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

Official Title: A Multicentre, Open, Long-term Clinical Investigation Evaluating 
Safety, Performance and Patient Reported Outcomes With an Active 
Osseointegrated Steady-State Implant System in Adult Subjects With 
Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural 
Deafness. 
 
NCT Number: NCT04754477        
 
Document Date: 19 January 2021 

 
CIP Number: CBAS5793 
 
 
 
 
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Clinical Investigation Plan 
 
Investigation Title: A multicentre, open, long-term clinical investigation evaluating 
safety, performance and Patient Reported Outcomes with an Active Osseointegrated 
Steady-State Implant System in adult subjects with conductive hearing loss, mixed 
hearing loss or single-sided sensorineural deafness. 
Short Tile: 
LoTeOS 
CIP Number: 
CBAS5793 
Version Number: 
3.0 
Date:  
19-JAN-2021 
Sponsor 
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14 
PO Box 82 
Mölnlycke, Sweden, SE-435 22   
+46 (0)31-792 44 00 
 
 
 
 
 
 
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki (1), International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice (2), and any regional or national 
regulations, as applicable. 
 
Confidential Information 
The information contained in this document is confidential and should not be copied or distributed to persons not involved 
in the conduct or oversight of the clinical investigation 
 

 
CIP Number: CBAS5793 
 
 
 
 
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Manufacturer 
Cochlear Limited 
1 University Avenue 
Macquarie University 
New South Wales 2109 
AUSTRALIA  
 
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14 
PO Box 82 
Mölnlycke 435 22  
SWEDEN  
Sponsor Organisations 
 
Sponsor: 
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14 
PO Box 82 
Mölnlycke 435 22  
SWEDEN   
 
Regional Sponsor: 
Cochlear Limited 
1 University Avenue 
Macquarie University NSW 2109 
AUSTRALIA  
Coordinating Investigator 
 
 
 
  
 
 
 
Clinical Research Organisation  
 
Statistical consultants:  
Statistiska Konsultgruppen 
Stigbergsliden 5 
Göteborg 414 63   
SWEDEN  
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 
Coordinating Investigator Approval and Declaration 
By my signature below, I confirm my review and approval of this Clinical Investigational Plan (CIP). 
I also confirm that I will strictly adhere to the requirements therein and undertake to ensure that all 
staff with delegated responsibilities in the conduct of this CIP have read, understood and will strictly 
adhere to the requirements therein. This CIP will not be implemented without prior written approval 
from the Ethics Committee, any applicable National Competent Authorities, and the Sponsor. If 
amendments to this plan become necessary, written approval by the Ethics Committee and any 
applicable National Competent Authorities will be obtained before the changes are clinically 
implemented per the amendment, except under emergency circumstances to protect the rights, 
safety, and well-being of subjects. 
Name 
Title 
 
Coordinating Investigator 
Signature 
Date 
 
 
 
Principal Investigator Declaration 
By my signature below, I confirm that I have read, understood and will strictly adhere to the 
requirements therein. I undertake to ensure that all staff with delegated responsibilities in the conduct 
of this CIP have also read, understood and will strictly adhere to the requirements therein. This CIP 
will not be implemented without prior written approval from the Ethics Committee, any applicable 
National Competent Authorities, and the Sponsor. If amendments to this plan become necessary, 
written approval by the Ethics Committee and any applicable National Competent Authorities will be 
obtained before the changes are clinically implemented per the amendment, except under 
emergency circumstances to protect the rights, safety, and well-being of subjects. 
Name 
Title 
 
Principal Investigator 
Site Name 
Site Address 
 
 
 
 
 
Signature 
Date 
 
 

 
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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. 
Name 
Title 
 
Principal Investigator 
Site Name 
Site Address 
 
 
  
  
 
Signature 
Date 
 
 
 
 

