet choice 
 
 
 
X 
X 
X 
X 
X 
BC Direct 
X2 
 
 
X 
X 
X 
X 
X 
Feedback measurements 
 
 
 
X 
X 
X 
X 
X 
 
Free field thresholds 
X2,3, 4 
 
 
X 
 
X 
X 
X 
Speech recognition in quiet 
X2,3, 4 
 
 
X 
 
X 
X 
X 
Speech recognition in noise 
X2,3, 4 
 
 
X 
 
X 
X 
X 
APHAB  
X3 
 
 
 
 
X 
 
X 
HUI 
X4 
 
 
 
 
X 
 
X 
SSQ 
X3 
 
 
 
 
X 
 
X 
Daily use5 
 
 
 
 
X 
X 
X 
X 
Numbness 
 
 
X 
X 
X 
X 
X 
X 
 
Device deficiency  
 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medication/treatment 
 
X 
X 
X 
X 
X 
X 
X 
Extra visits as needed 
 
 
 
 
 
 
 
 
 
1 Surgical variables: Soft tissue thickness (mm), Surgery time (time between first incision and last suture), Bone 
polishing/removal at the actuator site, BI300 Implant length (4mm, 3 mm), Location of BI300 Implant (mm), 
Type of anaesthesia (general, local), Soft tissue reduction performed (yes, no), Surgical incision type.  
2  BahaPower Sound Processor (BP110) on Baha Softband  
3 Unaided 
4 In a preoperative hearing situation 
5 Daily use: Usage time (hours/day), Comfort (visual analogue scale), Softpad use 
6 Only bone conduction 

 
 
 
 
