A Pivotal, Prospective, Multi-center, Open-label Study Evaluating the Safety and Effectiveness of the CochlearTM Osia® 2 System in a Pediatric Population.
Phase: NA
Conditions: Mixed Hearing Loss, Single-Sided Deafness, Conductive Hearing Loss
Sponsor: Cochlear

Official Title: A pivotal, prospective, multi-center, open-label study evaluating 
the safety and effectiveness of the CochlearTM Osia® 2 System in a pediatric 
population 
 
 
NCT Number: NCT05000931       
 
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Clinical Investigation Plan 
 
Investigation Title: A pivotal, prospective, multi-center, open-label study evaluating 
the safety and effectiveness of the Cochlear™ Osia® 2 System in a pediatric 
population. 
Short Title: 
Osia Peds Expansion 
CIP Number: 
CAM5766 
Version and Date:  
Refer to system version control 
Sponsor: 
Cochlear Americas 
10350 Park Meadows Drive 
Lone Tree, Colorado, USA 80124 
 
 
This clinical investigation shall be conducted in accordance with ethical principles that have their origin in the 
Declaration of Helsinki, International Standard ISO 14155:2020 Clinical investigation of medical devices for 
human subjects - Good Clinical Practice, 21 CFR Parts 812, 56, 54, 50 & 11 as well as 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 Limited  
1 University Avenue 
Macquarie University, NSW2109 
Sponsor Organisation(s) 
 
Cochlear Americas 
10350 Park Meadows Drive 
Lone Tree, Colorado USA 80124 
Funding Source 
Sponsoring Organisation(s)  
Contract Services 
Statistician 
NAMSA Minneapolis - St. Louis Park  
400 Highway 169 South, Suite 500  
Minneapolis, Minnesota 55426  
United States 
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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INVESTIGATOR AGREEMENT 
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. 
I also agree that my personal information may be provided to regulatory agencies and public clinical trial 
registry platforms and stored in their systems in order to comply with regulatory requirements. Examples of 
the type of personal information include my name, signature and summary of qualifications. 
Name 
Title 
 
Principal Investigator 
Site Name 
Site Address 
 
 
Signature 
Date 
 
 
 
 
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TABLE OF CONTENTS 
Definitions and Abbreviations ................................................................................................................. 7 
1 
Clinical Investigation Synopsis ........................................................................................................ 9 
2 
Schedule of Events ....................................................................................................................... 12 
3 
Background Information and Rationale ........................................................................................ 15 
3.1 
Introduction ......................................................................................................................... 15 
3.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 15 
3.2.1 
Nonclinical Data .................................................................................................... 15 
3.2.2 
Clinical Data .......................................................................................................... 15 
3.3 
Study Rationale .................................................................................................................. 17 
4 
Medical Device Information ........................................................................................................... 17 
4.1 
Identity and Description of the Investigational Medical Device (IMD) ................................ 17 
4.2 
Identity and Description of the Comparator ........................................................................ 18 
4.3 
Accessory Device Requirements ........................................................................................ 18 
5 
Objectives ..................................................................................................................................... 18 
5.1 
Primary Objective ............................................................................................................... 18 
5.2 
Secondary Objective ........................................................................................................... 18 
5.3 
Exploratory Objective .......................................................................................................... 18 
6 
Design of the Clinical Investigation ............................................................................................... 19 
6.1 
General ............................................................................................................................... 19 
6.1.1 
Design Rationale ................................................................................................... 19 
6.2 
Subjects .............................................................................................................................. 20 
6.2.1 
Inclusion Criteria ................................................................................................... 20 
6.2.2 
Exclusion Criteria .................................................................................................. 20 
6.2.3 
Number of Subjects Required ............................................................................... 21 
6.2.4 
Vulnerable Populations ......................................................................................... 21 
6.2.5 
Recruitment and Study Duration ........................................................................... 22 
6.2.6 
Criteria and Procedures for Subject Withdrawal ................................................... 23 
6.2.7 
Randomisation Procedures .................................................................................. 23 
6.2.8 
Post-investigation Medical Care ........................................................................... 23 
6.3 
Evaluations and Procedures ............................................................................................... 23 
6.3.1 
Screening/eligibility ............................................................................................... 24 
6.3.2 
Performance/Effectiveness ................................................................................... 24 
6.3.3 
Safety Evaluations and Procedures ...................................................................... 26 
6.3.4 
Detailed Visit Schedule ......................................................................................... 26 
6.4 
Equipment Used for Evaluations and Procedures .............................................................. 28 
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6.5 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 28 
7 
Benefits and Risks of the Investigational medical device and Clinical Investigation .................... 29 
7.1 
Anticipated Clinical Benefits ............................................................................................... 29 
7.2 
Anticipated Adverse Device Effects .................................................................................... 29 
7.2.1 
Risks Associated with the Surgery ....................................................................... 29 
7.2.2 
Risks Associated with Implantation of the Study Device ...................................... 29 
7.2.3 
Risks Associated with Use of the Study Device ................................................... 30 
7.2.4 
Risks Associated with Simultaneous Aural Atresia and Microtia Repair .............. 30 
7.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 31 
7.4 
Risk Mitigation .................................................................................................................... 31 
7.5 
Benefit-to Risk Rationale .................................................................................................... 31 
8 
Statistical Considerations .............................................................................................................. 32 
8.1 
General Considerations ...................................................................................................... 32 
8.2 
Endpoints ............................................................................................................................ 32 
8.2.1 
Primary Endpoint .................................................................................................. 32 
8.2.2 
Secondary Endpoints ............................................................................................ 32 
8.2.3 
Exploratory Endpoints ........................................................................................... 32 
8.3 
Hypotheses ......................................................................................................................... 33 
8.3.1 
Primary Hypothesis ............................................................................................... 33 
8.3.2 
Secondary Hypotheses ......................................................................................... 33 
8.3.3 
Exploratory Hypothesis ......................................................................................... 34 
8.4 
Sample Size Determination ................................................................................................ 34 
8.5 
Analysis Populations ........................................................................................................... 34 
8.6 
Endpoint Analyses .............................................................................................................. 35 
8.6.1 
Primary Endpoint Analyses ................................................................................... 35 
8.6.2 
Secondary Endpoint Analyses .............................................................................. 35 
8.6.3 
Exploratory Endpoint Analyses ............................................................................. 35 
8.7 
Safety Analyses .................................................................................................................. 35 
8.8 
Interim Analyses ................................................................................................................. 35 
9 
Informed Consent Process ........................................................................................................... 35 
10 Adverse Events and Device Deficiencies ..................................................................................... 36 
10.1 Definitions ........................................................................................................................... 36 
10.1.1 
Adverse Event ...................................................................................................... 36 
10.1.2 
Adverse Device Effect .......................................................................................... 36 
10.1.3 
Serious Adverse Event ......................................................................................... 36 
10.1.4 
Serious Adverse Device Effect ............................................................................. 37 
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10.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 37 
10.1.6 
Adverse Events of Special Interest ....................................................................... 37 
10.1.7 
Device Deficiency ................................................................................................. 37 
10.1.8 
Serious Health Threat ........................................................................................... 37 
10.2 Recording and Handling of Adverse Events ....................................................................... 38 
10.2.1 
Assessment of Severity ........................................................................................ 38 
10.2.2 
Assessment of Causality ...................................................................................... 38 
10.2.3 
Assessment of Seriousness ................................................................................. 40 
10.2.4 
Assessment of Expectedness .............................................................................. 40 
10.2.5 
Non-reportable Adverse Events ........................................................................... 40 
10.3 Recording and Handling of Device Deficiencies................................................................. 40 
10.4 Reporting Responsibilities .................................................................................................. 40 
10.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 41 
10.4.2 
Sponsor Notification of Events ............................................................................. 41 
10.5 Independent Data Monitoring Committee ........................................................................... 41 
11 Device Accountability .................................................................................................................... 41 
12 Deviations from the Clinical Investigation Plan ............................................................................. 42 
13 Data Management ........................................................................................................................ 43 
13.1 Source Data ........................................................................................................................ 43 
13.2 Methods for Data Entry and Collection ............................................................................... 43 
13.3 Database Lock .................................................................................................................... 43 
14 Confidentiality ................................................................................................................................ 44 
15 Ethics Committee and Regulatory Authority Approval .................................................................. 44 
16 Suspension or Premature Termination ......................................................................................... 44 
17 Amendments to the Clinical Investigation Plan ............................................................................. 45 
18 Record Keeping and Retention ..................................................................................................... 45 
19 Publication Policy .......................................................................................................................... 45 
20 Statements of compliance ............................................................................................................. 46 
21 Quality Control and Assurance ..................................................................................................... 46 
21.1 Monitoring ........................................................................................................................... 46 
21.2 Audits .................................................................................................................................. 47 
22 Trademarks and Copyright ........................................................................................................... 47 
23 References .................................................................................................................................... 47 
24 Change History. ............................................................................................................................ 48 
Appendices ........................................................................................................................................... 49 
Appendix 1: Statement/Declaration of Device Conformity ................................................................... 49 
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3 BACKGROUND INFORMATION AND RATIONALE 
3.1 
Introduction 
The Cochlear™ Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 
(K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 
55 dB HL) or single-sided-deafness (SSD). Published and unpublished data suggest significant pre to 
postoperative benefit and minimal risk in both children and adults who have received the Osia system. Due to 
the success of the Osia 2 system in the United States within the currently indicated patient population, clinical 
providers have since requested the ability to use the Osia 2 system in children aged 11 years and younger who 
meet the audiometric requirements. As the Osia 2 system is based on existing bone conduction and cochlear 
implant technologies which each possess a younger age of implantation requirement (5 years for bone 
conduction and 9 months for cochlear implantation), the current proposal is to align the age at implantation 
requirement with existing surgical bone conduction technology such as the Baha Connect and Baha Attract 
Systems to 5 years of age. Therefore, the objective of this study is to examine the safety and effectiveness of 
the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or 
mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the 
indications for use.  
