A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.
Phase: NA
Conditions: Conductive Hearing Loss, Mixed Hearing Loss
Sponsor: Cochlear

Official Title: A post-market interventional cohort study evaluating the clinical 
efficacy of the Osia 2 system in the US Market 
NCT Number: NCT04320407         
Document Date: 19 June 2020 

CIP Number: CAM5778 
 
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Clinical Investigation Plan 
 
A post-market interventional cohort study 
evaluating the clinical efficacy of the Osia 2 system in the US Market. 
 
 
Short Tile: 
Osia CPT Code Study 
CIP Number: 
CAM5778 
Version Number: 
3.0 
Date: 
19-June-2020 
Sponsor: 
Cochlear Americas 
10350 Park Meadows Drive 
Lone Tree, CO 80124 
 
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. 
 
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 

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Manufacturer 
Cochlear Bone Anchored Solutions AB 
Konstruktionsvägen 14 PO Box 82 435 22 
Mölnlycke Sweden Tel: 031- 792 44 74 
Sponsor Organizations 
Cochlear Americas 
10350 Park Meadows Dr 
Lone Tree, CO  80124 
Contract Services 
 
 
Safety Contact 
 
 
 
A complete list of participating Principal Investigators’ names, titles and addresses, and the 
names and addresses of participating institutions (sites) will be maintained by the Sponsor 
and will be provided as a separate Principal Investigator List. The definitive Principal 
Investigator list will be provided in the Clinical Investigation Report. 

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Table of Contents 
Table of Contents 
Table of Contents ........................................................................................................................ 4 
1 
DEFINITIONS AND ABBREVIATIONS ........................................................................ 8 
2 
CLINICAL INVESTIGATION SYNOPSIS ................................................................... 10 
3 
SCHEDULE OF EVENTS .......................................................................................... 12 
4 
BACKGROUND INFORMATION AND RATIONALE .................................................. 14 
4.1 Introduction ......................................................................................................................... 14 
4.1.1 
Nonclinical Data ............................................................................................ 15 
4.1.2 
Clinical Data .................................................................................................. 15 
4.2 Study Rationale .................................................................................................................. 15 
5 
MEDICAL DEVICE INFORMATION .......................................................................... 15 
5.1 Identity and Description of the Approved Medical Device on Test (AMDT) ......................... 15 
5.2 Identity and Description of the Comparator ......................................................................... 16 
5.3 Accessory Device Requirements ........................................................................................ 16 
6 
OBJECTIVES ............................................................................................................ 16 
6.1 Primary Objective ............................................................................................................... 16 
6.2 Secondary Objective ........................................................................................................... 16 
6.3 Exploratory Objective .......................................................................................................... 16 
7 
DESIGN OF THE CLINICAL INVESTIGATION.......................................................... 17 
7.1 General............................................................................................................................... 17 
7.1.1 
Design Rationale ........................................................................................... 17 
7.2 Subjects.............................................................................................................................. 17 
7.2.1 
Inclusion Criteria ........................................................................................... 17 
7.2.2 
Exclusion Criteria .......................................................................................... 18 
7.2.3 
Number of Subjects Required........................................................................ 18 
7.2.4 
Vulnerable Populations ................................................................................. 18 
7.2.5 
Enrollment & Study Duration ......................................................................... 18 
7.2.6 
Criteria for Subject Withdrawal ...................................................................... 19 
7.2.7 
Randomization Procedures ........................................................................... 20 

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7.2.8 
Blinding Procedures ...................................................................................... 20 
7.2.9 
Post-investigation Medical Care .................................................................... 20 
7.3 Performance Evaluations and Procedures .......................................................................... 20 
7.3.1 
Metrics .......................................................................................................... 20 
7.3.2 
Methods ........................................................................................................ 23 
7.3.3 
Safety Evaluations and Procedures ............................................................... 26 
7.3.4 
Concomitant Medication and Therapies ........................................................ 26 
7.4 Equipment Used for Evaluation of Performance and Safety ................................................ 26 
7.5 Sponsor Role in Conduct of the Clinical Investigation ......................................................... 27 
8 
RISKS AND BENEFITS OF THE CLINICAL INVESTIGATION AND ......................... 27 
8.1 Anticipated Clinical Benefits ................................................................................................ 27 
8.2 Anticipated Adverse Device Effects .................................................................................... 28 
8.2.1 
Risks Associated with the Surgery ................................................................ 28 
8.2.2 
Additional Risks Associated with Implantation of the Study Device ................ 28 
8.3 Risks Associated with Participation in the Clinical Investigation .......................................... 28 
8.4 Risk Mitigation .................................................................................................................... 29 
8.5 Risk-to-Benefit Rationale .................................................................................................... 29 
9 
STATISTICAL CONSIDERATIONS ........................................................................... 29 
9.1 General Considerations ...................................................................................................... 29 
9.2 Endpoints ........................................................................................................................... 30 
9.2.1 
Primary Endpoint ........................................................................................... 30 
9.2.2 
Secondary Endpoint ...................................................................................... 30 
9.2.3 
Exploratory Endpoints ................................................................................... 30 
9.3 Hypotheses ........................................................................................................................ 30 
9.3.1 
Primary Hypothesis ....................................................................................... 30 
9.3.2 
Secondary Hypothesis ................................................................................... 31 
9.3.3 
Exploratory Hypothesis .................................................................................. 31 
9.4 Sample Size Determination ................................................................................................ 31 
9.5 Analysis Populations........................................................................................................... 31 
9.6 Primary Endpoint Analyses ................................................................................................. 31 
9.7 Secondary Endpoint Analyses ............................................................................................ 31 