 
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9 RISK AND BENEFITS OF THE INVESTIGATIONAL DEVICE(S) AND 
THE CLINICAL INVESTIGATION 
9.1 
Anticipated clinical benefits 
The ATB System is an extension of the existing approved Baha product family and is expected to 
provide the same benefits as these systems in terms of hearing restoration. In addition, the ATB 
System will provide additional advantages as it combines benefits from both a percutaneous (skin-
penetrating) and transcutaneous Baha system 
The ATB System provides efficient sound transmission through direct bone conduction, similar to a 
percutaneous implant. Direct bone conduction through a transducer that is directly coupled to the 
bone is currently only achieved with the percutaneous Baha Connect System. With the active 
transcutaneous ATB System, the actuator is directly attached to the bone via the osseointegrated 
BI300 Implant underneath the skin, thus eliminating any loss of energy in the sound vibrations through 
the skin. Hence, efficiency of sound transmission is on a par with a percutaneous system. 
The ATB System provides the cosmetic benefits of a transcutaneous system, such as the Baha 
Attract System. A percutaneous implant is seen as a barrier and is often rejected by candidates due 
to cosmetic concerns. A transcutaneous system, without an abutment protruding through the skin, is 
often perceived as a more aesthetic option. 
The ATB System, like the Baha Attract System, will significantly reduce the risk of implant site 
infections, and eliminates the need for daily maintenance care. For the transcutaneous Baha Attract 
System and ATB System, the implant site is sealed and does not provide a direct path for infections. 
Skin irritation and/or infection requiring treatment and/or precluding the use of the sound processor 
are relatively frequent for percutaneous devices due to the exposed abutment and daily site care is 
required to maintain a reaction-free skin penetration. Some patients are not able—for medical or other 
reasons—to perform the daily implant site care that the skin-penetration requires.  
The ATB System is expected to be associated with a significantly lower risk of osseointegration failure 
than for the percutaneous Baha Connect System. This risk is expected to be similar to that of the 
Baha Attract System, which also uses the osseointegrated BI300 Implant. According to the latest post 
market surveillance reports13,14 no osseointegration failures have been reported to Cochlear’s 
complaints handling system, nor in the review of scientific literature for the Baha Attract System15. 
Transition pathway between the systems. Surgical transition between the three systems (reusing the 
same osseointegrating BI300 Implant) possible if the patient’s needs change over time (provided the 
location of the BI300 Implant is suitable for the transition). 
9.2 
Anticipated adverse device effects 
Just like any surgical treatment, ATB surgery is not free of risks. Risks associated with the 
implantation and use of the ATB System cannot be completely eliminated. General risks associated 
with surgery under general or local anaesthesia apply, and as with any surgical procedure, there is 
always a risk that unanticipated complications may occur. These risks are expected to be similar for 
ATB System as for traditional Baha surgery with the Baha Connect and Baha Attract Systems and the 
procedure for implanting the Cochlear Implants systems (Freedom Cochlear Implant platform 
(CI24RE) and Codacs® System, see section 2). 
Post market surveillance information is collected and those findings relevant for the ATB System is 
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9.2.1 
ATB Sound Processor (Osia Sound Processor) 
The ATB SP has identical hardware as the CP950 Sound Processor for Cochlear Implants, but with 
ATB specific firmware. Since the CP950 Sound Processor is recently new and no post market 
surveillance data is yet available, the safety data is based on literature reviews and reviewing the 
complaints and adverse event (reportable complaint) trending rates for the predicate devices and for 
the Baha Attract System. The most common complaint is magnetic retention issues of the sound 
processor. Skin irritation for predicate device is not reported as an issue. For the Baha Attract system 
skin irritation is fairly common but not reported as a serious problem and often solved by adjusting the 
magnet strength.  
9.2.2 
Receiver-stimulator (CI24RE) 
During the period 1 July 2009 to Dec 2015, the cumulative number of registered implant surgeries (IS) 
with CI24RE implants was 153 040 (14 402 surgeries during the last year). Of total number of 
registered implant surgeries, 80 reportable complaints (0,052% of total IS) have been attributed to the 
receiver-stimulator. Overall, reportable complaints in the category ‘Reliability/quality/defect’ occurred 
at an average rate of 0.006% of the total number CI24RE implant surgeries per month. The 
complaints are being monitored and there is no upward trend. The majority of complaints in the 
category ‘Medical/surgical issue’ have been coded as “Other medical”, “Skin flap infection” and 