 
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TABLE OF CONTENTS 
1 
Definitions and Abbreviations ......................................................................................................... 9 
2 
Clinical Investigation Synopsis ...................................................................................................... 11 
3 
Schedule of Events ....................................................................................................................... 14 
4 
Background Information and Rationale ........................................................................................ 16 
4.1 
Introduction ......................................................................................................................... 16 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 16 
4.2.1 
Nonclinical Data .................................................................................................... 16 
4.2.2 
Clinical Data .......................................................................................................... 16 
4.3 
Investigation Rationale ....................................................................................................... 18 
5 
Medical Device Information ........................................................................................................... 18 
5.1 
Identity and Description of the Investigational Medical Device (IMD) ................................ 18 
5.1.1 
The OSI200 Implant .............................................................................................. 19 
5.1.2 
BI300 Implant ........................................................................................................ 19 
5.1.3 
The Osia 2 Sound Processor (Osia 2 SP) ............................................................ 19 
5.1.4 
Osia 2 Sound Processor Magnets ........................................................................ 20 
5.1.5 
Manufacturer of investigational device(s) ............................................................. 20 
5.2 
Identity and Description of the Comparator ........................................................................ 20 
5.3 
Accessory Device Requirements ........................................................................................ 20 
5.3.1 
Accessories ........................................................................................................... 20 
5.3.2 
The Osia Fitting Software ..................................................................................... 21 
5.3.3 
Cochlear Device Image (CDI) tool ........................................................................ 21 
6 
Objectives ..................................................................................................................................... 21 
6.1 
Safety Objectives ................................................................................................................ 21 
6.2 
Performance Objectives ..................................................................................................... 22 
6.3 
Patient Reported Outcomes Objectives ............................................................................. 22 
6.4 
Exploratory Objective .......................................................................................................... 23 
7 
Design of the Clinical Investigation ............................................................................................... 23 
7.1 
General ............................................................................................................................... 23 
7.1.1 
Design Rationale ................................................................................................... 23 
7.2 
Subjects .............................................................................................................................. 24 
7.2.1 
Inclusion Criteria ................................................................................................... 25 
7.2.2 
Exclusion Criteria .................................................................................................. 25 
7.2.3 
Number of Subjects Required ............................................................................... 25 
7.2.4 
Vulnerable Populations ......................................................................................... 25 
7.2.5 
Recruitment & Investigation Duration ................................................................... 25 

 
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7.2.6 
Criteria for Subject Withdrawal ............................................................................. 26 
7.2.7 
Randomisation Procedures .................................................................................. 26 
7.2.8 
Post-investigation Medical Care ........................................................................... 26 
7.3 
Performance Evaluations and Procedures ......................................................................... 26 
7.3.1 
Demographics ....................................................................................................... 26 
7.3.2 
Post-Enrolment Evaluations and Procedures ....................................................... 27 
7.4 
Safety Evaluations and Procedures ................................................................................... 32 
7.4.1 
Concomitant Medication and Therapies ............................................................... 33 
7.4.2 
Client Service Receipt Inventory (CSRI)............................................................... 33 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 33 
7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 33 
8 
Risks and Benefits of the Investigational medical device and Clinical Investigation .................... 34 
8.1 
Anticipated Clinical Benefits ............................................................................................... 34 
8.2 
Anticipated Adverse Device Effects .................................................................................... 34 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 35 
8.4 
Risk Mitigation .................................................................................................................... 35 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 35 
9 
Statistical Considerations .............................................................................................................. 35 
9.1 
General Considerations ...................................................................................................... 35 
9.2 
Endpoints ............................................................................................................................ 36 
9.2.1 
Safety Endpoints ................................................................................................... 36 
9.2.2 
Performance Endpoints ........................................................................................ 37 
9.2.3 
Patient Reported Endpoints .................................................................................. 37 
9.2.4 
Exploratory Endpoint............................................................................................. 38 
9.3 
Hypotheses ......................................................................................................................... 38 
9.4 
Sample Size Determination ................................................................................................ 38 
9.5 
Analysis Populations ........................................................................................................... 38 
9.6 
Safety Endpoint Analyses ................................................................................................... 38 
9.7 
Performance Endpoint Analyses ........................................................................................ 38 
9.8 
Patient Reported Outcomes Endpoint Analyses ................................................................ 39 
9.9 
Exploratory Endpoint Analyses ........................................................................................... 39 
9.10 Interim Analyses ................................................................................................................. 39 
10 Informed Consent Process ........................................................................................................... 39 
11 Adverse Events and Device Deficiencies ..................................................................................... 39 
11.1 Definitions ........................................................................................................................... 39 
11.1.1 
Adverse Event ...................................................................................................... 39 