3.2 Findings of Previous Nonclinical and Clinical Studies 
3.2.1 
Nonclinical Data 
A summary of non-clinical data is available for reference in the Osia FDA clearance K190589. 
3.2.2 
Clinical Data 
3.2.2.1 
Data from Published Studies 
Mylanus et. al. 2020 reported results from a global, multi-center, prospective, adult newly implanted clinical 
investigation.  The study implanted 51 adult subjects across five clinical trial sites with the Osia system.  The 
primary goals of the study were to provide evidence of both safety and effectiveness of a new bone 
conduction system that deploys direct piezoelectric stimulation of the bone conduction pathway to treat 
conductive, mixed conductive and single-sided-deafness hearing loss. Outcomes of the study at 12 months 
post implantation in 45 subjects demonstrated statistically significant improvements in audibility at all 
measured test frequencies when compared to the preoperative unaided condition.  For speech recognition, 
study participants showed improvements in speech recognition in quiet as well as speech in noise using an 
adaptive speech test measure.  Health utility scores as captured using the HUI-3 demonstrated statistically 
significant improvement when comparing the unaided to aided conditions on questions relative to hearing 
and speech attributes. Subjects reported significant improvements in ease of communication, reverberation 
and background noise on the APHAB, as well as statistically significant improvements across all domains 
presented in the SSQ when comparing unaided to aided outcomes. The primary safety evaluation concluded 
that post-operative healing was satisfactory, and few complications were reported. One implant was removed 
out of 51 subjects implanted due to a post-operative infection deemed not to be related to the device but to 
the surgical procedure. 
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Goycoolea et. al. 2020 reported on a cohort of 9 subjects with conductive or mixed hearing loss (8 adults and 
1 child) who met the study inclusion criteria. Subjects were fit and evaluated with a Baha 5 Power sound 
processor on a Baha Softband compared to the aided performance using the Osia system.  Post-operative 
evaluations were performed measuring functional gain as well as speech recognition using the Hearing in 
Noise Test (HINT).  Patient reported outcomes were captured using the SSQ-12 and GBI questionnaires 
postoperatively.  Surgery was deemed uneventful in all patients. Sound processor fitting was performed at 6 
weeks after surgery in all patients. No skin or retention issues were observed. Overall pain scores were low 
indicating no or very limited pain at the initial fitting in the majority of cases with no reports of pain by 6 
months post-surgery, Performance results demonstrated significant improvement in speech recognition in 
quiet and in noise with the Osia system as compared to the pre-operative Baha 5 Power fitting on a Baha 
Softband.  Additionally, subjective patient reported outcomes were statistically significant pre to 
postoperatively.   
Lau et. al. 2020 reported on the surgical and audiological outcomes using the Osia System in the first 10 
United Kingdom patients. Five females and five males participated with a mean age of 52 years (range 30 – 
78) who presented with either mixed (n = 5) or conductive hearing losses (n = 3) or single sided deafness (n = 
2). All subjects had prior hearing aid experience and were fit with a Baha 5 Power for aided testing prior to 
implantation with the Osia system.  Audiometrically, there was no alteration of the bone conduction 
thresholds post implantation.  Additionally, when the subjects were segmented into the three different 
audiological indications, the mean gain was + 86.5 dB (range 79–94, SD = 10.6) for single-sided deafness, + 31 
dB (range 12–48, SD = 17.3) for mixed and + 22 dB (range 12–31, SD = 9.5) for conductive. The mean 
functional gain improvement for the study population was +39.4 dB. The authors state that the enhancement 
in gain appeared to be one of the largest gains amongst bone conduction devices especially in the higher 
frequencies. Speech recognition as measured by SRT went from 38.1 dB to 22.7 dB at 4 months post-surgery. 
In addition to objective assessments of outcome, patient-reported outcomes measured by use of the Client 
Oriented Satisfaction Inventory (COSI) indicated that being able to hear well in real-life situations as well as a 
decrease in hearing aid disability were significant findings.  
3.2.2.2 
Data from Non-Published Studies 
Cochlear sponsored a pediatric, newly implanted, prospective, ITA clinical trial (Cochlear CAM5706, ITA# 
272423) at the Hospital for Sick Children in Toronto, Ontario, Canada.  The aim of the study was to gather 
preliminary safety and effectiveness information on the feasibility of implanting children aged 5 years to 17 
years with the Osia System.  Fourteen subjects were implanted, 15 ears, aged 10 to 17 years of age with a 
mean age of 13.9 years who presented with either mixed or conductive hearing loss. The primary objective 
was to quantify the type and severity of adverse events that occurred in the study cohort.  A total of 15 
adverse events were recorded for the 14 subjects.   All adverse events were reported as resolved by study 
closure.  The study reported 1 serious adverse event related to a thick skin flap which prohibited the link to 
the external sound processor.  A revision surgery to reduce the thickness of the skin flap resolved the SAE and 
the subject completed the study successfully. In addition to safety information, surgical questionnaires, daily 
use and patient reported outcomes using the SSQ-12 Parent were collected.  Surgical data revealed a 
relatively standard procedure using a C shaped incision, general anesthesia and receipt of a 4mm BI300 
implant fixture.  Results of the study emphasized the importance of measuring skin flap thickness prior to 
implantation as well as the effectiveness of skin flap reduction in children. Daily use of the sound processor 
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post-operatively at six months revealed average use time of 8.4 hours daily indicating a significant use time 
during waking hours.  Self-reported outcomes using the SSQ-12 Parent revealed a mean improvement of 2.10 
for total score in the aided condition. Lastly, preliminary effectiveness data measured by both PTA 4 and 
speech perception in quiet using PBK monosyllabic words revealed a mean improvement in audibility of 
31.7dB and a 79.1% improvement in the unaided to aided conditions respectively at 6 months 
postoperatively.   
