A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
Phase: NA
Conditions: Hearing Loss
Sponsor: Cochlear

Official Title: A Prospective, Multicentre, Open Clinical Investigation Evaluating 
Clinical Performance, Safety and Patient Reported Outcomes With an Active 
Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With 
Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural 
Deafness 
 
NCT Number: NCT04041700 
 
Document Date: 08 November 2019 

 
CIP Number: CBAS5751 
 
 
 
 
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Clinical Investigation Plan 
 
Title: A prospective, multicentre, open clinical investigation evaluating 
clinical performance, safety and patient reported outcomes with an Active 
Osseointegrated Steady-State Implant System (OSI) in adult subjects with 
conductive hearing loss, mixed hearing loss or single-sided 
sensorineural deafness. 
 
Short Tile: 
Clinical performance, safety and PROs of an Active 
Osseointegrated Steady-State Implant System (OSI) 
CIP Number: 
CBAS5751 
Version Number: 
2.0 
Date:  
08-Nov-2019 
Sponsor 
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14 
PO Box 82 
Mölnlycke, Sweden, SE-435 22   
+46 (0)31-792 44 00 
 
 
 
This clinical investigation shall be conducted in accordance with ethical principles that have their origin 
in the Declaration of Helsinki (1), International Standard ISO 14155 Clinical investigation of medical 
devices for human subjects - Good Clinical Practice (2), and any regional or national regulations, as 
applicable. 
 
 
Confidential Information 
The information contained in this document is confidential and should not be copied or distributed to persons not involved 
in the conduct or oversight of the clinical investigation 
 

 
CIP Number: CBAS5751 
 
 
 
 
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Investigator Agreement 
Coordinating Investigator Approval and Declaration 
By my signature below, I confirm my review and approval of this Clinical Investigation Plan (CIP). 
I also confirm that I will strictly adhere to the requirements therein and undertake to ensure that all staff 
with delegated responsibilities in the conduct of this CIP have read, understood and will strictly adhere 
to the requirements therein. This CIP will not be implemented without prior written approval from the 
Ethics Committee, any applicable National Competent Authorities, and the Sponsor. If amendments to 
this plan become necessary, written approval by the Ethics Committee and any applicable National 
Competent Authorities will be obtained before the changes are clinically implemented per the 
amendment, except under emergency circumstances to protect the rights, safety, and well-being of 
subjects. 
Name 
Title 
 
Coordinating Investigator 
Signature 
Date 
 
 
 
 
 
 

 
CIP Number: CBAS5751 
 
 
 
 
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Principal Investigator Declaration 
By my signature below, I confirm that I have read, understood and will strictly adhere to the 
requirements therein. I undertake to ensure that all staff with delegated responsibilities in the conduct 
of this CIP have also read, understood and will strictly adhere to the requirements therein. This CIP will 
not be implemented without prior written approval from the Ethics Committee, any applicable National 
Competent Authorities, and the Sponsor. If amendments to this plan become necessary, written 
approval by the Ethics Committee and any applicable National Competent Authorities will be obtained 
before the changes are clinically implemented per the amendment, except under emergency 
circumstances to protect the rights, safety, and well-being of subjects. 
 
Name 
Title 
 
Principal Investigator 
Site Name 
Site Address 
The Royal Victorian Eye and Ear Hospital 
 
 
East Melbourne, VIC 3002 
AUSTRALIA 
Signature 
Date 
 
 
 
 
 
 
 

 
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Principal Investigator Declaration 
By my signature below, I confirm that I have read, understood and will strictly adhere to the 
requirements therein. I undertake to ensure that all staff with delegated responsibilities in the conduct 
of this CIP have also read, understood and will strictly adhere to the requirements therein. This CIP will 
not be implemented without prior written approval from the Ethics Committee, any applicable National 
Competent Authorities, and the Sponsor. If amendments to this plan become necessary, written 
approval by the Ethics Committee and any applicable National Competent Authorities will be obtained 
before the changes are clinically implemented per the amendment, except under emergency 
circumstances to protect the rights, safety, and well-being of subjects. 
 
Name 
Title 
 
Principal Investigator 
Site Name 
Site Address 
Sydney Cochlear Implant Centre  
 
 
Gladesville NSW 2111 
AUSTRALIA 
Signature 
Date 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
Investigator Agreement ........................................................................................................................... 3 
1 
Definitions and Abbreviations ....................................................................................................... 11 
2 
Clinical Investigation  Synopsis ..................................................................................................... 13 
3 
Schedule of Events ....................................................................................................................... 17 
4 
Background Information and Rationale ........................................................................................ 19 
4.1 
Introduction ......................................................................................................................... 19 
 
The Baha Systems................................................................................................ 19 
 
The Osia system ................................................................................................... 19 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 20 
 
Nonclinical Data .................................................................................................... 20 
 
Clinical Data .......................................................................................................... 20 
4.3 
Study Rationale .................................................................................................................. 22 
5 
Medical Device Information ........................................................................................................... 23 
5.1 
Identity and Description of the Investigational Device ........................................................ 23 
5.1.1 
The OSI200 Implant .............................................................................................. 24 
5.1.2 
The Osia 2 Sound Processor (Osia 2 SP) ............................................................ 24 
5.1.3 
Osia 2 Sound Processor Magnets ........................................................................ 25 
5.1.4 
BI300 Implant ........................................................................................................ 25 
5.1.5 
Surgery ................................................................................................................. 26 
5.1.6 
Training ................................................................................................................. 26 
5.1.7 
Manufacturer of investigational device(s) ............................................................. 27 
5.2 
Identity and Description of the Reference device ............................................................... 27 
5.3 
Accessory Device Requirements ........................................................................................ 27 
5.3.1 
Accessories ........................................................................................................... 27 
5.3.2 
The Osia Fitting Software ..................................................................................... 28 
5.3.3 
The Baha Fitting Software .................................................................................... 28 
5.3.4 
Surgical instruments ............................................................................................. 28 
6 
Objectives ..................................................................................................................................... 29 
6.1 
Primary Objective ............................................................................................................... 29 
6.2 
Secondary Objective ........................................................................................................... 30 
6.3 
Tertiary Objective ................................................................................................................ 31 
6.4 
Exploratory Objective .......................................................................................................... 31 
7 
Design of the Clinical Investigation Study ..................................................................................... 31 
7.1 
General ............................................................................................................................... 31 
7.1.1 
Design Rationale ................................................................................................... 32 

 
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7.2 
Subjects .............................................................................................................................. 33 
7.2.1 
Inclusion Criteria ................................................................................................... 33 
7.2.2 
Exclusion Criteria .................................................................................................. 34 
7.2.3 
Number of Subjects Required ............................................................................... 34 
7.2.4 
Vulnerable Populations ......................................................................................... 35 
7.2.5 
Enrolment & Investigation Duration ...................................................................... 35 
7.2.6 
Criteria for Subject Withdrawal ............................................................................. 35 
7.2.7 
Randomisation Procedures .................................................................................. 36 
7.2.8 
Post-Investigational Medical Care ........................................................................ 36 
7.3 
Performance Evaluations and Procedures ......................................................................... 36 
7.3.1 
Eligibility Evaluations and Procedures .................................................................. 36 
7.3.2 
Post-Enrolment Evaluations and Procedures ....................................................... 38 
7.4 
Safety Evaluations and Procedures ................................................................................... 46 
7.4.1 
Numbness ............................................................................................................. 47 
7.4.2 
Concomitant Medication and Therapies ............................................................... 47 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 48 
7.6 
Sponsor Role in Conduct of the Clinical investigation ........................................................ 48 
8 
Risks and Benefits of the Investigational device and Clinical Investigation ................................. 48 
8.1 
Anticipated Clinical Benefits ............................................................................................... 48 
8.2 
Anticipated Adverse Device Effects .................................................................................... 49 
8.3 
Risks Associated with Participation in the Clinical investigation ........................................ 50 
8.4 
Risk Mitigation .................................................................................................................... 50 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 51 
9 
Statistical Considerations .............................................................................................................. 52 
9.1 
General Considerations ...................................................................................................... 52 
9.2 
Outcome measures ............................................................................................................ 53 
9.2.1 
Primary Outcome measures ................................................................................. 53 
9.2.2 
Secondary Outcome measures ............................................................................ 53 
9.2.3 
Tertiary Outcome measures ................................................................................. 55 
9.2.4 
Exploratory Outcome measures. .......................................................................... 55 
9.3 
Hypotheses ......................................................................................................................... 55 
9.3.1 
Primary Hypothesis ............................................................................................... 55 
9.3.2 
Secondary Hypothesis .......................................................................................... 56 
9.3.3 
Exploratory Hypothesis ......................................................................................... 57 
9.4 
Sample Size Determination ................................................................................................ 58 
9.5 
Analysis Populations ........................................................................................................... 58 

 
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9.6 
Primary Outcome Analyses ................................................................................................ 59 
9.7 
Secondary Outcome Analyses ........................................................................................... 59 
9.8 
Teriary Outcome Analyses ................................................................................................. 59 
9.9 
Exploratory Endpoint Analyses ........................................................................................... 59 
9.10  Safety Analyses .................................................................................................................. 59 
9.10.1 
Implant site evaluation (numbness) ...................................................................... 59 
9.10.2 
Adverse events ..................................................................................................... 59 
9.10.3 
Device deficiency .................................................................................................. 60 
9.10.4 
Concomitant medication ....................................................................................... 60 
9.11  Interim Analyses ................................................................................................................. 60 
10  Informed Consent Process ........................................................................................................... 60 
11  Adverse Events and Device Deficiencies ..................................................................................... 60 
11.1  Definitions ........................................................................................................................... 60 
11.1.1 
Adverse Event ...................................................................................................... 60 
11.1.2 
Adverse Device Effect .......................................................................................... 61 
11.1.3 
Serious Adverse Event ......................................................................................... 61 
11.1.4 
Serious Adverse Device Effect ............................................................................. 61 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 62 
11.1.6 
Adverse Events of Special Interest ....................................................................... 62 
11.1.7 
Device Deficiency ................................................................................................. 62 
11.2  Recording and Handling of Adverse Events ....................................................................... 62 
11.2.1 
Assessment of Severity ........................................................................................ 63 
11.2.2 
Assessment of Causality ...................................................................................... 63 
11.2.3 
Assessment of Seriousness ................................................................................. 64 
11.2.4 
Assessment of Expectedness .............................................................................. 64 
11.3  Recording and Handling of Device Deficiencies................................................................. 65 
11.4  Reporting Responsibilities .................................................................................................. 65 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 65 
11.4.2 
Sponsor Notification of Events ............................................................................. 66 
11.5  Independent Data Monitoring Committee ........................................................................... 66 
12  Device Accountability .................................................................................................................... 66 
13  Deviations from the Clinical Investigation Plan ............................................................................. 67 
14  Data Management ........................................................................................................................ 67 
15  Confidentiality ................................................................................................................................ 68 
16  Ethics Committee Approval ........................................................................................................... 69 
17  Suspension or Premature Termination ......................................................................................... 69 

 
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18  Amendments to the Clinical investigation Plan ............................................................................. 70 
19  Record Keeping and Retention ..................................................................................................... 70 
20  Publication Policy .......................................................................................................................... 70 
21  Statements of compliance ............................................................................................................. 71 
22  Quality Control and Assurance ..................................................................................................... 71 
22.1  Monitoring ........................................................................................................................... 71 
22.2  Audits .................................................................................................................................. 71 
23  Trademarks and Copyright ........................................................................................................... 71 
24  References .................................................................................................................................... 72 
25  Change History ............................................................................................................................. 74 
Appendices ........................................................................................................................................... 75 
Appendix 1: Conformity Statement ....................................................................................................... 75 
 
 
 

 
 
 
 
 
 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 Introduction 
Developed in the late 1970’s, Bone Conduction hearing implant (BCHI) systems are a well-
established treatment modality that has proven to be a safe and effective way of providing 
hearing in patients with CHL, MHL or SSD. The Osia® System is the latest addition to 
Cochlear’s BCHI Systems – combining the distinct benefits of the Baha® Connect and the Baha 
Attract Systems. 
 