 
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11.1.2 
Adverse Device Effect .......................................................................................... 40 
11.1.3 
Serious Adverse Event ......................................................................................... 40 
11.1.4 
Serious Adverse Device Effect ............................................................................. 40 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 40 
11.1.6 
Adverse Events of Special Interest ....................................................................... 41 
11.1.7 
Device Deficiency ................................................................................................. 41 
11.2 Recording and Handling of Adverse Events ....................................................................... 41 
11.2.1 
Assessment of Severity ........................................................................................ 41 
11.2.2 
Assessment of Causality ...................................................................................... 42 
11.2.3 
Assessment of Seriousness ................................................................................. 43 
11.2.4 
Assessment of Expectedness .............................................................................. 43 
11.3 Recording and Handling of Device Deficiencies................................................................. 43 
11.4 Reporting Responsibilities .................................................................................................. 44 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 44 
11.4.2 
Sponsor Notification of Events ............................................................................. 44 
11.5 Independent Data Monitoring Committee ........................................................................... 45 
12 Device Accountability .................................................................................................................... 45 
13 Deviations from the Clinical Investigation Plan ............................................................................. 46 
14 Data Management ........................................................................................................................ 46 
15 Confidentiality ................................................................................................................................ 47 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 47 
17 Suspension or Premature Termination ......................................................................................... 48 
18 Amendments to the Clinical Investigation Plan ............................................................................. 48 
19 Record Keeping and Retention ..................................................................................................... 48 
20 Publication Policy .......................................................................................................................... 48 
21 Statements of compliance ............................................................................................................. 49 
22 Quality Control and Assurance ..................................................................................................... 49 
22.1 Monitoring ........................................................................................................................... 49 
22.2 Audits .................................................................................................................................. 49 
23 Trademarks and Copyright ........................................................................................................... 49 
24 References .................................................................................................................................... 50 
25 Change History ............................................................................................................................. 51 
 

 
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Abbreviations: APHAB, Abbreviated Profile of Hearing Aid Benefit; SSQ, Speech, Spatial and Qualities of 
Hearing Scale; HUI, Health Utilities Index; 
CSRI, Client Service Receipt Inventory 
a Should be performed if needed. 
b Investigates economic consequences of hearing rehabilitation by capturing major health care costs and 
productivity losses. 
c Specify what types of concomitant therapies are applicable e.g. prescription medications, over-the-counter 
medications, vitamins, and herbal supplements, and non-pharmacologic therapies such as [insert any other 
relevant therapies such as acupuncture, electrical stimulation, special diets and exercise regimens]. 
d From the 6-months visit in the CBAS5751 clinical investigation up to the 12-months visit. 

 
 
