Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
Phase: NA
Conditions: Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
Sponsor: Cochlear

 
 
 
 
 
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Clinical Investigation Plan (CIP) 
 
Early experience of a new implant system for bone 
conduction hearing in the pediatric population. 
 
 
Protocol Number 
 
CAM5706 
Version 
 
 
CONFIDENTIAL DRAFT 
Date 
 
 
 
August 30, 2017 
 
Sponsor 
 
 
Cochlear Americas 
13059 E. Peakview Ave., 
Centennial, CO 80111 
USA 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL – DO NOT COPY 
This document contains information that is confidential and proprietary to Cochlear. 
This information is being provided to you solely for the purpose of evaluating or 
conducting a clinical study for Cochlear. You may disclose the contents of this 
document only to study personnel under your supervision who need to know the 
contents for this purpose and to your Ethics Committee; the contents of this 
document may not be disclosed without the prior authorization from Cochlear. The 
foregoing shall not apply to disclosure required by governmental regulations or laws. 
Any supplemental information that may be added to this document also is 
confidential and proprietary to Cochlear and must be kept in confidence in the same 
manner as the contents of this document. 

 
 
 
 
 
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INVESTIGATOR RESPONSIBILITIES 
I, the undersigned, am responsible for the conduct of the study at the site below and by 
my signature below, I confirm that I have read, understand, and will strictly adhere to the 
study protocol, “Early experience of a new implant system for bone conduction hearing in 
the pediatric population.” 
 
Clinical Investigational Site 
 
Primary Investigator’s Name (print) 
 
Title 
 
Signature 
 
Sponsor Representative 
 
Title 
 
Signature 

 
 
 
 
 
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INVESTIGATIONAL SITES 
Principal Investigator  
 
 
 
 
 
 
 
CLINICAL INVESTIGATION MANAGEMENT 
Study Manager 
 
 
 
  
 
 
 

 
 
 
 
 
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SYNOPSIS 
Name of Sponsor 
Cochlear Americas 
Protocol number 
CAM5706 
Investigational title 
Early experience of a new implant system for bone conduction 
hearing in the pediatric population. 
Design 
Open, prospective, single center clinical investigation.  
Investigational 
device(s) 
ATB System (Osseointegrated Steady State Implant System, 
commercially to be named Osia™ System). 
Aim for conducting the 
investigation 
The aim of the investigation is to collect safety information on 
children and adolescents implanted with the ATB System. 
Inclusion criteria 
Individuals 5 through 18 years of age who have: 
• 
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. 
• 
Subject does not benefit from or will not wear a 
conventional hearing aid 
 
Note: Candidates include individuals seeking new 
implantation unilaterally (in one ear) or bilaterally (both ears) 
as well as individuals already implanted with a bone-
anchored device seeking a second-side implant. 
OR 
• 
Single-sided sensorineural deafness and a candidate for 
Baha surgery. 
• 
Air conduction thresholds with a pure-tone average 
(PTA4; mean of 0.5, 1, 2, and 3 kHz) of ≤ 20 dB HL in 
the good ear. 
• 
. Subject does not benefit from or will not wear a 
conventional hearing aid. 

 
 
 
 
 
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Exclusion criteria 
• 
Uncontrolled diabetes as judged by the investigator.  
• 
Subject who has received radiotherapy in the area of 
implantation, or such radiotherapy is planned during the 
study period. 
• 
Current use of ototoxic drugs. 
• 
Condition that could jeopardize osseointegration and/or 
wound healing 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, as determined by the surgeon.  
• 
Unable to follow investigational procedures. 
• 
Participation in another clinical investigation with 
pharmaceutical and/or device. 
Number of subjects 
Up to 20 subjects 
Duration of subjects 
participation 
12 months 
Number of sites 
 1 

 
 
 
 
 
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OBJECTIVES AND OUTCOME MEASURES 
Primary objective 
Outcome measure  
To quantify the type and severity of 
adverse events in the pediatric population 
implanted with the Osia system. 
Information will be collected from visit 2 
through visit 7 of the trial. 
 
Secondary objectives 
Outcome measures 
To collect surgical information. 
• 
Soft tissue thickness  
• 
Soft tissue reduction performed 
• 
Type of anesthesia 
• 
Surgery time  
• 
Bone polishing/removal at the 
actuator site 
• 
BI300 Implant length  
• 
Location of BI300 Implant 
• 
Surgical incision type/location 
To collect information about daily use of 
sound processor (dependent on child’s 
ability to report). 
• 
Daily usage time 
• 
SoftWear Pad use 
• 
Choice of magnet strength 
To compare the self-reported 
assessments of hearing outcome with the 
Investigational device and in a 
preoperative hearing situation. 
• 
Speech, Spatial and Qualities of 
Hearing Scale -12 (SSQ-12) using 
the investigational device at 6 
months postoperatively vs. the 
unaided condition preoperatively. 
• 
For children unable to complete the 
SSQ-12: Speech Spatial 
Questionnaire for Parents using 
the investigational device at 6 
months postoperatively vs. the 
unaided condition preoperatively. 

 
 
 
 
 
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ANCILLARY OBJECTIVES AND MEASURES  
Ancillary measures are additional measures that will be captured only if the child is 
capable of completing or performing the evaluation as determined by the Investigator.  
Ancillary objective 
Outcome measures 
To compare unaided hearing 
performance to aided hearing 
performance using the investigational 
device. 
Audiometric:  
Free-field thresholds (PTA4; mean of 0.5, 
1, 2, and 4 kHz) using the investigational 
device at 6 months postoperatively vs. the 
unaided condition preoperatively. 
 
Speech Perception: 
Aided monosyllabic words in quiet (% 
correctly perceived words at 60 dB SPL) 
using the investigational device at 6 
months postoperatively vs. the unaided 
condition preoperatively. 

 
 
 
 
 
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STUDY TEST SCHEDULE 
Visit 
1 
Preop 
2 
Surgery 
3 
Post-op 
Follow 
Up 
4 
Fitting 
5 
6 
7 
Visit time point 
 
0 
2W 
4W 
3M 
6M 
12M 
Visit window 
 
 
± 5D 
± 1W 
± 2W 
± 3W 
± 4W 
Demographics 
X 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
Baseline characteristics 
X 
 
 
 
 
 
 
Eligibility criteria 
X 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
Soft tissue thickness 
 
X 
 
 
 
 
 
Surgery 
 
X 
 
 
 
 
 
IOTS 
 
X 
 
 
 
 
 
Post-op follow up 
 
 
X 
 
 
 
 
Sound processor fitting 
 
 
 
X 
 
 
 
Magnet choice 
 
 
 
X 
X 
X 
X 
 
Audiogram 
X 
 
 
X2 
X2 
X2 
X2 
Free-field thresholds1 
X 
 
 
X 
X 
X 
X 
Speech recognition1 
X 
 
 
X 
X 
X 
X 
Patient reported outcomes 
X 
 
 
 
 
X 
X 
Daily use 
 
 
 
 
X 
X 
X 
 
Device deficiency  
 
X 
X 
X 
X 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
Concomitant medication or 
treatment 
 
X 
X 
X 
X 
X 
X 
Extra visits 
As needed 
1 These measures are ancillary, dependent on the child’s capability to complete the tests. If captured, measures will take 
place in the unaided condition preoperatively and in the aided condition, using the investigational system, 
postoperatively. 
2 Bone conduction only. 