 
The Baha Systems 
The Cochlear™ Baha bone conduction systems offer two ways to transmit vibrations from the 
external sound processor to the osseointegrated implant:  
The Baha Connect System uses a skin-penetrating abutment that provides a direct pathway 
for transmission of sound vibrations from the sound processor (SP) to the osseointegrated 
implant. The Baha Connect System thereby offers optimal efficiency of sound transmission via 
direct bone conduction. However, the skin-penetrating abutment of the Baha Connect System 
is seen as a barrier for many candidates and requires daily cleaning of the skin around the 
abutment in order to maintain a reaction-free implant site. 
The passive transcutaneous Baha Attract System uses a magnetic connection through intact 
skin. This offers the advantages over skin-penetrating systems by eliminating the daily 
cleaning, reduction in reported adverse skin reactions of the implant site and is perceived as 
more cosmetically appealing by many subjects. However, the 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. 
Both Baha Systems make use of the same external SPs and the same osseointegrated Implant 
(BI300). Both systems have been proven to be safe and effective through years of clinical use 
and data from clinical investigation (3) (4) (5). 
 
 
The Osia system  
The Osia® System is an Active Osseointegrated Steady-State Implant System (OSI) where the 
whole actuator/transducer (vibrating unit) is implanted and fixed to the same osseointegrated 
implant (BI300) as the Baha Systems. The system is developed to combine the benefits of a 
skin-penetrating system (direct bone conduction) combined with the benefits of a non-skin-
penetrating system (less need for maintenance care, cosmetic advantages, etc.). Compared 
to the passive transcutaneous Baha Attract System, the Osia System provides a more efficient 
transmission of sound, especially in the high frequency range, as the implantable transducer 
eliminates the attenuation of sound vibrations through the soft tissue that is inherent to the 
passive system. With the Osia System it is also possible to position the transducer closer to 
the ear canal, which may further improve audiological outcomes. 
The Osia System is intended to compensate for CHL, MHL, or SSD by transmitting amplified 
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for recipients with a fitting range of up to 55 dB SNHL (for mixed hearing loss), which is in the 
same fitting range as the Baha 5 Power Sound Processor. 
 
4.1.2.1 
The Osia 2 System 
The Osia 2 System is a further development of its predecessor device, the Osia System, which 
received regulatory approval (CE-mark) in 2018.  
The design modifications primarily consist in a more robust implant with a less complex surgical 
procedure, and a more advanced and aesthetically appealing sound processor. None of the 
changes that have been made to the Implant or SP are anticipated to significantly alter the 
safety or performance of the system. 
The predecessor device (the Osia System) has been tested in a prospective multicentre clinical 
investigation, and has, at the time of writing this CIP, been implanted in over 100 recipients. 
Results show that the system provides good audiological performance and patient-reported 
outcomes in patients with CHL, MHL and SSD and that complications are few. The following 
section(s) describe the findings from both non-clinical and clinical data supporting the safe and 
effective use of the Osia 2 System. 
 
4.2 
Findings of Previous Nonclinical and Clinical Studies 
 
Nonclinical Data 
The OSI200 Implant has been designed in a way to allow for less complex surgical procedure, 
involving fewer surgical instruments and less bone excavation during implantation than for the 
predecessor OSI100 Implant, and has been tested and reported (6). The OSI200 implant is 
also more robust in its design and is anticipated to perform in a similar manner as its 
predecessor device, with a safety profile equal to, or better than, the OSI100 Implant (7). 
The Osia 2 SP has the same intended performance but offers an improvement over the 
predecessor sound processor with regards to size, weight, signal processing and wireless 
functionality. Results from technical verification and validation activities are described in the 
currently released Investigator’s Brochure (7). 
 
 
Clinical Data 
The objective of this clinical investigation is to gather clinical data on the Osia 2 System; as 
such, no in-patient clinical data is currently available for the Osia 2 System itself. However, the 
predecessor Osia System is currently (at the time of this final CIP) being tested in a 
prospective, multicentre clinical investigation including 51 subjects with CHL, MHL (up to 55 
dB SNHL) or SSD (see section 4.2.2.1). In addition to clinical data on the predecessor, the 
Osia 2 SP and the predecessor SP are (by the time of finalising this CIP) being compared in 
patients already implanted with the precursor Implant (OSI100). Both the Osia 2 SP and the 
OSI200 Implant are also being clinically tested using an Osia Simulation model (section 
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4.2.2.1 
Multicentre Clinical Investigation with the Osia System 
By the time of this final CIP safety and performance of the predecessor device Osia System is 
being tested in a prospective, multicentre clinical investigation CBAS5539 (ClinicalTrials.gov 
Identifier NCT 03086135) including 51 adults with CHL (n=14), MHL (n=23), or SSD (n=14). 
Subjects were unilaterally (n=49), or bilaterally (n=2) implanted and serve as their own controls 
(i.e. pre-operative unaided hearing vs. aided hearing with the Osia System). All subjects have 
passed the 6 months follow-up and, as such, have completed the primary efficacy (3 months) 
and safety (6 months) endpoints, with data collection continuing until study completion at 12 
months (8). 
4.2.2.1.1 
Performance 
The results from the clinical investigation demonstrate the following benefits for subjects with 
CHL, MHL and SSD with regards to hearing performance and health related quality of life. 
The Osia System provided statistically significant improvements in hearing performance 
compared to the unaided condition with an improvement in hearing thresholds (PTA4, mean 
of 0.5, 1, 2, and 4 kHz) of 24.9 dB (SD 9.5 dB, range -50 to -6 dB, p<0.0001), speech 
recognition in quiet at 50, 65 and 80 dB SPL of 37.9 % (SD 25.2, range -40.0 to 80.0 %), 59.8 
% (SD 27.1, range -5.0 to 100.0 %) and 31.7 % (SD 32.0, range -4.0 to 100.0 %), respectively,  
and adaptive speech in noise (SNR) of -13.3 dB (SD 8.1, range -47.2 to 0.6 dB, p<0.0001).  
All SSQ parameters (Total, Speech, Spatial, and Quality) showed statistically significant 
improvements (p<0.0001) and APHAB scores showed significant improvements (p<0.0001) 
for the subscales Ease of Communication (EC), Background Noise (BN), Reverberation (RV), 
and the Global score. Health status and health related quality of life, measured with HUI3, 
showed statistically significant improvements for the parameters Comprehensive health state 
(p=0.035) and Hearing attribute (p=0.0014).  
Comfort with the use of the Osia System, measured using a visual analogue scale where 0% 
was defined as no comfort at all and 100% as most comfortable imaginable, showed a total 
mean comfort of 81% at 3 months and the mean reported daily use was 10.5 hours/day (SD 
4.3, range 1.0-18.0 hours/day). 
Analysis of the separate subgroups (CHL/MHL and SSD) showed similar trends as for the 
entire population. 
4.2.2.1.2 
Safety 
In total 68 Adverse Events (AEs) were reported during the first six months of the clinical 
investigation, whereof thirty-three (33) were judged as possibly, probably or causally related 
to the study device and/or procedure. Most of the AEs were reported as mild and related to 
post-operative pain or transient irritation/swelling.   
Three (3) Serious Adverse Events (SAEs) were reported within the first six months and within 
the same subject. Two (2) of these SAEs were unrelated to the study device and/or procedure, 
and one (1) was related to the surgical procedure: One Osia Implant was removed due to 
wound infection starting shortly after surgery. There were no device-related SAEs recorded 
during this time period. 
Seventy-one (71) Device Deficiencies (DDs) have been reported (to date); However, none of 
the DDs were related to the Implant (Fitting Software: 46.5%; Sound Processor: 41%; User 
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4.2.2.2 
Ongoing Clinical Investigation: Osia 2 System 
The Osia 2 SP, which is compatible with both the OSI100 and OSI200 Implants, is currently 
being tested in two different clinical investigations. The first investigation CBAS5731 
(ClinicalTrials.gov Identifier NCT NCT03848910 is designed to compare hearing performance 
and patient preference of the Osia 2 SP to the Osia SP in patients (n=11) that have completed 
the Osia System multicentre clinical investigation (i.e. that have already been implanted with 
the OSI100 Implant). The other investigation CBAS5749 compares hearing performance of the 
Osia 2 System to its predecessor device using a validated simulation model. In this 
investigation, audiological outcomes with the different combinations of the Osia System sound 
processors and implants are tested on actual Baha Connect users, which allows within-subject 
comparisons of the different SPs and Implants. 
While the final results from these clinical investigations are not yet available at the time of 
finalising this clinical investigation plan (will be finalised before the start of this clinical 
investigation), preliminary data suggests good outcomes with the Investigational device.  
 
4.3 Study Rationale 
The Osia 2 System is a further development of its predecessor device (the Osia System) which 
has been regulatory approved in Europe and has been proven safe and effective, providing 
significantly improved objective and subjective hearing outcomes and health-related quality of 
life in subjects with CHL, MHL or SSD when compared to the pre-operative unaided condition. 
Currently, there is nothing that would contradict the safety and performance of the Osia 2 
System; however, as with any surgical procedure, Osia surgery is not entirely free of risks.  
The clinical investigation on the Osia System (predecessor device) showed no serious adverse 
events or device deficiencies related to the Implant (OSI100) and most adverse events that 
were judged as possibly, probably or causally related to the procedure/device occurred within 
the first 1 to 3 months and were related to the surgical procedure (n=33). As mentioned in 
section 4.2.1, the design of the OSI200 Implant allows for a shorter, less complex surgical 
procedure with fewer surgical instruments, less bone excavation; as such, it is anticipated that 
any risks related to the surgical procedure will be similar or less than for the OSI100 Implant. 
The Osia 2 System also has the same performance requirements as the first Osia System, but 
includes a sound processor with added functionality, wireless connectivity and improved 
aesthetics, all of which are believed to provide added benefit to the user.  
The rationale for conducting this clinical investigation is to gather clinical data on patients 
implanted with the OSI200 Implant. While the non-clinical and clinical data all indicate that the 
Osia 2 System will perform as intended and provide a bone conduction hearing implant (BCHI) 
system with a similar, or improved, safety profile as its CE-marked predecessor device, which 
is currently being used by more than one hundred recipients world-wide, it is of utmost interest 
to assess the performance and safety of the Osia 2 System when used as intended. The study 
method proposed in this clinical investigation plan is considered relevant to the intended use 
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The regulatory classification of the system is expected to be Class AIMD in the EU and Class 
II in the US. The instruments of the Osia 2 System that have previously been CE marked and 
FDA cleared for the current Baha or Cochlear Implant (CI) systems maintain their current 
classification. The BI300 Implant will also maintain its classification in the EU (Class IIb), in the 
US (Class II), in Australia (Class II) and in Hong Kong (Class III).  
 
5.1.1 
The OSI200 Implant  
The OSI200 Implant is a single use device intended for long term implantation under the skin 
in the mastoid region of either side of the head. It is made up of the receiver coli, magnet 
assembly and the implant body (Figure 2). 
The radio frequency (RF) receiver coil receives power and data for the implant when it is 
inductively coupled to a similar coil in the external SP. The magnet assembly ensures that the 
SP is firmly attached and correctly aligned with the receiver coil. The implant body 
encapsulates the electronic assembly (EA) and actuator components. The EA receives the 
signal from the RF receiver coil and processes it accordingly, using the data received to drive 
the actuator. The actuator converts the electrical signal into an amplified mechanical 
stimulation and transmits it to the mastoid bone through the osseointegrated BI300 implant. 
The entire implant assembly is enclosed within a silicone overmould. The overmould material 
(MED-4860) is a medical grade, biocompatible silicone suitable for long term implantation. The 
OSI200 Implant attaches to the skull bone via a BI300 Implant (ossointegrating titanium 
fixture). 
Figure 2. Left: OSI200 Implant with the Receiver coil and magnet assembly (1) and the Implant body with 
actuator and electronic assembly (2); Right: The different subassemblies of the OSI200 Implant.  
 