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4 BACKGROUND INFORMATION AND RATIONALE 
4.1 Introduction 
The aim of this investigation is to collect long-term safety and performance data with the Active 
Osseointegrated Steady-State Implant System, Cochlear™ Osia® 2 System, by following subjects 
from the previous Osia clinical investigation CBAS5751. This is to meet expected requirements from 
any Notified Body or Regulatory agency. In addition, questions regarding device satisfaction, sound 
satisfaction, usability and health care utilisation will be asked. This data can be used for current and 
future comparison with other studies, and for supporting marketing claims.  
4.2 Findings of Previous Nonclinical and Clinical Studies 
4.2.1 
Nonclinical Data 
Results from technical verification and validation activities are described in the currently released 
Investigator’s Brochures (3) (4). 
4.2.2 
Clinical Data 
The Osia 2 system has been tested for 6 months in the recently completed prospective, multicentre 
clinical investigation, CBAS5751, including 29 subjects with CHL, MHL or SSD (see section 4.2.2.1) 
(5). 
In addition, a Controlled Market Release (CMR) and early post-launch surveillance activity have been 
conducted on the Osia 2 System in the United States of America (6) following FDA approval on 
November 15th 2019 (see section 4.2.2.2). 
4.2.2.1 
Multicentre Clinical Investigation with the Osia 2 System 
Safety and performance of the Osia 2 System were studied in a prospective, multicentre clinical 
investigation CBAS5751 (ClinicalTrials.gov Identifier NCT 04041700) including 29 adults with CHL 
(n=12), MHL (n=12), or SSD (n=5) (5). Subjects were unilaterally (n=28), or bilaterally (n=1) 
implanted and served as their own controls (i.e. pre-operative unaided hearing vs. aided hearing with 
the Osia 2 System). The subjects completed the primary efficacy and safety endpoints at 3 months, 
and data collection continued until investigation ended at 6 months. 
4.2.2.1.1 
Performance 
The results from the clinical investigation demonstrate the following benefits for subjects with CHL, 
MHL and SSD with regards to hearing performance and health related quality of life. 
The Osia 2 System provided statistically significant improvements in hearing performance compared 
to the unaided condition with an improvement in hearing thresholds at 3 and 6 months (PTA4, mean 
of 0.5, 1, 2, and 4 kHz) of -27.3, dB (SD 8.7 dB, range -46.3 to -10.0 dB), and -28.4 dB HL (SD=9.6, 
range -46.3 to -10.0 dB HL) respectively. 
Statistically significant improvements were also seen for ‘Speech recognition in quiet’ at all speech 
presentation levels (SPL), 50, 65 and 80 dB SPL and for ‘Adaptive speech recognition in noise’, at all 
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For ‘Speech recognition in quiet’ at 50 dB SPL the improvements were 62.7 percentage points (SD: 
20.7, range 22.0 to 88.0), and 62.3 percentage points (SD 22.1, range -4.0 to 84.0) at 3 and 6 
months respectively. 
At 65 dB SPL the improvements were 55.5 percentage points (SD 29.3, range 10.0 to 96.0) and 54.0 
percentage points (SD 29.8, range -6.0 to 98.0) at 3 and 6 months, respectively. 
At 80 dB SPL the improvements were 23.7 percentage points (SD 27.7, range -6.0 to 96.0, 
p<0.0001) and 24.3 percentage points (SD 28.0, range -7.0 to 92.0), at 3 and 6 months, respectively.   
For ‘Adaptive speech in noise’ mean improvements in SNR with the Investigational device compared 
to unaided was -9.1 dB (SD 7.9 dB, range -21.8 to 1.6 dB) and -8.8 (SD 7.9 range -21.8 to 1.4) at 3 
and 6 months respectively. 
All SSQ subscales (Total, Speech, Spatial, and Quality) showed statistically significant improvements 
(p<0.0001) at both 3 and 6 months. APHAB scores showed statistically significant improvements 
(p<0.001) at both 3 and 6 months for the subscales Ease of Communication (EC), Background Noise 
(BN), the Global score and Reverberation (RV). Health status and health related quality of life, 
measured with HUI3, showed statistically significant improvements for the attributes Comprehensive 
health state (p=0.0052) and Emotion attribute (p=0.033) at 3 months, and for the attributes 
Comprehensive health state (p=0.0093) and Hearing (p=0.045) at 6 months. 
4.2.2.1.2 
Safety 
In total, 54 AEs were reported in 22 (75.9%) of the 29 implanted subjects during the investigation. 
Fifty-one (51) of the fifty-four (54) events were classified as mild. Twenty-seven (27) events were 
judged as related to either the device (5 events), the procedure (12 events) or both device and 
procedure (10 events). 
Four (4) Serious Adverse Events (SAEs) were reported within the six months investigational period. 
One (1) event was judged as probably related to both the device and the procedure, and one as 
probably related to the procedure. Both were recorded as post-operative wound infections in the 
perioperative phase and were resolved after hospitalisation. The other two SAEs occurred in the 
same subject and were judged as not related to the device nor the procedure. 
Overall, eighty-nine (89) Device deficiencies (DDs) were reported for twenty-two (22) of the subjects 
during the 6 months investigation period. Of these, 79% (n=70) were described as related to the SP, 
12% (n=11) to the OFS, 8% (n=7) to accessories and 1% (n=1) to the implant. 
4.2.2.2 
Controlled Market Release Osia R4 and Post Launch Surveillance 
The objective of the CMR was to gain experience in various aspects of the Osia 2 System through 
the collection of observational and clinical experience data in the form of surveys, both through Field 
staff and Clinicians (6). The CMR was not aimed at providing clinical performance or clinical benefit 
data from patients, but rather usability among clinicians and safety during surgery. Twenty-three (23) 
surgeons performed 44 surgeries in 16 clinics on 43 recipients (1 bilateral). Five (5) complications 
were report: One (1) case of exposed dura and excessive bleeding (puncture of the transverse 
sinus), the BI300 implant was able to be implanted without further complication, two (2) post-
operative wound infections, both treated successfully with antibiotics and two (2) post-operative 
hematomas over the coil site. One resolved via application of ice and the other was treated by needle 
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The Osia 2 SP is compatible with the Cochlear wireless accessories available on the market as well 
as various other accessories like Nucleus® Safety Line and Cochlear SoftWear™ Pad. It is also 
compatible with iPhone via Bluetooth Low Energy enabling the use of apps and streaming. The 
subjects will be able to choose from five different front colors for their SP.  
The Osia 2 SP is powered by one battery which is expected to be enough for one full day of use. The 
Osia 2 SP is further described in the Cochlear Osia 2 Sound Processor User Manual.  
 