“Medical/surgical issue (recipient related)” and the maximum harm for a complaint that was attributed 
to the device was revision surgery to explant the device. 
Based on the post market surveillance activities performed, the CI24RE Series of Implants are 
considered to be performing in the field within acceptable limits and expectations. All known product 
issues are appropriately contained, or being managed through existing CAPAs. The Clinical 
Evaluation Report (411167, Clinical Evaluation Report Nucleus CI24RE Cochlear Implants) provides 
clinical evidence to establish the acceptability of the risk benefit analysis of the CI24RE Series of 
Implants16. 
9.2.3 
Codacs 
During the period 18 October 2013 to 31 October 2015, the cumulative number of registered implant 
surgeries with Codacs DI110 implant and DF110 Fixation System was 65 (39 during the last year). No 
reportable complaints were attributed to the receiver-stimulator or the lead. The number of reportable 
events related to medical/surgical issues or no-fault-found was 2 (3.1%). Based on the post market 
surveillance activities performed, the Codacs DI110 implant and the Codacs DF110 Fixation System 
are considered to be performing in the field within expectations (D701349, Post Market Surveillance 
Report, Codacs DI110 implant and DF110 Fixation system)17. 
9.2.4 
BI300 Implant with the Baha Connect System 
Since launch in 2010 to Oct 2015, 55 341 BI300 implants (including abutment) have been sold with a 
reported monthly complaint rate around 0.1-0.2%. The complaint relevant to the ATB System is BI300 
implant loss. The rate of implant loss for the Baha Connect System is around 1%. The overall 
complaint rates and reportable events are well below the pre-defined escalation threshold14. 
9.2.5 
BI300 Implant with the Baha Attract System  
During the period Aug 2013 to Jan 2017, approximately 11.000 BIM400 (Baha Attract Implant magnet 
including BI300) have been sold globally. The most commonly reported symptoms are skin reactions 
and/or pain around the implant magnet and magnet retention issues with an overall rate of up to 2%. 
The symptoms are usually reported to be mild and treated by adjusting Sound Processor (SP) Magnet 
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No cases of implant loss due to osseointegration failure have been confirmed. The overall complaint 
rates and reportable events are well below the pre-defined escalation threshold (D784107, Post 
Market Surveillance Report, Baha Attract, November 2015)13. 
9.3 
Risks associated with participation in the clinical 
investigation 
The Investigational device is reused by several parts from already CE marked products. There is no 
guarantee that the ATB Implant will not cause any adverse device events. The ATB Implant is 
expected to have a lifetime of about ten years. By the time of first implantation in the clinical 
investigation, spring 2017, it will be possible to claim approximately 30 months of equivalent lifetime. 
Test results will be reported periodically until an equivalent lifetime of 10 years is reached. As with any 
new surgical product and medical device, there is a risk that unanticipated Adverse Events may 
occur. The subjects will be closely monitored in the investigation and instructed to contact the 
responsible investigator if they experience any untoward effect. In the worst case scenario the patient 
would need a revision surgery to remove the ATB Implant, but this can be done with local 
anaesthesia. They will then end participation in the clinical investigation and follow normal clinical 
care and follow up. 
9.4 
Control and mitigation of risks 
The surgical procedure is described in the surgery guide for the ATB System 5. The guide has been 
developed by the Sponsor together with a group of experienced Baha and Cochlear Implant 
surgeons. Although most of the surgical tools are the same as for Baha and CI implantation, there are 
some new tools provided. These have been validated with presence of experienced implant 
surgeons during the surgical validation activity (cadaver surgical training and practical evaluation and 
testing of the surgical tools) and no patient implantation before these performed validation procedures 
were completed and reported. 
Before start of each site in the clinical investigation each investigator will have done documented 
surgery training according to the surgery guide either at a cadaver lab test or on a plastic skull.   
MRI examinations can be performed safely on a person with this implanted device only under very 
specific conditions. An MRI information package is supplied with each implant for additional 
information regarding magnetic resonance imaging18.  
Subjects enrolled in the investigation that receive the ATB System will receive an MRI card, for 
information to radiologists if an evaluation and planning of any MRI examination becomes necessary.  
Subjects that have received radiation therapy, or are planned for radiation therapy during the 
investigation, at the same side of the skull where the ATB System will be positioned are excluded 
from the investigation.  
 
