Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
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  
CBAS5731 
Version  
Version date 
3 Final 
11 December 2018 
 
Subject´s preference regarding hearing performance and 
functionality using a new sound processor 
 
Single-center, prospective, open within-subject comparison with 
randomised device test order. 
 
This CIP version 3 includes the following addition: 
 
CIP version 
Date 
Comments 
2 
02 October 2018 
Original submitted to HREC 
3 
11 December 2018 
A section regarding Safety 
assessment added after 
request by HREC. 
 
NCT03848910 
 

 
 
 
 
 
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SYNOPSIS 
Name of sponsor  
 
Cochlear Bone Anchored Solutions AB 
Investigation code 
CBAS5731 
 
Investigational title 
Subject´s preference regarding hearing performance and functionality 
using a new sound processor 
Design 
Single-centre, prospective, open, within-subject comparison with 
randomised device test order. 
Investigational device(s)  
Osia ® 2 Sound Processor (Osia 2 SP) 
 
Comparator(s) 
Osia Sound Processor (Osia SP) 
 
Aim for conducting the 
investigation  
To investigate test-subject overall preference, hearing performance 
and self-reported assessments with Osia 2 SP and Osia SP. 
Inclusion criteria  
• 
Completed clinical investigation CBAS5539, and an active user of 
the Osia System. 
• 
Signed Informed Consent. 
• 
Subject with conductive or mixed hearing loss in the implanted ear. 
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. 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. 
• 
Optimally fitted with Osia SP, according to subject’s experience 
prior to inclusion. 
Exclusion criteria  
• 
Any ongoing soft tissue complication that could affect the use of 
the Osia 2 SP 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 and instructions, e.g. 
inability to complete quality of life scales or audiological testing as 
described in this CIP. 
• 
Participation in another clinical investigation with pharmaceutical 
and/or device. 
 
Number of subjects  
Up to 12 
Duration of subjects 
participation 
6 weeks in total   
 

 
 
 
 
 
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Overall objective 
Measurements 
To compare the subject’s 
overall preference between 
the Osia 2 SP and Osia SP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Preferred choice made by selection between Osia 2 SP and 
Osia SP  
• 
Self-reported assessments 
➢ Abbreviated Profile of Hearing Aid Benefit (APHAB) 
➢ Speech, Spatial, and Qualities of Hearing Scale (SSQ) 
➢ Self-reported assessment regarding satisfaction and 
usability (QUEST version 2) 
• 
Audiometric thresholds in free field 
➢ 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 recognition tests in quiet and noise 
➢ Adaptive speech in noise [speech-to-noise ratio, 50% 
speech understanding]. 
➢ Speech in quiet [% correctly perceived words at 50dB, 65dB 
and 80dB SPL]. 
 
 
To assess the subject’s 
experience regarding Comfort 
and specific usage 
• 
Subjective experience regarding Comfort and specific usage 
➢ Comfort 
➢ Magnet choice 
➢ Battery life 
➢ SoftWear pad use 
➢ Safety line use 
➢ Wireless accessories and iPhone connectivity 
 
Safety objective(s) 
Outcome measure(s) 
Adverse Events and concomitant 
Information will be collected from Visit 1 

 
 
 
 
 
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medication/treatment 
Device deficiency 
Information will be collected from Visit 1 
 
 

 
 
 
 
 
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Procedures and timing  
Visit 1 
Visit 2/ 
Contact * 
Visit 3 
Day/Week/Month 
Day 0 
14 days 
6 weeks 
Time window 
 
± 5 days 
± 5 days 
Demographics 
X 
 
 
Medical history 
X 
 
 
Eligibility criteria 
X 
 
 
Audiogram 
X 
 
 
Baseline characteristics 
X 
 
 
Informed consent 
X 
 
 
Sound Processor Fitting 
 
Magnet choice 
X1 
X3 
 
Digital link calibration (DLC) 
X1 
X3 
 
Feedback measurement 
X1 
X3 
 
BC Direct 
X1 
X3 
 
Fine tuning1 
X1 
X3 
 
Randomised device test order 
 
 
X 
 
 
 
 
Thresholds audiometry, free-field 
 
 
X 
Speech recognition in noise 
 
 
X 
Speech recognition in quiet 
 
 
X 
APHAB 
X2 
 
X1 
SSQ 
X2 
 
X1 
QUEST 
X2 
 
X1 
Comfort and Specific usage: Comfort, magnet 
choice, battery life, SoftWear pad, Safety line  
X2 
 
X1 
Wireless accessories 
 
 
X1 
Subject´s overall preference 
 
 
X4 
 
 
 
 
Adverse events 
X 
X 
X 
Device deficiency  
X 
X 
X 
Concomitant treatment 
X 
X 
X 
Extra visit  
 
 
 
 
*Visit 2 is optional as a Visit. Can be done by contact via phone call 
1 Investigational device 
2 With Comparator 
3 As required, Investigational device 
4 Investigational Device vs Comparator 
 
 
 

 
 
 
 
 
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TABLE OF CONTENTS 
Synopsis .................................................................................................................................................. 2 
Table of Contents .................................................................................................................................... 6 
Abbreviations .......................................................................................................................................... 9 
1 
Introduction .................................................................................................................................... 10 
1.1 
Background ......................................................................................................................... 10 
1.1.1 
The Osia system ................................................................................................... 10 
1.2 
Aim of the clinical investigation ........................................................................................... 11 
2 
Medical device(s) used during and after the investigation ............................................................ 12 
2.1 
Investigational device and comparator ............................................................................... 12 
2.1.1 
Description of the Investigational device ............................................................... 12 
2.1.2 
Description of Comparator .................................................................................... 14 
2.2 
Blinding................................................................................................................................ 16 
2.3 
Other device(s) used in the investigation ............................................................................ 16 
2.3.1 
Osia Fitting Software ............................................................................................. 16 
2.3.2 
Osia System accessories ...................................................................................... 16 
2.4 
Treatment after the completion of the investigation ............................................................ 16 
3 
Subjects and subject protection .................................................................................................... 17 
3.1 
Selection of subjects ........................................................................................................... 17 
3.1.1 
Inclusion criteria .................................................................................................... 17 
3.1.2 
Exclusion criteria ................................................................................................... 17 
3.1.3 
Number of subjects ............................................................................................... 17 
3.1.4 
Duration of subject participation ............................................................................ 17 
3.2 
Subject enrolment and Informed consent ........................................................................... 17 
3.3 
Randomisation .................................................................................................................... 18 
3.4 
Discontinuation .................................................................................................................... 18 
3.5 
Replacement of subjects ..................................................................................................... 18 
3.6 
Insurance............................................................................................................................. 18 
4 
Design of the clinical investigation ................................................................................................ 19 
4.1 
Design of the clinical investigation ...................................................................................... 19 
4.2 
Justification for the design of the clinical investigation ....................................................... 19 
4.3 
Overall objectives and measurements ................................................................................ 20 
5 
Procedures .................................................................................................................................... 22 
5.1 
Test equipment ................................................................................................................... 22 
5.2 
Inform Consent and eligibility criterias ................................................................................ 22 
5.3 
Demographics ..................................................................................................................... 22 

 
 
 
 