 
 
Figure 2. The Osia 2 Sound Processor. 
 
5.1.4 
Osia 2 Sound Processor Magnets 
The Osia 2 Sound Processor Magnets are available in 4 different strengths; 1 being the weakest and 
4 the strongest. 
5.1.5 
Manufacturer of investigational device(s) 
Cochlear Limited, Sydney, Australia is the legal manufacturer for everything in the Osia 2 System, 
except the BI300 Implant. 
Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden is the legal manufacturer for the BI300 
Implant.  
The IMD and/or the packaging for the device will state that the device is exclusively for use in a 
clinical investigation. 
5.2 Identity and Description of the Comparator 
Not applicable 
5.3 Accessory Device Requirements 
5.3.1 
Accessories 
In the previous CBAS5751 investigation the following other approved accessories were distributed by 
Cochlear: 

 
 
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as a fast and efficient way to collect such data, since these subjects are already implanted with the 
Osia 2 system. To be able to compare performance and safety of the device over time similar 
endpoints as in the previous investigation will be chosen. In addition, the subjects will be asked 
questions regarding device satisfaction, sound satisfaction, usability and health care utilisation to 
collect information for current and future comparison with other studies. 
The audiometric thresholds (pure tone average PTA4 and individual frequencies) and speech 
recognition in noise measured in sound-field, are relevant and objective methods that are commonly 
used by clinics internationally as a way to assess hearing performance, and they were both used in 
the CBAS5751 investigation.  
Speech communication is a very important aspect in human communication. In everyday life, 
conversations usually occur in the presence of background noise and listeners with hearing-
impairment often complain about problems with understanding speech in noisy situations. Speech in 
noise tests simulate everyday situations (listening to complete sentences in noise) and can therefore 
be used to test the performance of hearing in noisy situations. The Hearing in Noise Test (HINT) is a 
speech in noise test designed to be used in an adaptive procedure to establish the speech 
recognition threshold for sentences, where 50% of the sentences are correctly repeated. The original 
HINT material was developed in 1994 and consists of short everyday sentences in English, which are 
judged to be natural by native speakers of American English (7). The Chinese Hearing in Noise Test 
(CHINT) to be used in this clinical investigation was developed using the same rationale as the 
English HINT and has shown to be comparable, allowing the two tests to be compared directly 
across languages (8). In Australia an adaptive Australian Sentence Test in Noise, the AuSTIN test 
will be used, which is validated in terms of test-retest reliability and efficiency (9). It is a speech in 
noise test designed to be used in an adaptive procedure to establish the speech recognition 
threshold for sentences, where 50% of the sentences are correctly repeated. 
Questionnaires to collect patient reported outcomes—Abbreviated Profile of Hearing Aid Benefit 
(APHAB) (10) and Speech, Spatial and Qualities of Hearing Scale (SSQ) (11) and the health related 
quality questionnaire, HUI (12) are well established methods that are abundantly referred to in the 
scientific literature. All three tests questionnaires were used in the CBAS5751 investigation. 
From a health economic perspective, HUI and an adapted version of the Client Service Receipt 
Inventory (CSRI) will be used. HUI will collect information on how the different quality of life aspects 
change over time. Do the initial improvements remain the same, and do some improvements 
decrease as a result of ageing or disease?  
CSRI is a research instrument developed to collect socio-economic information on service utilisation, 
income, accommodation and other cost-related variables (13). Its primary purpose is to allow 
resource use patterns to be described and support costs to be estimated using an appropriate unit 
cost. It has been used in over 500 studies according to PSSRU (Personal Social Service Research 
Unit). 
7.2 Subjects 
Written informed consent must be obtained before any investigation procedures are initiated.  