9.5 
Risk-to-benefit assessment 
The risks have been judged acceptable when weighed against the benefits of the intended 
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10 
STATISTICAL CONSIDERATION 
10.1 
Statistical Design and Objectives 
10.1.1 Primary statistical objectives 
To compare hearing performance with the Investigational device and the unaided hearing situation. 
10.1.2 Secondary statistical objectives 
• 
To compare the self-reported assessments of hearing outcome with the Investigational device 
and in an unaided hearing situation 
• 
To compare hearing performance with the Investigational device and the unaided hearing 
situation 
• 
To compare the self-reported assessments of hearing outcome with the Investigational device 
and in a preoperative hearing situation 
• 
To collect surgical information 
• 
To collect information about the magnet choice and daily use of sound processor 
• 
To measure hearing performance preoperatively with a Baha BP110 Power Sound Processor on 
a Baha Softband 
• 
To measure feedback on the Investigational device 
10.1.3 Tertiary statistical objective 
To measure hearing performance preoperatively with a current hearing aid (if applicable and not 
mandatory) 
 
10.2 Efficacy variables/endpoints 
10.2.1 Primary variables/endpoints 
The primary efficacy analysis will be determined by analysis of change in free-field threshold 
audiometry: PTA4 (mean of 500, 1000, 2000 and 4000Hz) and change in Adaptive speech 
recognition in noise (50% performance), from unaided versus Investigational device at the 3 months 
visit. 
 
• 
Thresholds audiometry, free-field [PTA4, Mean of 0.5, 1, 2 and 4 kHz] 
 
It is hypothesized that the group mean free-field PTA4 (average of 500, 1000, 2000, and 4000 Hz) 
with the Osia System at the 3-month postoperative interval will be improved over that measured 
preoperatively in the unaided condition (baseline). 
 
This endpoint is represented by the following hypotheses:  
  
  
where:  
 = baseline preoperative PTA4; 
 = mean follow-up PTA4 3 months postoperative. 

 
 
 
 
 
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• 
Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding] 
 
It is hypothezied that the group mean Adaptive speech recognition in noise (50% performance), 
speech to noise ratio (SNR) with the Osia System at the 3-month postoperative interval will be 
improved over that measured preoperatively in the unaided condition. 
 
This endpoint is represented by the following hypotheses:  
  
  
where:  
 = baseline preoperative Adaptive speech recognition in noise (50% performance), 
speech to noise ratio (SNR); 
 = mean follow-up Adaptive speech recognition in noise (50% performance), 
speech to noise ratio (SNR) 3 months postoperative. 
 