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9.8 Exploratory Endpoint Analyses ........................................................................................... 31 
9.9 Safety Analyses .................................................................................................................. 31 
9.10 
Interim Analysis ......................................................................................................... 32 
10 
INFORMED CONSENT PROCESS ........................................................................... 32 
11 
ADVERSE EVENTS AND DEVICE DEFICIENCIES .................................................. 32 
11.1 
Definitions.................................................................................................................. 32 
11.1.1 Adverse Event ............................................................................................... 32 
11.1.2 Adverse Device Effect ................................................................................... 33 
11.1.3 Serious Adverse Event .................................................................................. 33 
11.1.4 Serious Adverse Device Effect ...................................................................... 33 
11.1.5 Unanticipated Serious Adverse Device Effect ............................................... 33 
11.1.6 Adverse Events of Special Interest ................................................................ 34 
11.1.7 Device Deficiency .......................................................................................... 34 
11.2 
Recording and Handling of Adverse Events ............................................................... 34 
11.2.1 Assessment of Severity ................................................................................. 34 
11.2.2 Assessment of Causality ............................................................................... 35 
11.2.3 Assessment of Seriousness .......................................................................... 36 
11.2.4 Assessment of Expectedness ....................................................................... 36 
11.3 
Recording and Handling of Device Deficiencies......................................................... 37 
11.4 
Reporting Responsibilities ......................................................................................... 37 
11.4.1 Investigator Reporting of Serious Adverse Events ......................................... 37 
11.4.2 Sponsor Notification of Events ....................................................................... 37 
11.5 
Independent Data Monitoring Committee................................................................... 38 
12 
DEVICE ACCOUNTABILITY ..................................................................................... 38 
13 
DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN .................................. 39 
14 
DATA MANAGEMENT .............................................................................................. 39 
15 
CONFIDENTIALITY ................................................................................................... 40 
16 
ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL .................... 41 
17 
SUSPENSION OR PREMATURE TERMINATION .................................................... 41 
18 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN .................................... 42 
19 
RECORD KEEPING AND RETENTION .................................................................... 42 

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PUBLICATION POLICY ............................................................................................. 42 
21 
STATEMENTS OF COMPLIANCE ............................................................................ 43 
22 
QUALITY CONTROL AND ASSURANCE ................................................................. 43 
22.1 
Monitoring.................................................................................................................. 43 
22.2 
Audits ........................................................................................................................ 43 
23 
TRADEMARKS AND COPYRIGHT ........................................................................... 44 
24 
REFERENCES .......................................................................................................... 44 
25 
CHANGE HISTORY .................................................................................................. 45 
 

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4 
BACKGROUND INFORMATION AND RATIONALE 
4.1 
Introduction 
Bone conduction implant systems are designed to provide aural rehabilitation for individuals 
with moderate to severe conductive (CHL) or mixed (MHL) hearing losses or single-sided 
sensorineural deafness (SSD). The initial bone conduction system relied on percutaneous 
transmission of sound vibrations from an electromagnetic transducer connected to a skin- 
penetrating abutment attached to an osseointegrated screw-shaped fixture. Due to the 
efficient transmission pathway and availability of a range of powerful sound processors, 
percutaneous implants continue to offer the broadest audiological fitting range and remain 
the most commonly used bone conduction implant type. In recent years, there has been 
rapid development of new implantable transcutaneous options for patients in need of a bone 
conduction hearing solution that maintain efficient transmission but also reduce complication 
rates due to the percutaneous abutment. 
The Osia System is a new active transcutaneous implant system that uses piezoelectric 
instead of electromagnetic stimulation and is built on the experience gained from both 
transcutaneous and percutaneous bone conduction systems. The implanted piezoelectric 
element fixes to bone via an osseointegrated implant similar to current percutaneous 
devices. The digital sound signal is transferred from the sound processor to the implant 
through a digital radio frequency (RF) link. Due to this design, the Osia system is able to 
provide a more efficient transmission of sound, especially in the high frequency range, as the 
implantable transducer eliminates the attenuation of sound vibrations through soft tissue that 
is inherent to passive bone conduction systems. The additional high frequency output aids 
consonant recognition and word discrimination ultimately improving auditory comprehension, 
especially in noisy environments. 
Clearance for the Osia 2 system was supported by a global clinical trial evaluating safety 
and efficacy in a mixed, mixed conductive and single-sided deaf adult population. Fifty-one 
(51) adult subjects were included in the investigation and a total of 53 devices were 
implanted across five investigational sites. The overall study duration per subject was 12 
months post implantation with the primary efficacy time point at 3 months post implantation 
and primary safety at 6 months post implantation. The results are detailed in the Clinical 
Investigation Report for study CBAS5539 Clinical performance of a new implant system for 
bone conduction hearing Document No: D1478473. 
Upon clearance of the Osia 2 system in the United States, it was determined that the clinical 
evidence intended to support the reimbursement coverage of the Osia 2 system was 
inadequate. To further support the reimbursement efforts associated with the Osia 2 system, 
clinical evidence gathered in the United States will be collected. 

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4.1.1 
Nonclinical Data 
A summary of non-clinical data is available for reference in the Osia FDA clearance 
K190589. 
4.1.2 
Clinical Data 
The outcomes from CBAS5539 Clinical performance of a new implant system for bone 
conduction hearing are available in Document No: D1478473. 
 
4.2 
Study Rationale 
As it was determined that the clinical evidence intended to support the reimbursement 
coverage of the Osia 2 system was inadequate, clinical evidence gathered in the United 
States will be collected to further support the reimbursement efforts associated with the Osia 
2 system. 
 
5 
MEDICAL DEVICE INFORMATION 
5.1 
Identity and Description of the Approved Medical Device on 
Test (AMDT) 
The Osia System is made up of several components. The Osia Implant (OSI200) consists of 
a receiver/stimulator and an actuator (vibrator) which is surgically implanted on the skull 
bone. The external component of the Osia System is a sound processor, worn off-the-ear, 
which picks up the sound from the environment, and sends, after processing, the information 
to the implant via a transcutaneous inductive link. This link is also referred to as 
radiofrequency (RF) link. Each Osia System is configured to meet an individual’s hearing 
needs, using dedicated fitting software. The Osia System is illustrated in Figure 1 below. 
 