3.3 
Study Rationale 
Based on the supporting clinical evidence detailed above, the primary objective of this pivotal, multi-center, 
prospective, within subject, newly implanted pediatric study is to evaluate the safety and effectiveness of the 
Osia 2 system in children aged 5 – 11 years of age who present with conductive or mixed hearing loss (up to 
55 dB HL) or single-sided-deafness (SSD). The intent of the investigation is to gather the necessary information 
to support a change in indications for use reducing the age at implantation to 5 years of age.     
4 MEDICAL DEVICE INFORMATION 
4.1 
Identity and Description of the Investigational Medical Device (IMD) 
The Osia 2 System is composed of the following components: the Osia Implant (OSI200); BI300 implant; and 
the Osia 2 Sound Processor.  The Osia implant consists of a receiver/coil and an actuator/stimulator which is 
surgically implanted on the skull bone via a bone conduction implant surgery performed by a surgical 
physician trained in otolaryngology. The Osia implant connects to the BI300 implant which is secured within 
the skull bone.  The Osia Sound Processor is an off-the-ear device, which picks up the sound from the 
environment, and sends 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. Because the device is commercially cleared, devices will not be labelled as 
investigational. The external components shall be worn full-time during waking hours. The Osia System is 
illustrated in Figure 1 below. 
Figure 1: Overview of the Osia System, including the Osia Sound Processor 
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. 
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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).  
Devices are manufactured by Cochlear Limited. For additional device information refer to the Investigator’s 
Brochure (IB) and Instructions for Use (IFU) documents. 
4.2 
Identity and Description of the Comparator 
Not applicable. 
4.3 
Accessory Device Requirements 
Not applicable. 
5 OBJECTIVES 
5.1 
Primary Objective 
To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 – 11 years by quantifying the 
type, frequency and severity of adverse events. 
5.2 
Secondary Objective 
• 
To compare preoperative performance compared to postoperative performance in parental 
questionnaires using the Osia 2 System. 
• 
To compare preoperative unaided bone conduction thresholds to postoperative unaided bone 
conduction thresholds.  
• 
To compare unaided preoperative speech perception performance to aided speech perception 
performance postoperatively using the Osia 2 System. 
• 
To compare unaided preoperative adaptive speech in noise performance to aided adaptive speech in 
noise performance using the Osia 2 System. 
5.3 
Exploratory Objective 
There are no exploratory objectives. 
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6 DESIGN OF THE CLINICAL INVESTIGATION 
6.1 
General 
 
Figure 2. Schematic for study 
The clinical investigation is a pivotal, prospective, multi-center study that uses each participating subject as 
their own control. The study population consists of children aged 5 to 11 years of age who present with 
conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).  
The intent of the study is to gather the applicable safety and effectiveness data to expand the current 
indications for use of the Osia 2 System to include children aged 5 years and older. The primary endpoint is to 
demonstrate the safety of the Osia 2 System in a pediatric population aged 5 – 11 years by quantifying the 
type, frequency and severity of adverse events. Secondary endpoints are to assess effectiveness of the Osia 2 
System in the study population including a parental inventory, audibility, and speech perception in both quiet 
and noise.  Data collection for endpoint assessment and all other clinical investigation measures are detailed 
in the Schedule of Events.   
Planned study enrolment is for 50 subjects and up to 10 clinical investigation sites across the United States.  
Sites will be composed of both private practice and university-based hospital locations, geographically 
distributed across the United States who currently treat patients clinically with the Osia 2 system. Subject 
enrolment is anticipated to be 12 months with participation for each study subject being 14 to 18 months in 
duration. The Sponsor’s data monitoring requirements are described in detail in a separate Monitoring Plan. 
6.1.1 
Design Rationale 
The clinical investigation design ensures that the results obtained have clinical relevance, scientific validity 
and address the clinical investigation objectives. A repeated measure, 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. Blinding and masking are not appropriate design considerations 
due to the design and clinical use of the device.    
Pediatric subjects seeking treatment with an Osia 2 bone conduction device may present clinically for study 
inclusion as being either aided or unaided due to the varying etiologies of hearing loss. Consistent with the 
current indications for use, subjects will be tested in both the aided and unaided listening condition to 
capture preoperative performance with and without a non-surgical treatment.  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 softband 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. Preoperative 
parental inventories, tests for frequency specific audibility, as well as speech perception in quiet and noise will 
Screening & 
Baseline
Surgery
Visit 1
2 Week 
Follow Up
Visit 2
Device 
Fitting
Visit 3 
3 Months 
Post 
Surgery
Visit 4
6 Months 
Post 
Surgery
Visit 5 
12 Months 
Post 
Surgery
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be compared to performance gathered during the 3 and 6 months post-surgical evaluations to demonstrate 
the effectiveness of the Osia 2 system.  All safety events will be gathered for Surgery plus Visits 1 – 5 and 
quantified by type, frequency and severity to demonstrate the safety profile for the intended study 
population. 
6.2 
Subjects 
Written, informed consent must be obtained from the subject’s parent or legal guardian before any study 
specific procedures are initiated.   
A Sponsor representative (employee of Cochlear) will confirm eligibility criteria in accordance to inclusion and 
exclusion criteria.  The representative may be either the Clinical Project Manager, a qualified ENT surgeon, 
audiologist or qualified subject matter expert.  Following consent of a subject, the site must provide a de-
identified audiogram to be reviewed by the representative.      
Prior to implantation of a subject, the representative must have confirmed eligibility, and all screening and 
baseline assessments must be completed and entered into the EDC in accordance with the Schedule of 
Events.   
Throughout the duration of the clinical investigation, source document records must be maintained to 
validate subject data.      
6.2.1 
Inclusion Criteria 
Subjects must meet all of the inclusion criteria described below to be eligible for this clinical investigation. 
1. 
Subjects aged 5 to 11 years of age with the following audiometric criterion:  
A conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone 
average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better 
than or equal to 55 dB HL. 
OR 
A profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-
sided deafness or “SSD”). The pure tone average air conduction (AC) hearing thresholds of the hearing 
ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).  
2. 
Prior experience with amplified sound through properly fitted amplification device such as a 
hearing aid, a CROS device, or a bone conduction device on a softband or sound arc. 
3. 
Parent or legal guardian who is willing and able to provide written informed consent for the study 
participant.  
Note: Subjects may include individuals seeking new implantation unilaterally (in one ear) or individuals 
already implanted with a bone-anchored device seeking a second-side implant (sequential bilateral). 
6.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical 
investigation. 
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1. 
Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the 
OSI200 Implant. 
2. 
Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the 
device, as determined by the investigator.   
3. 
Abnormally progressive hearing loss.  
4. 
Evidence that hearing loss is bilateral retro cochlear or bilateral central origin.  
5. 
Evidence of conditions that would prevent speech recognition improvement as determined by the 
investigator.   
6. 
Skin or scalp conditions that may preclude attachment of the Sound Processor or that may 
interfere with the use of the Sound Processor.  
7. 
Unable or unwilling to comply with the requirements of the clinical investigation as determined 
by the Investigator. 
8. 
Investigator site personnel directly affiliated with this study and/or their immediate families; 
immediate family is defined as a spouse, parent, child, or sibling. 
9. 
Cochlear employees or employees of Contract Research Organizations or contractors engaged by 
Cochlear for the purposes of this investigation.  
10. 