 
 
 
 
 
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Table of Contents 
Synopsis ............................................................................................................................................ 4 
Objectives and Outcome Measures .................................................................................................. 6 
Study Test Schedule ......................................................................................................................... 8 
1 
Introduction .............................................................................................................................. 14 
1.1 
Background ................................................................................................................... 14 
 
The Baha Systems .......................................................................................... 14 
 
The Osia System ............................................................................................. 14 
1.2 
Aim ................................................................................................................................ 16 
1.3 
Investigational device .................................................................................................... 16 
 
Description of the investigational device ......................................................... 16 
 
Manufacturer of investigational device(s) ....................................................... 19 
1.4 
Description of comparator ............................................................................................. 19 
1.5 
Blinding ......................................................................................................................... 19 
1.6 
Other devices used in the investigation, non-investigational ........................................ 19 
 
Surgical instruments ........................................................................................ 19 
 
Fitting Software (FS) ....................................................................................... 20 
 
Programming pod ............................................................................................ 20 
 
Intraoperative test system ............................................................................... 20 
1.7 
Treatment after the completion of the investigation ...................................................... 22 
2 
Subjects and Subject Protection ............................................................................................. 23 
2.1 
Selection of Subjects ..................................................................................................... 23 
 
Inclusion criteria .............................................................................................. 23 
 
Exclusion criteria ............................................................................................. 23 
2.2 
Number of subjects ....................................................................................................... 24 
2.3 
Duration of subject participation .................................................................................... 24 
2.4 
Subject enrolment and informed consent/assent .......................................................... 24 
2.5 
Subject Identification ..................................................................................................... 24 
2.6 
Randomization .............................................................................................................. 25 
2.7 
Completed Subjects ...................................................................................................... 25 
2.8 
Discontinued Subjects................................................................................................... 25 
2.9 
Premature Study Termination ....................................................................................... 26 
2.10 Replacement of subjects ............................................................................................... 26 
3 
Design of the clinical investigation .......................................................................................... 26 
3.1 
Justification for the design of the clinical investigation ................................................. 26 

 
 
 
 
 
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3.2 
Objectives and outcome measures ............................................................................... 27 
 
Ancillary Objectives and Measures ................................................................. 28 
4 
Procedures .............................................................................................................................. 28 
4.1 
Test equipment ............................................................................................................. 28 
4.2 
Demographics ............................................................................................................... 28 
4.3 
Medical history .............................................................................................................. 29 
4.4 
Baseline characteristics ................................................................................................ 29 
4.5 
Preoperative Audiometric Assessments ....................................................................... 29 
4.6 
Soft tissue thickness ..................................................................................................... 29 
4.7 
Surgery .......................................................................................................................... 30 
4.8 
Intraoperative Test system (IOTS) ................................................................................ 30 
4.9 
Sound Processor fitting ................................................................................................. 30 
4.10 Magnet choice ............................................................................................................... 31 
5 
Assessments ........................................................................................................................... 31 
5.1 
Postoperative Audiometric Assessment ....................................................................... 31 
5.2 
Speech, Spatial, and Qualities of Hearing Scale (SSQ-12 version) ............................. 31 
5.3 
Daily use ....................................................................................................................... 32 
5.4 
Ancillary Assessments .................................................................................................. 32 
 
Free-field thresholds ....................................................................................... 32 
 
 Speech recognition in quiet ............................................................................ 33 
6 
Adverse event and device deficiencies ................................................................................... 33 
6.1 
Device deficiency reporting ........................................................................................... 33 
6.2 
Adverse Events (AE) ..................................................................................................... 34 
 
Definitions ........................................................................................................ 34 
 
Adverse Events ............................................................................................... 35 
 
Adverse Events of Special Interest (Osia Clinical Study only) ........................ 35 
 
Clinically significant threshold shifts ................................................................ 35 
 
Serious Adverse Events .................................................................................. 35 
 
Unanticipated Adverse Device Effect .............................................................. 36 
 
Assessment and Reporting of Adverse Events ............................................... 36 
6.3 
Concomitant medication(s) and treatment(s) ................................................................ 37 
7 
Risk and benefits of the investigational device(s) and the clinical investigation ..................... 37 
7.1 
Anticipated clinical benefits ........................................................................................... 37 
7.2 
Anticipated adverse device effects ............................................................................... 38 
 
Osia Sound Processor .................................................................................... 38 
 
Receiver-stimulator (CI24RE) ......................................................................... 38 

 
 
 
 
 
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Codacs ............................................................................................................ 39 
 
BI300 Implant with the Baha Connect System ................................................ 39 
 
BI300 Implant with the Baha Attract System ................................................... 39 
7.3 
Risks associated with participation in the clinical investigation .................................... 39 
7.4 
Control and mitigation of risks ....................................................................................... 40 
7.5 
Risk-to-benefit assessment ........................................................................................... 40 
8 
Data Analysis .......................................................................................................................... 40 
9 
Statement of compliance ......................................................................................................... 41 
9.1 
Ethical requirements for the conduct of the investigation ............................................. 41 
9.2 
Regulatory requirements for the conduct of the investigation....................................... 41 
9.3 
Updates ......................................................................................................................... 41 
9.4 
Quality standards .......................................................................................................... 42 
10 Administrative Aspects ............................................................................................................ 42 
10.1 Training ......................................................................................................................... 42 
10.2 Investigational data ....................................................................................................... 42 
 
Case report form ............................................................................................. 42 
 
Source data ..................................................................................................... 42 
 
Data management........................................................................................... 42 
 
Record Keeping and Retention ....................................................................... 43 
 
Archiving ......................................................................................................... 44 
10.3 Device accountability .................................................................................................... 44 
10.4 Quality control ............................................................................................................... 45 
 
Monitoring ....................................................................................................... 45 
 
Audit ................................................................................................................ 45 
 
Sponsor Expertise ........................................................................................... 45 
10.5 Clinical Investigation Plan ............................................................................................. 45 
 
CIP amendment .............................................................................................. 45 
 
Deviations from Clinical Investigation Plan ..................................................... 45 
10.6 Suspension or premature termination ........................................................................... 46 
10.7 Publication policy .......................................................................................................... 46 
10.8 Timetable ...................................................................................................................... 46 
10.9 Definition of end of investigation ................................................................................... 46 
11 Bibliography ............................................................................................................................. 47 
12 Appendices .............................................................................................................................. 49 

 
 
 
 
 
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LIST OF APPENDICES 
Appendix 
Title 
1 
New ATB specific instruments and templates. 
2 
Other devices used in the investigation, non-investigational. 
 