5.1.2 
The Osia 2 Sound Processor (Osia 2 SP) 
The Osia 2 SP is a button-type SP, worn off-the-ear (OTE) (Figure 3), to be used with the 
OSI200 Implant.  
During use, the Osia 2 SP is in contact with the skin or hair and is kept in place by two magnets, 
one external magnet in the Osia 2 SP and one internal magnet in the OSI200 Implant. The 

 
 
 
 
 
 
 
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intended use is daily and as long as the subjects feels they need to have amplification, which 
could mean a full day. 
The Osia 2 SP is compatible with the Cochlear wireless accessories available on the market 
as well as various other accessories like Safety line and SoftWear pad. It is also compatible 
with iPhone via Bluetooth Low Energy enabling the use of apps and streaming. The subjects 
will be able to choose from five different front colors for their SP.  
The Osia 2 SP is powered by one battery which is expected to be enough for one full day of 
use. The Osia 2 SP is further described in the Cochlear Osia 2 Sound Processor User Manual.  
 
 
 
Figure 3. The Osia 2 Sound Processor. 
5.1.3 
Osia 2 Sound Processor Magnets 
Sound Processor Magnets for the SP comes in 4 different strengths; 1 being the weakest and 
4 the strongest.  
 
5.1.4 
BI300 Implant 
The Osia 2 System uses the same osseointegrated BI300 Implant for anchorage in the bone 
as in existing first Osia System, Baha Connect and Baha Attract systems. The BI300 Implant 
is 4.5 mm in diameter and comes in two different lengths, 4 mm and 3 mm, and is made of 
titanium. The surface is moderately roughened (TiOblast™) on its intraosseous parts. A cover 
screw (92136) is available in case of the need to close the surgical incision after implanting the 
BI300 without attaching the actual OSI200 Implant. 
The OSI200 Implant body attaches to the internal connection of the BI300 Implant using a 
fixation screw. 
 
 
 

 
 
 
 
 
 
 
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Figure 4. BI300 Implant 4 mm  
 
Table 1. List of parts of the Investigational device. 
Name 
Description 
Part Number 
CochlearTM Osia® 2 Sound 
Processor Kit 
One SP base, all five covers, one 
programming front and one inner 
case and Tamperproof tool in one 
package. 
P1233400 
CochlearTM Osia® OSI200 
Implant 
OSI200 Implant 
P1170466 
CochlearTM Osia® 2 Sound 
Processor Magnet pack  
Strength 1-4 
P1343790 (strength 1, 4 pcs) 
P1343791 (strength 2&3, 1+1 pcs) 
 P1343793 (strength 4, 4 pcs) 
BI300 Implant 
3 and 4 mm 
92128, 92129 
 
5.1.5 
Surgery 
The Osia OSI200 Implant is surgically implanted under the skin behind the ear.  
The surgical procedure includes the following: 
1. Preparation of implant site  
2. Coil pocket creation and incision  
3. BI300 Implant placement  
4. OSI200 Implant placement  
5. Closure  
The surgical procedure is further described in section 7.3.2.1 and in the Cochlear Osia OSI200 
Implant Physicians Guide (9). The physician’s guide is intended for surgical staff involved in 
implanting the device. Surgeons implanting the device should be experienced in cochlear 
implant and/or bone conduction implant surgery or have received appropriate information 
and/or training to perform the surgery. The physician’s guide also includes important 
information on MRI, indications, contraindications, adverse effects, warnings and precautions. 
    
5.1.6 
Training 
The Sponsor will organise an initiation visit during which the handling of the medical device(s), 
the clinical investigation plan, procedures including the informed consent process, instructions 
regarding case report form (CRF) 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 study is given to 
the medical, nursing and other staff involved at the clinic and that new information of relevance 
to the performance of this study is forwarded to the staff involved. 

 
 
 
 
 
 
 
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 
Programming Cables CS45 long, blue and red (P1343629 and P1343630). 
 
SoftWear pads (ID P793402). 
 
Tool kit (Magnet tool, tamperproof tool & programming cover) 
 
Magnet packs (Size 1 to 4 magnets) 
 
5.3.2 
The Osia Fitting Software  
To adjust and fit the Osia 2 SP to each recipient needs, programming software will be used—
the Osia Fitting Software (OFS) with the currently released version at the time of the clinical 
study. Communication between the computer-based software and the sound processor is 
achieved using a Hi-Pro 2 programming unit. The OFS 2 is a further developed fitting software, 
based on the first Osia fitting Software (OFS 1.0) and Baha Fitting Software (BFS 5.4)  
Cochlear Limited, Sydney, Australia is the legal manufacturer for the OFS.  
 
5.3.3 
The Baha Fitting Software 
To adjust and fit the Baha 5 Power SP to each recipient needs at the Screening and Baseline 
visit, a programming software will be used— Baha Fitting Software (BFS 5.0).  
Cochlear Bone Anchored Solutions, Mölnlycke, Sweden is the legal manufacturer for the BFS.  
 
5.3.4 
Surgical instruments  
The surgical procedure for the Osia 2 System combines steps of the recommended surgical 
procedure for implantation of the BI300 Implant and the BIM400 Implant Magnet of the Baha 
Attract System. Hence, Osia surgery reuses existing surgical tools for Baha surgery. There are 
only one surgical tool and one template that are specific to the Osia 2 System. Table 3 lists the 
recommended surgical instruments.  
The Bone Bed Indicator is a reusable instrument to be used to verify the clearance between 
the actuator bottom plane and the bone surface. It is hand tightened to the BI300 Implant and 
then turned clockwise around to check the clearance of the surrounding area. The OSI200 
Implant Template is a single-use sterile marking template to be used during marking of the 
skin and the bone during surgery to indicate placement of the OSI200 Implant. 
Cochlear Limited, Sydney, Australia is the legal manufacturer for the Bone Bed Indicator and 
the Implant Template.  
Cochlear Bone Anchored Solutions, Mölnlycke, Sweden is the legal manufacturer for all 
existing instruments relating to the BI300, which are already on the market.  
 
Table 3: List of surgical instruments. 

 
 
 
 
 
 
 
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The subjects include men and women aged 18 years or older with a CHL, MHL or SSD. 
Subjects will be screened, and 30 eligible subjects will be included in the clinical investigation. 
Subjects who drop out prior to surgery will be replaced, in order to reach a total of 30 evaluable 
(implanted) subjects. 
 
After surgical implantation of the device, subjects will attend scheduled study visits over a six-
month study period to be assessed as described in the CIP Schedule of Events (Section 3). At 
study visits, subjects will be evaluated through objective audiological hearing tests, patient 
reported outcomes and safety assessments. The primary outcome is to determine the hearing 
performance of the Investigational device compared to unaided hearing, assessed by free field 
thresholds audiometry, [PTA4, Mean of 0.5, 1, 2 and 4 kHz] and Adaptive speech recognition 
in noise at 3 months post-surgery. Safety will be assessed by recording and summarising all 
AEs/ADEs and DDs. 
 
7.1.1 
Design Rationale 
This clinical investigation is designed to collect data regarding the objective and subjective 
hearing performance and quality of life for the Investigational device. Safety parameters will 
also be collected. This investigation is limited to adult subjects, although the device is intended 
for both peadiatric and adult patients. The peadiatric population constitutes a heterogeneous 
patient group (age-related), and there are currently no audiological tests suitable for 
comparisons across age ranges and across multiple countries/languages. Subjects with either 
CHL or MHL (≤ 55 dB SNHL) or SSD are included, since these are the intended patient 
populations for the Investigational device. 
The investigation will be performed in an open design since it is not possible to perform the 
investigation in a blinded fashion.  
The main evaluations of the investigation, i.e. audiometric thresholds (pure tone average 
PTA4) and speech recognition in noise measured in free-field, are relevant and objective 
methods that are commonly used by clinics internationally as a way to assess hearing 
performance.  
Threshold audiometry is not language specific (no words used), thus rendering comparative 
data in an international, multilingual setting.  
Speech communication is a very important aspect in human communication. In everyday life, 
conversations usually occur in the presence of background noise and listeners with hearing-
impairment often complain about problems with understanding speech in noisy situations. 
Speech in noise tests resemble everyday situations (listening to complete sentences in noise) 
and can therefore be used to test the performance of hearing in noisy situations. The Hearing 
in Noise Test (HINT) is a speech in noise test designed to be used in an adaptive procedure 
to establish the speech recognition threshold for sentences, where 50% of the sentences are 
correctly repeated. The original HINT material was developed in 1994 and consists of short 
everyday sentences in English, which are judged to be natural by native speakers of American 
English (10). The Chinese Hearing in Noise Test (CHINT) was developed using the same 
rationale as the English HINT and have shown to be comparable, allowing the two tests to be 
compared directly across languages (11). In Australia an adaptive Australian Sentence Test in 

 
 
 
 
 
 
 
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Noise, the AuSTIN test will be used, which is validated in terms of test-retest reliability and 
efficiency (12).Questionnaires to collect patient reported outcomes—Abbreviated Profile of 
Hearing Aid Benefit (APHAB) (13) and Speech, Spatial and Qualities of Hearing Scale (SSQ) 
(14) and the health related quality questionnaire, HUI (15) are well established methods that 
are abundantly referred to in the scientific literature. 
The Baha 5 Power Sound Processor on a Softband was chosen as a secondary assessment. 
The Baha 5 Power Sound processor has the same fitting range (55 dB SNHL) and intended 
target population as the Investigational device. When used on a Softband, the Baha 5 Power 
Sound Processor is a relevant choice to present as a pre-operative listening for the subject, 
thus offering the patient the possibility to experience bone conducted sound prior to 
implantation.  
The follow-up period of 3 months post-surgery for the primary analysis is chosen as it is judged 
as long enough for the subjects to adapt and get used to the hearing performance with the 
Investigational device. The total length of the investigation is judged to be adequate for 
evaluating safety, as most safety issues are likely to be related to general risks associated the 
surgical intervention and thus occur early in the study. Six months data from a clinical study 
with a predecessor device of the Investigational device confirmed that the device is effective 
and safe.  
In summary, this investigation is expected to demonstrate that the Investigational device 
performs within its intended use and is a suitable treatment for adult patients with a CHL, MHL 
or SSD. 
 
7.2 Subjects 
Signed informed consent must be obtained from the subject before any study procedures are 
initiated. 
Eligibility of enrolled subjects must be supported by unaided audiometric threshold measures 
(including both air- and bone conduction thresholds) at screening to demonstrate that the 
subject meets the audiological inclusion criteria.  
Bilateral surgeries are allowed. However, performance data for the Investigational device will 
only be collected for one of the ears, as judged by the investigator as the “test ear”. 
 
7.2.1 
Inclusion Criteria 
Subjects must meet all of the inclusion criteria described below to be eligible for this clinical 
investigation. 
1. Subject with CHL or MHL 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 SNHL. 
OR 
Subject with SSD who is 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 SNHL in the good 
ear OR subject who is indicated for an AC CROS but—for some reason—cannot or 
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2. Adult subjects (18 years or older). 
3. Previous experience from amplified sound through properly fitted amplification (for 
example but not limited to Hearing aid, CROS device, Bone conductional hearing 
device on softband).  
4. Candidate is a fluent speaker in the language used to assess speech perception 
performance 
5. Willing and able to provide written informed consent. 
 