Currently participating, or participated within the last 30 days, in another clinical investigation 
involving an investigational drug or device that could impact the safety or effectiveness of the 
Osia 2 system as determined by the investigator. 
11. 
Individuals undergoing simultaneous single-stage aural atresia or microtia repair due to the 
increased risk of skin complications associated with ear reconstruction.  
6.2.3 
Number of Subjects Required 
Sample size for the study is not driven by power requirements for a formal statistical hypothesis test. The 
planned sample size of 50 subjects will provide data to characterize safety and effectiveness with a reasonable 
degree of statistical precision. Additionally, the planned sample size will allow for a high probability of 
observing events of interest. For example, with 50 subjects, the half-width of a two-sided 95% confidence 
interval for a continuous endpoint based on a t-distribution would be 0.284 units on the effect size scale. 
Similarly, with 50 subjects, there is a greater than 95% probability of observing one or more events that occur 
at a population rate of 5.9%.   
Stratification of the 50 subjects will include a minimum of 10 subjects with single-sided-deafness.  In addition, 
at least one-third (15) of the subjects represented at the youngest ages (5-6 years) will be implanted with the 
remaining 35 subjects represented by the other age groups as evenly as possible. 
6.2.4 
Vulnerable Populations 
Children aged 5 to 11 years of age who present with conductive or mixed hearing loss (up to 55 dB HL) or 
single-sided-deafness (SSD) will be recruited for participation in this investigation. Subjects will be recruited 
from both private practice and university-based hospital locations, geographically distributed across the 
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initiate treatment as part of the study and continue care following study completion as part of standard 
medical and/or clinical care. Information pertaining to the study objective, visit schedule, and associated 
procedures will be reviewed in an age appropriate manner with both the potential subject and their parent or 
legal guardianprior to study participation. Verbal assent will be required for subjects aged 7 – 11 years of age 
and is documented according to each Institutional Review Board (IRB) requirements.  Recruitment must 
include processes to ensure the investigator discusses the informed consent with all subjects, parent(s)or 
legal guardian(s) as well as addresses all questions to the individual’s satisfaction.  Additional measures taken 
to review the study with potential subjects must be documented in the informed consent process.  The IRBs 
may have additional requirements which must be followed.  
The subject’s parent or legal guardian will be compensated on behalf of the subject for their time participating 
in the clinical investigation in alignment with fair market value, and the payment rate and process is detailed 
within the informed consent. 
6.2.5 
Recruitment and Study Duration 
The following subject status definitions apply: 
• 
Enrolled: A subject who has a signed Informed Consent form for the study.  
• 
Screened: A subject who has a signed Informed Consent form and has met the eligibility criteria. 
• 
Screen Fail: An enrolled subject who has been determined to not meet one or more eligibility criteria. 
• 
Participated: An enrolled subject who has met eligibility criteria and has been treated with the Osia 2 
System. 
• 
Discontinued: An Enrolled subject who withdrew consent, was discontinued by the Investigator or 
Sponsor before the expected End of Study visit or was lost to follow-up. Discontinued subjects may still 
have safety follow-up data collection until their scheduled End of Study visit, for reasons described in 
section 6.2.6. 
• 
Completed: Enrolled subjects who complete the required treatment and visit schedule.  
The recruitment period for the clinical investigation is estimated to be 12 months from the time of first 
subject consent to recruitment of the last subject.  
The expected duration of each subject’s participation in the clinical investigation, is anticipated to be 14 to 18 
months from the time of informed consent to End of Study Visit 5. 
Clinical Investigation completion is last subject last visit. AE recording will continue for each subject until 
completion of their End of Study visit. Ongoing SAEs and SADEs will be followed for an additional 30 days, or 
until resolution or stabilization within the 30-day period following End of Study.  Management of the 
SAE/SADE beyond clinical investigation completion will be absorbed into standard clinical and medical care by 
the participating clinical investigational site.   
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6.2.6 
Criteria and Procedures for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the reason(s); 
however, subjects have the right to withhold their reason if preferred. The reason for withdrawal should be 
documented in the subject’s source files and the case report form (CRF), if provided. 
The Investigator or Sponsor may also decide to withdraw a subject from the clinical investigation or stop the 
use of the investigational device if it is considered to be in the subject’s best interests. 
Subject withdrawal may be for any of the following reasons: 
• 
Adverse Event (AE) 
• 
Device Deficiency (DD) 
• 
CIP or GCP deviation 
• 
Subject withdrew consent 
• 
Subject lost to follow-up 
• 
Subject death 
• 
Sponsor decision 
• 
Investigator decision 
• 
Other (specify) 
If subject withdrawal is due to problems related to the safety or performance of the Osia 2 system, the 
Investigator may ask for the subject's permission to continue in safety follow up (for example, adverse events 
and device deficiencies) until their scheduled End-of-Study visit at Visit 5. 
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 must be documented. 
Participating subjects who are withdrawn/discontinued will not be replaced.  
6.2.7 
Randomisation Procedures 
Not applicable. 
6.2.7.1 
Blinding Procedures 
Blinding is not an appropriate study design consideration based on the design and use of the Osia 2 System. 
6.2.8 
Post-investigation Medical Care 
Following the investigation, subjects will continue with standard of care treatment. 
6.3 
Evaluations and Procedures 
For each enrolled subject, the clinical investigation will include Screening and preoperative Baseline 
procedures, Surgery to implant the Osia 2 device, and 5 post-surgery visits. 
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6.3.1 
Screening/eligibility 
6.3.1.1 
Informed Consent 
Informed consent and assent, as applicable, will be obtained as outlined in section 9 of this CIP prior to any 
study procedures taking place. 
6.3.1.2 
Unaided Audiometric Testing 
Unaided audiometric thresholds will be obtained for each ear independently, using the standard audiometric 
technique for pure-tone air and bone conduction testing preoperatively to establish candidacy for 
participation in the clinical investigation. 
• 
Air Conduction:  500, 1000, 2000, 3000 & 4000Hz  
Hearing thresholds that exceed the air conduction limits of the audiometer, where the participant reports 
feeling the acoustic stimuli, shall be recorded as vibrotactile (VT). Appropriate masking will be employed 
where required. 
• 
Bone conduction: 500, 1000, 2000, 3000 & 4000Hz 
Where the participant reports feeling rather than hearing the acoustic stimuli, the response shall be recorded 
as vibrotactile (VT). Appropriate masking will be employed where required. 
For participants with conductive or mixed hearing loss, the bone conduction PTA will be captured and 
rounded to the nearest whole number to document audiometric eligibility. For participants with single-sided 
deafness (SSD), the air conduction PTA will be captured and rounded to the nearest whole number to 
document audiometric eligibility. 
6.3.1.3 
Medical, Hearing & Device History 
• 
Hearing History will document the subject’s history of hearing loss (may be subject reported) and 
hearing loss etiology.  
• 
Device history will document the subject’s history with hearing aids and/or surgical or non-surgical 
bone conduction technology (may be subject reported).  
• 
Medical History will document the subject’s medical history relevant to the conduct of the study. 
6.3.2 
Performance/Effectiveness 
6.3.2.1 
Description of Audiometric Testing 
Preoperatively, unaided audiometric thresholds will also be obtained in sound field using narrowband noise. 
Postoperatively at Device Fitting Visit 2, unaided bone conduction thresholds will be obtained as described in 
section 6.3.1.2 in the implanted ear to assess the impact of implantation and aid in the fitting of the sound 
processor.  The contralateral ear will be masked accordingly. 
• 
Unaided Sound Field Thresholds: 500, 1000, 2000 & 4000Hz 
Aided audiometric thresholds will be obtained preoperatively and in the postoperative aided condition using 
narrowband noise in sound field.  The contralateral ear will be plugged for all tests. 