 
Figure 1: Overview of the Osia System, including the Osia Sound Processor 
 

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In normal operation, the Osia System functions as follows (Figure 1): 
1. The external sound processor captures and digitally processes sound. 
2. The sound processor transmits power and digital information to the implant coil/receiver. 
3. The implant stimulator/actuator converts the digital information into an electric analogue 
signal that is converted to vibrations by the implant piezoelectric actuator. 
4. This implant is fixed to the bone by the BI300 implant. 
The actuator converts the electrical signal into an amplified mechanical stimulation, 
bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and 
providing some level of mechanical amplification in order to compensate for the damaged 
inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss). 
 
5.2 
Identity and Description of the Comparator 
The Baha 5 Power will be utilized on a Sound Arc as the pre-surgical reference for the aided 
test condition. Each subject will be assessed in both the aided and unaided condition pre- 
operatively and then compared to their performance aided and unaided at the 3 months 
post- surgical test visit using the AMDT, the Osia 2 system. The signal processing of the 
Baha 5 Power is most comparable to the Osia Sound Processor and therefore has been 
chosen as the comparator. 
5.3 
Accessory Device Requirements 
Not applicable. 
 
6 
OBJECTIVES 
6.1 
Primary Objective 
To evaluate the performance of the Osia 2 system on an adaptive speech in noise test. 
 
6.2 
Secondary Objective 
To evaluate the safety of the Osia 2 system in a group of adult newly implanted recipients. 
 
6.3 
Exploratory Objective 
Not Applicable. 

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7 
DESIGN OF THE CLINICAL INVESTIGATION 
7.1 
General 
A post-market interventional cohort study evaluating the clinical efficacy of the Osia 2 system 
in the US Market. 
The subjects include adults aged 18 years and older who meet the pre-specified study 
inclusion and exclusion criteria. Up to 20 eligible subjects will be enrolled.   
Study subjects will be implanted with the Osia 2 system according to the commercially 
approved Physicians Guide. Subjects will attend scheduled study visits as described in the 
CIP Schedule of Events (Section 3). At study visits, subjects will undergo hearing and safety 
assessments.  The primary endpoint is to evaluate the performance of the Osia 2 system on 
an adaptive speech in noise test.  Safety associated with implantation of the Osia 2 system 
will be assessed by recording and summarizing device or procedure related AEs and DDs.  
No data monitoring committee will be used for this clinical investigation. An analysis will be 
conducted once all subjects complete Visit 5. All subjects will attend an End-of-Study visit at 
the time they complete the study. 
7.1.1 
Design Rationale 
This clinical investigation design ensures that the results obtained have clinical relevance, 
scientific validity and address the clinical investigation objectives. A within subject research 
design has been employed to utilize each subject as his or her own control as it 
accommodates the heterogeneity that characterizes hearing impaired populations.  
Subjects seeking treatment with an Osia 2 bone conductive device may present clinically as 
being aided or unaided, therefore it is important to capture both listening conditions to 
ensure a representative sample. Since the Osia 2 Sound Processor cannot be utilized in a 
non- surgical wearing configuration, each subject will be fit with the Baha 5 Power device on 
a Baha Sound Arc according to the Cochlear Baha Fitting prescription. The Baha 5 Power 
device is most comparable from a sound processing perspective to the Osia 2 Sound 
Processor. 
A test order randomization paradigm has been employed to minimize test order effects and 
demonstrate the unaided to aided benefits of bone conduction technology. Due to the 
physiology of a conductive or mixed conductive hearing loss, there are no carry-over effects 
associated with the use of an osseointegrated bone conduction intervention and therefore 
comparisons can be made. 
 
7.2 
Subjects 
7.2.1 
Inclusion Criteria 
Subjects must meet all of the inclusion criteria described below to be eligible for this clinical 

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investigation. 
• 
Willing and able to provide written informed consent. 
• 
Proficient in English. 
• 
Hearing loss etiology of Conductive or Mixed Conductive loss. 
• 
Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the 
treatment ear. 
• 
Aged 18 years and older.  
7.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this 
clinical investigation. 
• 
Unwilling to wear the treatment device or comply with the surgical and rehabilitation 
requirements of the study. 
• 
Unable or unwilling to comply with the requirements of the clinical investigation as 
determined by the Investigator. 
• 
Medical, audiological or psychological conditions, as judged by the investigator that 
might contraindicate participation in the clinical investigation. 
• 
Investigator site personnel directly affiliated with this study and/or their immediate 
families; immediate family is defined as a spouse, parent, child, or sibling. 
• 
Cochlear employees or contractors engaged by Cochlear for the purposes of this 
investigation. 
• 
Currently participating, or participated within the last 30 days, in another 
interventional clinical investigation/trial involving an investigational drug or device. 
• 
Prior experience with a surgical bone conduction treatment option 
Insufficient bone quality to support the BI300 implant as determined by the surgeon 
Written, informed consent must be obtained from the subject before any study procedures 
are initiated. 
 
7.2.3 
Number of Subjects Required 
A total of up to 20 newly implanted subjects is planned.  This sample size should provide 
adequate power for statistical tests of the primary endpoint under conservative assumptions. 
7.2.4 
Vulnerable Populations 
Not applicable. 
7.2.5 
Enrollment & Study Duration 