ABBREVIATIONS 
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 
CI 
Cochlear Implants 
CIP 
Clinical Investigation Plan 
Codacs 
Cochlear® Direct Acoustic Cochlear Stimulator 
EC 
Ethic Committee 
eCRF 
Electronic Case Report Form  
FS 
Fitting Software 
IFU 
Instruction For Use 
IOTS 
Intraoperative Test System 
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 

 
 
 
 
 
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SSD 
Single-sided sensorineural deafness 
SSQ 
Speech, Spatial, and Qualities of Hearing Scale 
WHO 
World Health Organization 
PP 
Per Protocol 
USADE 
Unanticipated Serious Adverse Device Effect 
 

 
 
 
 
 
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1 INTRODUCTION 
1.1 Background 
 
The Baha System 
The Cochlear Baha bone conduction system 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 
whereas, the passive Baha Attract System uses a magnetic connection through intact 
skin.  
Magnetic conduction has the advantage over skin-penetrating systems of eliminating 
daily cleaning, reduction in reported adverse skin reactions of the implant site and has 
been perceived as more cosmetically appealing by potential candidates. The skin-
penetrating abutment of the traditional Baha System has been seen as a barrier for 
many candidates. The passive Baha Attract System incorporates both internal and 
external parts as illustrated in Figure 1. 
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 safe and effective through years of clinical use and data from clinical 
investigations 1, 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. 
 
The Osia System 
The Osia System (Osseointegrated Steady State Implant System) has been 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 Osia System will provide a more efficient transmission of sound, especially in the 
Figure 1: The passive Baha Attract System. 

 
 
 
 
 
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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 Osia 
System, it will also be possible to position the transducer closer to the ear canal, which 
may further improve audiological outcomes to include better speech perception.  
The Osia System is a bone-conduction hearing device that allows direct bone conduction 
through an implanted actuator on the osseointegrated BI300 Implant (Figure 2). 
The Osia 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 an electric analog 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 through the osseointegrated BI300 Implant (5). 
With the Osia 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 Osia System that combines aesthetics with higher performance to meet 
the needs of subjects with mixed hearing loss. The target fitting range is up to 55 
dB HL 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.  
Figure 2: The ATB System. 

 
 
 
 
 
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1.2 Aim 
The primary aim of the investigation is to collect preliminary safety and efficacy 
information on children and adolescents who present with conductive or mixed hearing 
loss or single-sided sensorineural deafness (SSD) and are implanted with the Osia 
System. 
1.3 Investigational device 
 
Description of the investigational device 
The Osia 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 Osia System has a fitting range of up to 55 dB HL 
SNHL, and shall be implanted and fitted unilaterally in this clinical investigation. 
  
 
The ATB System (Figure 3) consists of the following components: 
• 
Osia Sound Processor (SP) (1): The sound processor consists of an all-in-one 
off-the-ear processor that includes:  an active coil, magnet (with seven possible 
strengths), and two battery cells. The SP has identical hardware as the 
commercially approved Nucleus CP950 Sound Processor for cochlear implants, 
but with Osia specific firmware.  
 
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 that 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 Osia SP is 
found in the Osia Sound Processor User Manual 4. 
Figure 3: The ATB System parts. 1. Sound Processor, 2. 
Receiver, 3. Stimulator, 4. Actuator, 5. BI300 Implant, 6. Lead. 

 
 
 
 
 
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• 
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® 
system1 also use identical coil, magnet, and case. A magnet located at the center 
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 Osia specific electronics, which is powered by two batteries in the 
external sound processor. The receiver-stimulator is completely over-molded by a 
silicone coating. 
• 
Actuator (4): The 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 Osia Actuator are over-molded 
by a silicone coating (Figure 5). 
                                               
 
1 The CE-marked Codacs system refers to the Cochlear Direct Acoustic Stimulator, implant 
technology not commercially available in the U.S. 
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. 

 
 
 
 
 
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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 1.6.4. 
• 
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-
molded by a silicone coating. 
• 
BI300 Implant (5): The Osia 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 comes in two different lengths, 4mm and 
3 mm and is made of titanium. The surface is moderately roughened (TiOblast™) 
on its intraosseous parts.  
Table 1 lists the investigational device components used in this clinical investigation. 
Table 1: List of investigational device components. 
Name 
Description  
Part Number 
Osia™ Sound 
Processor 
Sandy Blonde 
Chocolate Brown 
Slate Grey 
Black 
P798644 – P798667 
Osia Implant 
Receiver-Stimulator 
Actuator 
Lead 
Z398787 
CP950 Magnets 
Strength from 0.5 – 6 
Z566412, Z502922, Z502923, 
Z502924, Z502925, Z566414, Z566415 
BI300 Implant 
4 mm, 3 mm 
92129, 92128 
Complete information for the ATB implant is found in the professional user guides 5, 6. 
Figure 5: The ATB Actuator. 

 
 
 
 
 
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Manufacturer of investigational device(s) 
Cochlear Limited, Sydney, Australia 
Osia™ Sound Processor 
ATB Implant 
CP950 Magnets 
Cochlear Bone Anchored Solutions AB 
BI300 Implant 
1.4 Description of comparator 
No comparator will be used in this clinical investigation. All patients will be their own 
control. 
1.5 Blinding 
No blinding will be used in this clinical investigation. 
1.6 Other devices used in the investigation, non-investigational 
 
Surgical instruments 
The surgical procedure for the Osia 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 Nucleus CI24RE 
cochlear implant. Hence, Osia 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 Osia System. Table 2 lists the recommended 
surgical instruments for Osia surgery. The Osia specific surgical instruments used to 
prepare the bone bed for the Osia 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 Osia Actuator compared to Baha Attract 
implant magnet (rectangular versus circular).  
Table 2: Osia surgical instruments. 
Instrument 
Description  
Part 
Number 
Osia specific 
Reusable Instruments 
Actuator Template 
P772551 
Clearance indicator 
P772552 
OSI100 Recess checking gauge 
P795943 
Osia specific Single 
Use Instruments 
OSI100 Single use kit (Sterile, 
single use) 
Includes: Guide Pin, OSI100 
template 
Z496667 
 
OSI100 template (Non sterile, 
single use) 
P794316 
 
 
 

 
 
 
 
 
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Instrument 
Description  
Part 
Number 
Cochlear Baha 
Reusable Instruments 
Screwdriver Unigrip 95mm  
90469 
Multi wrench with ISO adapter 
92143 
Machine Screwdriver Unigrip 25 
mm 
90381 
Implant inserter   
92142 
Drill indicator 
91116 
Soft tissue gauge 6 mm 
95070 
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 
 
More information about the new Osia specific instruments and templates are found in 
Appendix 1. Complete information for the Osia surgical instruments is found in the 
professional guides 5, 6. Also, see Appendix 2 for a list non-investigational instruments, 
and supportive items. 
 