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• 
Aided Sound Field Thresholds: 500, 1000, 2000 & 4000Hz 
6.3.2.2 
Description of Speech Perception Testing 
6.3.2.2.1 
Consonant Nucleus Consonant (CNC) Monosyllabic Words 
The CNC Word Test (Peterson & Lehiste, 1962) consists of 10 recorded lists of 50 monosyllabic words. For this 
study, one list will be administered per test condition at 60 dBA at 0º azimuth (S0) in sound field and scored as 
the number of phonemes and words correct, which will be expressed as a percentage correct when analyzed. 
Preoperatively, CNC Words will be assessed in the unaided condition as well as the aided condition using the 
Baha 5 Power on a softband.  Postoperatively, CNC Words will be assessed only in the aided condition using 
the Osia 2 sound processor. Pre and postoperative testing will be completed with the contralateral ear 
plugged or muffed in an effort to isolate the treated ear. 
6.3.2.2.2 
Bramford-Kowal-Bench Speech-In-Noise (BKB-SIN) 
BKB-SIN (Etymotic Research, 2005) is composed of 36 lists of BKB sentences (Bench, Kowal, & Bamford, 1979), 
spoken by a male target talker amidst four-talker babble. The 36 lists are divided into 18 equally difficult pairs 
of sentence lists. The list-pairs are composed of 16 to 20 sentences that each have 3 or 4 key words. Target 
speech is presented at 65 dBA and the level of the noise is varied in 3 dB steps at fixed SNRs, beginning at +21 
dB SNR (very easy), and descending to 0 or –6 dB SNR (very difficult), depending on the list. Speech reception 
threshold (SRT) is calculated in dB, which is referred to as the SNR-50, is defined as the signal-to-noise ratio 
(SNR) required for the subject to repeat 50% of the key words correctly. One list pair of sentences will be 
presented at 0° azimuth in the sound field, with babble presented at 0º azimuth (S0N0). Preoperatively, BKB-
SIN will be assessed in the unaided condition as well as the aided condition using the Baha 5 Power on a 
softband.  Postoperatively, BKB-SIN will be assessed only in the aided condition using the Osia 2 sound 
processor. Pre and postoperative testing will be completed with the contralateral ear plugged or muffed in an 
effort to isolate the treated ear. 
6.3.2.3 
Description of Questionnaires 
6.3.2.3.1 
Speech, Spatial, and Qualities of Hearing Questionnaire (SSQ) for Parents 
The Speech, Spatial, and Qualities of Hearing questionnaire (SSQ) from MRC Institute of Hearing Research, UK 
modified for parental response will be used as a subject self-assessment in three categories:  
1. 
Speech hearing rating scale 
2. 
Spatial rating scale 
3. 
Sound qualities rating scale 
6.3.2.3.2 
Device Use Questionnaire (DUQ) 
A Sponsor-designed Device Use Questionnaire or DUQ will be administered to the subject’s parent or legal 
guardian to determine subjective preferences with regards to device use and satisfaction in a variety of 
listening environments. 
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6.3.3 
Safety Evaluations and Procedures 
Safety data will be reviewed in accordance with the Sponsor’s standard operating procedures regarding safety 
events. The risks and anticipated ADEs for the Osia 2 system, as identified in Sections 7.2 and 7.3 below, will 
be assessed in the clinical investigation via reporting of all AEs/ADEs from the time of subject implantation 
until subject last visit.  Ongoing SAEs and SADEs will be followed for an additional 30 days, or until resolution 
or stabilization within the 30-day period following End of Study. Management of the SAE/SADE beyond clinical 
investigation completion will be absorbed into standard clinical and medical care by the participating clinical 
investigational site.   
6.3.3.1 
Concomitant Medication and Therapies 
Concomitant Medications recorded in the CRF includes all prescription medications, routine over-the counter 
medications, and any use of steroids. Medications used during surgery, vitamins, herbal and natural remedies 
are not included. There are no further prohibited medications under this clinical investigation.  Medications 
taken for anesthesia purposes during surgery will not be recorded unless their use deviates from normal 
clinical practice.  
6.3.4 
Detailed Visit Schedule 
6.3.4.1 
Screening  
• 
Written informed consent 
• 
Demographics: Document date of birth and sex 
• 
Eligibility: Confirm subject meets all inclusion criteria and no exclusion criteria.  Source 
documentation must be available before confirming eligibility 
• 
Hearing History: Document history of hearing loss (may be subject reported) 
• 
Device history: Document history with hearing aids and/or surgical or non-surgical bone 
conduction technology (may be subject reported) 
• 
Medical History: Document medical history 
• 
Audiometric testing: Includes unaided air and bone conduction testing. Must be 
completed less than 60 days prior to implantation and document single sided deafness or 
mixed or conductive hearing losses. 
6.3.4.2 
Baseline 
• 
Audiometric testing: Includes both unaided and aided threshold testing. Must be 
completed less than 60 days prior to implantation in the aided and unaided condition.  
The aided condition includes testing with the Baha 5 Power on a softband. 
• 
Speech Perception testing: Includes both unaided and aided testing using CNC words and 
BKB-SIN sentences.  Must be completed less than 60 days prior to implantation in the 
aided and unaided condition.  The aided condition includes testing with the Baha 5 Power 
on a softband. 
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• 
SSQ Parent: Completed interview-style based on everyday listening condition - not aided 
condition with Baha 5 Power on the day of testing.  Must be completed within 60 days 
prior to implantation. 
6.3.4.3 
Surgery (day 0) 
• 
Surgical Questionnaire: documentation of surgical procedure completed day of surgery. 
6.3.4.4 
Visit 1: 2 Week Follow Up 
• 
Surgical follow up: wound and incision check 
6.3.4.5 
Visit 2: 4 Week Device Fitting 
• 
Bone Conduction testing: Includes unaided bone conduction threshold testing.  
• 
Device programming: Fitting and programming of the Osia 2 sound processor.  
• 
Sound field thresholds: Includes aided thresholds using the Osia 2 sound processor. 
6.3.4.6 
Visit 3: 3 Months Postoperative 
• 
Device programming: Optional and only as needed.   
• 
Device Use Questionnaire: Completed interview-style  
• 
Sound field thresholds: Includes aided thresholds using the Osia 2 sound processor. 
• 
Speech Perception testing: Includes aided testing using CNC words and BKB-SIN sentences 
and the Osia 2 sound processor.  
• 
SSQ Parent: Completed interview-style based on everyday listening using the Osia 2 
sound processor. 
6.3.4.7 
Visit 4: 6 Months Postoperative 
• 
Device programming: Optional and only as needed.   
• 
Device Use Questionnaire: Completed interview-style  
• 
Sound field thresholds: Includes aided thresholds using the Osia 2 sound processor. 
• 
Speech Perception testing: Includes aided testing using CNC words and BKB-SIN sentences 
using the Osia 2 sound processor.  
• 
SSQ Parent: Completed interview-style based on everyday listening using the Osia 2 
sound processor. 
6.3.4.8 
Visit 5: 12 Months Postoperative - End of Study 
• 
Document Subject’s study completion.   
• 
Ensure device deficiencies, device exposure, adverse events, concomitant medications, 
and deviations are reviewed, and end dates recorded where appropriate. 
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6.3.4.9 
Collected from Baseline 
• 
Concomitant Medication: Includes all prescription medications, routine over-the counter 
medications, and any use of steroids. Medications used during surgery, vitamins and 
herbal or natural remedies are not included. Concomitant medications should be 
reviewed at each visit. 
• 
Protocol Deviations: Includes approved and unapproved deviations. 
6.3.4.10 
Collected from Surgery  
• 
Adverse Events: Includes initial report and review of ongoing adverse events.  Adverse 
events should be reviewed at each visit. 