10.2.2 Secondary variables/endpoints 
• 
Abbreviated Profile of Hearing Aid Benefit (APHAB) 
• 
Thresholds audiometry, free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] 
• 
Speech in quiet [% correctly perceived words at 50dB, 65dB and 80dB SPL] 
• 
Feedback measurement 
• 
Health Utilities Index (HUI23S1EN.15Q) 
• 
Speech, Spatial and Qualities of Hearing Scale (SSQ) 
• 
Soft tissue thickness  
• 
Soft tissue reduction performed 
• 
Type of anaesthesia 
• 
Surgery time  
• 
Bone polishing/removal at the actuator site 
• 
BI300 Implant length  
• 
Location of BI300 Implant 
• 
Surgical incision type/location 
• 
Daily usage time 
• 
Comfort 
• 
Softpad use 
• 
Choice of magnet strength 
• 
BC Direct [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz] 
 
10.2.3 Safety variables/endpoints 
• 
Numbness 
• 
Adverse Events and concomitant medication/treatment 
 
• 
Device deficiency  
• 
Audiogram 
 

 
 
 
 
 
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10.3 
Sample size calculation 
10.3.1 Sample size calculation for the primary efficacy analysis 
In order to achieve 90% power to detect a clinically significant difference of 10 dB in free-field hearing 
thresholds or 10 dB SNR between the unaided situation and the ATB System at the 3 months visit 
with Fisher’s non-parametric permutation test for paired observations, one-sided test with significance 
level 0.025, on the ITT population 11 (PTA-4) and 13 (SNR) evaluable subjects are needed. The 
sample size was calculated using simulation on study id CBAS5675 (Cochlear 2017) data which used 
the simulated ATB system on Mixed/Conductive subjects. The within subject SD for change Unaided 
to ATB in PTA4 was 9.5 dB and 11.3 SNR. Since significant result want to be detected in both arms 
(SSD and Conductive/Mixed) 13+13=26 subjects should be included in the investigation. 
10.3.2 Sample size calculation for the secondary analysis 
In order to achieve 90% power to detect a clinically significant difference of 15 units in APHAB Benefit 
between the unaided situation and use of the Investigational device at the 3 months visit with Fisher’s 
one-sided non-parametric permutation test for paired observations, one-sided test with significance 
level 0.025, on the pooled ITT population (SSD and Conductive/Mixed together), 28 evaluable 
subjects are needed assuming a within subject standard deviation (SD) of 23.3 units. The within 
subject SD has been estimated to 23.3 in a previous Cochlear-sponsored multi-centre clinical 
investigation which compared APHAB scores for pre-operative unaided hearing and for post-operative 
use of a Baha sound processor mounted on a percutaneous implant over 12 months (Study ID 
CBAS5439). To compensate for drop out of two patients in the study, 30 subjects should be included 
in the investigation. 
10.3.3 Sample size estimation for the primary safety analysis at 6 months 
Primary safety analysis will be evaluated at 6 months and an estimation of 50 subjects results in 25 
patient years at 6 months, which will yield enough safety data for the primary safety analysis. At the 
12-month analysis 50 subjects results in 50 patient years. 
10.3.4 Overall sample size considerations 
In order to achieve 90% power both for the primary analysis (PTA4 and SNR, Investigational Device 
vs. Unaided) and the primary safety analysis, 50 evaluable subjects are needed. Each arm SSD and 
Conductive/Mixed should at least consist of 13 patients to assure a power of 90% in both arms for the 
primary analysis. 
10.4 General statistical methodology 
All statistical analyses will be paired non-parametric. In order to choose the most powerful test, the 
Fisher’s non-parametric permutation test for paired observations will be used for all paired analyses of 
continuous variables. For paired analysis of dichotomous and ordered categorical variables the Sign 
test will be used. 
The main efficacy analysis will be performed on the ITT population and complementary efficacy 
analyses will be performed on the PP population. The main analysis will be performed after the 3 
month visit. A complementary analysis will be performed 9 months after the main analysis (12-month 
visit). All significance tests will be one-sided and performed at the 5% significance level. 
Imputation of missing values (definitions made in SAP) will be performed for all efficacy variables. No 
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All analyses, tables and figures will be produced for SSD and Conductive/Mixed separately and also 
pooled as on population. 
10.5 
Efficacy analysis 
10.5.1 Primary efficacy analysis 
Primary efficacy analysis will be determined by analysis of change in free-field threshold audiometry: 
PTA4 (mean of 500, 1000, 2000 and 4000Hz) and change adaptive speech recognition in noise (50% 
performance), from preoperative Unaided versus Investigational device at the 3 months visit for the 
ITT population, using Fisher’s one-sided non-parametric permutation test for paired observations at a 
significance level of 0.025 to demonstrate an improvement in PTA4. Each arm SSD and 
Conductive/Mixed will be tested separately. Both PTA4 and SIQ must be significant at alpha 0.025 for 
the primary analysis to be considered as confirmative in each arm separately. In addition, a pooled 
analysis for all subjects will be made. 
10.5.2 Secondary efficacy analyses 
The second efficacy analyses will be performed for Investigational Device vs. Unaided. Baha BP110 
Power Sound Processor on a Baha Softband will be presented (where applicable) but not compared 
to Investigational Device. 
 