Fitting Software (FS) 
The investigator shall use the Osia Fitting Software (OFS) to configure the operational 
features of the Osia Sound Processor for each subject at visit 4. Communication 
between the fitting software and the sound processor is achieved using a 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. 
The fitting software for the Osia Sound Processor is built on and has the equivalent 
graphical user interface and features as the current regulatory approved Baha Fitting 
Software (BFS). Complete information is found in the user guides 7, 8. 
 
Programming pod  
The Programming Pod, approved and used for Cochlear’s CI products, will be used as it 
is with the Osia System. The programming pod provides a connection between the 
programming computer and the Osia Sound Processor via a USB cable and a 
programming shoe with cable as well as an adaptor cable kit and two batteries. 
 
Intraoperative test system 
An intraoperative test system (IOTS) will be available to confirm device integrity at the 
time of implantation. An intraoperative test system is available and in use for Cochlear 
Implants (CI) and Codacs to verify the functionality. For the Osia System, the IOTS will 

 
 
 
 
 
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evaluate any potential damage 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 just before the actuator is mounted onto the BI300 Implant. The IOTS 
functions by measuring the 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, 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 6)). The test also relies on 
the use of a custom silicone Isolator to provide mechanical isolation for the actuator 
during the test (Figure 7). 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 
1. Adapter cable. 
2. Battery retention clip. 
3. Clothing clip. 
Figure 6: Intraoperative Test System (IOTS) concept. 

 
 
 
 
 
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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. 
1.6.4.1 
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  
• 
Programming Pod 
• 
Osia Intraoperative Test Software  
• 
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 
1.7 Treatment after the completion of the investigation 
After the clinical investigation, the subjects will be able to continue with their 
investigational device (Osia 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 Osia Implant is expected to have a lifetime of at least 10 years. Any changes to the 
implant during or after this time-period should be performed according to the implant 
revision/replacement procedure described in the professional guide 5.  
Figure 7: ATB Implant, with actuator pre-mounted onto the Isolator. 

 
 
 
 
 
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Future upgrades of the Osia Sound Processor, used together with the implant in this 
clinical investigation, may be possible. 
2 SUBJECTS AND SUBJECT PROTECTION 
2.1 Selection of Subjects 
 
Inclusion criteria 
Individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all 
of the criteria below are met: 
• 
Conductive or mixed hearing loss in the ear to be implanted. 
o Bone conduction thresholds with pure-tone average (PTA4; mean of 0.5, 
1, 2, and 4 kHz) of ≤ 55 dB HL. 
• 
Subject does not benefit from or will not wear a conventional hearing aid. 
Note: Candidates may include individuals seeking new implantation unilaterally (in one 
ear) or bilaterally (both ears) as well as individuals already implanted with a bone-
anchored device seeking a second-side implant. 
OR 
• 
Single-sided sensorineural deafness who is a candidate for Baha surgery. 
o Air conduction thresholds with a pure-tone average (PTA4; mean of 0.5, 
1, 2, and 3 kHz) of ≤ 20 dB HL in the good ear. 
• 
Subject does not benefit from or will not wear a conventional hearing aid. 
 
Exclusion criteria 
• 
Uncontrolled diabetes as judged by the investigator.  
• 
Subject who has received radiotherapy in the area of implantation, or such 
radiotherapy is planned during the study period. 
• 
Current use of ototoxic drugs. 
• 
Condition that could jeopardize osseointegration and/or wound healing 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, as 
determined by the surgeon.  
• 
Unable to follow investigational procedures. 
• 
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2.2 Number of subjects 
Up to 20 subjects will be recruited for this study at 1 investigational site. 
2.3 Duration of subject participation 
Subjects will participate in a 12-month protocol in total. 
2.4 Subject enrolment and informed consent/assent 
As part of the informed consent and/or assent process, an investigator must explain the 
following to the potential investigational subject and/or the parent or legal guardian: 
• 
The rationale, aims, and objectives of the investigation. 
• 
Risks and benefits. 
• 
Alternative treatments. 
• 
Extent of the subject’s involvement. 
• 
That the subject can withdraw from the study at any time. 
• 
That the confidentiality of patient data will be maintained at all times. 
• 
That the subject and/or parent/legal guardian will be informed if new information 
becomes available that may be relevant to continued, willing participation in the 
trial. 
The subject and/or parent/legal guardian must be provided the opportunity to ask any 
questions he/she/they might have. Signed and dated informed consent and/or assent 
must be obtained before any investigational procedure can be performed. A copy of the 
Informed Consent/Assent Forms shall be given to the subject and parent/legal guardian, 
when applicable.  
The Sponsor and the Investigator(s) shall avoid improper influence on or inducement of 
the subject, monitor, the Investigator(s), or other parties participating in or contributing to 
the clinical investigation. 
2.5 Subject Identification 
To maintain confidentiality, the subject’s name will not be recorded on any study 
document other than the informed consent form.  All individuals who provide informed 
consent (sign the informed consent form) are considered consented into the study and 
will be assigned a unique identifier.  A unique alphanumeric code will identify the subject 
throughout the course of the study. For example, CA01-OSI-0000, where: 
• 
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• 
01 = a sequential numeral corresponding the order in which a subject is enrolled 
into the study for a given study site, in this case this would correspond to the first 
subject recruited into the study for a particular site, 
• 
OSI = an abbreviation for the study,  
• 
0000 = a unique, numeric study site identification. 
2.6 Randomization 
This is an open study with no comparator device. Randomization is not possible. 
2.7 Completed Subjects 
Each subject in the study will be considered completed when all assessments through 12 
months postactivation have been performed in accordance with the study protocol.  To 
be considered a primary endpoint success, subjects must retain their originally implanted 
device through the 6 month visit. 
2.8 Discontinued Subjects 
Any subject may voluntarily discontinue the study at any time without prejudice. The 
Investigator may discontinue a subject from the study at any time if (s)he considers that 
remaining in the study compromises the subject’s health or the subject is not sufficiently 
cooperative. In either event, reason(s) for discontinuation should be recorded on a study 
withdrawal form, provided as part of the CRFs for the study.  
Possible reasons for study discontinuation include the following: 
 
AE necessitating discontinuation from the study. 
 