 
 
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7.2.1 
Inclusion Criteria 
Subjects must meet all of the inclusion criteria described below to be eligible for this clinical 
investigation. 
1. Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation 
CBAS5751 
2. Willing and able to provide written informed consent 
7.2.2 
Exclusion Criteria 
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical 
investigation. 
1. Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to 
comply with the requirements of the clinical investigation as determined by the investigator 
2. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator 
7.2.3 
Number of Subjects Required 
The subjects are participants who have performed the 3- and/or 6-month visit in the completed Osia 
clinical investigation CBAS5751. The maximum number of subjects will be 27. 
7.2.4 
Vulnerable Populations 
Not applicable 
7.2.5 
Recruitment & Investigation Duration 
The following subject status definitions apply: 
• 
Consented: Signed consent and eligibility evaluations underway 
• 
Screen Fail: Subject determined not to be eligible to proceed for participation 
• 
Enrolled: First use of the Investigational device following completion of screening activities and 
confirmation of eligibility 
• 
Withdrawn: Enrolled subjects who withdraw or are withdrawn by the Investigator or Sponsor 
before the expected last visit.  
• 
Complete: Enrolled subjects who complete the planned follow up visits according to this CIP. 
The enrolment period for the clinical investigation is anticipated to be four months from the time of 
first subject consent to enrolment of the last subject. 
The expected duration of each subject’s participation in the clinical investigation, is 12 months, from 
the time of informed consent through to the End of Investigation visit 12 months after visit 1. 
Clinical Investigation completion is last subject last visit. The anticipated total duration of the clinical 
investigation is 17 months, including visit windows and follow-up time in the event of an ongoing 
SAEs/SADEs at the time of this last visit. Ongoing SAEs/SADEs will extend the clinical investigation 
completion for a further 30 days, or until resolution or stabilisation of the event, whichever comes 
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7.2.6 
Criteria for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the 
reason(s). The reason for withdrawal should to be documented in the subject’s source files and the 
case report form (CRF). 
The Investigator or Sponsor may also decide to withdraw a subject from the clinical investigation if it 
is considered to be in their best interest. 
Subject withdrawal may be for any of the following reasons: 
• 
Adverse Event (AE) 
• 
Device Deficiency (DD) 
• 
CIP or GCP deviation 
• 
Subject lost to follow-up 
• 
Subject withdrew consent 
• 
Subject death 
• 
Sponsor decision 
• 
Investigator decision 
If subject withdrawal is due to problems related to the investigational device, safety or performance, 
the Investigator shall ask for the subject's permission to continue in safety follow up (i.e., adverse 
events) until their scheduled End-of-Investigation visit. 
If a subject is lost to follow-up, every possible effort must be made by the investigation 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. 
Enrolled subjects who are withdrawn/discontinued will not be replaced. 
7.2.7 
Randomisation Procedures 
Not applicable 
7.2.7.1 
Blinding Procedures 
Not applicable 
7.2.8 
Post-investigation Medical Care 
After the clinical investigation the subjects will be able to continue with their Investigational device. 
Routine controls with audiological checks will follow local routines according to the standard 
treatment program for bone conduction hearing implant systems. The Investigational device will be 
warranted and supported with service according to normal regional Cochlear routines. 
7.3 Performance Evaluations and Procedures 
7.3.1 
Demographics 
The following demographic data will be collected from the previous CBAS5751 investigation: 