 
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5.4 
Medical history .................................................................................................................... 22 
5.5 
Baseline characteristics ...................................................................................................... 22 
5.6 
Audiogram ........................................................................................................................... 23 
5.7 
Sound Processor Fitting ...................................................................................................... 23 
5.7.1 
Magnet  selection .................................................................................................. 23 
5.7.2 
Digital Link Calibration........................................................................................... 24 
5.7.3 
Feedback measurement ....................................................................................... 24 
5.7.4 
Bone conduction (BC) Direct ................................................................................. 24 
5.7.5 
Fine tuning ............................................................................................................. 24 
5.8 
Randomised device test order ............................................................................................ 24 
6 
Measurements ............................................................................................................................... 25 
6.1 
Free-field thresholds audiometry ........................................................................................ 25 
6.2 
Speech recognition in noise ................................................................................................ 26 
6.3 
Speech recognition in quiet ................................................................................................. 26 
6.4 
Abbreviated Profile of Hearing Aid Benefit (APHAB form A) .............................................. 27 
6.5 
Speech, Spatial, and Qualities of Hearing Scale (SSQ-12 version) ................................... 27 
6.6 
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST version 2)
 
28 
6.7 
Comfort and specific usage................................................................................................. 28 
6.8 
Use of Wireless (WL) accessories and iPhone apps .......................................................... 29 
6.9 
Subject’s overall preference ................................................................................................ 30 
6.10 Adverse event and device deficiencies ............................................................................... 31 
6.10.1 
Device deficiency reporting ................................................................................... 31 
6.10.2 
Adverse Event (AE) and Serious Adverse Event (SAE) ....................................... 31 
6.10.3 
Reporting to ethical committees and regulatory authorities .................................. 32 
6.11 Concomitant medication(s) and treatment(s) ...................................................................... 32 
7 
Flow chart ...................................................................................................................................... 33 
8 
Risk and benefits of the investigational device(s) and the clinical investigation ........................... 34 
8.1 
Anticipated clinical benefits ................................................................................................. 34 
8.2 
Anticipated adverse device effects ..................................................................................... 34 
8.3 
Residual risks associated with the investigational device ................................................... 34 
8.4 
Risks associated with participation in the clinical investigation .......................................... 34 
8.5 
Control and mitigation of risks ............................................................................................. 34 
8.6 
Risk-to-benefit assessment ................................................................................................. 35 
8.7 
Safety Assessment ............................................................................................................. 35 
9 
Statistical consideration ................................................................................................................. 36 
9.1 
Statistical design and general statistical methodology ....................................................... 36 

 
 
 
 
 
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9.1.1 
Sample size calculation ......................................................................................... 36 
9.1.2 
Analysis sets – populations ................................................................................... 36 
9.2 
Overall objective analyses .................................................................................................. 36 
9.3 
Safety analyses ................................................................................................................... 36 
9.4 
Interim analysis ................................................................................................................... 36 
9.5 
Statistical Analysis Plan ...................................................................................................... 36 
10 Statement of compliance ............................................................................................................... 37 
10.1 Ethical requirements for the conduct of the investigation ................................................... 37 
10.2 Regulatory requirements for the conduct of the investigation ............................................. 37 
10.3 Updates ............................................................................................................................... 37 
10.4 Quality standards ................................................................................................................ 37 
11 Administrative Aspects .................................................................................................................. 38 
11.1 Training ............................................................................................................................... 38 
11.2 Investigational data ............................................................................................................. 38 
11.2.1 
Case report form ................................................................................................... 38 
11.2.2 
Patient questionnaires........................................................................................... 38 
11.2.3 
Source data ........................................................................................................... 38 
11.2.4 
Data management ................................................................................................. 38 
11.3 Archiving.............................................................................................................................. 38 
11.4 Device accountability .......................................................................................................... 39 
11.5 Quality control ..................................................................................................................... 39 
11.5.1 
Monitoring ............................................................................................................. 39 
11.5.2 
Audit ...................................................................................................................... 39 
11.6 Clinical Investigation Plan ................................................................................................... 39 
11.6.1 
CIP amendment .................................................................................................... 39 
11.6.2 
Deviations from Clinical Investigation Plan ........................................................... 39 
11.7 Suspension or premature termination ................................................................................. 40 
11.8 Publication policy ................................................................................................................ 40 
11.9 Timetable............................................................................................................................. 41 
11.10 Definition of end of investigation ......................................................................................... 41 
12 Bibliography ................................................................................................................................... 42 
13 Signature – sponsor ........................................................................ Error! Bookmark not defined. 
14 Signature – principal investigator .................................................... Error! Bookmark not defined. 
 
 
 
Appendix 
Title 
NA 
NA 

 
 
 
 
 
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ABBREVIATIONS  
 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest  
APHAB 
Abbreviated Profile of Hearing Aid Benefit 
Baha  
Bone anchored hearing device 
BC 
Bone Conduction 
CBAS 
Cochlear Bone Anchored Solutions AB 
CE 
Conformité Européenne 
CHL 
Conductive Hearing Loss 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form  
DCL 
Digital link calibration 
FDA 
Food and Drug Administration  
ISO 
International Organization for Standardization 
ICMJE 
International Committee of Medical Journal Editors 
LED 
Light Emitting Diodes 
MHL 
Mixed Hearing Loss 
OFS 
Osia Fitting Software 
QUEST 
Quebec User Evaluation of Satisfaction with assistive Technology 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event   
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SNHL 
Sensorineural Hearing Loss  
SP 
Sound Processor 
SSD 
Single Sided sensorineural Deafness 
SSQ 
Speech Spatial and Qualities of Hearing Scale 
TGA 
Therapeutic Goods Administration 
US 
United States  
USADE 
Unanticipated Serious Adverse Device Effect 
 

 
 
 
 
 
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1 INTRODUCTION 
1.1 
Background 
1.1.1 
The Osia system 
The Investigational device, the Osia ® 2 Sound Processor, is part of the Osia ® System, 
which is an active implantable bone conduction hearing system intended to compensate for 
conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural 
deafness (SSD) by transmitting amplified acoustic signals to the cochlea through mechanical 
vibration of the skull bone.  
The Osia System consists of an internal and an external part (figure 1). The internal part is 
the implant consisting of a receiver/stimulator and an actuator (vibrator) which is surgically 
implanted on the temporal bone and attached to an osseointegrated titanium fixture (BI300 
Implant). The external part is a sound processor, an off-the-ear button processor, which 
picks up the sound from the environment and sends the information, after processing, to the 
implant via an inductive radio frequency link. Each system is configured to meet an 
individual’s impaired hearing needs by using a dedicated fitting software, the Osia Fitting 
Software. 
The actuator converts the electrical signal into an amplified mechanical stimulation and 
transmits it to the mastoid bone through the osseointegrated BI300 implant, bypassing the 
impaired middle ear (origin of the conductive part of the hearing loss) and optionally 
providing mechanical amplification in order to compensate for the damaged hair cells 
(sensorineural part of the hearing loss, in case of mixed hearing loss). For SSD subjects the 
amplified mechanical stimulation is transferred though bone conduction to the contralateral 
functioning cochlear. 
Figure 1. Overview of the Osia System 
 