• 
Device Exposure  
• 
Device Deficiencies 
6.4 
Equipment Used for Evaluations and Procedures 
The clinical investigation includes use of equipment to complete assessments.  Equipment including 
programming software and sound equipment (e.g. speakers) are used to assess speech perception 
performance.  Programming software should be kept current at the direction of the Sponsor.  For equipment 
used in this clinical investigation, records of equipment calibration requirements and the calibration records 
for equipment used to assess Secondary Endpoint testing must be maintained in site files and copies provided 
to the Sponsor.  As part of the Site Initiation Visit, requirements and records should be provided to the 
Sponsor and records confirmed to be up to date.  Records will be monitored at interim monitoring visits, in 
accordance with the Sponsor’s Monitoring Plan. 
Osia Fitting Software (OFS) will be used to fit and program the Osia 2 sound processor according to patient 
preference.  All OFS data will be provided to Sponsor for analysis, which may be done automatically or 
through manual file sharing.   
Speech perception testing using CNC words and BKB-SIN sentences will be assessed using a loudspeaker 
configuration with the signal from the front, zero Azimuth (S0) at head height and 1-meter distance from the 
subject.  The Sponsor may provide equipment (such as test materials, laptop, software, microphone and 
speaker) if the clinical site does not possess the necessary tools to facilitate testing.   
The use of equipment will be logged and reviewed as per the Sponsor’s Monitoring Plan. 
6.5 
Sponsor Role in Conduct of the Clinical Investigation 
The Sponsor may support certain activities at the clinical investigation site.  Sponsor representatives may be 
present in the operating room with the surgical team and subject.  The representative will not provide 
medical assistance and will not discuss the trial with the subject.   
The Sponsor may pay for third party clinical trial support (“coordinator”) at clinical investigation sites should 
there be resource constraints, which may support subject recruitment, data entry and reporting under the 
authority of the Principal Investigator.  The coordinator will be required to comply with hospital policy and will 
be trained on the CIP and GCP.  The coordinator will not complete any activities on behalf of the Sponsor. 
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A Sponsor representative will review evidence of subject eligibility before the subject is accepted for 
implantation.   
7 BENEFITS AND RISKS OF THE INVESTIGATIONAL MEDICAL DEVICE AND CLINICAL 
INVESTIGATION 
7.1 
Anticipated Clinical Benefits 
Most recipients of a bone conduction hearing solution will experience an improved hearing performance and 
quality of life compared to unaided listening. 
Potential benefits associated with participation in this clinical investigation include: 
• 
Helping to find better treatments, therapies and/or diagnostic tests in the area of hearing 
loss or other associated conditions. 
• 
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 currently receiving. 
• 
The opportunity to access the newest innovations in the treatment of their hearing loss 
type.  
• 
Advice, care, and support from trained clinical staff who understand hearing loss and any 
associated conditions.  
• 
Closer monitoring of their hearing loss. 
7.2 
Anticipated Adverse Device Effects 
Based on the available safety reference information and literature, the potential clinical risks have been 
documented below. 
7.2.1 
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. 
7.2.2 
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: 
▪ 
Concurrent CSF leakage: a leak of CSF (cerebrospinal fluid) through the hole in the 
skull 
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▪ 
Subdural injury: blood vessels near the brain may burst 
▪ 
Subcutaneous hematoma: bruises and contusions on the skin 
▪ 
Skin-flap infection, irritation or inflammation 
▪ 
Extrusion of the device caused by a foreign body under the skin 
▪ 
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 magnet may be necessary prior to 
MRI scanning. 
7.2.3 
Risks Associated with Use of the Study Device 
• 
Impact or injury to the head in the area of the Osia implant could damage the implant and 
result in its failure. Impact to external components (e.g. sound processor) while being 
worn could result in damage to the device or injury. Young children who are developing 
motor skills are at greater risk of receiving an impact to the head from a hard object, e.g. 
table or chair. 
• 
Small parts and accessories could be hazardous if swallowed and could cause choking if 
ingested or inhaled 
• 
Parents and caregivers should be advised that unsupervised use of long cables (such as 
the safety line) may present a risk of strangulation. 
• 
Parents and caregivers should routinely check the device for signs of overheating and for 
signs of discomfort or skin irritation at the implant site. Subjects should remove the 
processor immediately if there is any discomfort or pain (i.e., if device becomes hot or 
sound is uncomfortably loud) and inform their hearing care professional. 
7.2.4 
Risks Associated with Simultaneous Aural Atresia and Microtia Repair 
When deemed appropriate by the implanting physician, a second-stage microtia/atresia reconstruction may 
be performed under protocol.  Patients undergoing first- stage ear reconstructions in combination with Osia 
implantation are excluded from study participation due to the additional dissection and trauma to the area of 
implantation resulting in increased risk of associated skin complications. Five study subjects have undergone 
simultaneous aural atresia and microtia repair (3 first-stage and 2 second-stage). Two of three children who 
underwent first-stage ear reconstruction have required additional skin grafting on the auricle of the Medpor. 
The third subject experienced contact dermatitis associated with the ointment prescribed postoperatively.  
There have been no adverse events reported on the 2 children who underwent second-stage reconstructions.  
There may also be side effects that are not known at this time. 
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7.3 
Risks Associated with Participation in the Clinical Investigation 
In addition to the anticipated surgical and adverse device effects of the Osia 2 System, 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 Baha 5 Power on the softband 
• 
Possible interactions with concomitant medications and residual risks for the device are 
not anticipated in this clinical investigation. 
7.4 
Risk Mitigation 
The following will be performed during the clinical investigation to mitigate the risks identified above: 
• 
All clinical investigation sites selected have pediatric surgical bone conduction and Osia 2 
system experience. The Osia 2 system being implanted is the same as the commercially 
cleared device currently indicated for children aged 12 years and older.  
• 
The current surgical guidelines associated with the Osia 2 system will be reviewed during 
Site Initiation, specifically topics surrounding skin flap thickness and bone integrity. 
• 
In addition, the Sponsor’s surgical support may be present during surgeries performed by 
the investigational site(s) either in person or virtually.   
• 
All reported AEs, ADEs and DDs will be regularly reviewed by the Sponsor’s Clinical Review 
Board for the duration of the study to facilitate early detection and appropriate 
intervention if events are unanticipated with respect to incidence, severity, or outcome. 
• 
All subject’s and their parent or legal guardian will be provided with the Osia System 
Important Information Booklet which contains important safety warnings and cautions 
related to the device and its use. 
7.5 
Benefit-to Risk Rationale 
The clinical safety (risks) and benefit relevant to the anticipated performance of the Osia 2 system were 
evaluated in the Osia Clinical Evaluation Report (CER) (D1179760) and it was concluded that the data 
reviewed provided clinical evidence for the safe and effective use of the OSI200 Implant within the Osia 2 
System. Significant improvements in both objective and subjective hearing performance were observed with 
the device as compared to the unaided condition and resulted in an improved quality of life. The Osia 2 
system has been cleared in the United States since November of 2019 for children aged 12 years and older.  
Cochlear-sponsored clinical investigations and a systematic literature review, coupled with the design 
verification/validation and post-market surveillance data, established that the benefits of the Osia 2 system 
outweigh the risks. 
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8 STATISTICAL CONSIDERATIONS 
8.1 
General Considerations 
There is one primary endpoint and four secondary endpoints. Formal statistical hypothesis tests are planned 
for the secondary endpoints.  
The overall type I error rate will be maintained via a gatekeeping approach whereby statistical tests will 
proceed in order until a non-significant test is obtained, at which point, formal testing for the purposes of 
labelling claims will cease.  A detailed summary of statistical analysis is documented in the Statistical Analysis 
Plan (SAP). 