7.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this 
clinical investigation. 
1. Uncontrolled diabetes as judged by the investigator. 
2. Condition that could jeopardise osseointegration and/or wound healing (e.g. 
osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that 
may have an impact on the outcome of the investigation as judged by the 
investigator. 
3. Insufficient bone quality and quantity to support successful implant placement.  
4. Previous surgery and/or implantation with any bone conduction/active device on the 
side to be implanted, which jeopardize the implantation and use of the Osia 2 system, 
as judged by the investigator. 
5. Use of ototoxic drugs that could be harmful to the hearing, as judged by the 
investigator. 
6. Unable to follow investigational procedures, e.g. to complete quality of life scales, or 
unwilling to comply with the requirements of the clinical study as determined by the 
Investigator. 
7. Condition with a likely negative progression and/or with expected relapses jeopardising 
general wellbeing and health-related quality of life as judged by the investigator. 
8. Subject that has received radiotherapy in the area of implantation or is planned for 
such radiotherapy during the study period. 
9. Investigator site personnel directly affiliated with this study and/or their immediate 
families; immediate family is defined as a spouse, parent, child, or sibling. 
10. Cochlear employees or employees of Contract Research Organisations or contractors 
engaged by Cochlear for the purposes of this investigation.  
11. Currently participating, or participated within the last 30 days, in another 
interventional clinical investigation involving an investigational drug or device. 
 
7.2.3 
Number of Subjects Required 
Thirty subjects are to be enrolled in the investigation, i.e. will receive the implant. 
It is expected that approximately 33 subjects are to be screened to meet this sample size. 

 
 
 
 
 
 
 
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7.2.4 
Vulnerable Populations 
Not applicable. 
 
7.2.5 
Enrolment & Investigation Duration 
The following subject status definitions apply: 
Screened: A consented subject who is being assessed for eligibility according to the Screening 
requirements. 
Screen Fail: A consented subject that has been determined to not meet all eligibility criteria for 
enrolment. 
Enrolled: Subjects who have met all eligibility criteria and have received the implant.  
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 30 evaluable subjects. 
The enrolment period for the investigation is anticipated to be approximately 4 - 6 months from 
the time of first subject consent to enrolment of the last subject. 
The expected duration of each subject’s participation in the investigation, is 6 months from 
surgery.  
The anticipated total duration of the clinical investigation is maximum 12 - 15 months.  
Completion of investigation is defined as last subject last visit. In the event of an ongoing 
SADEs at the time of this last visit, the investigation completion will be extended for a further 
30 days, or until resolution or stabilisation of the event, whichever comes first.  
 
7.2.6 
Criteria for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The investigator shall ask 
for the reason(s). The reason for withdrawal should to be documented in the subject’s source 
files and the CRF. 
The investigator or Sponsor may also decide to withdraw a subject from the clinical study if it 
is considered to be in their best interests. 
Subject withdrawal may be for any of the following reasons: 
 
Adverse Event (AE) 
 
Device Deficiency (DD) 
 
Repeated and severe CIP or GCP deviation 
 
Subject lost to follow-up 
 
Subject withdrew consent 

 
 
 
 
 
 
 
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 
Subject death 
 
Sponsor decision 
 
Investigator decision 
 
Other (specify) 
If subject withdrawal is due to problems related to the Investigational device, safety or 
performance, the investigator shall ask for the subject's permission to continue in safety follow 
up (i.e. adverse events) until their scheduled final study visit.  
If a subject is lost to follow-up, every possible effort must be made by the study site personnel 
to contact the subject and determine the reason for discontinuation. At least three separate 
attempts taken to contact the subject must be documented. 
 
7.2.7 
Randomisation Procedures 
Not applicable. 
 
7.2.7.1 
Blinding Procedures 
Not applicable. 
 
7.2.8 
Post-Investigational Medical Care 
After the clinical study the subjects will be able to continue with their Investigational device. 
Routine controls with audiological checks will follow local routines according to the standard 
treatment program for bone conduction hearing implant systems. The Investigational device 
will be warranted and supported with service according to normal regional Cochlear routines. 
 
7.3 Performance Evaluations and Procedures 
7.3.1 
Eligibility Evaluations and Procedures  
Demographics 
The following demographic data will be recorded at Screening and Baseline: 
 
Age collected as date of birth (month and year) 
 
Gender 
 
Race   
 
Nicotine use (Cigarettes/day)  
 
Medical history 

 
 
 
 
 
 
 
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The following information will be recorded at Screening and Baseline: 
 
Relevant medical and surgical treatment during the past three years as judged by 
the investigator 
 
Current concomitant medication and treatments 
 
Hearing history 
During Screening and Baseline a number of baseline characteristics will be recorded:  
 
Type of hearing loss: (Conductive, Mixed or SSD)  
 
 Aetiology of hearing loss: (chronic) infection, tumor, trauma, malformation, 
otosclerosis, other 
 
Device history 
 
Current hearing aid (yes/no, specify model and brand, side and years of hearing aid 
use, reason for change)  
 
Previous experience from amplified sound through properly fitted amplification 
(specify type, duration of use, when stopped use, reasons stop using) 
 
Has the subject previously been suggested a bone conduction hearing implant 
solution? (yes/no, reason for rejection)  
 
Has the subject previously had a Baha implant (yes/no, reason for changing) 
 
Treatment ear 
Treatment ear (indicate left or right or both. In case of both, indicate “test ear”). 
  
Audiogram 
Unaided audiometric threshold measures (including both air- and bone conduction thresholds) 
should demonstrate whether the subject has a CHL, MHL or SSD and meets the audiological 
inclusion criteria.  
An existing audiogram may be used as long as it has been completed during the last six 
months, and contains all the required relevant frequencies. Frequencies required for air 
conduction thresholds are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000Hz. 
For bone conduction thresholds the required frequencies are 250, 500, 750, 1000, 1500, 2000, 
3000, 4000 and 6000Hz.  The subject’s pre-operative Pure Tone Average PTA4 for CHL and 
MHL (mean of 500, 1000, 2000 and 4000Hz) using unmasked BC thresholds and the Pure 
Tone Average PTA4 for SSD (mean of 500, 1000, 2000 and 3000Hz) using air conduction 
thresholds should be computed and measured in order to ensure that the subject meets the 
inclusion criteria.  
If an audiogram is older than 6 months or does not contain the required frequencies, a new 
audiogram shall be performed at Screening/Baseline. Frequencies required for air conduction 

 
 
 
 
 
 
 
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thresholds are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000Hz. For bone 
conduction thresholds the required frequencies are 250, 500, 750, 1000, 1500, 2000, 3000, 
4000 and 6000Hz. Contralateral masking should be used if needed, and according to local 
practice. The site staff shall always measure both the unmasked thresholds, as well as and 
the masked thresholds if applicable.  
 
Soft tissue thickness 
At Screening and Baseline or at Surgery, depending on local practice and requirements, soft 
tissue thickness should be measured. The measurement should be performed in the centre of 
the marked coil position. For complete instruction and recommendation regarding the soft 
tissue thickness, see the Cochlear Osia OSI200 Implant Physicians Guide (9).  
 
7.3.2 
Post-Enrolment Evaluations and Procedures 
7.3.2.1 
Surgery 
The Cochlear Osia OSI200 Implant Physicians Guide does not take into account any particular 
circumstances or factors relevant to an individual patient or case. Other surgical approaches 
and variations are practiced and may be more appropriate in certain patient cases. After 
considering all relevant circumstances, factors and information in each case, the appropriate 
surgical procedure is determined by the responsible investigator exercising independent 
medical judgement. Complete information is found in the Cochlear Osia OSI200 Implant 
Physicians Guide (9). However, the ideal position of the OSI200 Implant is with the actuator 
close to and in horizontal line with the ear canal without touching the pinna (Figure 5). The 
ideal angulation of the implant is around 0° for the coil and the actuator (Figure 5). Depending 
on the anatomy and medical history of the patient the placement may vary, and the maximal 
deviation 
should 
be 
45° 
for 
the 
coil 
or 
actuator 
(Figure 
6 
A 
and 
B).  
The transmitting range of the OSI200 Implant is dependent of the soft tissue thickness; if the 
soft tissue thickness is exceeding the recommended thickness it will have a negative impact 
on the sound processor performance and magnet retention. Take patient hair and potential 
use of optional Cochlear SoftWear Pad into consideration when determining if soft tissue 
thinning is needed.  
 
                    Figure 5: Ideal OSI200 Implant placement. 

 
 
 
 
 
 
 
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performed for the “test ear” alone and the other ear blocked.  Selection of the “test ear” will be 
as judged by the responsible investigator prior to surgery. Patient-reported outcomes (APHAB, 
SSQ) and quality of life assessment (HUI), will be collected post-surgery in a bilateral hearing 
situation. Safety-related information, including adverse events and device deficiencies, will be 
collected and reported for each side receiving the Investigational device, i.e. for the whole 
subject. 
 
Current hearing aid 
If the subject is currently using a hearing aid at Screening/Baseline, the speech in noise test 
shall also be performed with the current hearing aid. 
 
Blocking 
All audiometric tests shall be performed with the non-test ear blocked (in case of normal or 
near-normal hearing or a large asymmetry with the non-test ear having significantly better 
hearing thresholds). Before blocking of the non-test ear a free-field measurement on PTA4 
frequencies (500, 1000, 2000, 4000 Hz) shall be performed. The blocking shall then be done 
with earplug and muff and a additional free-field measurement on PTA4 frequencies shall then 
be performed to verify effective blockage and document the hearing level after blockage.  
 
Settings for the Sound Processors 
The Investigational device and the Baha 5 Power SP should be tested using the Everyday 
program.  
 
AUDIOLOGICAL ASSESSMENTS 
General set up 
All tests shall be performed in a sound insulated room. Equipment used for audiological testing 
shall be calibrated before initiation of the study. The speakers should be at the height of the 
test subject’s head and more than 1 metre away from the test subject. There should preferably 
be more than 1 metre of free space around the test subject in all directions. This is in 
accordance with the current standard (16). It is important to keep the same sound room and 
test equipment set-up during the entire clinical study. Changes may be necessary and 
allowed, but only after approval by the Sponsor. 
 
Sound Processor fitting 
The BFS of current market release will be used at Screening and Baseline when the fitting 
procedure should be performed for the Baha 5 Power Sound Processor on a Softband as a 
reference device.  

 
 
 
 
 
 
 
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The currently released version of OFS will be used to adjust the Investigational device settings 
for a specific subject. This will be performed during fitting, and throughout the study as needed 
(for example if the magnet is replaced with a different strength or start/stop of use of a soft 
pad). If the gain needs to be adjusted or changes to the program configuration are needed, a 
fine tuning is recommended. The fitting software will be installed on a laptop computer provided 
by the Sponsor, and the fitting-data will be saved on the laptop until the study is ended when 
it will be transferred to the Sponsor in a coded way.  
Coil-to-coil measurement 
The Digital Link Calibration (e.g. coil-to-coil measurement) that is a step in the connection step 
in the OFS, should be performed at each occasion the software is being used to fit or finetune 
the device to optimise the performance of the device for the user throughout the study. This 
will also provide an indication of the soft tissue thickness during the course of the study. 
Feedback measurements 
For the sound processor’s Individual Stable Gain (e.g. feedback measurements as part of the 
FS) the feedback analyser test should be performed at each occasion the software is being 
used to fit or finetune the device to optimise the performance of the device for the user 
throughout the study. For the Investigational device this data will be collected, saved and 
eventually transferred to the Sponsor for analysis. 
 