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The following subject status definitions apply: 
Consented: A subject who has provided informed consent and 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/Treated: Subjects who have met all eligibility criteria, have qualified for surgery 
and have received the Osia 2 implant. 
Withdrawn: Enrolled subjects who withdraw or are withdrawn by the Investigator or Sponsor 
before their expected end of study visits. Withdrawn subjects may still continue in safety 
follow-up until their scheduled end of study visit for reasons described in section 7.2.6. 
The enrollment period for the clinical investigation is anticipated to be 6 - 8 months from the 
time of first subject consent to enrollment of the last subject. 
The expected duration of each subject’s participation is 7-8 months. 
During this time there will be required research related visits. 
• 
Screening 
• 
Visit 1 
• 
Visit 2: Surgery - Treatment 
• 
Visit 3: 2-week check post-surgery 
• 
Visit 4: 4-week post-surgery fitting 
• 
Visit 5: 3 Months post-surgery 
• 
Visit 6: 6 Months post-surgery (End of Study) 
The anticipated total duration of the clinical investigation is therefore 12 - 18 months 
including set up, execution and closure. The execution phase of the Clinical Investigation is 
considered complete after the last subject, last visit. IRBs should remain open through 
closeout monitoring activities, until Sponsor notifies site of database lock. 
7.2.6 
Criteria for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall 
ask the reason(s). The reason for withdrawal should to be documented in the subject’s 
source files and the case report form (CRF). 
The Investigator or Sponsor may also decide to withdraw a subject from the clinical 
investigation if it is considered to be in their best interests. 
Subject withdrawal may be for any of the following reasons: 
• 
Adverse Event (AE) 

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• 
Device Deficiency (DD) 
• 
CIP or GCP deviation 
• 
Subject lost to follow-up 
• 
Subject withdrew consent 
• 
Subject death 
• 
Sponsor decision 
• 
Investigator decision 
• 
Other (specify) 
If subject withdrawal is due to problems related to the AMDT or comparator 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 End-of-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 3 
separate attempts taken to contact the subject may be documented in the medical chart. 
Treated subjects who are withdrawn/discontinued will not be replaced. 
7.2.7 
Randomization Procedures 
Subjects who meet eligibility criteria for enrolment will be randomized to a test order for the 
3-month interval prepared by the Sponsor. Subjects will be randomly assigned to one of two 
test order configurations using a ratio of 1:1. 
7.2.8 
Blinding Procedures 
Not applicable for the current clinical investigation. 
7.2.9 
Post-investigation Medical Care 
Not applicable for the current clinical investigation. 
 
7.3 
Performance Evaluations and Procedures 
7.3.1 
Metrics 
7.3.1.1  Audiometric Thresholds 
7.3.1.1.1 
Unaided audiometric thresholds 
Unaided audiometric thresholds will be obtained for each ear, with insert earphones or 
headphones, using the standard audiometric technique for pure-tone air-conduction testing. 
All preimplantation testing will be completed using an audiometer calibrated to American 
National Standards Institute (ANSI) standards with maximum output for frequencies of 0.5 to 
4 kHz. Pure tone threshold exploration will be completed using the adaptive Hughson & 

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Westlake procedure1. 
Testing in each ear will include the following: 
Air conduction thresholds: 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz with 
appropriate masking as required; 
Bone conduction thresholds: 250, 500, 1000, 2000, 3000 & 4000 Hz with appropriate 
masking as required. 
NOTE: An audiogram completed up to 90 days prior to Screening will be considered valid for 
determination of eligibility and data collection as part of Screening if all required frequencies 
detailed above were assessed. 
7.3.1.1.2 
Aided audiometric thresholds 
Aided audiometric thresholds will be obtained in a calibrated sound field, using the standard 
audiometric technique for sound field testing. The purpose of this assessment is to establish 
hearing thresholds in the free-field through a speaker in the front position (0º azimuth). All 
testing will be completed using narrow band noise in a sound field calibrated to American 
National Standards Institute (ANSI) standards with maximum output for frequencies of 0.5 to 
4 kHz. The test shall be performed with the non-test ear blocked. Testing will include the 
following:  
Aided sound field thresholds: 500, 1000, 2000, 4000, 6000Hz. 
7.3.1.2 Speech perception in quiet 
7.3.1.2.1 
CNC Monosyllabic Words 
The CNC Word Test2 is a validated test used clinically and in research to assess the 
performance of adults with hearing loss on open-set word recognition. The test consists of 
10 recorded lists of 50 monosyllabic words in CD format. Two lists will be administered in 
quiet at a level equal to 60 dBA in the sound field and scored as total number of words and 
phonemes correct, which will be expressed as a percentage correct for this study. Subjects 
will be tested using a configuration of speech at 0º azimuth in quiet (S0). The test shall be 
performed with the non-test ear blocked.  Visit 1 will be performed in the unaided and aided 
condition using the Baha 5 Power on a Sound Arc. Visits 4, 5, and 6 will be performed using 
the Osia 2 Sound Processor.  
7.3.1.3 Speech perception in noise 
7.3.1.3.1 
AzBio Sentences in Noise 
The AzBio Sentence Test3 is a validated test used clinically and in research to assess the 
open- set sentence recognition in speech-weighted noise of adults with hearing loss. It 
consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in 
a conversational style with limited contextual cues that the listener can use to predict or ‘fill 
in’ unintelligible words. The sentences will be presented at a fixed level of 65 dBA at a fixed 
+5 dB signal-to-noise ratio (SNR) using the accompanying noise stimulus. Each list includes 