1 
2 
3 
4 
5 
Investigational device 
 
1. 
The external sound processor, 
captures and digitally processes 
sound. 
 
2. 
The sound processor transmits 
power and digital information to 
the implant. 
 
3. 
The implant receiver-stimulator 
converts the digital information 
into an electric analogue signal. 
 
4. 
This electric signal is converted 
to vibrations by the implant 
piezoelectric actuator. 
 
5. 
The vibrations are transmitted to 
the skull bone through the BI300 
Implant, and onwards to the 
cochlea. 

 
 
 
 
 
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The Osia System is indicated for people with uni- or bilateral conductive or mixed hearing 
loss and for people with single-sided sensorineural deafness (SSD). It is indicated for adult 
recipients, with a fitting range of up to 55 dB SNHL (for mixed hearing loss).  
The Osia System with the second generation sound process—the Osia 2 Sound 
Processor—combines favourable aesthetics with improved features (Wireless, Noise 
reduction and Active Gain) compared to the first generation Osia Sound Processor. The 
sound processor is worn on the skin over the implant site on a daily basis for up to a full day. 
1.2 
Aim of the clinical investigation 
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing 
performance and self-reported assessments with the Osia 2 Sound Processor 
(Investigational device) and the Osia Sound Processor (Comparator) after 6 weeks in 
subjects with conductive/mixed hearing loss or SSD.  
 
 

 
 
 
 
 
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2 MEDICAL DEVICE(S) USED DURING AND AFTER THE 
INVESTIGATION 
2.1 
Investigational device and comparator 
2.1.1 
Description of the Investigational device 
The Osia 2 Sound Processor (Osia 2 SP) is a button-type, second generation sound 
processor to be used with an OSI100 Implant already implanted and in use by the subjects 
taking part in the clinical investigation. The Osia 2 SP offers an improvement over the 
previous generation sound processor (Osia SP) with regards to size (figure 2), weight, signal 
processing and wireless functionality (see table 1). 
 
Figure 2. The Osia ® 2 Sound Processor views and size. 
 
 
 
 
During use, the Osia 2 SP is, like the first generation Osia SP, in contact with the skin or hair 
and is kept in place by two magnets, one magnet in the Osia 2 SP and one implanted 
magnet in the OSI100 Implant (Figure 3). The intended use is daily and as long as the 
subjects feels they need to have amplification, which could mean a full day.  
 
 
 
 

 
 
 
 
 
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Table 1. The Osia ® 2 Sound Processor features 
Feature 
Osia 2 SP 
Material Processor unit 
Polyamide 
Weight (with battery and magnet 4) 
11,6 g 
Battery 
One PR44  
Compatible implant 
OSI100 Implant 
Digital sound processing 
NEOXS and Lacerta C4.5 
Wireless Accessories 
As specified in 2.3.2 
 
The Osia 2 SP is compatible with the Cochlear wireless accessories available on the market 
as well as various other accessories like Safety line and SoftWear pad. It is also compatible 
with iPhone via Bluetooth Low Energy (BLE) enabling the use of apps. The subjects will be 
able to choose from five different front colours for their SP. 
 
The Osia 2 SP is powered by one battery which is expected to be enough for one full day of 
use. 
 
Figure 3. Osia System: Top. Osia 2 Sound Processor with the OSI100 Implant. Below: partially exploded view. 
 
 
 
 
 
 
Face 
Base 
Bottom cover 
Door 
Button 

 
 
 
 
 
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In normal operation, the Osia 2 SP and OSI100 Implant function as follows: 
• 
The sound is picked up by the microphone in the sound processor and is digitally 
processed. 
• 
The sound processor transmits the digital information and power to the implant. 
• 
The implant receiver-stimulator converts the digital information into an electric analog 
signal. 
• 
This electric signal is converted to vibrations by the implant piezoelectric actuator 
• 
The Actuator is attached to the fixture, BI300 Implant, which transfers the vibrations 
into and through the scull bone to the Cochlea. 
 
2.1.1.1 
Manufacturer of investigational device(s) 
The Osia 2 SP, magnets and packaging case are sourced and manufactured by Jabil Nypro 
in Shanghai China, outsourced by the legal manufacturer Cochlear Limited, Sydney, 
Australia. The facility is ISO13485 certified (Medical devices - Quality management 
systems). 
2.1.2 Description of Comparator 
The Osia Sound Processor (Osia SP) is the SP currently being used by the subjects who 
can participate in this clinical investigation. It 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 Osia SP and the OSI100 implant are CE-marked, and constitute the first 
generation Osia System. The Osia SP unit also contains light emitting diodes (LED) and one 
command button, which allows the patient to control the processing unit (Figure 4). The 
mode of operation is the same as for the Osia 2 SP, described in section 2.1.1.  
Features of the Osia SP is presented in table 2.  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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Figure 4.Osia Sound Processor. Upper left: external view (upper surface). Upper right: partially exploded view. 
Low left : size. Low Right: SP and Implant In Vivo 
   
 
 
 
 
 
 
 
Table 2. The Osia Sound Processor features 
Feature 
Osia SP 
Material Processor unit 
Polyamide 
Weight (with batteries and magnet 6) 
18.7 g 
Battery 
Two  675 Zinc-Air batteries 
Compatible implant 
OSI100 Implant 
Digital sound processing 
NEO 
Wireless Accessories 
Not available 
 
In this clinical investigation the Comparator will only be used in testing once, at Visit 3, to 
collect data to be compared with data from the Osia 2 SP. 
2.1.2.1 
Justification for the choice of comparator(s) 
The Osia SP is the first generation Osia sound processors, and is CE marked. Cochlear 
Bone Anchored Solution AB´s internal testing and preliminary data from clinical investigation 
CBAS5539 1 has shown that the Osia System works as intended and improves the subject’s 
ability to hear. The intention from Cochlear is that the next generation sound processor, the 
Osia 2 SP, will provide at least as good hearing performance and be preferred by the 

 
 
 
 
 
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subjects that have the possibility to upgrade. Data collected from both SPs in this clinical 
investigation will be used to indicate this. 
2.1.2.2 
Manufacturer of comparator(s) 
Cochlear Limited, Sydney, Australia. 
2.2 
Blinding 
No blinding will be used in this clinical investigation. 
2.3 Other device(s) used in the investigation 
2.3.1 
Osia Fitting Software 
To adjust and fit the Osia 2 SP to each recipient a programming software will be used—the 
Osia Fitting Software (OFS) with the currently released version at the time of the clinical 
investigation. Communication between the computer-based software and the sound 
processor is achieved using a Hi-Pro 2 programming unit. This OFS to be used for the Osia 
2 SP is built on and has comparable graphical user interface and features as the previous 
OFS 1.0 developed for the Osia SP, but with improved data logging and wireless 
capabilities/accessories which are the same as in the Baha Fitting Software (BFS 5.0).  
2.3.2 
Osia System accessories 
Accessories which are approved and compatible with the Osia 2 SP will be available for use 
in the clinical investigation (free of charge for the subjects). The accessories are: 
• 
Cochlear Wireless Phone-clip (ID 94773). 
• 
Cochlear Baha Remote control 2 (ID 94793). 
• 
Cochlear Wireless Mini-microphone 2+ (ID P770847). 
• 
Cochlear Baha Safety line (ID P72062). Can be used to secure the Osia 2 SP in case 
of loss of magnetic retention. 
• 
SoftWear pads (ID P793402). 
 