Bone Conduction (BC) Direct 
BC Direct is a tool in the OFS and BFS (current versions) to establish the unmasked bone 
conduction threshold with tones presented through the sound processor. At Baseline, BC 
Direct data shall be collected with the Baha 5 Power SP on a Softband using the BFS and shall 
be used to calculate the fitting (settings) of the SP for the Softband test. BC Direct 
measurements (as part of the OFS) will also be performed from fitting to Follow up 6M when 
the subject is using the Investigational device. BC thresholds obtained at the following 
frequencies will be recorded; 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 Hz. 
 
Free-field thresholds 
The purpose of this test is to establish the hearing thresholds in free field through a speaker in 
front position (0 degrees azimuth) according to the so-called ascending or modified Hughson-
Westlake method (Figure 7). The frequencies to be tested are [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 
3.0, 4.0, 6.0 and 8.0 kHz], the signal to be used shall be warble tones.   
At Baseline, free-field thresholds shall be measured for the unaided situation and with the Baha 
5 Power Sound Processor on a Baha Softband.  
At the fitting visit and at 3 and 6 months this test shall be performed with the Investigational 
device. 
 

 
 
 
 
 
 
 
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Figure 7: The setup of the speaker when testing Free-field thresholds and Speech recognition in quiet. 
 
Speech tests 
Speech recognition in quiet 
The purpose of this test is to establish the test subject’s ability to recognise speech in a quiet 
surrounding. The speech test in quiet shall be performed using phonetically balanced 
monosyllabic words presented in free field through a speaker from the front (0 degrees 
azimuth) (Figure 8). The test material shall be monosyllables and presented at 50-, 65- and 
80-dB sound pressure level (SPL) and scores shall be recorded as % correctly repeated words 
at each presentation level. The length of the list shall be validated according to the language, 
preferably a 50 word list.  
At Baseline the speech in quiet test shall be performed for the unaided situation and Baha 5 
Power Sound Processor on a Baha Softband.  
At the fitting visit and at 3 and 6 months this test shall be performed with the Investigational 
device. 
 
Adaptive Speech recognition in noise 
The purpose of this test is to establish the test subject’s ability to recognize speech in the 
presence of background noise. The adaptive speech test in noise shall be conducted using 
validated lists for the language it is presented in. The first list shall be used as a training list 
before the test is performed and the training list shall be used at each visit.  Both speech and 
noise will be presented in free field from the front speaker (0 degrees azimuth) (Figure 8). In 
Hong Kong software and speech material to be used is the CHINT (11), where the noise shall 
be kept constant at 65 dB SPL, and the speech shall be adapted stepwise according to the 
software used to establish the signal-to-noise ratio (SNR) where the test subject repeats 50% 
of the material correctly.  In Melbourne and Sydney, the test to be used is AuSTIN (12). The 
sentences shall be presented at a constant level of 65 dB SPL throughout the test, and the 

 
 
 
 
 
 
 
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babble noise shall be adapted stepwise according to the software used to establish the speech-
to-noise ratio (SNR) providing a 50% level of correctly repeated morphemes. 
 
 
      BACK 
 
Speech and noise 
 
    FRONT 
Figure 8. The setup of the speakers when testing Adaptive Speech recognition in noise. 
 
At Baseline, the speech in noise test shall be performed for the unaided situation and Baha 5 
Power sound processor on a Baha Softband. If the subject has a current hearing aid, the test 
shall also be performed with the hearing aid at Baseline. At the fitting visit and at 3 and 6 
months this measurement shall be performed with the Investigational device.  
 
7.3.2.3 
Patient reported outcomes 
Abbreviated Profile of Hearing Aid Benefit (APHAB form A) 
The APHAB form “A” questionnaire (13) from HARL (Hearing Aid Research Lab, University of 
Memphis, USA) is a 24-item self-assessment inventory that evaluates the benefit experienced 
by the subject when using hearing amplification compared to the unaided listening. APHAB 
produces a global score and scores for four subscales: Ease of Communication, 
Reverberation, Background Noise, and Aversiveness.  
The subjects will complete the APHAB questionnaire at Screening/Baseline, 3 and 6 months 
follow up.  
 
At Baseline, the subjects shall complete the questionnaire prior to the Softband test, 
and the questionnaire shall be answered with respect to the unaided hearing, even 
for subjects with a previous hearing device.  
 
At Follow up at 3 and 6 months, the subjects shall complete the questionnaire for the 
aided situation (with the Investigational device).  
The APHAB questionnaire is available for free and in different languages on the HARL home 
page. 
 

 
 
 
 
 
 
 
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Speech, Spatial and Qualities of Hearing Scale (SSQ-12 version) 
The short form of Speech, Spatial, and Qualities of Hearing Scale questionnaire (SSQ-12) (17) 
from MRC Institute of Hearing Research, UK, is a scaled-down version of the 49 items SSQ 
questionnaire (14). It is designed to compile a sub-set of items from the longer original 49 
version to represent the scale as a whole, measuring self-reported auditory disability, reflecting 
the reality of hearing in the everyday world. It has been shown to provide similar results to 
SSQ49 (17). It covers:  
 
Hearing speech in a variety of competing contexts  
 
The directional, distance and movement components of spatial hearing  
 
Segregation of sounds and attending to simultaneous speech streams  
 
Ease of listening  
 
The naturalness, clarity and identifiability of different speakers, different musical 
pieces and instruments, and different everyday sounds  
 
The subjects will complete the SSQ questionnaire at Screening/Baseline, 3 and 6 months 
follow up. 
 
At Baseline, the subjects shall complete the SSQ questionnaire prior to the Softband 
test and the SSQ questionnaire shall be answered with respect to an unaided 
hearing, even for subjects with a previous hearing device.  
 
At Follow up at 3 and 6 months, the subjects shall complete the questionnaire for the 
aided situation (with the Investigational device).  
The SSQ-12 questionnaire was approved for use in this clinical study for free by Professor 
Michael Akeroyd, former Director of MRC Institute of Hearing Research, which closed down 
2018. 
 
Health Utilities Index (HUI) 
HUI® (15) is a generic preference-based system for measuring comprehensive health status 
and health-related quality of life (HRQoL). HUI provides descriptive evidence on multiple 
dimensions of health status, a score for each dimension of health and an overall health-related 
quality of life (HRQoL). The scoring systems provide utility (preference) scores on a generic 
scale where dead = 0.00 and perfect health = 1.00.  HUI3 will be used in this clinical study 
(Questionnaire HUI23S1EN.15Q). The HUI3 classification system is comprised of 8 attributes: 
Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain – each with 5 or 
6 levels of ability/disability (18). The version in this clinical study uses a recall time of 1 week.  
The subjects will complete the HUI at Screening/Baseline, 3 and 6 months follow up. 
 
At Baseline, the subjects shall complete the HUI questionnaire prior to the Softband 
test and with respect to their current hearing situation.  
 
At Follow up at 3 and 6 months, the subjects shall complete the questionnaire for the 
aided situation (with the Investigational device).  

 
 
 
 
 
 
 
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The license to use the HUI questionnaire is purchased from Health Utilities Inc., 88 Sydenham 
Street, Dundas, ON, L9H 2V3 Canada. 
 
7.3.2.4 
Usability 
 
Magnet choice 
At fitting the most suitable magnet for the SP shall be selected, and the instruction for use are 
found in Osia 2 Sound Processor User Manual shall be followed. It is important that the 
strength is not too weak or too strong. There are 4 different strengths, ranging from 1 to 4, 
strength 1 being the weakest. During the follow up visits the choice of SP magnet shall be 
checked and recorded. There may be a need to decrease or increase the strength depending 
on the subject’s preference. Every time a change occurs it is important to perform a new fitting 
procedure according to the OFS. 
 
Sound Processor retention 
At first fitting and all follow up visits, the subjects shall estimate the experienced retention of 
the SP.  
The estimation shall be performed using the VAS scale (visual analogue scale 100mm) with 
insufficient retention to the left and excellent retention to the right.  
 
With regard to your Sound processor, please rate the overall retention by placing a single vertical line 
on the scale. 
 
 
 
Sound Processor wearing comfort 
At first fitting and all follow up visits, the subjects shall estimate the experienced wearing 
comfort of the SP.  
The estimation shall be performed using the VAS scale (visual analogue scale 100mm) with 
no comfort at all to the left and excellent comfort to the right. 
 
With regard to your Sound processor, please rate the overall comfort by placing a single vertical line on 
the scale. 
 
 
 Not comfortable 
 
 
 
                Most comfortable 
      at all 
 
 
 
 
 
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Daily use 
At all follow up visits data regarding daily use of the sound processor will be collected.  
Average hours of daily use (hours/day) during the last week before each Follow up visit shall 
be recorded. 
 
Daily streaming 
At all follow up visits, data regarding daily streaming using the sound processor shall be 
collected.  
Average hours of daily streaming (hours/day) during the last week before follow up shall be 
recorded.  
 
Battery lifetime 
During the clinical investigation SP battery lifetime will be followed from 6 weeks post surgery. 
At the follow up visit, data regarding battery lifetime for the sound processor will be collected. 
Average hours of the battery lifetime for a single battery during the last week before each follow 
up visit. Subjects will be encouraged to use each battery until the “low battery” is signaled by 
the 
SP.  
 
 
 
SoftWear Pad use 
During the clinical study at first fitting and at each follow up visit, data regarding SoftWear pad 
use (Yes/No) for the sound processor will be collected. 
 
7.3.2.5 
Device exposure 
Device exposure is information about for how long the subject is exposed to the Osia 2 
Implant and the Osia 2 Sound Processor. Data is summarized from other data fields in the 
same case report form. 
 
7.4 Safety Evaluations and Procedures 
Subjects will be carefully monitored during the study for possible adverse events and 
appropriate treatment of the subject will be initiated. Any adverse events observed will be fully 
investigated by the investigator and documented in the CRF including assessment of 
seriousness, severity (mild, moderate or severe) and relationship to the medical device.The 
risks and anticipated ADEs for Osia 2 System, as identified in Section 8.3 of the CIP, will be 
assessed in the clinical study via reporting of all AEs/ADEs from the time of first subject first 
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events are judged as device related or serious. A safety monitor, appointed by the Sponsor, 
will be contacted regarding events that are uncertain, serious or unexpected.  
 
7.4.1 
Numbness 
At all visits from Suture removal the subjects will be assessed for any presence of numbness 
over and around the implant area at Suture removal and throughout the study. The following 
scale will be used: 
1. No numbness 
2. Numbness over the implant Magnet Assembly area (inside red circle in Figure 9). 
3. Numbness over the implant Magnet Assembly area (inside red circle in Figure 9) and 2 cm 
beyond the implant.  
Numbness will be assessed by means of a pin and a cotton swab. Randomly picked locations 
over the implant Magnet Assembly area and from the edge of the implant and 2 cm out (beyond 
the implant) will be tested by gently touching the skin with the pin and the cotton swab. No 
sampling on the incision line or above the surface of the actuator. 
The scale above shall be used to score the subject’s sensation to stimulus with the pin and 
with the cotton swab. 
                                               
 
Figure 9: Numbness will be measured over the implant  
Magnet Assembly area or over and beyond the implant  
Magnet Assembly area. 
 
7.4.2 
Concomitant Medication and Therapies 
All medications and treatments given, whether or not to treat AEs/ADEs, must be recorded in 
the appropriate section of the CRF. 
Prohibited therapies are the following: 
 
long-term systemic use of corticosteroids 

 
 
 
 
 
 
 
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 
ototoxic drugs 
 
radiotherapy in the area of implantation 
If a subject receives a prohibited therapy each situation will be evaluated case by case and 
judged by the responsible investigator. 
 
7.5 Equipment Used for Evaluation of Performance and Safety 
All tests shall be performed in a sound insulated room. Equipment used for audiological testing 
shall be calibrated in accordance the local procedures at each clinic. A work instruction will be 
provided by the time of the Site Initiation Visit. 
A laptop with OFS together with a user manual for the software according to current released 
version and a HiPro box will be provided by the sponsor. 
 