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5 sentences from 4 different male and female speakers. The average level of intelligibility of 
each list is 85% +/- 1%. Each word in the sentence counts towards the overall score (percent 
correct). Subjects will be tested using a configuration of speech and noise at 0º azimuth 
(S0N0). The test shall be performed with the non-test ear blocked. Visit 1 will be performed 
in the unaided and aided condition using the Baha 5 Power on a Sound Arc and Visit 5 will 
be performed using the Osia 2 Sound Processor. 
7.3.1.3.2 
QuickSin 
The QuickSin4 was developed to provide a quick way for clinicians to quantify a patient’s 
ability to hear in noise, determine if extended high frequency emphasis improves or 
degrades understanding of speech in noise and provide a large number of equivalent test 
lists for use in clinical and research work. Each track consists of six sentences with five key 
words per sentence presented in four-talker babble noise. The sentences are presented at 
signal-to- noise ratios which will be decreased manually in 5-dB steps from 25 (very easy) to 
0 (extremely difficult). The SNRs used are: 25, 20, 15,10, 5 and 0, encompassing normal to 
severely impaired performance in noise. Subjects will be tested on 4 individual tracks (24 
sentences) at 65dB(A) using a configuration of speech at 0º and noise at 180º azimuth 
(S0N180) for each condition. The split noise tracks are numbered 24 – 35. The test shall be 
performed with the non-test ear blocked.  Visit 1 will be performed in the unaided and aided 
condition using the Baha 5 Power on a Sound Arc. Visits 4, 5, 6 will be performed using the 
Osia 2 Sound Processor.  
7.3.1.4 Speech, Spatial, and Qualities of Hearing Scale (SSQ-12) 
The short form of Speech, Spatial, and Qualities of Hearing questionnaire (SSQ-12)5 from 
MRC Institute of Hearing Research, UK, is a scaled-down version of the 49-item SSQ 
questionnaire. It is designed to compile a sub-set of items from the longer original 49-item 
version to represent the scale as a whole, measuring self-reported auditory disability, 
reflecting the reality of hearing in the everyday world. 
Categories of assessment include: 
• 
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 SSQ-12 will be completed in the everyday listening condition at Visit 1 and Visit 5.  
7.3.1.5 Patient Reported Questionnaire 
The Patient Reported Questionnaire is an in-house developed questionnaire designed to 
collect subjective ratings on each subject’s experiences with their current technology. The 
Patient Reported Questionnaire will be completed in the everyday listening condition at Visit 

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1 and Visit 5. 
7.3.1.6 Medical History 
Medical history CRFs will be collected at Visit 1. Information collected will include current or 
past medical or surgical conditions relevant to the conduct of the study. 
7.3.1.7 Hearing History 
Hearing history will be collected at Visit 1. Information collected will include duration, type 
and etiology of hearing loss in addition to any non-surgical hearing loss treatment details 
(e.g. hearing aid use). 
 
7.3.2 Methods 
7.3.2.1 Screening and Informed Consent 
Subjects who have been deemed appropriate candidates for implantation according to 
standard clinical practice will be considered potential research subjects for this study. 
Informed consent must occur prior to study related activities with the exception of an 
audiogram performed within 90 days of Screening/Candidacy. Individuals will be 
appropriately counselled on the risks and benefits of study participation prior to participating 
in any study related activity. The risks of surgery shall be explained to the subjects as 
outlined in the Informed Consent Form. After reviewing the Informed Consent Form, the 
candidate will be given the opportunity to review and ask questions about the Informed 
Consent Form and/or the study prior to signing the Informed Consent Form. The candidates 
will be offered the opportunity to take the form home to discuss with family members should 
they choose to do so. If the participant agrees to participate, a copy of the executed informed 
consent will be provided to the participant. All individuals who provide informed consent will 
be assigned a unique identifier. A unique alphanumeric code will identify each subject 
throughout the course of the study. 
7.3.2.2 Screening Visit  
Subjects are consented into the study and the following data should be collected on all 
subjects who meet eligibility criteria. The only required documentation for subjects who do 
not meet eligibility criteria at the Screening visit is the Informed Consent Form and Eligibility 
electronic Case Report Form. 
7.3.2.2.1 
Electronic Case Report Forms 
• 
Inclusion/Exclusion – Eligibility 
• 
Demographics 
• 
Hearing history 
• 
Medical history 
• 
Device History 

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7.3.2.2.2 
Audiometric testing 
Testing in each ear will include the following: 
• 
Unaided air conduction thresholds: 250, 500, 1000, 2000, 3000, 4000, 6000, 
8000 Hz with appropriate masking as required 
• 
Unaided bone conduction thresholds: 250, 500, 1000, 2000, 3000, 4000 Hz with 
appropriate masking as required 
7.3.2.3 Visit 1 
7.3.2.3.1 
Electronic Case Report Forms 
• 
Concomitant Medications - See section 7.2.4 below for additional information. 
7.3.2.3.2 
Sound field hearing thresholds – 500, 1000, 2000, 4000 and 6000 Hz 
• 
Unaided 
• 
Aided with Baha 5 Power on a Sound Arc. 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.3.3 
CNC Word Test (Speech perception testing in quiet) – 2 lists 60dB(A) in 
sound field - S0 
• 
Unaided 
• 
Aided with Baha 5 Power on a Sound Arc 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.3.4 
AzBio Sentence Test in Noise – 1 list 65 dB(A) +5dB SNR in sound field – 
S0N0 
• 
Unaided 
• 
Aided with Baha 5 Power on a Sound Arc 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.3.5 
QuickSin Test – 4 lists 65 dB(A) in sound field – S0N180 
• 
Unaided 
• 
Aided with Baha 5 Power on a Sound Arc 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.3.6 
Patient Reported Outcomes 
• 
SSQ-12 
• 
Patient Reported Questionnaire 
7.3.2.4 Visit 2: Surgery 
Subjects will be implanted with a commercially cleared Osia 2 system according to the 
surgical technique detailed in the Physicians Guide. Surgery is considered treatment, and 
thus the start of adverse event reporting. 

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7.3.2.5 Visit 3: 2 Week Post Surgery  
Subjects will be seen for a 2-week post-surgical follow up to ensure the incision and implant 
site are healing appropriately in preparation for fitting at 4 weeks post- surgery. If applicable, 
device or procedure related adverse events and device deficiencies will be collected during 
this visit. 
7.3.2.6 Visit 4: 4 Week Post Surgery 
7.3.2.6.1 
Fitting 
• 
Optimization of the Osia 2 Sound Processor and device counselling 
7.3.2.6.2 
Sound field hearing thresholds – 500, 1000, 2000, 4000 and 6000Hz 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.6.3 
CNC Word Test (Speech perception testing in quiet) – 2 lists 60dB(A) in 
sound field - S0 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.6.4 
QuickSin Test – 4 lists 65 dB(A) in sound field – S0N180 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.7 Visit 5: 3 Months Post Surgery  
7.3.2.7.1 
Sound field hearing thresholds – 500, 1000, 2000, 4000 and 6000 Hz 
• 
Unaided 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.7.2 
CNC Word Test (Speech perception testing in quiet) – 2 lists 60dB(A) in 
sound field - S0 
• 
Unaided 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.7.3 
AzBio Sentence Test in Noise – 1 list 65 dB(A) +5dB SNR in sound field – 
S0N0 
• 
Unaided 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.7.4 
QuickSin Test – 4 lists 65 dB(A) in sound field – S0N180 