The subject is lost to follow-up. 
 
Voluntary decision to withdraw consent made by the subject2. 
 
Investigator decision3. 
 
Other reason. 
In case of a subject lost-to-follow-up, the Investigator must attempt to contact the subject 
(or relative/family contact) by phone, email or letter at least three times. If attempts are 
unsuccessful, the ‘subject withdrawal’ form is to be completed in the study file and 
reported, as appropriate, in required reports to the Sponsor, Ethics and Health Canada. 
                                               
 
2 Withdrawal of consent is defined as the subject’s voluntary decision to revoke consent to 
continue participation in the study. 
3 Subject withdrawal from the study is defined as an Investigator decision. The Investigator may 
elect to withdraw a subject from the study at any time if he/she considers that remaining in the 
study compromises the patient’s health or if the Investigator considers the subject lost to follow-
up. 
 

 
 
 
 
 
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2.9 Premature Study Termination 
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. 
• 
The may be other reasons 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. 
2.10 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 up to 20 evaluable 
subjects. 
3 DESIGN OF THE CLINICAL INVESTIGATION 
This clinical investigation is an open, prospective, single center clinical investigation with 
a duration of 12 months. Performance for each subject at 6 months postoperative will be 
compared to his/her own preoperative unaided hearing situation. 
3.1 Justification for the design of the clinical investigation 
The primary intent for this study involves the collection of preliminary safety and efficacy 
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3.2 Objectives and outcome measures  
Primary objective 
Outcome measure  
To quantify the type and severity of 
adverse events in the pediatric population 
implanted with the Osia system. 
Information will be collected from visit 2 
through visit 7 of the trial.  
 
Secondary objectives 
Outcome measures 
To collect surgical information. 
• 
Soft tissue thickness  
• 
Soft tissue reduction performed 
• 
Type of anesthesia 
• 
Surgery time  
• 
Bone polishing/removal at the 
actuator site 
• 
BI300 Implant length  
• 
Location of BI300 Implant 
• 
Surgical incision type/location 
To collect information about daily use of 
sound processor (dependent on child’s 
ability to report). 
• 
Daily usage time 
• 
SoftWear Pad use 
• 
Choice of magnet strength 
To compare the self-reported 
assessments of hearing outcome with the 
investigational device and in a 
preoperative hearing situation. 
• 
Speech, Spatial and Qualities of 
Hearing Scale -12 (SSQ-12) using 
the investigational device at 6 
months postoperatively vs. the 
unaided condition preoperatively. 
• 
For children unable to complete the 
SSQ-12: Speech Spatial 
Questionnaire for Parents using 
the investigational device at 6 
months postoperatively vs. the 
unaided condition preoperatively. 
 

 
 
 
 
 
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Ancillary Objectives and Measures  
Ancillary measures are additional measures that will be captured only if the child is 
capable of completing or performing the evaluation as determined by the Investigator.  
Ancillary objective 
Outcome measures 
To compare unaided hearing 
performance preoperatively to aided 
hearing performance using the 
investigational device postoperatively 
Audiometric:  
Free-field thresholds (PTA4; mean of 0.5, 
1, 2, and 4 kHz) using the investigational 
device at 6 months postoperatively vs. the 
unaided condition preoperatively. 
 
Speech Perception: 
Aided monosyllabic words in quiet (% 
correctly perceived words at 60 dBA) 
using the investigational device at 6 
months postoperatively vs. the unaided 
condition preoperatively. 
4 PROCEDURES 
Procedures performed during the clinical investigation are outlined in the flow chart, 
under Study Test Schedule. 
4.1 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 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. 
4.2 Demographics 
The following demographic data will be recorded at visit 1: 
• 
Age collected as date of birth (month and year).  
• 
Gender.  
• 
Ethnicity.  
• 
Nicotine use, if applicable. 
 
 

 
 
 
 
 
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4.3 Medical history 
The following information will be recorded at visit 1:  
• 
Relevant medical and surgical treatment as judged by the investigator. 
• 
Current concomitant medication and treatments. 
4.4 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). 
• 
Etiology: (chronic) infection, tumor, trauma, otosclerosis, unknown. 
• 
Current hearing aid (yes/no, specify model, side and years of hearing aid use, 
reason for change). 
• 
Previous experience from amplified sound through a non-surgical solution 
(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). 
4.5 Preoperative Audiometric Assessments 
Preoperative 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 is acceptable, as long as it has been completed during the last 6 
months, and contains all the required frequencies (minimally air and bone conduction at 
500, 1000, 2000, and 4000 Hz) per protocol. The subject’s pre-operative PTA4 (pure-
tone average of 500, 1000, 2000, and 4000 Hz) should be computed and recorded to 
ensure the subject meets the inclusion criteria. 
If an audiogram is older than 6 months and/or does not contain required frequencies, an 
entirely new audiogram should be performed at visit 1. Contralateral masking should be 
used, if needed, according to local practice. The hearing care professional shall always 
record the unmasked threshold and record the masked threshold, if applicable.  
4.6 Soft tissue thickness 
At visit 2 (start of surgery) soft tissue thickness should be measured. For the Osia 
System, the skin thickness should not exceed 6 mm to ensure optimal retention and 

 
 
 
 
 
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system performance. The measurement should be performed in the center of the marked 
coil position. For complete instruction, see the surgery guide 5.  
4.7 Surgery 
The surgery is performed at visit 2. 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 guide 5. 
During surgery, the following variables should be collected: 
• 
Surgery time (time between first incision and last suture). 
• 
Bone polishing/removal at the actuator site (yes/no). 
• 
BI300 Implant length (3 mm/4 mm). 
• 
Location of BI300 Implant (mm from the ear channel). 
• 
Type of anesthesia (general/local/conscious sedation). 
• 
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. 
4.8 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 use 10. The 
software used for the IOTS is installed on a laptop provided by the Sponsor. The 
software collects data from the transducer of the implant and will assist understanding of 
the behavior and performance of the transducer once implanted on a recipient. IOTS 
data will be saved on the laptop until study is ended when it will be transferred to the 
Sponsor in a coded way. 
4.9 Sound Processor fitting 
The Osia Fitting Software 7 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. The fitting software will be installed on a laptop provided by the Sponsor, and 
the fitting-data will be saved on the laptop until study is ended when it will be transferred 
to the Sponsor in a coded way. 