7.6 Sponsor Role in Conduct of the Clinical investigation 
The test set-up regarding speaker placement, sound room facility and software used at each 
clinic shall be checked and approved by the Sponsor at the latest during the Site initiation visit. 
Equipment used for audiological testing shall be calibrated before initiation of the study. 
Calibration certificates will be asked for by the Sponsor as part of the study documentation.  
The sponsor will have a representative as support during the first surgery (or surgeries) as well 
as during first audiological testings and/or fitting.  
 
8 RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND 
CLINICAL INVESTIGATION  
8.1 
Anticipated Clinical Benefits  
The Investigational device is an active implantable BCHIs combining the distinct advantages 
of the percutaneous and transcutaneous Baha systems. A recipient is expected to experience 
the following clinical benefits when using the system: 
Efficient sound transmission through direct bone conduction, without the inherent 
medical and cosmetic drawbacks of a percutaneous (skin-penetrating) abutment. 
Compared to passive transcutaneous BCHIs (e.g. the Baha Attract System), the 
Investigational device provides a more efficient transmission of sound, especially in the high 
frequency range, as the actuator (vibrator) is directly coupled to the bone, eliminating the 
attenuation of vibrations through the soft tissue that is inherent to the passive system. With the 
Investigational device it is also possible to position the transducer closer to the ear canal, which 
may further improve audiological outcomes. The Investigational device is designed to provide 
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similar to a Power SP (e.g. Baha 5 Power) on abutment. Skin complications requiring treatment 
and/or precluding the use of the sound processor are relatively frequent for percutaneous 
devices (e.g. the Baha Connect System) due to the exposed abutment. For percutaneous 
abutments, daily site care is required to maintain a reaction-free skin penetration, but is not a 
guarantee for successful outcomes. For this transcutaneous Investigational device, the implant 
site is sealed and does not provide a direct path for infections. In addition, a transcutaneous 
system, without an abutment protruding through the skin, is often perceived as a more 
aesthetic option. 
State-of-the-Art signal processing and wireless connectivity  
The Investigational device is built around the same platform for audio signal processing and 
wireless functions as the Baha 5 family of Sound Processors with Bluetooth® Smart 
technology, made for iPhone (MFi) with support for direct audio and data streaming, and 2.4 
GHz wireless technology that connects to Cochlear Wireless Accessories (e.g. MiniMic 2 and 
2+, Phone clip, TV streamer, Remote control 2). 
In addition to the overall clinical benefits provided by the Investigational device, participation 
in this clinical study is anticipated to benefit the subject by providing early, pre-market access 
to the latest technology within BCHI Systems. 
8.2 
Anticipated Adverse Device Effects 
The Investigational device has been designed and manufactured to ensure that all risks have 
been reduced as far as possible. However, certain adverse device effects (ADEs) may occur 
even after all state-of-the-art risk control measures have been implemented and verified.  
As per section 4.2.2, safety and performance of the Osia System (predecessor device) has 
been tested in a prospective, multicentre clinical study. The following adverse device effects 
have been reported (to date) and may be relevant to the participants of this clinical study (more 
detail provided in the IB):  
 
One (1) serious adverse event (SAE) has been reported for the Osia System involving 
the removal of an Osia Implant due to a wound infection starting shortly after surgery: 
possibly related to the procedure (reported by investigator). 
 
Forty one precent (41%) of system related adverse events (n=28) were related to the 
surgical procedure. These adverse events were mostly mild and transient (e.g. post-
operative pain, swelling or irritation). The device-related adverse events (n=11 were 
reported as warmth from SP (n=2), headache (n=1), position vertigo (n=1), feeling of 
tension at implant site (n=1), pain (1), numbness (n=1) and change in bone conduction 
thresholds (3). 
More information and details with regards to any risks with the use of the Investigational device 
is provided in the Investigator´s Brochure.  
 

 
 
 
 
 
 
 
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8.3 Risks Associated with Participation in the Clinical 
investigation 
Subjects participating in the clinical study are exposed to the anticipated adverse device, and 
or procedure related effects associated with standard Baha and Osia implant surgery and in 
connection with general anaesthesia. 
The following potential complications and adverse effects are stated in the OSI200 Implant 
Physician’s guide (9). 
Prospective implant recipients should be advised of the following risks: 
 
General risks associated with surgery and general anaesthesia. 
 
Osseointegration failure – potential causes for failure of osseointegration include lack of 
adequate bone quantity/quality, trauma, infection, generalised diseases and surgical 
complications. 
 
Other medical complications that may require additional medical treatment, such as: 
- 
Concurrent Cerebrospinal Fluid (CSF) leakage 
- 
Subdural injury 
- 
Subcutaneous haematoma 
- 
Irritation, inflammation or breakdown of the skin flap; infection; and in some 
cases, extrusion of the device caused by the presence of a foreign body under 
the skin 
Failure of device component parts (both external and internal) could result in the perception of 
an uncomfortably loud sound sensation, intermittent sound, or no sound. 
Partial or full failure of the device could require removal or replacement of the implant. 
While the majority of risks are associated with the surgery it cannot be excluded that soft tissue 
related complications may occur. 
Investigators and users shall be aware of the following:  
 
If the user experience tightness, numbness or even pain at the implant site, or 
develop significant skin irritation, he/she shall stop using the sound processor and 
contact the investigator. 
 
Signs of overheating and signs of discomfort or skin irritation at the implant site.  
 
Occasional feedback and/or noise may occur.   
 
8.4 Risk Mitigation 
The Osia 2 System has been designed and manufactured to ensure that all risks have been 
reduced as far as possible; however, as with any surgical intervention, a 100% success rate 
cannot be guaranteed. As such, the following will be performed during the clinical study to 
further mitigate the risks identified above: 

 
 
 
 
 
 
 
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 
Before start of each site in the clinical study each investigator will have done 
documented surgery training according to the Cochlear Osia OSI200 Implant 
Physician’s Guide either at a cadaver lab or on a plastic skull.   
 
The suggested surgical approach and the two new tools have been validated by 27 
surgeons in 4 regions and will be described in a usability report under preparation by 
the time of this final CIP (6). 
 
CBAS qualified staff will be present during one or more of the first surgeries at each 
clinic in order to support any surgical questions or issues related to the OSI200 
Implant. 
 
All reported ADEs and DDs will be reviewed regularly by the Sponsor for the duration 
of the study to facilitate early detection and appropriate intervention if events are 
unanticipated with respect to incidence, severity, or outcome. 
 
MRI examinations can be performed safely on a person with this implanted device 
only under very specific conditions. An MRI information package is supplied with each 
implant for additional information regarding magnetic resonance imaging (19).  
Subjects enrolled in the study that receive the Osia 2 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 study, at the same side of the skull where 
the Osia 2 System will be positioned are excluded from the study.  
 
Users shall routinely check the device for signs of overheating and for signs of 
discomfort or skin irritation at the implant site and inform the study staff.  
 
Do not apply continued pressure to the processor when in contact with the skin (e.g. 
sleeping while lying on processor, or using tight fitting headwear). 
 
8.5 Risk-to-Benefit Rationale 
The Investigational device has been designed to make the implant more robust, reduce 
complexity of the surgery and provide a more advance sound processor compared to the 
precursor Osia System. The predecessor system has been shown to be safe and effective in 
a multicentre clinical investigation.  
As with the predecessor device, most of the risks identified for the Investigational device are 
related to surgery and/or implant failures leading to explantation (further details are provided 
in the Investigator´s Brochure).  
The design modifications to the Investigational device compared to the predecessor implant 
(OSI100), as described above, have resulted in a more robust implant thought to reduce the 
occurrence rate / likelihood of implant failures leading to explantation. In addition, the shorter 
and less complex surgical procedure required for Investigational device implantation is 
believed to mitigate the general risks associated with surgery and general anaesthesia.  
Based on the data presented herein, the relatively low risk associated with the intended use of 
the device, and the added benefit to the patient, it is believed that the anticipated risks related 

 
 
 
 
 
 
 
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to the intended use of the Investigational device are well within the acceptable limits when 
weighed against the benefits to the patient.  
 
9 STATISTICAL CONSIDERATIONS 
9.1 General Considerations 
The distribution of continuous variables as well as change in continuous variables will be given 
as n, mean, SD, SEM, Median, Min and Max and the distribution of dichotomous and 
categorical variables will be given as number and percentages. For continuous variables 
estimated mean and the 95% two-sided confidence interval (bootstrapped) for difference 
between groups will be presented. 
Since all included subjects will have measurements of the primary and important secondary 
efficacy variables for unaided hearing, with the Investigational device and with a Baha Power 
sound processor on a Baha Softband, all statistical analyses will be paired. All statistical 
analyses will be non-parametric. In order to choose the most powerful test, the Fisher’s non-
parametric permutation test for paired observations will be used for all paired analyses of 
continuous variables. The permutation tests use the measured values and not only the ranks 
in the calculations. For paired analysis of dichotomous and ordered categorical variables the 
Sign test will be used. 
The main efficacy analyses will be performed at 3 months after surgery on the ITT population 
and complementary efficacy analyses will be performed 6 months after surgery on the ITT 
population. In addition, all analyses will be made on the PP population. Sub analyses will also 
be performed on one group consisting of Mixed/conductive subjects and one consisting of SSD 
subjects.  
Imputation of missing values will be performed for all efficacy variables using stochastic 
regression imputations. All ITT analyses will be performed/presented both for the imputed and 
for the non-imputed data (sensitivity analyses).  
The final definition of the analysis sets (ITT, PP and Safety) will be taken at the clean file 
meeting before database lock. See separate paragraph for definitions. 
A statistical analysis plan (SAP) with detailed statistical analyses specified for all variables and 
time points will be written and signed before the database lock. 
The approximate number of subjects per site is 10 and the maximum is approximately 15. See 
separate paragraph for Sample size calculation. 
Major protocol deviations are those that are considered to have an effect on the analysis. The 
number of patients with major protocol deviations will be summarised per treatment group. A 
list of protocol deviations will be produced. 
Imputation of missing values will be performed for all efficacy variables. No imputation of 
baseline values or baseline carry forward will be made. Imputations will be made according to 
the following rules: 

 
 
 
 
 
 
 
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1. If a value is missing at the end of a patient, last observation will be carried 
forward. 
2. If a missing value is occurring between two time points with values, an 
interpolation will be made for continuous variables and for categorical 
variables the value from the previous visit will be carried forward. 
 
The number of patients with major protocol deviations will be summarised per treatment 
group. A list of all protocol deviations will be produced. 
 
9.2 Outcome measures 
9.2.1 
Primary Outcome measures 
The improvement in hearing performance when using the Investigational device at 3 
months post-surgery compared to the preoperative unaided situation assessed as: 
o Thresholds audiometry, free-field [PTA4, mean of 0.5, 1, 2 and 4 kHz].  
o Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding].  
9.2.2 
Secondary Outcome measures 
 
The improvement in hearing performance at fitting and 6 months post-surgery when 
using the Investigational device compared to the unaided situation assessed as: 
o The improvement in Thresholds audiometry, free-field [PTA4, mean of 0.5, 1, 
2 and 4 kHz]  
o The improvement in Adaptive speech in noise [signal-to-noise ratio, 50% 
speech understanding].  
 
The improvement in hearing performance at fitting, 3- and 6 months post-surgery 
when using the Investigational device compared to the unaided situation assessed 
as: 
o  The improvement in Thresholds audiometry, free-field [0.25, 0.5, 0.75, 1.0, 
1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. 
o The improvement in Speech in quiet [% correctly perceived words at 50dB, 
65dB and 80dB SPL]. 
 