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• 
Unaided 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.7.5 
Patient Reported Outcomes 
• 
SSQ-12 
• 
Patient Reported Questionnaire 
7.3.2.8 Visit 6: 6 Months Post Surgery, End of Study  
7.3.2.8.1 
Sound field hearing thresholds – 500, 1000, 2000, 4000 and 6000Hz 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.8.2 
CNC Word Test (Speech perception testing in quiet) – 2 lists 60dB(A) in 
sound field - S0 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed. 
7.3.2.8.3 
QuickSin Test – 4 lists 65 dB(A) in sound field – S0N180 
• 
Aided with Osia 2 Sound Processor 
Note: The test shall be performed with the non-test ear plugged/muffed 
7.3.3 Safety Evaluations and Procedures 
The identified risks and anticipated device related adverse events detailed in Sections 8 and 
11 of the CIP will be assessed in the clinical investigation via reporting of all device and 
procedure related AEs/ADEs. Reporting timeframe will start for each individual subject at the 
time of treatment and end at either subject withdraw or completion in the study. 
Safety data adjudication may be conducted by the Sponsor’s Medical Officer in accordance 
with the Sponsor’s standard operating procedures. 
7.3.4 Concomitant Medication and Therapies 
A comprehensive list of concomitant prescription medications will be captured in subjects 
who meet eligibility at the screening visit. Medications available over the counter will not be 
collected. Changes to concomitant prescription medications associated with device or 
procedure related adverse events will also be captured throughout the course of the trial.  
 
7.4 Equipment Used for Evaluation of Performance and Safety 
The following equipment will be used to evaluate performance and safety: 
• 
Audiometers: data collected on this equipment will be used for candidacy 
determination and screening as well as postoperative assessments. 

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• 
Sound booth: location where a subject will be assessed. The sound booth will be 
outfitted with two speakers. 
• 
Calibration records should include audiometer, insert earphones and/or headphones 
and sound field environment. 
No other equipment calibration records will be required for this clinical investigation. 
 
7.5 Sponsor Role in Conduct of the Clinical Investigation 
Sponsor representatives may be present for intraoperative surgical support and clinical 
support of programming visits. 
Sponsor representatives will be actively engaged in monitoring and operational 
communications with clinical sites for appropriate oversight and to ensure compliance. 
Further details regarding site communications and roles/responsibilities are documented in 
the Safety Data Handling Plan and Communications Plan. 
To mitigate any potential bias, if it is requested that the Sponsor enter data into the 
electronic data capture system, the assigned individuals will not be involved in analysis of 
data. The Clinical Project Manager as well as the Clinical Review Board will be tasked with 
reviewing data listings for any abnormal trends associated with protocol compliance and/or 
safety issues. Formal analyses will be performed according to the Statistical Analysis Plan. 
 
8 
RISKS AND BENEFITS OF THE CLINICAL INVESTIGATION AND 
APPROVED MEDICAL DEVICE ON TEST 
8.1 
Anticipated Clinical Benefits 
Potential benefits associated with participation in the clinical investigation include: 
 
• 
Helping to find better treatments, therapies and/or diagnostic tests in the area of 
hearing loss or other condition 
• 
The opportunity to be given a new intervention that may be better for their 
condition or that has fewer side effects or limitations than they are receiving now 
• 
The opportunity to access the newest innovations in the treatment of hearing loss 
• 
The chance to play an active role in their own hearing health and gain a greater 
understanding of their condition 
• 
Advice, care, and support from trained clinical staff who understand hearing loss 
or their condition 
• 
Closer monitoring of their hearing loss or condition 

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8.2 
Anticipated Adverse Device Effects 
Based on the available safety reference information and literature, the potential clinical risks 
have been documented below. 
8.2.1 Risks Associated with the Surgery 
• 
General risks associated with surgery including pain, scarring, bleeding and 
infection 
• 
General risks associated with anesthesia during the surgery (e.g., risks for 
the heart, lungs, kidneys, liver, and brain) which, in rare cases, can result in 
death 
8.2.2 Additional Risks Associated with Implantation of the Study Device 
• 
Pain or discomfort 
• 
Skin irritation near the implant, swelling or redness near the magnet site, skin 
breakdown 
• 
Sense of numbness or stiffness in the area of the surgery 
• 
Failure of the implant to properly anchor to the skull-bone due to a lack of 
adequate bone quantity/quality, trauma, infection, generalized diseases and 
surgical complications 
• 
Other medical complications that may require additional medical treatment, such 
as: 
o 
Concurrent CSF leakage: a leak of CSF (cerebrospinal fluid) through the 
hole in the skull 
o 
Subdural injury: blood vessels near the brain may burst 
o 
Subcutaneous hematoma: bruises and contusions on the skin 
o 
Skin-flap infection, irritation or inflammation 
o 
Extrusion of the device caused by a foreign body under the skin 
o 
Revision surgery to remove the study implant in the event of device 
failure 
• 
Failure of the implant or sound processor could result in the perception of an 
uncomfortably loud sound sensation, intermittent sound, or no sound. 
• 
The implanted magnet may affect MRI (Magnetic Resonance Imaging) 
procedures. The magnet may influence the MRI scanner or the ability of the 
scanner to detect certain changes. Under certain circumstances removal of the 
AMDT may be necessary prior to MRI scanning. 
• 
There may be side effects that are not known at this time. 
8.3 
Risks Associated with Participation in the Clinical 