8.2 
Endpoints 
8.2.1 
Primary Endpoint 
The primary endpoint is adverse events and serious adverse events Surgery through Visit 4 (6 Months). Events 
will be summarized by type, frequency, and severity. 
8.2.2 
Secondary Endpoints 
8.2.2.1 
Secondary endpoint 1 – SSQ Parent 
Secondary endpoint 1 – SSQ Parent is defined as the mean difference between preoperative and 
postoperative performance on the Speech Spatial & Qualities of Hearing Questionnaire (SSQ) – Parent version 
at 6 months post-surgery. 
8.2.2.2 
Secondary endpoint 2 – PTA 4 
Secondary endpoint 2 is defined as the mean difference in individual subject PTA 500, 1, 2, and 4kHz Baseline 
to 4 weeks post-surgery. 
8.2.2.3 
Secondary endpoint 3 – CNC Words 
Secondary endpoint 3 is defined as the mean difference between baseline unaided speech perception in quiet 
and the aided condition using the Osia 2 system at 6 months post-surgery on open-set monosyllabic word 
recognition (CNC Words) in quiet. 
8.2.2.4 
Secondary endpoint 4 – BKB-SIN 
Secondary endpoint 4 is defined as the mean difference between baseline unaided speech perception in noise 
and the aided condition using the Osia 2 system at 6 months post-surgery on an adaptive speech in noise test 
BKB SIN. 
8.2.3 
Exploratory Endpoints 
There are no exploratory endpoints. 
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8.3 
Hypotheses 
8.3.1 
Primary Hypothesis 
There is no formal hypothesis test for the primary endpoint. 
8.3.2 
Secondary Hypotheses 
8.3.2.1 
Secondary Endpoint 1 – SSQ Parent 
Secondary endpoint 1 will be assessed with the following hypothesis: 
H0: Δ ≤ 0  
Ha: Δ > 0  
where Δ represents the difference between preoperative and postoperative performance on the Speech 
Spatial & Qualities of Hearing Questionnaire (SSQ) – Parent version at 6 months post-surgery, specifically Δ = 
SSQ6 Months – SSQpreop. This difference is parameterized so that a positive value is indicative of a clinical 
improvement in the questionnaire.  
The hypothesis will be evaluated using a one-sample, one-sided 0.025 alpha level t-test for a mean against the 
null of zero. The objective will be met if the null hypothesis is successfully rejected. 
The endpoint will be presented with descriptive statistics and the corresponding two-sided 95% confidence 
interval based on the t-distribution. 
8.3.2.2 
Secondary Endpoint 2 – PTA4 
The secondary endpoint 2 will be assessed with the following hypothesis: 
H0: Δ ≤ 0  
Ha: Δ > 0  
where Δ represents the difference between baseline PTA and 4 weeks-post surgery PTA, specifically Δ = PTA4 
weeks – PTApreop. This difference is parameterized so that a positive value is indicative of a clinical improvement.  
 The hypothesis will be evaluated using a one-sample, one-sided 0.025 alpha level t-test for a mean against 
the null of zero. The objective will be met if the null hypothesis is successfully rejected.  
The endpoint will be presented with descriptive statistics and the corresponding two-sided 95% confidence 
interval based on the t-distribution. 
8.3.2.3 
Secondary Endpoint 3 – CNC Words 
The secondary endpoint 3 will be assessed with the following hypothesis: 
H0: Δ ≤ 0  
Ha: Δ > 0  
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where Δ represents the difference between baseline unaided speech perception CNC and 6 months-post 
surgery CNC, specifically Δ = CNC6 Months – CNCpreop. This difference is parameterized so that a positive value is 
indicative of a clinical improvement.  
 The hypothesis will be evaluated using a one-sample, one-sided 0.025 alpha level t-test for a mean against 
the null of zero. The objective will be met if the null hypothesis is successfully rejected.  
The endpoint will be presented with descriptive statistics and the corresponding two-sided 95% confidence 
interval based on the t-distribution. 
8.3.2.4 
Secondary Endpoint 4 – BKB-SIN 
The secondary endpoint 4 will be assessed with the following hypothesis: 
H0: Δ ≤ 0  
Ha: Δ > 0  
where Δ represents the difference between baseline unaided speech perception BKB SIN test and 6 months-
post surgery BKB SIN test, specifically Δ = BKB6 Months – BKBpreop. This difference is parameterized so that a 
positive value is indicative of a clinical improvement.  
 The hypothesis will be evaluated using a one-sample, one-sided 0.025 alpha level t-test for a mean against 
the null of zero. The objective will be met if the null hypothesis is successfully rejected.  
The endpoint will be presented with descriptive statistics and the corresponding two-sided 95% confidence 
interval based on the t-distribution. 
8.3.3 
Exploratory Hypothesis 
There are no exploratory hypotheses. 
8.4 
Sample Size Determination 
Sample size for the study is not driven by power requirements for a formal statistical hypothesis test. The 
planned sample size of 50 subjects will provide data to characterize safety and effectiveness with a reasonable 
degree of statistical precision. Additionally, the planned sample size will allow for a high probability of 
observing events of interest. For example, with 50 subjects, the half-width of a two-sided 95% confidence 
interval for a continuous endpoint based on a t-distribution would be 0.284 units on the effect size scale. 
Similarly, with 50 subjects, there is a greater than 95% probability of observing one or more events that occur 
at a population rate of 5.9%.   
Stratification of the 50 subjects will include a minimum of 10 subjects with single-sided-deafness.  In addition, 
at least one-third (15) of the subjects represented at the youngest ages (5-6 years) will be implanted with the 
remaining 35 subjects represented by the other age groups as evenly as possible. 
8.5 
Analysis Populations 
Analysis will be based on subjects who are successfully implanted with the device. 
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8.6 
Endpoint Analyses 
8.6.1 
Primary Endpoint Analyses 
There is no formal hypothesis test for the primary endpoint.  
The endpoint will be presented in tabular format, displaying the number and percentage of subjects with 
adverse events. Events will also be summarized by type and severity. Results will be based on observed events 
without imputation. 
8.6.2 
Secondary Endpoint Analyses 
The secondary endpoint (1 – 4) analyses will be presented with descriptive statistics and the corresponding 
two-sided 95% confidence interval based on the t-distribution. 
8.6.3 
Exploratory Endpoint Analyses 
There are no exploratory endpoints. 
8.7 
Safety Analyses 
Adverse events (AEs) will be tabulated with the number of events and subjects with event for each event type 
and overall. Rates will be reported as the number of subjects who experience at least one event during the 
analysis interval out of the total number of subjects with follow-up to the beginning of the analysis interval. 
Serious adverse events (SAEs) will also be tabulated.  
All AEs and SAEs will also be summarized by relatedness as described above. Adverse events leading to death 
or study discontinuation will be provided in listing format. 
8.8 
Interim Analyses 
No formal interim analyses for the purposes of early stopping for effectiveness or for adaptive sample size re-
estimation are planned. Periodic reports on study progress may be reported to regulatory agencies. 
Regulatory submission is planned following the collection of the 6-month study data. Data through 12 months 
will be considered supplemental. 
9 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject’s parent or legal guardian using an 
approved ICF prior to any clinical investigation-related examination or activity. The rationale of the clinical 
investigation, as well as the benefits and risks, what participation will involve, and established alternatives to 
participation will be explained to the subject and their parent or legal guardian in native non-technical 
language, understandable to the subject. Ample time will be provided for the subject and parent or legal 
guardian 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 parent or legal guardian. Subjects shall not be coerced or unduly influenced to participate or to 
continue to participate in a clinical investigation. They shall not waive or appear to waive their legal rights. 
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Each subject’s parent or legal guardian, and the person who conducted the informed consent discussion, shall 
sign and personally date the Informed Consent Form (ICF). Where required, an independent and impartial 
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. 