 
The benefit in self-reported hearing outcome when using the Investigational device  at 
3- and 6-months post-surgery compared to the unaided hearing assessed by:  
o The improvement in scores using the Abbreviated Profile of Hearing Aid 
Benefit (APHAB). 
o The improvement in scores using the Speech, Spatial and Qualities of Hearing 
Scale (SSQ). 

 
 
 
 
 
 
 
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 
The benefit in health-related quality of life (HRQoL) measured by the difference in 
scores with HUI when using the at 3 and 6-months post-surgery compared to the pre-
operative hearing situation.  
 
Surgical information: 
o Soft tissue thickness 
o Surgery time  
o Bone polishing/removal at the actuator site 
o BI300 Implant length  
o Location of BI300 Implant  
o Type of anaesthesia  
o Soft tissue reduction  
o Surgical incision type  
o Length of the surgical incision  
o Placement of the coil 
o Location of the surgical incision in relation to the actuator 
 
Usage information: 
o Magnet choice 
o Sound Processor retention 
o Sound Processor wearing comfort 
o Use of SoftWear pad 
o Daily use 
o Daily streaming 
o Battery lifetime  
 
The difference in hearing performance between the Investigational device and to a 
Baha 5 Power Sound Processor on a Baha Softband (preoperative) assessed at 
fitting, 3- and 6-months post-surgery as: 
o The difference in Thresholds audiometry, free-field [PTA4, mean of 0.5, 1, 2 
and 4 kHz].  
o The difference in Thresholds audiometry, free-field [0.25, 0.5, 0.75, 1.0, 1.5, 
2.0, 3.0, 4.0, 6.0 and 8.0 kHz].  
o The difference in Adaptive speech in noise [signal-to-noise ratio, 50% speech 
understanding].  
o The difference in Speech in quiet [% correctly repeated words at 50dB, 65dB 
and 80dB SPL].  
 
BC Direct [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz] will be performed using 
a Baha Softband (preoperatively) at screening/baseline and using the Investigational 
device at fitting, 3- and 6-months post-surgery. 
 

 
 
 
 
 
 
 
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9.2.3 
Tertiary Outcome measures 
 
The difference in hearing performance at fitting- 3- and 6 months post-surgery when 
using the Investigational device compared to a preoperative hearing aid (if used by 
the patient) assessed as: 
o The difference in Adaptive speech in noise [signal-to-noise ratio, 50% speech 
understanding].  
 
Feedback measurements to be collected the Investigational device. 
 
9.2.4 
Exploratory Outcome measures. 
There are no exploratory Outcome measures.  
9.3 Hypotheses 
The hierarchical testing procedure below is introduced to guarantee that the probability of Type 
I error is < 2.5% for all confirmative statements. The order of the hierarchical testing procedure 
will be: 
  
1. PTA 4 pre-operative unaided vs. 3 months post-surgery (Primary efficacy analysis)  
2. Adaptive speech recognition in noise (50% performance), signal to noise ratio (SNR) 
pre-operative unaided vs. 3 months post-surgery 
3. Speech in quiet at 65dB SPL pre-operative unaided vs. 3 months post-surgery 
4. APHAB Global pre-operative unaided vs. 2 months post fitting aided  
5. Hearing attribute (HUI) pre-operative situation vs. 3 months post-surgery 
6. Mean of the 12 items (Total score) in the SSQ pre-op unaided vs. 3 months post-
surgery 
 
If the first analysis is significant the probability mass 0.025 will go to the second analysis. If the 
second analysis is also significant the probability mass 0.025 will go to the third analysis and 
so on. When the first non-significant analysis is reached this and all analyses thereafter will be 
non-confirmative while the previous analyses will be confirmative. If the first analysis is non-
significant no analysis will be confirmative. All testing will be Alpha level of 0.025 and one sided 
test will be used and the analysis will be performed on the ITT. 
 
9.3.1 
Primary Hypothesis 
Group mean free-field PTA4 (average of 500, 1000, 2000, and 4000 Hz) with the 
Investigational device at the 3-month postoperative interval will be improved over that 
measured preoperatively in the unaided condition (baseline). 
This endpoint is represented by the following hypotheses:  
H଴: 𝜇ிെ𝛼଴ൌ0,  
Hୟ: 𝜇ிെ𝛼଴്0,  
 

 
 
 
 
 
 
 
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where:  
𝛼଴ = baseline preoperative PTA4; 
𝜇ி = mean follow-up PTA4 3 months postoperative. 
Alpha level of 0.05 and two sided test will be used and the analysis will be performed on the 
ITT population. 
 
Group mean Adaptive speech recognition in noise (50% performance), speech to noise ratio 
(SNR) with the Investigational device at the 3-month postoperative interval will be improved 
over that measured preoperatively in the unaided condition. 
 
This endpoint is represented by the following hypotheses:  
H଴: 𝜇ிെ𝛼଴ൌ0,  
Hୟ: 𝜇ிെ𝛼଴്0,  
 
where:  
𝛼଴ = baseline preoperative Adaptive speech recognition in noise (50% performance), 
speech to noise ratio (SNR); 
𝜇ி = mean follow-up Adaptive speech recognition in noise (50% performance), 
speech to noise ratio (SNR) 3 months postoperative. 
Alpha level of 0.05 and two sided test will be used and the analysis will be performed on the 
ITT population. 
. 
9.3.2 
Secondary Hypothesis 
Group mean Speech in quiet at 65dB when using the Investigational device at 3 months 
postoperative compared to the unaided hearing. 
This endpoint is represented by the following hypotheses:  
H଴: 𝜇ிെ𝛼଴ൌ0,  
Hୟ: 𝜇ிെ𝛼଴്0,  
 
where:  
𝛼଴ = baseline preoperative word recognition score; 
𝜇ி = mean follow-up word recognition score 3 months postoperative.  
 
Group mean Global score using the Abbreviated Profile of Hearing Aid Benefit (APHAB) 
when using the Investigational device at 3 months post surgery compared to unaided 
hearing. 

 
 
 
 
 
 
 
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This endpoint is represented by the following hypotheses:  
H଴: 𝜇ிെ𝛼଴ൌ0,  
Hୟ: 𝜇ிെ𝛼଴്0,  
 
where:  
𝛼଴ = baseline APHAB Global score; 
𝜇ி = mean follow-up APHAB Global score 3 months postoperative. 
 
Group mean Hearing attribute (HUI) when using the Investigational device at 3 months post 
surgery compared to the preoperative hearing situation. 
This endpoint is represented by the following hypotheses:  
H଴: 𝜇ிെ𝛼଴ൌ0,  
Hୟ: 𝜇ிെ𝛼଴്0,  
 
where:  
𝛼଴ = baseline Hearing attribute (HUI); 
𝜇ி = mean follow-up Hearing attribute (HUI) 3 months post-fitting. 
 
Group mean Total score using the Speech, Spatial and Qualities of Hearing Scale (SSQ) 
when using the Investigational device at 3 months post surgery compared to the unaided 
hearing. 
This endpoint is represented by the following hypotheses:  
H଴: 𝜇ிെ𝛼଴ൌ0,  
Hୟ: 𝜇ிെ𝛼଴്0,  
 
where:  
𝛼଴ = baseline SSQ Total score; 
𝜇ி = mean follow-up SSQ Total score 2 months post-fitting. 
 
All other secondary outcomes will not be formally hypothesis tested but summarized and p-
values will be calculated as described in 9.1 General considerations. 
9.3.3 
Exploratory Hypothesis 
There are no exploratory hypotheses. 
 

 
 
 
 
 
 
 
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9.4 Sample Size Determination 
Based on 6 months safety data from 51 subjects implanted with the predecessor Osia System 
at 5 clinics in the multicentre clinical investigation described in section 4.2.2.1 (8) it is judged 
that approximately 10 subjects per clinic and 3 clinics is reasonable for detecting any safety 
issues with the Investigational device in this study. The primary safety evaluation will be 
performed 3 months post-surgery, which with an estimation of 30 subjects will equate 7.5 
patient years. This is considered to be enough safety data for the primary safety analysis. 
 
With a total of 30 subjects, there will be a very high power to detect significant changes in the 
primary performance evaluations audiometric thresholds (PTA4) and adaptive speech in noise 
(speech to noise ratio, SNR).  
PTA4:  Assuming the same mean reduction in PTA4 as in the multicentre clinical investigation 
of the predecessor Osia System (Mean change -25 dB, SD 9.5 dB), the resulting power 
with 30 subjects is 0.99.  
SNR:  In the multicentre clinical investigation of the predecessor Osia System a change in 
SNR from 4.98 dB (SD 7.76 dB) unaided to -8.19 dB (SD 6.58 dB) aided resulted in a 
mean improvement in SNR of -13.3 dB (SD 8.1 dB). In that investigation, speech was 
presented from the front and noise from the rear speaker. In the present investigation, 
however, both speech and noise will be presented from the front speaker, which is 
known to result in higher SNR values in the aided situation (the SNR in the unaided 
situation is not expected to change significantly). In a pilot clinical investigation 
conducted at Cochlear’s own research facility (CBAS5271, Sub study 118), a mean 
SNR value of -2.5 dB was recorded with the Investigational device (Osia 2 System). 
Assuming that in the present investigation the unaided mean SNR is similar to the 
unaided scores in the multicenter investigation and that the aided mean SNR is similar 
to the pilot investigation, a mean improvement in SNR of approximately -7.6 dB (SD 
8.1 dB) is expected. With 30 subjects, the resulting power is 0.99.  
 
9.5 Analysis Populations 
The final definition of the analysis sets (ITT, PP and Safety) will be taken at the clean file 
meeting before database lock. 
 
The Intention-to-Treat population (ITT) will include all subjects who have undergone 
surgical intervention. 
 
The Per Protocol population (PP) will include subjects that have completed the study 
according to the protocol. Subjects that were incorrectly included or were considered 
major protocol violators that affect the primary analysis should be removed from the 
PP population. 
 
The Safety population consists of all surgically treated subjects  
All efficacy analyses will be performed on both ITT and PP populations. 
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9.6 Primary Outcome Analyses 
Primary efficacy analysis will be determined by analysis of change in free-field threshold 
audiometry: PTA4 (mean of 500, 1000, 2000 and 4000Hz) and change in Adaptive speech 
recognition in noise (50% performance), from unaided versus Investigational device at 3 
months post-surgery visit for the ITT population, using Fisher’s two-sided non-parametric 
permutation test for paired observations at a significance level of 0.05 to demonstrate an 
improvement in PTA4. Both PTA4 and SNR must be significant at alpha 0.05 for the primary 
analysis to be considered as confirmative.  
See paragraph 9.1 General considerations for further details. 
 
9.7 Secondary Outcome Analyses 
See paragraph 9.1 General considerations for details. 
 
9.8 Teriary Outcome Analyses 
See paragraph 9.1 General considerations for details. 
 
9.9 Exploratory Endpoint Analyses 
Speech in noise data will be assessed for the total population and separately for the 
individual sites. Data will be tabulated for comparison, no statistical analysis will be 
performed. 
9.10 Safety Analyses 
Primary safety analysis will be performed at 3 months post-surgery. 
 
9.10.1 Implant site evaluation (numbness)  
Implant site evaluation (numbness) will be summarised by frequency and percent of 1. No 
numbness, 2. Numbness over the implant Magnet Assembly area and 3. Numbness over the 
implant Magnet Assembly area and 2 cm outside the implant Magnet Assembly area by visit. 
 
9.10.2 Adverse events 
Separate tabulations of AEs, ADEs, SAEs, SADEs and AESIs will be produced. AEs, ADEs 
and AESIs will also be produced by severity (mild, moderate or severe) and relationship 
(related defined as Possibly, Probably and Definitely related). Adverse events will be coded 
and summarized by number of events and also by number of subject and percent with 
events.(see section 11.2) 
 
 

 
 
 
 
 
 
 
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9.10.3 Device deficiency 
 
DDs will be reported by visit as described in 11.3 General considerations. 
 