2.3.2.1 
Manufacturer of other non-investigational devices 
For Wireless: Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden. 
For Safety line and SoftWear pads: Cochlear Limited, Sydney, Australia. 
2.4 
Treatment after the completion of the investigation 
After the clinical investigation the subjects will have the option to keep and continue to use 
their Osia 2 SP. Routine controls with audiological checks will follow local routines according 
to the standard treatment program for similar devices (e.g. active and non-skin penetrating, 
bone conduction hearing devices). 
The Osia 2 SP will be warranted and supported with service according to normal Cochlear 
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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: 
• 
Completed clinical investigation CBAS5539, and an active user of the Osia System. 
 
• 
Signed Informed consent. 
 
• 
Subject with conductive or mixed hearing loss in the implanted ear. 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. 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. 
• 
Optimally fitted with Osia Sound processor, according to subject’s experience prior to 
inclusion. 
3.1.2 
Exclusion criteria 
A subject will be excluded from participation in the investigation if he/she meets any of the 
criteria below: 
• 
Any ongoing soft tissue complication that could significantly affect the use of the Osia 
2 Sound Processor during the 6 weeks period 
• 
Use of ototoxic drugs that could be harmful to the hearing, as judged by the 
investigator 
• 
Unable to follow investigational procedures and instructions, e.g. inability to complete 
quality of life scales or audiological testing as described in this CIP. 
• 
Participation in another clinical investigation with pharmaceutical and/or device. 
3.1.3 
Number of subjects 
Up to 12 subjects will be included in the investigation.  
3.1.4 
Duration of subject participation 
Subjects will participate during a 6 weeks period, involving up to 3 prescheduled visits. 
3.2 
Subject enrolment and Informed consent 
Before a subject is asked to sign an informed consent form, the investigator must explain the 
following to the potential investigational subject: 
• 
The rationale, aims and objectives of the investigation 
• 
Any risks and benefits 

 
 
 
 
 
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• 
Alternative treatment solutions 
• 
Extent of the subject’s involvement  
• 
He/she can withdraw his/her consent at any time  
• 
The confidentiality of patient data will be maintained at all time 
• 
The subject will be informed if new information becomes available that may be 
relevant to the subject's willingness to continue participation in the clinical 
investigation 
The subject must have the opportunity to ask any questions. Signed and dated informed 
consent from potential subjects must be obtained before any investigational procedures can 
be performed. The enrolled subject will keep their subject number/Id number that was 
assigned to them in the previous completed CBAS5539 clinical investigation. 
3.3 
Randomisation 
This is an open investigation. Randomisation will be performed for the device test order at 
Visit 3 (Osia 2 SP and Osia SP). See section 5.8.  
3.4 
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 is for example failure of 
OSI100 Implant function   
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. 
3.5 
Replacement of subjects 
If a subject discontinues participation in the investigation, he/she will not be replaced. 
3.6 
Insurance  
In case of any damage or injury occurring during the participation in the investigation, the 
Sponsor has contracted an insurance company, Chubb Insurance 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, single-centre, prospective, within-subject comparison, 
with 2-3 visits over a period of 6 weeks. The data for the overall objectives will be collected 
at Visit 1 and at Visit 3. Subjects enrolled will all be previous participants in the CBAS5539 
study conducted at the same clinic. No new implantations will be performed. A 
randomisation will be performed regarding the device test order at Visit 3 and each subject 
will be compared to his/her own questionnaire answers from Visit 1 and test results at Visit 3.  
4.2 Justification for the design of the clinical investigation 
The design consists of a within-subject comparison in terms of “preference”. The subjects 
are already using the Osia SP and comparisons will be made with the Osia 2 SP after 6 
weeks of use. The sponsor is interested in gathering information regarding the user’s 
subjective everyday preference when using their own preferred settings.  
Questionnaires to collect self-reported outcomes—Abbreviated Profile of Hearing Aid Benefit 
(APHAB) 2, Speech, Spatial and Qualities of Hearing Scale (SSQ) 3 and Quebec User 
Evaluation of Satisfaction with assistive Technology (QUEST) 4—have been proven to be a 
helpful tools measuring changes in subjects benefits 5. 
In addition to the subjective evaluations, thresholds audiometry in free-field (pure tone 
average - PTA4 and per frequency), Adaptive speech in noise and Speech in quiet tests will 
be carried out in order to objectively assess hearing performance with the two sound 
processors. These tests are all relevant and objective methods used by clinics internationally 
as a way to assess hearing performance. The same audiological tests were used in the 
CBAS5539 clinical investigation 1. 
The rationale for using Osia SP as comparator against the Osia 2 SP is that both are within 
the same fitting range, and Osia 2 SP is developed as the next generation sound processor 
to be used in conjunction with the OSI100 Implant which is already implanted in the selected 
subjects. The subjects have used the Osia SP for at least a year when they start this clinical 
investigation. Hence, it is considered a valid justification for the comparison. 
This investigation is limited to adult subjects coming only from the clinic in Melbourne and 
will include a mix of subjects with conductive hearing loss, mixed hearing loss and SSD. 
The rationale for the chosen follow-up period is based on the following: In terms of time 
required for acclimatisation/patients being used to a hearing device, there is no consensus in 
the literature, especially in terms of speech recognition. However, within audiology and 
based on clinical experience, it is expected that subjective acclimatisation would occur 
somewhere between 30-60 days after first fitting. All subjects to be enrolled are used to 
hearing through bone conduction with their Osia SP. The period of 6 weeks is estimated to 
be long enough for the subjects to adapt and get used to the hearing performance with the 
Investigational device, but still not override the experience of the previous sound processor. 
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In the current investigation, none of the subjects will have an acclimatisation period with the 
Osia SP as they are already familiar with this device and use it on a daily basis (i.e. 
acclimatisation has already taken place). However, it is important to highlight that all subjects 
enrolled in the current study have taken part of the CBAS5539 study, meaning that they all 
have recently been optimally fitted. In addition, these subjects were informed that they could 
contact the clinic as needed after completion of that study. Thus, the probability of the 
subjects coming in at visit 1 with an ill-fitted Osia SP is low. 
4.3 
Overall objectives and measurements  
Overall objective 
Measurements 
To compare the subjects’ overall preference 
regarding the Osia 2 SP and Osia SP 
• 
Preferred choice made by selection 
between Osia 2 SP and Osia SP  
• 
Self-reported assessments 
➢ Abbreviated Profile of Hearing Aid 
Benefit (APHAB) 
➢ Speech, Spatial, and Qualities of 
Hearing Scale (SSQ) 
➢ Self-reported assessment regarding 
satisfaction and usability (QUEST 
version 2) 
• 
Audiometric thresholds in free field 
➢ 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 recognition tests in quiet and 
noise 
➢ Adaptive speech in noise [speech-to-
noise ratio, 50% speech 
understanding]. Osia 2 SP vs Osia 
SP at 6 weeks 
➢ Speech in quiet [% correctly 
perceived words at 50dB, 65dB and 
80dB SPL]. Osia 2 SP vs Osia SP at 
6 weeks. 
 