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Investigation 
In addition to the anticipated surgical and adverse device effects of the AMDT, the following 
risks may also present when participating in the clinical investigation: 
• 
Exposure to sounds produced in the test battery that could be perceived as too loud 
• 
Testing procedures that may produce anxiety or fatigue 
• 
Discomfort and potential abrasion to the ear canal due to placement of insert 
earphones 
• 
Discomfort associated with the fitting of the Sound Arc 
 
8.4 
Risk Mitigation 
The clinical investigation sites chosen for participation in the study have been previously 
trained as part of the Sponsors Controlled Market Release (CMR). Each have experience 
treating the indicated population with the AMDT. 
The study design introduces minimal risk outside of the standard commercial risks 
associated with bone conduction technology. Additionally, all reported device or procedure 
related adverse events and device deficiencies captured during the course of the study will 
be regularly reviewed by the Sponsor’s Clinical Review Board to facilitate early detection and 
appropriate intervention if events are unanticipated with respect to incidence, severity, or 
outcome. Device associated adverse events and deficiencies will also be entered into our 
Global Quality Complaint Management System to allow for post market trending and any 
applicable reporting to regulatory authorities. 
 
8.5 
Risk-to-Benefit Rationale 
The subjects recruited for this study are already considering treatment with an 
osseointegrated bone conduction device. The risk benefit rationale is such that participation 
in this study will provide subjects with additional hearing health information pertaining to their 
outcome with the Osia 2 bone conduction system than they would receive commercially. 
 
9 STATISTICAL CONSIDERATIONS 
9.1 
General Considerations 
Except where otherwise specified, the following general principles apply to the planned 
statistical analyses. All statistical analysis will be conducted using 
 
 or other widely-accepted statistical or graphical software as 
required. 
Continuous data will be summarized with mean, standard deviation, median, minimum, 

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maximum, and number of evaluable observations. Categorical variables will be summarized 
with frequency counts and percentages. Confidence intervals may be presented, where 
appropriate, using the t-distribution for continuous data and Clopper-Pearson Exact method 
for categorical variables. 
All investigational sites will follow the requirements of a common protocol and standardized 
data collection procedures and forms. All efforts will be put forth to ensure near complete 
follow-up, with particular focus on the assessment of the primary outcome and occurrence of 
adverse events. Regular reminders of subject follow-up due dates will be provided to 
participating centers to facilitate scheduling of follow-up visits. Further details regarding 
statistical considerations can be found in the Statistical Analysis Plan. 
 
9.2 
Endpoints 
9.2.1 Primary Endpoint 
To demonstrate significant difference between the aided and unaided conditions at 3 months 
using an adaptive speech in noise test when compared to the preoperative (Visit 1) unaided 
condition. 
9.2.2 Secondary Endpoint 
The secondary endpoint is to evaluate the safety of the Osia 2 system in a group of adult 
newly implanted recipients by estimating the incidence of device or procedure related 
adverse events. 
9.2.3 Exploratory Endpoints 
There are no exploratory endpoints. 
 
9.3 
Hypotheses 
Formal hypothesis tests are planned for the primary endpoint to establish superiority of the 
aided over unaided conditions. Statistical hypothesis tests will be based on t-tests with a 
one-sided 0.025 alpha level. 
9.3.1 Primary Hypothesis 
The primary objective is to evaluate the performance of the Osia 2 system on an adaptive 
speech in noise test. A t-test of superiority for the adaptive speech in noise test, comparing 
the aided and unaided conditions at 3-months relative to the preoperative (Visit 1) unaided 
condition. The mathematical statement of this hypothesis test is written as: 
H0: ΔOn ≥ ΔOff H1: ΔOn < ΔOff 
where ΔOn is the mean change in the adaptive speech in noise test between the 3-month 
aided (on) condition and the preoperative unaided condition, and ΔOff is the mean change in 
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preoperative (Visit 1) unaided condition. Successful rejection of the null hypothesis indicates 
the aided performance of the Osia 2 system is superior to the unaided performance based 
on the adaptive speech in noise test. 
9.3.2 Secondary Hypothesis 
There is no secondary hypothesis as the intent is to capture the observed rate of incidence 
for device and procedure related adverse events.  
9.3.3 Exploratory Hypothesis 
There are no exploratory hypotheses. 
 
9.4 
Sample Size Determination 
The planned sample size of 20 will provide greater than 95% power under a conservatively 
assumed mean of 12 and standard deviation of 15. Calculations are based on a one-sided 
0.025 alpha and include allowance for attrition of up to 20%. 
 
9.5 
Analysis Populations 
Analysis will be based on the intent-to-treat population. In order to obtain a complete ITT 
population, multiple imputation will be used for any missing outcome data. 
 
9.6 
Primary Endpoint Analyses 
Analysis of the primary endpoint will be based on a paired t-test of means comparing the 
change from preoperative (Visit 1) between the 3-month aided and unaided conditions. This 
will be a superiority test based on a one-sided 0.025 alpha level. Sensitivity analyses will 
include testing for a period and for a crossover effect. 
 
9.7 
Secondary Endpoint Analyses 
Descriptive statistics, specifically counts and percentages of device or procedure related 
adverse events captured through 6 months post-surgery, will be summarized.  
 
9.8 
Exploratory Endpoint Analyses 
There are no exploratory hypotheses. 
 
9.9 
Safety Analyses 
Descriptive statistics, specifically counts and percentages of device or procedure related 
AEs, will be summarized for the subject population. Any subjects who die, are treatment 

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failures, or discontinued an intervention due to an adverse event will be summarized 
separately. 
 
9.10 
Interim Analysis 
Analysis will be conducted upon completion of Visit 5 (3 months post-surgery) or once the 
minimum sample size requirements are met for the primary endpoint. 
 
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 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 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. 
NOTE 1: This definition includes events related to the medical device or the comparator 
device. 