 
 
 
 
 
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4.10 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 use 5 should be followed. It is 
important that the strength is not too weak or too strong. There are 7 different strengths, 
ranging from ½ to 6. During the following visits, the choice of sound processor magnet 
should be checked. There may be a need to decrease or increase the strength 
depending on subject preference. 
5 ASSESSMENTS 
Assessments, including ancillary measures that will be performed during the clinical 
investigation are shown in the flow chart, under Study Test Schedule. 
During the assessments with the study device, the signal processing of the sound 
processors will be harmonized according to given instructions given in the CRF. This will 
also be included in the staff training at each participating center during the site initiations.    
5.1 Postoperative Audiometric Assessment 
Bone conduction thresholds for the study ear will be monitored, to characterize observed 
unaided thresholds postoperatively. Appropriate masking should be used, if needed, 
according to local practice. Recognizing that a pediatric subject may not be able to 
complete measures at all frequencies, minimally thresholds at 500, 1000, 2000, and 
4000Hz need to be captured for the study ear. 
5.2 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 the standard SSQ 12. 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-12 questionnaire at visits 1, 6, and 7. 

 
 
 
 
 
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• 
At visit 1, the subjects shall complete the SSQ-12 questionnaire prior to testing 
and shall be answered with respect to an unaided hearing situation, even for 
subjects with a previous hearing device. 
• 
At visits 6 and 7, the subjects shall complete the questionnaire for the aided 
situation (with the investigational device). 
In the event the subject cannot self-report on the SSQ-12, the SSQ for Parents will be 
deployed. 
5.3 Daily use 
During the clinical investigation, data regarding daily use of the sound processor will be 
collected. 
• 
Average hours of daily use (hours/day) during the last month before visits 5-7. 
• 
SoftWear Pad use (Yes/No) and frequency of change. The number of times the 
subject changed the SoftWear Pad between study visits. 
5.4 Ancillary Assessments 
The following measures are ancillary, dependent on the child’s capability to complete the 
tests. If captured, measures will take place in the unaided condition preoperatively, at 
visit 1, and in the aided condition, using the Osia system, postoperatively. 
 
Free-field thresholds 
The purpose of this assessment is to establish hearing thresholds in the free-field 
through a speaker in the front position (0° azimuth) according to the so-called ascending 
or modified Hughson-Westlake method (Figure 8). The test shall be performed with the 
non-test ear blocked (in the case of normal or near-normal hearing, or a large asymmetry 
with the non-test ear having significantly better hearing thresholds). The signal to be 
used should be narrow-band noise. Recognizing that a pediatric subject may not be able 
to complete measures at all frequencies, minimally thresholds at 500, 1000, 2000, and 
4000Hz need to be captured. 
 

 
 
 
 
 
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 Speech recognition in quiet 
The purpose of this assessment is to establish the test subject’s monosyllabic word 
recognition in quiet. The test shall be performed at 60 dB SPL using words presented in 
the free-field through a speaker located in front of the listener, at 0° azimuth (Figure 8). 
Scores shall be recorded as the percentage of words correctly identified. The test shall 
be performed with the non-test ear blocked (in cases of normal or near-normal hearing or 
a large asymmetry with the non-test ear having significantly better hearing thresholds). 
6 ADVERSE EVENT AND DEVICE DEFICIENCIES 
6.1 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). 
 
Figure 8: Free-field front speaker position. 
BACK 
Signal 
FRONT 

 
 
 
 
 
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6.2 Adverse Events (AE)  
 
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 the 
Sponsor 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. 
c. A life-threatening illness or injury. 
d. A permanent impairment of a body structure or a 
body function. 
e. Led to unplanned in-patient or prolonged 
hospitalization. 
f. Medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment 
to a body structure or a body function. 
g. Led to fetal distress, fetal 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. 
 

 
 
 
 
 
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Adverse Events 
An Adverse Event is the development of an untoward medical occurrence or the 
deterioration of a pre-existing medical condition following or during exposure to an 
investigational product, whether or not considered causally related to the product or the 
surgical procedure to implant it. An untoward medical condition can be symptoms (e.g., 
nausea), signs (e.g., tachycardia, fever) or clinically significant abnormal results of an 
investigation (e.g., laboratory findings, chest x-ray). 
Adverse events that occur during this study may be associated with the implant 
procedure, including adverse effects from general anesthesia, or specifically associated 
with the use of the device. An adverse event will be considered to be device-related 
when, in the judgment of the Primary Investigator, there is a logical connection between 
the use of the device and the occurrence of the event, above and beyond the study 
procedure itself. 
 
Adverse Events of Special Interest (Osia Clinical Study only) 
The following AEs are defined as adverse events of special interest (AESIs) and should 
be reported as soon as possible:  
• 
AE that interferes 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. 
 
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. 
 
Serious Adverse Events 
A Serious Adverse Event (SAE) is any untoward medical occurrence which: 
 
Results in death; 
 
Is life-threatening; 
 
Requires in-patient hospitalization for > 24 hours or prolongation of hospitalization 
which is not specifically required by the protocol; 
 
Results in permanent impairment of a body function or permanent damage to a body 
structure; or 
 
Requires medical or surgical intervention to preclude permanent impairment of a 
body function or permanent damage to a body structure. 

 
 
 
 
 
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Unanticipated Adverse Device Effect 
An unanticipated adverse device effect (UADE) is “any serious adverse effect on health 
or safety or any life-threatening problem or death caused by, or associated with, a 
device, if that effect, problem, or death was not previously identified in nature, severity, 
or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects” [FDA 21 
CFR 812.3(s)].  The Sponsor will promptly conduct an investigation upon notification by 
an Investigator of a UADE. The competent authority, all reviewing Ethic Committees and 
participating Investigators will be notified within 10 working days after the sponsor first 
receives notice of the effect. Thereafter, the Sponsor will submit such additional reports 
concerning the effect as requested. 
For the purposes of this study, only unanticipated adverse device effects will be reported 
promptly following occurrence.  Annual progress reports will contain information 
regarding SAE/AE occurrences. 
 
Assessment and Reporting of Adverse Events 
6.2.7.1 
Investigator’s Responsibilities 
Throughout the course of the study, all efforts will be made by the Investigators to remain 
alert to possible AEs. The first concern will be the safety and welfare of the subject and 
for providing appropriate medical intervention, as indicated. Detailed information 
regarding adverse events (AEs) will be recorded by the Investigator at the time an 
adverse event occurs using CRFs for the study. All adverse events will be recorded from 
the day of enrollment (Day 0) to termination of study, approval of the product, or when 
the subject exits the study, whichever is the last, even if the event was acknowledged as 
a risk factor in the Informed Consent Form. 
AEs will be recorded on the CRF will include the following information: 
 
Date of onset 
 
Date reported to the clinic 
 
Description of the AE 
 
Seriousness 
 
Investigator’s assessment of the relationship of the AE to the device and/or 
procedure 
 
Treatment 
 
Outcome 
6.2.7.1.1 
Adverse Event Follow-up 
All AEs must be followed until resolution, or the condition stabilizes. The Investigator is 
responsible to ensure that follow-up includes any supplemental investigations as may be 
indicated to elucidate as completely as possible the nature and/or causality of the AE. 
This may include additional laboratory tests or investigations, or consultation with other 
health care professionals. Cochlear or its designee may request that the Investigator 
perform or arrange for the conduct of supplemental measurements and/or evaluations. 
AE follow up information will be recorded using the CRFs for the study. 