 
 
 
 
 
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Overall objective 
Measurements 
To assess the subjects’ experience 
regarding Comfort and specific usage 
• 
Subjective experience regarding comfort 
and specific usage 
➢ Comfort 
➢ Magnet choice 
➢ Battery life 
➢ SoftWear pad use 
➢ Safety line use 
➢ Wireless accessories 
 
Safety objective(s) 
Outcome measure(s) 
Adverse Events and concomitant 
medication/treatment 
Information will be collected from visit 1 
Device deficiency 
Information will be collected from visit 1 
 

 
 
 
 
 
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5 PROCEDURES 
Procedures that will be performed during the clinical investigation are outlined in the flow 
chart, see Synopsis and Section 7. In this clinical investigation, Visit 2 can either be 
performed as a visit at the clinic or as a telephone contact, as required by the subject. 
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 prior to inclusion of the first subject in 
the investigation. All tests shall be performed in a 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 sound room set-up for the speech perception testing and free field 
testing unchanged during the entire clinical investigation. Changes are not allowed. 
However, baseline audiograms can be performed in a separate room using audiological 
standards 
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. Calibration 
documentation should be kept with the Investigator File. 
5.2 
Inform Consent and eligibility criterias 
At Visit 1, informed consent must be obtained before any investigational procedures starts 
During this visit all the inclusion and exclusion criteria should also be checked and fulfilled. 
5.3 
Demographics 
The following demographic data will be recorded at Visit 1: 
• 
Age collected as date of birth (month and year)  
• 
Gender  
• 
Ethnicity  
5.4 
Medical history 
The following information will be recorded at Visit 1:  
• 
Current concomitant medication and treatments and 6 months back. 
5.5 
Baseline characteristics 
During Visit 1, a number of baseline characteristics will be recorded: 
• 
Treatment ear (indicate left or right)  
• 
Type of hearing loss: (Conductive, Mixed or SSD) 
• 
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5.6 
Audiogram 
Unaided audiometric threshold measures (including both air- and bone conduction 
thresholds) should demonstrate that the subject has a conductive hearing loss, mixed 
hearing loss or SSD and is a suitable subject for the Osia 2 SP as per the third 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), with a PTA4 of ≤55dB for conductive or mixed and 
PTA4 of ≤20dB in the non-test ear for single-sided sensorineural deafness. 
If an audiogram is older than 6 months, does not contain the required frequencies or the 
subject experience a change in hearing, a new audiogram has to be performed at Visit 1. 
Frequencies required for air conduction thresholds are 250, 500, 750, 1000, 1500, 2000, 
3000, 4000, 6000 and 8000Hz. Frequencies required for 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.  
 
Note: for SSD subjects it is acceptable to use an audiogram older than 6 months that 
confirms the type of hearing loss as SSD. However, an audiogram not older than 6 months 
for the hearing ear is required.  
5.7 
Sound Processor Fitting 
The Osia Fitting Software (currently released version at the time of the start of investigation) 
will be used to adjust the Osia 2 SP settings for a specific subject. 
Prior to the study start it should be ensured that the subjects to be included are completely 
satisfied with the Osia SP settings as part of the normal clinical routine. The subjects will be 
asked before the inception of the study whether they are satisfied with their current fitting or 
if they want to make any adjustments in Osia SP. Hence, during Visit 1, we perceive them to 
be as optimally fitted as possible with the current device (i.e. Osia SP). 
This will enable the subjects to answer the questions at Visit 1 in the most appropriate way.  
At Visit 1 the subjects will then receive the Osia 2 SP which should be used during the 
following 6 weeks. Fitting of the Osia 2 SP will be performed in the same way in order to 
achieve the best possible hearing situation for the subjects. At Visit 2 or any extra visit 
adjustments for Osia 2 SP will be possible.   
In this investigation the aim at Visit 3 is that the subjects are satisfied with the wearing 
comfort and sound in the SP, and that no further adjustments are required before initiating 
the audiology tests and answering any questions.  
5.7.1 
Magnet  selection 
At Visit 1 the most suitable magnet should be selected for the sound processor to be tested, 
and the current instruction for use should be followed. It is important that the strength is not 
too weak or too strong. There are 4 different strengths, starting from 1 to 4. During Visit 2 

 
 
 
 
 
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and any extra visit the choice of sound processor magnet should be checked for the most 
optimal comfort. There may be a need to decrease or increase the strength depending on 
the subject’s preference. 
 
5.7.2 
Digital Link Calibration 
The Digital Link Calibration (e.g. coil-to-coil measurement) which is a step in the connection 
step in the Osia Fitting Software, should be performed at first fitting and potentially at Visit 2 
or any extra visits if it is needed. For the Osia 2 SP this data will be collected, saved on the 
provided laptop and eventually transferred to the Sponsor for analysis. 
5.7.3 
Feedback measurement 
A feedback measurement is performed to establish the Individual Stable Gain and should be 
performed at Visit 1 and as required at Visit 2 and any extra visit. For the Osia 2 SP this data 
will be collected, saved on the provided laptop and eventually transferred to the Sponsor for 
analysis. 
5.7.4 
Bone conduction (BC) Direct 
BC Direct is a tool in the Fitting Software to establish the unmasked bone condition threshold 
with tones presented through the sound processor. BC Direct should be performed at Visit 1 
and as required at Visit 2 and any extra visits.  All generated BC Direct data shall be 
collected and saved for further analysis. BC thresholds obtained at the following frequencies 
will be recorded; 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 Hz. 
5.7.5 
Fine tuning 
Fine tuning will be performed as required during Visit 1 when the subject first receives the 
Osia 2 SP, and potentially at Visit 2 or any extra visits as needed. At Visit 3 the aim is that 
the subjects is satisfied with the sound in the SP, and no further fine tuning is required.  
The OFS will be installed on a laptop provided by the Sponsor, and the fitting data will be 
saved on the laptop and being transferred to the Sponsor in a coded way. 
5.8 
Randomised device test order 
The order in which Osia SP and Osia 2 SP will be tested for each subject at Visit 3, will be 
randomised to reduce the risk of bias. See example for two subjects in table below. 
Subject 1 
Osia SP 
Thresholds audiometry 
Speech in quiet 
Speech in noise 
Osia 2 SP 
Thresholds audiometry 
Speech in quiet 
Speech in noise 
Subject 2 
Osia 2 SP 
Thresholds audiometry 
Speech in quiet 
Speech in noise 
Osia SP 
Thresholds audiometry 
Speech in quiet 
Speech in noise 
 
 
 
 

 
 
 
 
 
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6 MEASUREMENTS 
Measurements employed in the clinical investigation are outlined in the flow chart, see 
section 7. 
During the measurements, the signal processing of the sound processors will be 
standardised according to given instructions found in a separate Work Instruction which will 
be available by the time of study start. This will also be included in the site staff training 
material handed out at the Site Initiation Visit.  
All tests 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). Before blocking of the non-test ear a free-field measurement on PTA4 
frequencies (500, 1000, 2000, 4000 Hz) shall be performed. The blocking shall then be done 
with earplug and cuff and an additional free-field measurement on PTA4 frequencies shall 
then be performed to verify effective blockage and document the hearing level after 
blockage. 
6.1 
Free-field thresholds audiometry 
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 5). The signal to be used should be Warble Tones.  
At Visit 3, free-field thresholds shall be measured aided with the Osia 2 SP and the Osia SP 
according to the randomised device test order under section 5.8. Both sound processors will 
be tested according to the settings given in a separate final Work Instruction by the time of 
the study start. 
 