 
 
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• 
Age collected as date of birth (month and year) 
• 
Gender 
• 
Race   
• 
Nicotine use (Cigarettes/day)  
 
7.3.2 
Post-Enrolment Evaluations and Procedures 
7.3.2.1 
Audiometry testing 
If the study team experience an "unreasonable value" in any test, the test should be performed again 
after a short while to confirm validity. 
7.3.2.1.1 
Audiogram 
To follow how the subject’s hearing thresholds change over time, unaided audiometric threshold 
measures (including both air- and bone conduction thresholds) will be recorded at 12 and 24 months 
and compared with the same data collected at baseline before implantation in the CBAS5751 
investigation.  
Frequencies required for air conduction thresholds are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 
6000 and 8000Hz. For bone conduction thresholds the required frequencies are 250, 500, 750, 1000, 
1500, 2000, 3000, 4000 and 6000Hz.  
7.3.2.1.2 
General instructions for audiological assessments 
A detailed work instruction regarding the audiological assessments will be available during training 
before the start of the investigation. 
All tests shall be performed in a sound insulated room. Equipment used for audiological testing shall 
be calibrated according to the clinic’s normal standard before initiation of the investigation. The 
speakers should be at the height of the test subject’s head and more than 1 meter away from the test 
subject. There should preferably be more than 1 meter of free space around the test subject in all 
directions. This is in accordance with the current standard (14). It is important to keep the same 
sound room and test equipment set-up during the entire clinical investigation. Changes may be 
necessary and allowed, but only after approval by the Sponsor. 
7.3.2.1.2.1 Blocking 
All audiometric tests shall be performed with the non-test ear blocked (in case of normal or near-
normal hearing or a large asymmetry with the non-test ear having significantly better hearing 
thresholds). Before blocking of the non-test ear, a sound-field measurement on PTA4 frequencies 
(500, 1000, 2000, 4000 Hz) shall be performed. The blocking shall then be done with earplug and 
muff and an additional sound-field measurement on PTA4 frequencies shall then be performed to 
verify effective blockage and document the hearing level after blockage.  
7.3.2.1.2.2 Settings for the Sound Processors 
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7.3.2.1.3 
Audiological assessments 
7.3.2.1.3.1 Sound Processor fitting 
OFS (version 2) will be used to adjust the Investigational device settings for a specific subject. This 
will be performed during fitting at the 12- and 24-month visit and at an extra visit if needed (for 
example if the magnet is replaced with a different strength or start/stop of use of a soft pad). If the 
gain needs to be adjusted or changes to the program configuration are needed, a fine tuning is 
recommended. The fitting software will be installed on a laptop computer provided by the Sponsor, 
and the fitting-data will be saved on the laptop until the investigation is ended when it will be 
transferred to the Sponsor in a coded way.  
Coil-to-coil measurement 
The Digital Link Calibration (e.g. coil-to-coil measurement) that is a step in the connection step in the 
OFS, should be performed at each occasion the software is being used to fit or finetune the device to 
optimise the performance of the device for the user throughout the investigation. This will also 
provide an indication of the soft tissue thickness during the course of the investigation. 
7.3.2.1.3.2 Bone Conduction (BC) Direct 
BC Direct is a tool in the OFS (current version) to establish the unmasked bone conduction threshold 
with tones presented through the sound processor. BC Direct measurements (as part of the OFS) will 
be performed at 12 and 24 months when the subject is using the Investigational device. BC 
thresholds obtained at the following frequencies will be recorded; 250, 500, 750, 1000, 1500, 2000, 
3000, 4000, 6000 Hz. 
7.3.2.1.3.3 Sound-field thresholds 
The purpose of this test is to establish the hearing thresholds in free field through a speaker in front 
position (0 degrees azimuth) according to the so-called ascending or modified Hughson-Westlake 
method (Figure 3). The frequencies to be tested are [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 
8.0 kHz], the signal to be used shall be warble tones.   
 
      BACK 
 
Signal 
FRONT 
 
     
 
Figure 3: The setup of the speaker when testing sound-field thresholds. 