 
 
 
 
 
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6.2.7.2 
Sponsor’s Responsibilities 
All AEs will be reported annually to competent authorities in accordance with local 
regulations. All unanticipated adverse device effects (UADEs) will be reported within 10 
calendar days of the event.  Cochlear Americas or its designee will notify all participating 
Investigators of any new information that alters the current risk-benefit assessment of the 
study device or that would be sufficient to consider changes in management of the 
Nucleus cochlear implant or in the overall conduct of the trial. 
6.3 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 surgery should not be recorded in the CRF. 
7 RISK AND BENEFITS OF THE INVESTIGATIONAL DEVICE(S) AND 
THE CLINICAL INVESTIGATION 
7.1 Anticipated clinical benefits 
The Osia 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 Osia System may provide additional advantages as it combines benefits 
from both a percutaneous (skin-penetrating) and transcutaneous Baha system. 
The Osia 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 Osia 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, it is 
expected that efficiency of sound transmission will be on a par with a percutaneous 
system. 
The Osia System provides the cosmetic benefits of a transcutaneous system, such as 
the Baha Attract System. A percutaneous implant is often seen as a barrier and is 
rejected by candidates due to cosmetic concerns. A transcutaneous system, without an 
abutment protruding through the skin, may be perceived as a more aesthetic option. 
The  Osia System, like the Baha Attract System, may significantly reduce the risk of 
implant site infections, and eliminate the need for daily maintenance care. For the 
transcutaneous Baha Attract System and Osia 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 
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The Osia System may 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 reports 13, 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. 
7.2 Anticipated adverse device effects 
Just like any surgical treatment, Osia surgery is not free of risks. Risks associated with 
the implantation and use of the Osia System cannot be completely eliminated. General 
risks associated with surgery under general or local anesthesia 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 the Osia 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]. 
Postmarket surveillance information is collected and those findings relevant for the Osia 
System is presented below: 
 
Osia Sound Processor 
The Osia SP has identical hardware as the CP950 Sound Processor for Cochlear 
Implants, but with Osia 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 possible but not reported as a serious problem and often solved by adjusting the 
magnet strength. Potential skin irritation problems will be managed by a combination of 
adjustment of magnet strength and/or use of the Softwear Pad.  
 
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 the 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. 

 
 
 
 
 
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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. 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 Implants 16. 
 
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. 
 
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 Osia 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 threshold 14. 
 
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 strength.  
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. 
7.3 Risks associated with participation in the clinical 
investigation 
Risks associated with participation in this study are anticipated to be similar for a child in 
relation to the adult population. The investigational device incorporates several 
components from already FDA and Health Canada approved products. There is no 
guarantee that the Osia Implant will not cause any adverse device events. The Osia 
Implant is expected to have a lifetime of about 10 years. As with any new surgical 
product and medical device, there is a risk that Unanticipated Adverse Event 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 

 
 
 
 
 
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scenario, the patient would need a revision surgery to remove the Osia Implant. The 
subject will then end participation in the clinical investigation and follow normal clinical 
care and follow-up. 
7.4 Control and mitigation of risks 
The surgical procedure is described in the surgery guide for the Osia 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 during the surgical validation activity. 
Before the enrollment of the clinical investigation site, each participating investigator will 
have completed surgical training using the Osia device according to the surgery guide.   
MRI examinations may be performed safely with this implanted device 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 Osia 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 Osia 
System will be positioned are excluded from the investigation.  
7.5 Risk-to-benefit assessment 
The risks have been judged acceptable when weighed against the benefits of the 
intended performance of the investigational device. 
8 DATA ANALYSIS 
All subjects who are consented into the clinical study will constitute the intention-to-treat 
(ITT) population for the purposes of safety evaluation. Only subjects implanted with the 
Osia implant will be considered as the completed cases (CC) population and per protocol 
(PP). 
Since the primary intent of this study is to provide preliminary safety and efficacy 
information, no formal hypotheses or sample size estimates were derived for this study. 
Demographic and outcomes data for primary, secondary, and ancillary objectives will be 
tabulated individually along with group summary descriptive statistics where relevant. 

 
 
 
 
 
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9 STATEMENT OF COMPLIANCE 
9.1 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/favorable opinion from ethics committee 
(EC) and institutional review board (IRB) has been obtained. 
9.2 Regulatory requirements for the conduct of the 
investigation 
The investigation involves devices that are not regulatory approved in the EU, Canada or 
US, (not received CE mark or 510k clearance/PMA approval), therefore the investigation 
needs approval from the appropriate regulatory authorities.  
The investigation shall not begin until approval/favorable opinion from the regulatory 
authorities has been obtained. 
The investigation will be conducted in accordance with applicable local regulations, e.g., 
data protection legislation. 
9.3 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, and competent authorities. 

 
 
 
 
 
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9.4 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 19.’  
10 ADMINISTRATIVE ASPECTS 
10.1 Training 
The Sponsor will organize a Site Initiation and Training 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.  
10.2 Investigational data 
 Case report form 
Data collection will be done using a combination of paper case report forms (CRFs) and 
electronic data capture (EDC) system.  Specific training and instruction on how to 
complete the CRFs and enter the data into the EDC will be provided to the investigator 
and other site staff according to the delegation log. Upon request by the investigator, the 
Sponsor may transfer data collected on the paper CRF by the investigational site to the 
EDC under special circumstances such as during EDC maintenance or system updates. 
Completed eCRFs within the EDC will be reviewed and signed off by an investigator 
prior to the completion of the trial.  
 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. 
 Data management 
All study data will be entered into an Electronic Database Capture (EDC) system. Study 
personnel requiring access will have their own Login/Password. Access to clinical study 
information will be based on an individual’s role and responsibilities.  The application 

 
 
 
 