• 
APHAB  
• 
Threshold audiometry: PTA4 (Mean of 500, 1000, 2000 and 4000 Hz)  
• 
Threshold audiometry: 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz  
• 
Adaptive speech recognition in noise (50% performance)  
• 
Speech in quiet (50dB, 65dB and 80dB)  
• 
HUI-III (compared with current hearing situation) 
• 
SSQ  
• 
Choice of SP magnet  
• 
BC Direct 
• 
Feedback measurements. Investigational device 
 
The secondary analyses will be presented for ITT and PP populations. 
 
 
10.5.3 Tertiary efficacy analyses 
The tertiary analyses will be presented for Current Hearing Aid. 
 
• 
Adaptive speech recognition in noise (50% performance)  
 
The tertiary analyses will be presented for ITT population. 
10.6 
Safety analyses 
10.6.1 Implant site evaluation 
Evaluation regarding numbness will be presented. 
10.6.2 Adverse Events 
Adverse Events and Serious Adverse Events will be presented overall and by relationship (Device 
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10.6.3 Device deficiency 
Device deficiency will be presented by visit. 
10.7 
Analyses of concomitant medications and treatments 
Prior and concomitant medication will be summarised. 
10.8 
Demographics and baseline characteristics 
Demographics and baseline characteristics will be descriptively summarised. 
10.9 
Interim analysis 
An interim safety analysis will be performed when all subjects at the site in Melbourne have 
completed the 3 month visit (i.e. visit 6). Based on the result of this interim analysis a ‘go/no go’ 
decision will be taken if to proceed with the investigation at the other sites. Focus of this safety 
analysis will be on reported Serious Adverse Event (SAEs) and Adverse Event of Special Interest 
(AESIs), i.e.: 
• 
AE that interfere with the daily use of the medical device(s) 
• 
AE at the site of the implant that lead to 
o 
Revision surgery including explantation 
o 
Severe soft tissue complication 
o 
Prescription of antibiotics 
The ’go/no go’ decision will be taken by the co-ordinating investigator and the Sponsor in 
collaboration with the principal investigator at the Melbourne site 
10.10 Statistical Analysis Plan 
A statistical analysis plan (SAP) with detailed statistical analyses specified for all variables and time 
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11 STATEMENT OF COMPLIANCE 
11.1 
Ethical requirements for the conduct of the investigation 
The investigation will be conducted in accordance with the ethical principles as described in the latest 
version of the Declaration of Helsinki adopted by the World Medical Association. 
The Clinical Investigation Plan (CIP), the informed consent form and any other written information that 
will be given to subjects will be submitted to the appropriate ethics committee and institutional review 
board. 
The investigation shall not begin until approval/favourable opinion from ethics committee (EC) and 
institutional review board (IRB) has been obtained. 
11.2 
Regulatory requirements for the conduct of the investigation 
The investigation involves devices that are not regulatory approved in the EU or US, (not received CE 
mark or 510k clearance/PMA approval), therefore the investigation needs approval from regulatory 
authorities within EU and from FDA in the US.  
The investigation shall not begin until approval/favourable opinion from the regulatory authorities has 
been obtained. 
The investigation will be conducted in accordance with applicable local regulations, e.g. data 
protection legislation. 
11.3 
Updates 
The appropriate ethics committees, institutional review board and competent authorities shall after 
initial approval of the investigation receive the following information: 
• 
Status reports and written summary of the investigation as required  
• 
Documentation required in order to apply for an extension 
• 
Documentation required in order to apply for an amendment to the CIP or the informed 
consent form 
• 
Report(s) with new information that may affect the safety of the subjects or the conduct of the 
study 
A protocol amendment must be approved by concerned ethics committees, institutional review board 
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11.4 
Quality standards 
The staff at the investigational site and the Sponsor shall follow the guidelines provided in the ISO 
standard ‘Clinical investigation of medical devices for human subjects – Good clinical practice19.  
In the US, the FDA recognises ISO 14155:2011 with the following exceptions: 
• 
Sections 4.5.2-5, 7.1.2: Institutional review board membership and procedures must follow 
US regulations 
• 
Sections 4.7.3.4, 4.7.4-5: Informed consent content and procedures must follow US 
regulations 
• 
Sections 6.4.1, 8.2.4.5.j-k, 8.2.5, 9.7-8. Annex A.14, Annex F: Adverse event reporting 
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12 ADMINISTRATIVE ASPECTS 
12.1 
Training 
The Sponsor will organise an initiation visit where the handling of the medical device(s), the CIP, 
investigational procedures including the informed consent process, instructions regarding case report 
form completion and any other matters relating to running the investigation at the site will be 
discussed with the investigators and queries clarified. 
The principal investigator will ensure that appropriate training relevant to the investigation is given to 
the medical, nursing and other staff involved at the clinic and that new information of relevance to the 
performance of this investigation is forwarded to the staff involved. 
Each Investigator performing the surgery in the clinical investigation will be trained in the surgical 
procedures for the investigational device.  
12.2 
Investigational data 
12.2.1 Case report form 
Data collection will be done by using electronic system (eCRF) for each subject in which information 
will be reported. Specific training and instruction on how to complete the eCRF will be provided to the 
investigator and other site staff according to the delegation log. Completed eCRFs will be reviewed 
and signed off by an investigator. 
12.2.2 Source data 
Defined as all the information in original records, certified copies of original records of clinical findings, 
observations, or other activities in a clinical investigation, necessary for the reconstruction and 
evaluation of the clinical investigation. 
The eCRF could be source data and before the initiation of the investigation the Principal 
investigators should together with the CRA/monitor complete the template ‘Origin of source data’ 
stipulating where source data should be recorded at the investigational site. 
12.2.3 Data management 
A data management plan will be written that describes the overall data handling process including 
data validation, clarification of data and the clean file process. 
All outstanding questions regarding data should be taken during the clean file meeting. After declaring 
clean file the data will be locked. 
12.3 
Archiving 
The Sponsor and Principal investigator shall maintain the investigation documents as required by the 
applicable regulatory requirements. 
12.4 
Device accountability 
Access to investigational devices shall be controlled and the investigational devices shall be used 
only in the clinical investigation and according to this CIP. 
The Principal investigator or an authorized designee shall keep records documenting the receipt, use, 
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a) the date of receipt 
b) identification of each investigational device (batch number/serial number or unique code) 
c) the expiry date, if applicable 
d) the date of use 
e) subject identification 
f) date on which the investigational device was returned/explanted from subject 
g) the date of return of unused, expired or malfunctioning investigational devices 
12.5 
Quality control 
12.5.1 Monitoring 
The Sponsor will work in collaboration with a Contract Research Organisation (CRO) that will appoint 
a monitor that will visit sites during the investigation. The Sponsor will ensure that monitor will be 
appropriately trained and informed about the nature of the investigation. The CRO will ensure that the 
monitor will be appropriately training according to ISO standard19 and applicable regulatory 
requirements. 
The monitoring process (including access to source data and extent of source data verification will be 
described in a monitoring plan.  
The monitor will verify the informed consent of participating subject, that the investigational team is 
adhering to the protocol and that data are accurately recorded in the CRF. 
The monitor must have direct access to source data. 
12.5.2 Audit 
Audits of the clinical investigation may be conducted by the Sponsor or third party designated by the 
Sponsor to evaluate compliance with the CIP, written procedures, ISO standard19 and applicable 
regulatory requirements. 
12.5.3 Sponsor expertise 
Sponsor representatives such as engineers or regional staff shall be present at each site during first 
surgery and first fitting of the Osia™ Sound Processor to provide technical expertise to the study 
team. The patient´s name or identifying details should not be disclosed. 
12.6 
Clinical Investigation Plan 
12.6.1 CIP amendment 
Changes to this CIP must be described in an amendment that is signed by the Sponsor and the 
Coordinating investigator. Necessary approvals must have been obtained before the amendment can 
be implemented. 
12.6.2 Deviations from Clinical Investigation Plan 
Investigators are not allowed to deviate from the CIP unless 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 as soon as possible and to the EC/IRB and Competent Authority according to local 
regulation. 