9.10.4 Concomitant medication 
 
Concomitant medications will be defined as start or end date from surgery to end of study 
and will be presented by listings. 
 
9.11 Interim Analyses 
Not applicable. 
10 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject using an approved ICF 
prior to any clinical investigation related examination or activity. The rationale of the clinical 
investigation, as well as the risks and benefits, what participation will involve, and alternatives 
to participation will be explained to the subject. Ample time will be provided for the subject to 
enquire about details of the clinical investigation and to decide whether to participate. 
All questions about the clinical investigation shall be answered to the satisfaction of the subject 
or the subject’s legally acceptable representative. Subjects shall not be coerced or unduly 
influenced to participate or to continue to participate in a clinical investigation. 
Each subject (or their legally authorised representative) and the person who conducted the 
informed consent discussion, shall sign and date the Informed Consent Form (ICF). Where 
required, a witness shall sign and personally date the ICF. A copy of the signed ICF shall be 
given to the subject. The original signed ICF shall be archived in the Investigator’s Site File or 
subject file at the investigational site. 
The subject, or the subject’s legally authorised representative, shall be informed in a timely 
manner if new information becomes available that may be relevant to the subject’s willingness 
to continue participation in the clinical investigation. The communication of this information 
must be documented as an update to the ICF and re-consent of the subject. 
 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 Definitions 
11.1.1 Adverse Event  
An adverse event (AE) is 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 or the procedures required for implant or 
use. 

 
 
 
 
 
 
 
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NOTE 1: This definition includes events related to the medical device or the comparator 
device. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users and other persons, this definition is restricted to events related to medical 
devices. 
 
11.1.2 Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of a medical device. 
NOTE 1: This includes any AE resulting from insufficiencies or inadequacies in the instructions 
for use, the deployment, the implantation, the installation, the operation, or any malfunction of 
the medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse 
of the medical device. 
 
11.1.3 Serious Adverse Event 
A serious adverse event (SAE) is any AE that: 
 
led to a death,  
 
led to a serious deterioration in the health of the subject that either resulted in: 
 a life-threatening illness or injury, or 
 a permanent impairment of, or damage to, a body structure or a body function, or 
 in-patient hospitalisation or prolonged hospitalisation, or 
 medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment or damage to a body structure or a body function, or 
 Chronic disease. 
 
led to foetal distress, foetal death or a congenital physical or mental abnormality, or 
birth defect 
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a SAE. 
 
11.1.4 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an ADE that has resulted in any of the 
consequences characteristic of a SAE. 
 

 
 
 
 
 
 
 
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11.1.5 Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is a SADE, which by its nature, 
incidence, severity, or outcome has not been identified in the current version of the 
Investigator’s Brochure (7). 
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, 
severity, or outcome has been identified in the Investigator’s Brochure (7). 
 
11.1.6 Adverse Events of Special Interest 
The following AEs are defined as adverse events of special interest (AESIs) and should be 
reported within 24 hours, after being aware of an event: 
 
AE that interferes with the daily use of the medical device(s) 
 
AE at the site of the implant that leads to 
o Revision surgery including explantation 
o Severe soft tissue complication 
o Prescription of antibiotics 
 
11.1.7 Device Deficiency 
A DD is an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance. 
NOTE: Device Deficiencies include malfunctions, use errors, and inadequate labelling or 
information supplied by the manufacturer. 
 
11.2 Recording and Handling of Adverse Events 
Subjects shall be carefully monitored during the clinical investigation and the investigator 
should enquire about AEs at each visit.  
All AEs will be recorded from Screening/Baseline. AE recording will continue for each subject 
until completion of the final visit. Ongoing SAEs, SADEs and/or AESI will be followed for 30 
days, or until resolution or stabilisation of the event, whichever comes first. 
Source notes should indicate the evaluation for AEs, even if none to report. All required AEs 
will be reported if observed, even if anticipated and/or acknowledged as a risk factor in the 
consent. 
All AEs will have the following information documented: start and stop dates, action taken, 
outcome, severity and investigators opinion on the potential relationship to the Investigational 
device and investigational procedures. If an AE changes in severity, the most severe (highest) 
grade will be captured for that event on the Adverse Events CRF.  

 
 
 
 
 
 
 
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 
Screen Fail: Subject determined not to be eligible to proceed for participation 
 
Enrolled: First use of the Investigational device  following completion of screening 
activities and confirmation of eligibility 
 
Withdrawn: Enrolled subjects who withdraw or are withdrawn by the Investigator or 
Sponsor before the expected last visit.  
 
Complete: Enrolled subjects who complete the planned follow up visits according to this 
CIP. 
Source data will be captured in clinic notes, paper-based source data worksheets, or printed 
directly from testing software. Before initiation of the clinical investigation the PI should together 
with the CRA complete the template “Origin of source data” stipulating were source data should 
be recorded at the investigation site. If electronic medical records do not permit read only 
access for monitoring purposes, a verified printout must be provided. 
Data collection will be performed using 
 for electronic data capture (EDC) on 
electronic Case Report Forms (eCRFs). Site staff will be trained on the completion of the 
eCRFs prior to obtaining access to the system, and will have their own Login/Password. 
Access to clinical investigation information will be based on an individual’s role and 
responsibilities. 
 uses role-based user permissions for data entry, viewing, and reporting 
options. All communications between users and the EDC server are encrypted. Web servers 
are protected by a managed firewall. This application is designed to be in compliance with 
applicable regulations including 21 CFR Part 11. 
The application will include programmed data consistency checks and supports manual 
generation of data clarifications/queries, including documentation of site responses. The 
application maintains a comprehensive audit trail for all data entered, including updates and 
queries, and documents the time that each entry occurred and who made the entry. 
Principal Investigators will affirm that the data for each subject at their site is accurate and 
complete by way of an electronic signature. 
In addition, de-identified electronically generated data will be collected from the OFS. The 
unamended data file shall be regarded as the source. 
. 
15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in 
accordance with governing data privacy regulations [such as the EU GDPR regulations]. 
Data will be reported to the Sponsor on CRFs or related documents (for example, 
questionnaires). Subjects will be identified on CRFs and other related documents only by a 
unique subject identification code and shall not include the subject’s name or other personal 
identifiable information. Completed CRFs or related documents are confidential and will only 
be available to the Investigator and site staff, the Sponsor and their representatives, and if 
requested to the Ethics Committee and national regulatory authorities. Publications or 
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16 ETHICS COMMITTEE APPROVAL 
The clinical investigation will not commence prior to the written favourable opinion or approval 
from the EC is obtained. 
The final Sponsor-approved version of the CIP, Informed Consent Form, and other necessary 
documents shall be submitted to the EC. A copy of the EC opinion/approval shall be provided 
to the Sponsor. 
The Investigator shall forward to the Sponsor, for review and approval, any amendment made 
to the approved ICF and any other written information to be provided to the subject prior to 
submission to the EC. 
The Sponsor and Principal Investigator will continue communications with the EC, as required 
by national regulations, the clinical investigation plan, or the responsible regulatory authority. 
Any additional requirements imposed by the EC or regulatory authority will be implemented by 
the Sponsor. 
The Investigator shall submit the appropriate documentation if any extension or renewal of the 
EC approval is required.  In particular, substantial amendments to the CIP, the ICF, or other 
written information provided to subjects will be approved in writing by the EC. 
The Investigator shall report to the EC any new information that may affect the safety of the 
subjects or the conduct of the clinical investigsation. The Investigator will send written status 
summaries of the clinical investigation to the EC regularly, as per local EC requirements. 
Upon completion of the clinical investigaton, the Investigator shall provide the EC with a brief 
report of the outcome of the clinical investigation, as per local EC requirements. 
The clinical investigation is covered by clinical trial insurance, meeting the requirements of the 
participating countries. 
 
17 SUSPENSION OR PREMATURE TERMINATION 
The Sponsor will discontinue the clinical investigation site if: 
1) major non-adherence to the CIP or GCP principles is occurring 
2) it is anticipated that the subject recruitment will not be adequate to meet the 
objectives of the clinical investigation 
An ongoing clinical investigation  may be discontinued in case of: 
1) device failure 
2) serious or intolerable ADE, leading to the explant or discontinued use of the device 
3) subject’s death 
Should the Sponsor discontinue the clinical investigation, the Sponsor will continue to support 
those subjects who were already implanted with the device under investigation according to 
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Medical Journal Editors (ICMJE) to enable communication in a timely manner. All contributors 
who do not meet the criteria for authorship will be listed in an acknowledgments section of the 
publication. 
 
21 STATEMENTS OF COMPLIANCE 
This clinical investigation shall be conducted in accordance with ethical principles that have 
their origin in the Declaration of Helsinki, International Standard ISO 14155 Clinical 
investigation of medical devices for human subjects - Good Clinical Practice, and any regional 
or national regulations, as applicable. 
 
22 QUALITY CONTROL AND ASSURANCE 
In accordance with Cochlear’s Quality Management System, all clinical investigations shall be 
conducted according to internationally recognised ethical principles for the purposes of 
obtaining clinical safety and performance data about medical devices. 
The Sponsor employees (or designee) shall use standard operating procedures (SOP) to 
ensure that clinical investigation procedures and documentation are consistently conducted 
and compliant with the ISO 14155 Standard, Good Clinical Practice (GCP), and applicable 
local regulations. 
 
22.1 Monitoring 
The Sponsor will perform on-site and remote monitoring visits as frequently as necessary to 
oversee conduct, data collection and record keeping by sites. The clinical investigation 
monitoring plan is a separate document describing all the activities performed during site 
qualification, initiation, monitoring, and close out. 
 
22.2 Audits 
An Investigator must, in reasonable time, upon request from a relevant health authority or 
regulatory agency, permit 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 immediately.   
The Investigator will grant the Sponsor representatives the same access privileges offered to 
relevant health authority or regulatory agents, officers, and employees. 
23 TRADEMARKS AND COPYRIGHT 
Cochlear, Baha, Osia, Carina, the elliptical logo, and marks bearing an ® or ™ symbol, are 
either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB.  © 
Cochlear [2019] 
 
 

 
 
 
 
 
 
 
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24 REFERENCES 
 
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declaration‐of‐helsinki‐ethical‐principles‐for‐medical‐research‐involving‐h.  
2. International Organization for Standardization. ISO 14155:2011 Standard: Clinical investigation 
of medical devices for human subjects – Good clinical practice. 2011. Available at: 
https://www.iso.org/obp/ui/#iso:std:iso:14155:ed‐2:v1:en.  
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MKS. 8, 2016, Otol Neurotol., Vol. 37, ss. 1077‐83. 
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9. P1536337_D1536338, Cochlear Osia OSI200 Implant Physician's Guide. 2019.  
10. Development of the Hearing in Noise Test for the measurement of speechreception thresholds 
in quiet and in noise. Nilsson M, Soli SD, Sullivan JA. 2, 1994, J Acoust Soc Am., Vol. 95, ss. 1085‐99. 
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Hear., Vol. 26, ss. 276‐89. 
12. An adaptive Australian Sentence Test in Noise (AuSTIN). Dawson PW, Hersbach AA, Swanson 
BA. 5, u.o. : Ear Hear, 2013 Sep, Vol. 34, ss. 592‐600. 
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14. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Gatehouse S, Noble W. 2, Feb 2004, 
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15. Torrance, Multi‐Attribute Health Status Classification Systems: Health Utilities Index. Feeny, 
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APPENDICES 
APPENDIX 1: CONFORMITY STATEMENT 
Document will be provided separately as Appendix.