This process shall be documented in the subject’s source documents. 
The subject and the subject’s parent or legal guardian, 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. 
10 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
10.1 Definitions 
10.1.1 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, and whether anticipated or unanticipated. 
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 the use of medical 
devices. 
10.1.2 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. 
NOTE 3: This includes ‘comparator’ if the comparator is a medical device. 
10.1.3 Serious Adverse Event 
A serious adverse event (SAE) is any AE that led to any of the following: 
1) death,  
2) serious deterioration in the health of the subject, users, or other persons as defined by one or more of the 
following: 
• 
a life-threatening illness or injury, or 
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• 
a permanent impairment of, or damage to, a body structure or a body function including chronic 
diseases, 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, 
3) foetal distress, foetal death or a congenital physical or mental abnormality, or birth defect including 
physical or mental impairment. 
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. 
10.1.4 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. 
10.1.5 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 IB and IFU. 
A USADE is also known as a UADE (Unanticipated Adverse Device Effect) for the purposes of US FDA reporting. 
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, severity, or 
outcome has been identified in the IB and IFU. 
10.1.6 Adverse Events of Special Interest 
There are no adverse events of special interest for this clinical investigation. 
10.1.7 Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety, or performance. 
NOTE 1: Device Deficiencies include malfunctions, use errors, and inadequacy in the information supplied by 
the manufacturer including labelling.  
NOTE 2: This definition includes device deficiencies related to the IMD or the comparator. 
10.1.8 Serious Health Threat 
A signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious 
deterioration in the health in subjects, users or other persons, and that requires prompt remedial action for 
other subjects, users or other persons. 
NOTE: This would include events that are of significant and unexpected nature such that they become 
alarming as a potential serious health hazard or possibility of multiple deaths occurring at short intervals. 
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13 DATA MANAGEMENT 
The CRF will capture the datapoints necessary to determine the subject status according to the criteria 
described in section 6.3. 
13.1 Source Data 
An Origin of Source Data Form will be used to capture the location of source data kept at each site, outlining 
the individual site’s process for certification. 
Source data will be captured in clinic notes, paper-based source data worksheets, or printed directly from 
testing software. As indicated on the Origin of Source form, data collected may be entered directly into the 
eCRF which shall be considered source data for these items. If electronic medical records do not permit read 
only access for monitoring purposes, a certified printout must be provided, indicated by a dated signature by 
a member of the site team or generated through a validated process. 
13.2 Methods for Data Entry and Collection 
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. This 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 Osia Fitting Software. The 
unamended data file shall be regarded as the source. 
13.3 Database Lock 
The database will be locked upon the completion of collection of data from Visit 4 6-months and again at the 
completion of the study. 
The process for database lock is described in the Data Management Plan. 
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14 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance with 
governing data privacy regulations, including Good Clinical Practices (GCPs) and with the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA). 
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 
submission to a regulatory authority shall not disclose the identity of any subject. 
15 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
The clinical investigation will not commence prior to the written favourable opinion or approval from the EC 
and regulatory authority 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. 
16 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. 
17 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
Sponsor will notify all site Principal Investigators of changes to the CIP. No changes in the CIP or investigation 
procedures shall be made without mutual agreement of the Principal Investigator and the Sponsor. 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. 
18 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. 
19 PUBLICATION POLICY 
This clinical investigation will be prospectively registered at a public clinical trial registry, 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 (for 
example, 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 
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the International Committee of Medical Journal Editors (ICMJE) to enable communication within 12 months of 
the Clinical Investigation Report (CIR) approval. All contributors who do not meet the criteria for authorship 
will be listed in an acknowledgments section of the publication. 
20 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 14155:2020 Clinical investigation of medical devices for 
human subjects - Good Clinical Practice, 21 CFR Parts 812, 50, 54, 56 & 11, and any other regional or national 
regulations, as applicable. 
21 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 (SOPs) 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 as noted in section 20 above. 
21.1 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 
for the sponsor to follow, describing all the activities performed during site qualification, initiation, 
monitoring, and close out. 
In accordance with applicable regulations, GCP, and sponsor’s/CRO’s procedures, monitors will contact the 
site prior to the start of the study to review with the site staff the CIP, study requirements, and their 
responsibilities to satisfy regulatory, ethical, and sponsor’s requirements. When reviewing data collection 
procedures, the discussion will also include identification and documentation of source data items. 
The sponsor/designee will monitor the site activity to verify that the: 
• 
Data are authentic, accurate and complete 
• 
Safety and rights of subjects are being protected 
• 
Study is conducted in accordance with the currently approved CIP 
• 
Any other study agreements, GCP, and all applicable regulatory requirements are met. 
The investigator and the head of the medical institution (where applicable) agrees to allow the monitor direct 
access to all relevant documents. 
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21.2 Audits 
To ensure compliance with GCP, the CIP, study procedures and applicable regulatory and EC requirements, an 
independent audit of the study may be conducted. The investigator/institution will be informed of the 
outcome for audits involving their site.  
In addition, inspections by regulatory health authority representatives and EC(s) are possible. 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, for the purposes of a Sponsor audit of the site, or in 
preparation for an inspection. 
Audits and inspections may occur at any time during or after completion of the study. 
22 TRADEMARKS AND COPYRIGHT 
ACE, Advance OffStylet, AOS, Ardium, AutoNRT, Autosensitivity, Baha, Baha SoftWear, BCDrive, Beam, Bring 
Back the Beat, Button, Carina, Cochlear, 科利耳, コクレア, 코클리어, Cochlear SoftWear, Contour, コントゥ
ア, Contour Advance, Custom Sound, DermaLock,  Freedom, Hear now. And always, Hugfit, Human Design, 
Hybrid, Invisible Hearing, Kanso, LowPro, MET,  MP3000, myCochlear, mySmartSound, NRT, Nucleus,Osia, 
Outcome Focused Fitting, Off-Stylet, Piezo Power, Profile, Slimline, SmartSound, Softip, SoundArc,  True 
Wireless, the elliptical logo, Vistafix, Whisper, WindShield and Xidium are either trademarks or registered 
trademarks of the Cochlear group of companies. © Cochlear 2022 
23 REFERENCES 
1) 
Bench J, Kowal A, Bamford J. The BKB (Bamford-Kowal-Bench) sentence lists for partially-hearing 
children. Br J Audiol. 1979;13(3):108‐112. 
2) 
Galvin K. & Noble W. (2013). Adaptation of the Speech, Spatial and Qualities of Hearing Scale for use with 
Children, Parents and Teachers. Cochlear Implant International. 14(3): 135 – 141. 
3) 
Goycoolea M., Riabalta G., Tocornal F., et. al. (2020). Clinical Performance of the Osia system, a new 
active osseointegrated implant system. Results from a prospective clinical investigation. Acta Oto-
Laryngologica. 140(3): 212 – 219. 
4) 
International Organization for Standardization.  ISO 14155:2020 Standard:  Clinical investigation of 
medical devices for human subjects – Good clinical practice. 2020.  Available at: 
https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-3:v1:en  
5) 
Lau K., Scotta G., Wright K., et. al. (2020). First United Kingdom experience of the novel Osia active 
transcutaneous piezoelectric bone conduction implant. European Archives of Oto-Rhino-Laryngology. 
277(11): 2995 – 3002.  
6) 
Mylanus E., Hua H., Wigren S., et. al. (2020). Multicenter Clinical Investigation of a New Active 
Osseointegrated Steady-State Implant System. Otology Neurotology. 41(9): 1249 – 1257.  
7) 
Peterson GE, Lehiste I. Revised CNC lists for auditory tests. The Journal of speech and hearing disorders. 
1962;27:62-70. 
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