Figure 5. Free field front speaker position. 
BACK 
      
 
                         Signal 
 
             FRONT 
 
 

 
 
 
 
 
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6.2 
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. Software and speech material to be used is the AuSTIN 6. 
The AuSTIN test is an adaptive speech-in-noise test with a 4 talker babble noise and shall 
be conducted using validated lists. The speech and babble noise signals presented in free 
field from the front (0 degrees azimuth) (Figure 6). The sentences shall be presented at a 
constant level of 65 dB SPL throughout the test, and the babble noise shall be adapted 
stepwise according to the software used to establish the speech-to-noise ratio (SNR) 
providing a 50% level of correctly repeated morphemes.  
The speakers should be at the height of the test subject’s head and at least 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 standard 7. 
 
Figure 6. Speech in noise test speaker position and signal and noise presentation. 
    
             BACK 
       
 
                     Signal & Noise 
FRONT 
 
At Visit 3, the speech in noise test will be performed aided with the Osia 2 SP and the Osia 
SP according to the randomised device test order. Both sound processors will be tested 
according to the settings given in a separate final Work Instruction by the time of the study 
start. 
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  5). 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. At Visit 3, the 

 
 
 
 
 
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speech in quiet test will be performed aided with the Osia 2 SP and the Osia SP according to 
the randomised device test order. 
6.4 
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 2. APHAB produces a global score and scores for four subscales: ease of 
communication, reverberation, background noise, and aversiveness. The APHAB 
questionnaire is available for free and in a number of different translations on the HARL 
home page, http://www.harlmemphis.org 
The subjects will complete the APHAB questionnaire at Visit 1 and 3 by rating the aided 
subscale only (i.e. no rating of the non-aided subscale will be assessed in this study). 
• 
At Visit 1, the subjects shall complete the questionnaires and the questions shall be 
answered with respect to “pre-study experience” using the Osia SP.  
• 
At Visit 3, the subjects shall complete the questionnaires answering with respect to 
the past 6 week period using the Osia 2 SP. 
 
NOTE: at Visit 3 the questionnaire should be answered by considering the Osia 2 SP alone 
without the Wireless accessories. 
6.5 
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 SSQ49 3. The SSQ-12 questionnaire has 
been approved for use for free by the MRC Institute of Hearing Research. 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 and 3. 
• 
At Visit 1, the subjects shall complete the questionnaire and the questions shall be 
answered with respect to “pre-study experience” using the Osia SP.  

 
 
 
 
 
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• 
At Visit 3, the subjects shall complete the questionnaire answering with respect to the 
past 6 week period using the Osia 2 SP. 
 
NOTE: at Visit 3 the questionnaire should be answered by considering the Osia 2 SP 
alone without the Wireless accessories. 
6.6 
The Quebec User Evaluation of Satisfaction with assistive 
Technology (QUEST version 2) 
During the clinical investigation at Visit 1 and 3 information regarding the subject’s 
preference regarding aesthetics, comfort, usage time and ease of use will be collected. At 
Visit 1 for Osia SP, at Visit 3 for the past 6 weeks period using the Osia 2 SP. 
Questionnaire to be used for these assessments is the Quebec User Evaluation of 
Satisfaction with assistive Technology (QUEST) version 2. 
The QUEST is an outcome measurement instrument designed to evaluate a person’s 
satisfaction with his or her assistive technology device. It can be used with adolescents, 
adults and elderly persons who as a result of a physical or sensory impairment have 
acquired an assistive technology device. The assistive devices targeted include seating and 
mobility aids environmental control units, hearing and visual aids as well as aids to assist in 
the performance of daily living activities.  
The QUEST form displays the scoring of the 12 satisfaction items in two parts: Device (eight 
items) and Services (four items). The satisfaction items related to the characteristics of the 
device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of 
use, 7) comfort and 8) effectiveness. In the current investigation, the service part of the 
questionnaire will not be employed as the purpose is not to evaluate the service surrounding 
the experimental device. Each item is scored using a 5-point scale ranging from 1 to 5, 
where: 1 (dissatisfied), 2 (somewhat satisfied), 3 (more or less satisfied), 4 (very satisfied), 
to 5 (totally satisfied). The examiner must record the number of invalid answers. The 
subscale scores of each domain are calculated by adding the valid answers and dividing the 
sum by the number of items for each subscale. Moreover, the questionnaire lists 12 
satisfaction items and prompts the user to choose the three most important items.  
Studies of the QUEST have shown high internal consistency reliability and validity 4. 
NOTE: at Visit 3 the questionnaire should be answered by considering the Osia 2 SP alone 
without the Wireless accessories. 
6.7 
Comfort and specific usage 
Similar to the CBAS5539 clinical investigation, a visual analogue scale (VAS) will be used to 
capture the comfort experienced by the subject. Subjects will be asked to complete this at 
Visit 1 for Osia SP and at Visit 3 for Osia 2 SP. Subjects will also be asked questions 
regarding the choice of magnet for Osia 2 SP, battery change and the use of SoftWear Pad: 
• 
Comfort: By visual analogue scale 100 mm. Subject will be asked to put a line where 
they find most appropriate: 
 

 
 
 
 
 
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With regard to your current Sound processor, please rate the overall comfort by placing a 
single vertical line on the scale. 
 
 
 
 
  Not comfortable 
 
 
 
                          Most comfortable 
 
        at all 
 
 
 
 
 
                   imaginable 
 
• 
Magnet choice: What strength of magnet was chosen for Osia 2 SP at Visit 1. If there 
is a need for magnet change this will be captured at Visit 2 or any extra visit. 
• 
Change of battery: How often do you change battery, what is the estimated average 
battery life? For Osia SP at Visit 1 and for Osia 2 SP at Visit 3. 
• 
SoftWear Pad: Do you use SoftWear Pad? No/Yes – Frequency for change? For 
Osia SP at Visit 1 and for Osia 2 SP at Visit 3. 
• 
Safety Line: Do you use the Safety line? No/Yes. For Osia SP at Visit 1 and for Osia 
2 SP at Visit 3. 
6.8 
Use of Wireless (WL) accessories and iPhone apps 
At Visit 1 the subjects should choose at least one of the available accessories stated below.  
The audiologist will instruct the subject on how to connect and use the chosen 
accessory(ies) according to each User Manual 8,9,10.  
 