 
 
 
 
 
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Any deviation from the CIP will be recorded together with an explanation of the deviation. Deviations 
will be reported to the Sponsor, who is responsible for analysing them and assessing their 
significance. The appropriate ethics committee and institutional review board and regulatory 
authorities will be informed of any significant protocol deviations. 
12.7 
Suspension or premature termination 
The sponsor may suspend or prematurely terminate either an individual investigation site or the entire 
clinical investigation for significant and documented reasons. A Principal investigator may suspend or 
prematurely terminate participation in the clinical investigation at the investigation site for which 
he/she is responsible. 
Circumstances that may warrant termination include, but are not limited to: 
- Suspicion of an unacceptable, significant or unacceptable risk to subjects  
- Insufficient adherence to protocol requirements repeatedly identified during monitoring or auditing 
In case of suspension or premature termination the sponsor shall remain responsible for providing the 
resources to fulfil the obligations of the protocol and existing agreements for following up the subjects 
that are enrolled in the clinical investigation. 
12.8 
Publication policy 
The result of this clinical investigation will be published in accordance with the “WHO 
statement on public disclosure of clinical trial results” in which it is stated that trial results 
should both be submitted for publication in a peer reviewed medical journal and posted in 
the result section in the primary clinical trial registry: 
• 
The submission to a peer reviewed journal should occur within 12 months of study 
completion (last subject, last visit) and the results should be publicly available within 
24 months of study completion.   
• 
In addition, the key outcomes are to be made publicly available within 12 months of 
study completion by posting the results in the primary clinical trial registry. 
Authors of the primary publication based on this clinical investigation must fulfil the criteria 
defined by the International Committee of Medical Journal Editors (ICMJE). 
The primary publication must be published before any secondary publications are submitted 
for publication. 
12.9 
Timetable 
First subject first visit  
Q1/Q2 2017 
Last subject first visit  
Q2/Q3 2018 
Last subject last visit 
Q2/Q3 2019 
12.10   Definition of end of investigation 
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13 
BIBLIOGRAPHY 
1. Briggs R, Van Hasselt A, Luntz M, Goycoolea M, Wigren S, Weber P, Smeds H, Flynn M, Cowan R. 
Clinical performance of a new magnetic bone conduction hearing implant system: results from a 
prospective, multicenter, clinical investigation. Otol Neurotol. 2015 Jun;36(5):834-41. 
2. Den Besten CA, Stalfors J, Wigren S, Ivarsson Blechert J, Flynn M, Eeg-Olofsson M, Aggarwal R, 
Green K, Nelissen RC, Mylanus EAM, Hol MKS. Stability, survival and tolerability of an auditory 
osseointegrated implant for bone conduction hearing: long term follow-up of a randomized controlled 
trial. Otol Neurotol. 2016 (Accepted, in print) 
3. Nelissen RC, Stalfors J, de Wolf MJ, Flynn MC, Wigren S, Eeg-Olofsson M, Green K, Rothera MP, 
Mylanus EA, Hol MK. Long-term stability, survival, and tolerability of a novel osseointegrated implant 
for bone conduction hearing: 3-year data from a multicenter, randomized, controlled, clinical 
investigation. Otol Neurotol. 2014 Sep;35(8):1486-91. 
4. P1114536 - Osia Sound Processor user manual 
5. P1114535 - OSI100 Implant Physician’s Guide 
6. P893137, OSI100 Implant Surgical Instrument Sterilisation Reprocessing Guide 
7. P773697, Osia Fitting Software User Guide 
8. P803354 Baha Fitting Software - CSDS (Download) or P803254 Baha Fitting 
9. D800778 – Clinical Investigation Report CBAS5439, 12 Months clinical, 1.B 
10. Osia Intraoperative Test Software 1.0 User Guide 
11. ISO 8253-1 2010 
12. Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and 
Qualities of Hearing scale suitable for clinical use: the SSQ12. International Journ.of Audiol.2013 
52(6), 409-12 
13. D784107, Post Market Surveillance Report, Baha Attract, November 2015 
14. D788296, Post Market Surveillance Report, Baha Connect, November 2015) 
15. D769711, Literature Search and Evaluation: Protocol and Report. Baha Attract System 
16. 411167, Clinical Evaluation Report Nucleus CI24RE Cochlear Implants 
17. D701349, Post Market Surveillance Report, Codacs DI110 implant and DF110 Fixation system 
18. D893156 OSI100 Implant MRI Guidelines 
19. ISO 14155:2011 
 
 

 
 
 
 
 
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APPENDIX 1 - NEW ATB SPECIFIC INSTRUMENTS AND TEMPLATE 
 
1. 
   
 
Actuator template. Used to ensure the actuator is positioned correctly and  
the lead exit placed properly. Reusable instrument. 
 