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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: 
a) led to a death, 
b) 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 hospitalization or prolonged hospitalization, 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. 
c) led to fetal distress, fetal death or a congenital physical or mental abnormality, or birth 
defect 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the 
CIP, without serious deterioration in health, is not considered a 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. 
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 
instructions for use (IFU). 
USADE are also known as a UADE (Unanticipated Adverse Device Effect) for the purposes 
of US FDA reporting. 

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• 
Screen Fail: Subject determined not to be eligible to proceed for participation 
• 
Enrolled/Treated: Subjects who are considered enrolled or treated have been 
successfully implanted with the AMDT. Any participant who is not successfully 
implanted will be considered a treatment failure and classified accordingly.  
• 
Withdrawn: Enrolled subjects who withdraw or are withdrawn by the Investigator or 
Sponsor before the expected End of Study visit. 
• 
Complete: Enrolled subjects who complete the planned follow up schedule and End of 
Study visit. 
Source data will be captured in clinic notes, paper-based source data worksheets, or printed 
directly from testing software. The Origin of Source Form will be completed for each site 
prior to first subject consented, to support clear and concise identification of source data at 
each clinical site. If electronic medical records do not permit read only access for monitoring 
purposes, a verified printout and/or certified copy 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 study 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 clinical fitting 
software. 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 

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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 
submission to a regulatory authority shall not disclose the identity of any subject. 
 
16 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
The clinical investigation will not commence prior to the written favorable opinion or approval 
from the EC and or regulatory authority (if appropriate) 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 investigational 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 investigation. The Investigator will send written status 
summaries of the investigation to the EC regularly, as per local EC requirements. 
Upon completion of the clinical investigation, 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 

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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 
In the event of premature study termination, the subjects will continue to be managed 
clinically by their medical provider. 
 
18 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
Sponsor will notify all site Principal Investigators of changes to the CIP. This agreement will 
be documented as a CIP amendment. Amendments will require notification to the Ethics 
Committees (ECs) by the Principal Investigators (and to the relevant regulatory authority(s) 
by the Sponsor, if applicable). 
 
19 RECORD KEEPING AND RETENTION 
Data generated from the clinical investigation will be stored in a limited-access file area and 
be accessible only to representatives of the study site, the Sponsor and its representatives, 
and relevant health authorities/regulatory agencies. All reports and communications relating 
to study subjects will identify subjects only by subject unique identification code. Complete 
subject identification will be maintained by the Investigator. This information will be treated 
with strict adherence to professional standards of confidentiality. 
Per 21 CFR 812.140 (d), An investigator or sponsor shall maintain the records required by 
this subpart during the investigation and for a period of 2 years after the latter of the 
following two dates: The date on which the investigation is terminated or completed, OR the 
date that the records are no longer required for purposes of supporting a premarket approval 
application, a notice of completion of a product development protocol, a humanitarian device 
exemption application, a premarket notification submission, or a request for De Novo 
classification. 
The Sponsor will notify the Principal Investigator when records are no longer needed. The 
Investigator will not discard any records without notifying the Sponsor. If the Principal 
Investigator moves from the current investigational site, the Sponsor should be notified of the 
name of the person who will assume responsibility for maintenance of the records at the 
investigational site or the new address at which the records will be stored. The Investigator 
will notify the Sponsor as soon as possible in the event of accidental loss or destruction of 
any study documentation. 
 
20 PUBLICATION POLICY 
This clinical investigation will be prospectively registered at a public clinical trial registry, 

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ClinicalTrials.gov. 
A joint peer-reviewed publication authored by the clinical investigator(s) and Sponsor will be 
prepared. In addition, the results of the clinical investigation may also be disseminated as 
conference presentations (e.g., abstract and poster session). Manuscript authorship and 
responsibilities will be discussed and agreed upon prior to investigation start and in 
accordance with guidelines and recommendations provided by the International Committee 
of 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 recognized 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 study 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. 

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23 TRADEMARKS AND COPYRIGHT 
ACE, Advance Off-Stylet, AOS, AutoNRT, Autosensitivity, Beam, Button, CareYourWay, 
Carina, Cochlear, 科 利 耳 , コ ク レ ア , Cochlear SoftWear, Codacs, ConnectYourWay, 
Contour, Contour Advance, Custom Sound, ESPrit, Freedom, Hear now. And always, 
HearYourWay, Hugfit, Hybrid, Invisible Hearing, Kanso, MET, MicroDrive, MP3000, 
myCochlear, mySmartSound, NRT, Nucleus, Off-Stylet, Slimline, SmartSound, Softip, 
SPrint, True Wireless, the elliptical logo, WearYourWay and Whisper are either trademarks 
or registered trademarks of Cochlear Limited. Ardium, Baha, Baha SoftWear, BCDrive, 
DermaLock, EveryWear, Vistafix, and WindShield are either trademarks or registered 
trademarks of Cochlear Bone Anchored Solutions AB. © Cochlear 2019 
 
24 REFERENCES 
1) Hughson W, Westlake HD. Manual for program outline for rehabilitation of aural 
casualties both military and civilian. Trans Am Acad Ophthal Oto-lar. 1944(Suppl.):3-15. 
2) Peterson GE, Lehiste I. Revised CNC lists for auditory tests. The Journal of speech and 
hearing disorders. 1962;27:62-70. 
3) Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, et al. 
Development and validation of the AzBio sentence lists. Ear and hearing. 
2012;33(1):112-7. 
4) QuickSin Speech-in-Noise Test Version 1.3 User Manual.2001.Etymotic Research Inc. 
5) Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, 
Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 
2013;52(6):409-12. 
6) Verheij E, Bezdjian A, Grolman W et al. A systematic review on complications of tissue 
preservation surgical techniques in percutaneous bone conduction hearing devices. 
Otology & Neurotology. 2016; 37:829-837. 
7) 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 
8) World Medical Association Declaration of Helsinki – Ethical Principles for Medical 
Research Involving Human Subjects. 2013. Available at: https://www.wma.net/policies- 
post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving- 
human-subjects/.