Between Visit 1 and Visit 3 the subjects should be encouraged to use the accessory(ies) as 
much as possible. 
- 
Cochlear Wireless Phone-clip 
- 
Cochlear Baha Remote control 2  
- 
Cochlear Wireless Mini-microphone 2+ 
 
At Visit 3, open follow-up questions should be asked to capture the subjects’ experience: 
- 
Which of the WL accessories did you use? 
- 
In what situations did you use the accessory(ies) 
- 
For how long time did you use them on average? 
- 
Experienced benefit or difficulty with the accessory(ies) 
 
For subjects using iPhone it will also be possible and encouraged to pair their iPhone to the 
Osia 2 SP and use the wireless features. This will enable the user to; change volume, 
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At Visit 3, open follow-up questions should be asked to capture the subjects’ experience: 
- 
Did you pair and use your iPhone together with the Osia 2 SP? 
- 
In what situations did you use the Osia 2 SP with the iPhone? 
- 
For how long time did you use the Osia 2 SP with the iPhone on average? 
- 
Experienced benefit or difficulty with the paired iPhone? 
6.9 
Subject’s overall preference 
For the Overall Objective, the subject shall at Visit 3 decide the preferred choice based on 
their subjective experience of the overall hearing performance together with the sound 
quality, aesthetics, comfort, and usability experience of the sound processors. 
• 
The subject should in relation to this final choice indicate what influenced his/her 
decision the most (several options possible):  
o Hearing performance 
o Sound quality 
o Aesthetic 
o Comfort and sound processor ease of use 
o Possibility to use Wireless accessories 
o Possibility of iPhone pairing 
o Other (free text) 
 
 
 

 
 
 
 
 
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6.10 Adverse event and device deficiencies 
6.10.1 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 electronic case report form (eCRF). 
A device deficiency that could have led to a Serious Adverse Event (SAE) should be 
reported immediately (see next section). 
6.10.2 Adverse Event (AE) and Serious Adverse Event (SAE) 
6.10.2.1 
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 
illness or injury or permanent impairment 
• 
to a body structure or a body function 
 
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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 
 
6.10.2.2 
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, starting from Visit 1 until Visit 3.  
Any adverse events observed will be fully investigated by the investigator and documented 
in the eCRF including assessment of seriousness, severity (mild, moderate or severe) and 
relationship to the medical device. 
6.10.2.3 
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: 
• 
AE that interferes with the daily use of the investigational 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 
6.10.2.4 
Handling and reporting of AESIs, SAEs and device deficiency that could 
have lead 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 via the eCRF to 
Cochlear Bone Anchored Solutions AB (Sponsor). If this is not possible the SAE report form 
should be send via email or fax to the Sponsor. Contact information is available on the paper 
version of the SAE form. 
6.10.3 Reporting to ethical committees and regulatory authorities 
SAEs/SADEs/USADEs and device deficiencies that could have led to a SAE should be 
reported to ethics committees and regulatory agencies in accordance with local 
requirements. 
6.11 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 eCRF. 

 
 
 
 
 
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7 FLOW CHART 
Procedures and timing  
Visit 1 
Visit 2/ 
Contact* 
Visit 3 
Day/Week/Month 
Day 0 
14 days 
6 weeks 
Time window 
 
± 5 days 
± 5 days 
Demographics 
X 
 
 
Medical history 
X 
 
 
Eligibility criteria 
X 
 
 
Audiogram 
X 
 
 
Baseline characteristics 
X 
 
 
Informed consent 
X 
 
 
Sound Processor Fitting 
 
Magnet choice 
X1 
X3 
 
Digital link calibration (DLC) 
X1 
X3 
 
Feedback measurement 
X1 
X3 
 
BC Direct 
X1 
X3 
 
Fine tuning1 
X1 
X3 
 
Randomised device test order 
 
 
X 
 
 
 
 
Thresholds audiometry, free-field 
 
 
X 
Speech recognition in noise 
 
 
X 
Speech recognition in quiet 
 
 
X 
APHAB 
X2 
 
X1 
SSQ 
X2 
 
X1 
QUEST 
X2 
 
X1 
Comfort and Specific usage: Comfort, magnet 
choice, battery life, SoftWear pad, Safety line  
X2 
 
X1 
Wireless accessories 
 
 
X1 
Subject´s overall preference 
 
 
X4 
 
 
 
 
Adverse events 
X 
X 
X 
Device deficiency  
X 
X 
X 
Concomitant treatment 
X 
X 
X 
Extra visit  
 
 
 
 
*Visit 2 is optional as a Visit. Can be done by contact via phone call 
1 Investigational device 
2 With Comparator 
3 As required, Investigational device 
4 Investigational Device vs Comparator 
 
 
 
 

 
 
 
 
 
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8 RISK AND BENEFITS OF THE INVESTIGATIONAL DEVICE(S) AND 
THE CLINICAL INVESTIGATION 
8.1 
Anticipated clinical benefits 
All subjects to be enrolled in this clinical investigation have previously been part of the 
CBAS5539 clinical investigation performed at the same clinic, as part of an international 
multicentre study. They have all ended and completed that clinical investigation and follow 
up is supposed to be performed according to normal clinical practice. Each patient was able 
to keep the sound processor (the comparator Osia SP) used in the previous clinical 
investigation according to approval by ethics committee. 
Taking part in this clinical investigation will not provide or mean any immediate or 
considerable clinical benefit compared to normal clinical practice except that the patients will 
get some extra follow up and attention for 6 weeks once the investigation has started.  
One outcome that could be seen as a considerable benefit taking part in this clinical 
investigation is that all subjects will receive an upgrade of the Osia sound processor during 
the clinical investigation. This upgrade, the Osia 2 SP, is technically more advanced, smaller 
and lighter. The Osia 2 SP will not yet be available for the market, which is beneficial for the 
subjects participating in the investigation. The participants will also be offered to keep the 
Osia 2 SP once the investigation is completed. 
8.2 
Anticipated adverse device effects 
The complaints received from subjects with this type of device may be related to magnetic 
retention issues of the sound processor. Considering that the Osia 2 SP is smaller and has 
less weight, the retention issue is judged as limited or absent. Skin irritation has not been 
reported so far for the precursor device, Osia SP, in the ongoing CBAS5539 clinical 
investigation. For Osia 2 SP no additional new risks are anticipated compared to the 
previous Osia SP, see Hazards Analysis Osia 2 Sound Processor 11. 
8.3 
Residual risks associated with the investigational device 
There are not residual risks associated with the Osia 2 SP. 
8.4 Risks associated with participation in the clinical investigation 
The Sponsor does not consider that there are any specific risks associated with participating 
in the clinical investigation, compared to the potential risks present in normal clinical 
practice. 
8.5 
Control and mitigation of risks 
Participating investigators are very experienced and have more than one year of experience 
from the Osia System, with the previous Osia SP and the OSI100 Implant. They also know 
their patients very well as they are not new patients. Each patient will be followed up for 
these 6 weeks and monitored for any adverse events.  
At the time of finalising this Clinical Investigation Plan, testing, validation and verification 
activities are completed, ongoing or to be initiated as specified in the Investigators Brochure 

 
 
 
 
 
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(IB) 12. Necessary activities to ensure safety and technical performance for study subjects 
will be completed and reported according to the IB before any study specific activities begin. 
8.6 
Risk-to-benefit assessment 
The risks have been judged acceptable when weighed against the benefits of the intended 
performance of the investigational device. 
8.7 
Safety Assessment 
The Sponsor will do the Safety Monitoring within the study team at Cochlear Bone Anchored 
Solutions and use a Medical Advisor as judged necessary.  The Medical Advisor is an 
independent ENT surgeon contracted for use by Cochlear for medical questions and advice. 
The Sponsor study team keeping the entire data of the safety situation of the device being 
tested, also based on the previous CBAS5539 study, will continuously review the reported 
events in this study. Once there are events reported that are outside what is normally 
reported and are related, possibly related or unexpected the responsible Study Lead 
contacts the independent Medical Advisor to ask for a judgment and opinion. This could lead 
to further contact with the reporting site to clarify or advise. By using and training the site of 
the term AESI, Adverse Event of Special Interest (section 6.10.2.3) the Sponsor also ensure 
that the site will report any specifically interesting or unusual events in the same way as 
Serious Adverse Event (within 24 hours). 
 