2. 
 
 
Clearance indicator. Used to ensure there is adequate clearance 
for the actuator above the level of bone. Reusable instrument. 
 
3. 
 
 
OSI100 Recess checking gauge. Used to mark the bone recess on the skull, and measure 
the depth of the bone recess after drilling. Reusable instrument. 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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4. 
 
 
Guide Pin, Attaches to the BI300 implant. Provides an attachment point 
for the Clearance indicator , Actuator Template and Isolator. Single use instrument. 
 
 
5. 
 
 
OSI100 template. Silicon template of the entire implant to be used inside the sterile field. Single use 
item. 
 
 
 
6. 
      
 
 
OSI100 Non sterile template. Used to determine, or check, the optimum implant position and mark it 
onto the skin before incision. Single use item. 
 

 
 
 
 
 
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14 APPENDIX 2 -  SUPPORTIVE AND SURGICAL NON-  
INVESTIGATIONAL DEVICES USED IN THE INVESTIGATION  
 
 
Product 
Article name  
Sterile/  
non-sterile 
Single/  
re-usable 
Regulatory 
approved 
 
Surgical tools  
90469 
Screwdriver Unigrip 95mm  
Non sterile 
Reusable 
Yes 
92143 
Multi wrench with ISO adapter 
Non sterile 
Reusable 
Yes 
90381 
Machine Screwdriver Unigrip 25mm 
Non sterile 
Reusable 
Yes 
92142 
Implant inserter   
Non sterile 
Reusable 
Yes 
91116 
Drill indicator 
Non sterile 
Reusable 
Yes 
95070 
Soft tissue gauge 6 mm 
Non sterile 
Reusable 
Yes 
93363 
Conical guide drill 3+4 mm 
Sterile 
Single use 
Yes 
92140 
Widening drill 3mm 
Sterile 
Single use 
Yes 
92141 
Widening drill 4mm 
Sterile 
Single use 
Yes 
Z60479 
Bone Recess Template 
Non sterile 
Reusable 
Yes 
Z33017 
Array Exit Marking Template 
Non sterile 
Reusable 
Yes 
P772551 
Actuator Template 
Non sterile 
Reusable 
No 
P772552 
Clearance indicator 
Non sterile 
Reusable 
No 
P795943 
OSI100 Recess checking gauge 
Non sterile 
Reusable 
No 
Z496667 
OSI100 Single use kit: Guide Pin, OSI100 templ. 
Sterile 
Single use 
No 
Z60479 
Bone Recess template 
Non sterile 
Reusable 
Yes 
P794316 
OSI100 template (Non sterile, single use) 
Non sterile 
Single use 
No 
90944 
Raspatorium 
Non sterile 
Reusable 
Yes 
90943 
Dissector 
Non sterile 
Reusable 
Yes 
93339 
Baha Ruler 
Non sterile 
Reusable 
Yes 
 
Supportive items 
P783571 
Osia™ Fitting Software CSDS Clin Trial (version 
1.0.2) 
NA 
Reusable 
No 
N/A 
Baha Fitting Software – CSDS (Download) 
N/A 
Reusable 
Yes 
P803254 
Baha Fitting Software version 4.0 SR2 
NA 
Reusable 
Yes 
B13033 
BATTERY ZN AIR P675 IMPLANT PLUS 
Non-sterile 
Single use 
Yes 

 
 
 
 
 
CBAS5539 
CIP Version 5 
 
 
 
 
 
 
 
Template 1015045 Version 5.0 
60 of 60 
 
Z60686 
Freedom Programming Pod 
Non-sterile 
Reusable 
Yes 
Z327114 
 
Cochlear Nucleus Programming Shoe with Cable 
Non sterile 
Reusable 
Yes 
Z544308        
CP950 Programming Shoe Adaptor Cable Kit 
Non sterile 
Reusable 
Yes 
Z22502 
Signal Check wand 
Non sterile 
Reusable 
Yes 
D1132381 
Osia™ Intraoperative Test Software CSDS Clin 
Trial (version 1.0.1) 
N/A 
Reusable 
No 
92841 
Cochlear Baha BP110 Power Sound Processor 
N/A 
Reusable 
Yes 
95750 
Baha Softband 
N/A 
Reusable 
Yes 
P793402 
Cochlear Softwear Pad (5pcs) 
Non-sterile 
Single use 
Yes 
P993402 
Baha SoftWear Pad (15pcs) 
Non-sterile 
Single use 
Yes