 
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provides hierarchical user permission for data entry, viewing, and reporting options. For 
optimum security, all communications between the users and the EDC operate on a 
secured socket layer (SSL) using 256-bit encryption. The web servers are protected by a 
managed firewall from potential web and network attacks and the network is guarded by 
an intrusion detection and protection surveillance system against malicious threats. 
This application is designed to be in full compliance with International Conference on 
Harmonization and Good Clinical Practices (ICH-GCP), FDA CFR 21 Part 11 Electronic 
Record and Electronic Signatures, the FDA's “Guidance: Computerized Systems Used in 
Clinical Trials (May 2007), and the Privacy Rule of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA).” 
As part of the data entry and validation process, the data stored in the EDC is checked 
against the source data, and also against edit check queries to confirm that the data 
received is within expected ranges. If any data is missing or is outside of expected limits, 
a query is created and sent to the site coordinator so that data may be verified and 
corrected. All changes made to a form are stored in an audit trail. 
 Record Keeping and Retention 
Data generated for the study should be stored in a limited-access file area and be 
accessible only to representatives of the study site, the Sponsor and its representatives, 
and FDA/relevant health authorities/regulatory agencies. All reports and communications 
relating to study subjects will identify subjects only by subject unique identification code. 
Complete subject identification will be kept by the Investigator. This information will be 
treated with strict adherence to professional standards of confidentiality. 
An Investigator must in reasonable time, upon request from any properly authorized 
officer or employee of FDA/relevant health authority or regulatory agency, permit such 
officer or employee to have access to requested records and reports, and copy and 
verify any records or reports made by the Investigator. Upon notification of a visit by a 
regulatory authority, the Investigator will contact the Sponsor or its designee 
immediately. The Investigator will also grant Sponsor representatives the same 
privileges offered to relevant health authority or regulatory agents/officers/employees. 
The Investigator must provide the Sponsor or its designee with the following documents 
at the time of site qualification and prior to study initiation and retain a copy in the site 
study file: 
 
Signed and dated curriculum vitae for the Principal Investigator. 
 
A copy of the original approval for conducting the study by the Ethics Committee. 
Renewals, with continuance of the study, must be submitted at yearly intervals or 
as required by policy and a copy of the approved and dated renewal provided to 
the Sponsor. 
 
A copy of the approved informed consent form along with any modifications 
initiated by the Sponsor over the course of the study. 
 
An Ethics member list and Federal Wide Assurance (FWA) Number. 

 
 
 
 
 
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 
A signed Financial Disclosure Form for each Investigator. 
 
An Investigator Agreement for this protocol signed and dated by each 
Investigator. 
In addition to the documents listed above, the study site will also retain the following 
items and make them available for Sponsor review upon request.   
 
Certifications, applicable study equipment (audiometers, etc.) calibration records 
and laboratory reference ranges for all local laboratories used for this study. The 
Sponsor will verify all equipment requirements at the study qualification and/or 
initiation. Sites with outdated and/or non-compliant equipment will either not be 
approved for study participation or will be advised to discontinue study-related 
activities should non-compliance be noted during regular study monitoring visits. 
 
All original informed consent forms with required signatures. 
 
All Ethics correspondence (i.e., informed consent [including any approved 
revisions], protocol, AEs, advertisements, newsletters). 
 
Copy of the Study Monitoring Log Sheet. 
 
Clinical and non-clinical supply shipment forms and device accountability logs. 
 
Copies of all correspondence pertaining to the study between Sponsor and the 
site. 
 
Copies of all SAEs reports submitted to the Sponsor. 
 
Copies of all Health Canada progress reports submitted to the site by the 
Sponsor. 
 
Site Delegation Signature Log. 
 Archiving  
All study-related records must be maintained for at least 2 years after a marketing 
application (PMA) is approved for the study device; or if the application is not approved, 
until at least 2 years after shipment and delivery of the last device for investigational use 
is discontinued and FDA/health authorities or regulatory agencies have been notified of 
study closure. The Sponsor will notify the principal Investigator when records are no 
longer needed. The Investigator will not discard any records without notifying the 
Sponsor. If the Principal Investigator moves from the current investigational site, the 
Sponsor should be notified of the name of the person who will assume responsibility for 
maintenance of the records at the investigational site or the new address at which the 
records will be stored. The Investigator will notify the Sponsor as soon as possible in the 
event of accidental loss or destruction of any study documentation. 
10.3 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: 

 
 
 
 
 
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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. 
10.4 Quality control 
 Monitoring 
The Sponsor will ensure that the monitor will be appropriately trained and informed about 
the nature of the investigation. 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 subjects, 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. 
 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 
standard 19 and applicable regulatory requirements. 
 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. 
10.5 Clinical Investigation Plan 
 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. 
 Deviations from Clinical Investigation Plan 
A deviation refers to a study-related activity that is not in compliance with the 
investigational protocol.  Investigators are not allowed to deviate from the CIP unless 

 
 
 
 
 
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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. 
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 analyzing them and 
assessing their significance. The appropriate ethics committee and institutional review 
board and regulatory authorities will be informed of any significant protocol deviations. 
10.6 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. 
10.7 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. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov. 
10.8 Timetable 
First subject first visit  
Q3 2017 
Last subject first visit  
Q4 2017 
Last subject last visit 
Q4 2018 
10.9   Definition of end of investigation 
End of investigation is defined as ‘last subject last visit.’ 

 
 
 
 
 
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11 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 Sterilization 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. 

 
 
 
 
 
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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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12 APPENDICES 
APPENDIX 1: NEW OSIA SPECIFIC INSTRUMENTS AND 
TEMPLATES 
 
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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APPENDIX 2: OTHER DEVICES USED IN THE INVESTIGATION, 
NON-INVESTIGATIONAL  
 
 
Product 
Article name  
Sterile/  
non-
sterile 
Single/  
reusable 
Regulatory 
approved 
 
Surgical tools  
90469 
Screwdriver Unigrip 95 mm  
Non 
sterile 
Reusable 
Yes 
92143 
Multi wrench with ISO adapter 
Non 
sterile 
Reusable 
Yes 
90381 
Machine Screwdriver Unigrip 25 
mm 
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 3 mm 
Sterile 
Single use Yes 
92141 
Widening drill 4 mm 
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 

 
 
 
 
 
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90944 
Raspatorium 
Non 
sterile 
Reusable 
Yes 
90943 
Dissector 
Non 
sterile 
Reusable 
Yes 
93339 
Baha Ruler 
Non 
sterile 
Reusable 
Yes 
 
Supportive items 
N/A 
Osia Fitting Software  
NA 
Reusable 
No 
N/A 
Baha Fitting Software – CSDS 
(Download) 
N/A 
Reusable 
Yes 
P803254 
Baha Fitting Software  
NA 
Reusable 
Yes 
B13033 
BATTERY ZN AIR P675 
IMPLANT PLUS 
Non-
sterile 
Single 
use 
Yes 
Z60686 
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 
N/A 
Osia Intraoperative Test Software 
CSDS  
N/A 
Reusable 
No 
 
Cochlear SoftWear Pad 
Non-
sterile 
Single 
use 
Yes 
P993402 
Baha SoftWear Pad (15pcs) 
Non-
sterile 
Single 
use 
Yes