 
 
 
 
 
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9 STATISTICAL CONSIDERATION 
9.1 
Statistical design and general statistical methodology 
No formal statistical testing will be made between Osia 2 SP and Osia SP. The study is not 
dimensioned to present or test significances by groups/subgroups.  
All variables will be presented descriptively by Osia 2 SP and Osia SP where applicable. The 
change/difference between Osia 2 SP and Osia SP (with 95% confidence interval for the 
mean difference) will be calculated and presented.  
Continuous variables will be presented with mean, standard deviation, standard error of the 
mean, median, minimum, maximum and number and categorical variables with number and 
percentage. 
All measurements will be made on the Full analysis set except for the safety variables which 
will be presented for the Safety population. 
9.1.1 
Sample size calculation 
Only subjects who completed the CBAS5539 clinical investigation at the Melbourne site will 
be included in this clinical investigation. No sample size calculation is made. Up to 12 
subjects will be included. 
9.1.2 
Analysis sets – populations 
Full analysis set consist of all subjects attending the 6 weeks visit. Safety population consists 
of all subjects attending Visit 1. 
9.2 Overall objective analyses 
The results will be presented by Osia 2 SP and Osia SP and for the change/difference as 
described 9.1 Statistical design and general statistical methodology. 
9.3 
Safety analyses 
Adverse events, concomitant medication/treatment and device deficiency will be presented 
descriptively for the Osia 2 SP. 
9.4 
Interim analysis 
No interim analyses are planned to be performed. 
9.5 
Statistical Analysis Plan 
A statistical analysis plan (SAP) with detailed statistical analyses specified for all variables 
and time points will be written and signed before the database lock. 

 
 
 
 
 
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10 STATEMENT OF COMPLIANCE 
10.1 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. 
The investigation shall not begin until approval/favourable opinion from ethics committee has 
been obtained. 
10.2 Regulatory requirements for the conduct of the investigation 
This investigation involves a device that is not regulatory approved in the EU, (not received 
CE mark) nor is it approved by the Australian Authority, TGA. The clinical investigation is a 
single centre investigation only involving an Australian site, therefore the investigation does 
not need formal approval from regulatory authority TGA. But the investigation shall not begin 
until a notification has been acknowledged by the TGA. 
The investigation will be conducted in accordance with applicable local regulations, e.g. data 
protection legislation. 
10.3 Updates 
The appropriate ethics committee shall after initial approval of the investigation receive the 
following information: 
• 
Status reports and written summary of the investigation as required by the ethics 
committee 
• 
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 committee. 
10.4 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 practice (ISO 14155:2011)’. 

 
 
 
 
 
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11 ADMINISTRATIVE ASPECTS 
11.1 Training 
The Sponsor will organise an initiation visit during which 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 
performing the investigation at the site will be discussed and clarified with the investigator. 
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. 
11.2 Investigational data 
11.2.1 Case report form 
Data Collection will be done by using an electronic system (eCRF) for each subject in which 
information will be reported. Specific instructions on how to complete the eCRF will be 
provided to the investigator and other site staff. Completed eCRFs will be reviewed and 
signed by an investigator.  
11.2.2 Patient questionnaires 
As part of the investigational data the sponsor will gather information using patient 
questionnaires. These will be administrated separately from the eCRF but entered into the 
same database.  
11.2.3 Source data 
Source data is 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 complete the template ‘Origin of source data’ 
stipulating where source data should be recorded at the investigational site. 
11.2.4 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. 
11.3 Archiving 
The sponsor and principal investigator shall maintain the investigation documents as 
required by the applicable regulatory requirements. 

 
 
 
 
 
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11.4 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, return and disposal of the investigational devices, which shall include 
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 being used 
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 
11.5 Quality control 
11.5.1 Monitoring 
The sponsor will appoint a monitor that will visit sites during the investigation. The monitor 
will be appropriately trained and informed about the nature of the investigation, ISO 
14155:2011 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 eCRF. 
The monitor must have direct access to source data. 
11.5.2 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-14155:2011 
and applicable regulatory requirements. 
11.6 Clinical Investigation Plan 
11.6.1 CIP amendment 
Changes to this CIP must be described in an amendment that is signed by the sponsor and 
Principal investigator. Necessary approvals must have been obtained before the amendment 
can be implemented. 
11.6.2 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 

 
 
 
 
 
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subjects may proceed without prior approval of the sponsor and the EC. Such deviations 
shall be documented and reported to the sponsor and the EC as soon as possible. 
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 will be informed of any 
significant protocol deviations. 
11.7 Suspension or premature termination 
The sponsor may suspend or prematurely terminate the clinical investigation for significant 
and documented reasons. The Principal investigator may suspend or prematurely terminate 
participation in the clinical investigation at the investigation site for which he 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. 
 
11.8 Publication policy 
The result of this study 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 study 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. 
 
 
 

 
 
 
 
 
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11.9 Timetable 
First subject first visit  
Q1 2019 
Last subject first visit  
Q1 2019 
Last subject last visit 
Q2 2019 
11.10 Definition of end of investigation 
End of investigation is defined as “last subject last visit”. 

 
 
 
 
 
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12 BIBLIOGRAPHY 
1. CBAS5539, Clinical performance of a new implant system for bone conduction hearing 
2. Cox, RM. "Administration and application of the APHAB". Hearing Journal, 50(4): 32-48 
(1997)  
3. 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. Int J Audiol, 2013 
52(6): 409-12. 
4. Demers L, Weiss R, Ska, B. The Quebec User Evaluation of Satisfaction with Assistive 
Technology (QUEST 2.0): An overview and recent progress. J Tech Disab. 2002;14:101-
105. 
5. CBAS5477, 6 months Primary Analysis, Post-market clinical follow-up of a magnetic bone 
conduction implant (Cochlear Baha Attract System) 
6. Dawson et al., An Adaptive Australian Sentence Test In Noise.  EAR & HEARING, VOL. 
34, NO. 5, 592–600 
7. ISO 8253-1 2010, Acoustics — Audiometric test methods — Part 1: Pure-tone air and 
bone conduction audiometry 
8. 94491, Cochlear wireless phone clip user manual 
9. 95128, Cochlear Baha remote control 2 user manual 
10. P778452, Cochlear wireless mini microphone 2+ user manual 
11. D1115078, Hazard Analysis, Osia 2 Sound Processor 
12. D1503289, Investigators Brochure Osia 2 Sound processor