 
 
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7.3.2.1.3.4 Speech test 
Adaptive Speech recognition in noise 
The purpose of this test is to establish the test subject’s ability to recognize speech in the presence of 
background noise. The adaptive speech test in noise shall be conducted using validated lists for the 
language it is presented in. The first list shall be used as a training list before the test is performed 
and the training list shall be used at each visit. Both speech and noise will be presented in sound field 
from the front speaker (0 degrees azimuth, S0N0) (Figure 4). In Hong Kong software and speech 
material to be used is the CHINT (8), where the noise shall be kept constant at 65 dB SPL, and the 
speech shall be adapted stepwise according to the software used to establish the signal-to-noise 
ratio (SNR) where the test subject repeats 50% of the material correctly.  In Melbourne and Sydney, 
the test to be used is AuSTIN (9), where the sentences shall be presented at a constant level of 65 
dB SPL throughout the test, and the babble noise shall be adapted stepwise according to the 
software used to establish the speech-to-noise ratio (SNR) providing a 50% level of correctly 
repeated morphemes. 
 
      BACK 
 
Speech and noise 
 
    FRONT 
Figure 4. The setup of the speakers when testing Adaptive Speech recognition in noise. 
 
This measurement shall be performed with the Investigational device at 12 and 24 months. 
 
7.3.2.1.3.5 Cochlear Device Image (CDI) tool 
The CDI tool is an engineering software used to establish the unmasked bone conduction high 
frequency thresholds with tones presented through the sound processor. The CDI measurements will 
be performed at 12 and 24 months when the subject is using the Investigational device. The CDI 
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7.3.2.2 
Patient reported outcomes 
7.3.2.2.1 
Abbreviated Profile of Hearing Aid Benefit (APHAB form A) 
The APHAB form “A” questionnaire (10) from HARL (Hearing Aid Research Lab, University of 
Memphis, USA) is a 24-item self-assessment inventory that evaluates the benefit experienced by the 
subject when using hearing amplification compared to the unaided listening. APHAB produces a 
global score and scores for four subscales: Ease of Communication, Reverberation, Background 
Noise, and Aversiveness.  
The subjects will complete the APHAB questionnaire at 12 and 24 months follow up for the aided 
situation (with the Investigational device).  
The APHAB questionnaire is available for free and in different languages on the HARL home page. 
7.3.2.2.2 
Speech, Spatial and Qualities of Hearing Scale (SSQ-12 version) 
The short form of Speech, Spatial, and Qualities of Hearing Scale questionnaire (SSQ-12) (15) from 
MRC Institute of Hearing Research, UK, is a scaled-down version of the 49 items SSQ questionnaire 
(11). It is designed to compile a sub-set of items from the longer original 49 version to represent the 
scale as a whole, measuring self-reported auditory disability, reflecting the reality of hearing in the 
everyday world. It has been shown to provide similar results to SSQ49 (15). It covers:  
• 
Hearing speech in a variety of competing contexts  
• 
The directional, distance and movement components of spatial hearing  
• 
Segregation of sounds and attending to simultaneous speech streams  
• 
Ease of listening  
• 
The naturalness, clarity and identifiability of different speakers, different musical pieces and 
instruments, and different everyday sounds  
The subjects will complete the SSQ questionnaire at the 12- and 24-months follow-up for the aided 
situation (with the Investigational device). 
The SSQ-12 questionnaire is free for use, confirmed by 
, former Director 
of MRC Institute of Hearing Research, which closed down 2018. 
7.3.2.2.3 
Health Utilities Index (HUI) 
HUI® (12) is a generic preference-based system for measuring comprehensive health status and 
health-related quality of life (HRQoL). HUI provides descriptive evidence on multiple dimensions of 
health status, a score for each dimension of health and an overall health-related quality of life 
(HRQoL). The scoring systems provide utility (preference) scores on a generic scale where dead = 
0.00 and perfect health = 1.00.  HUI3 will be used in this clinical investigation (Questionnaire 
HUI23S1EN.15Q). The HUI3 classification system is comprised of 8 attributes: Vision, Hearing, 
Speech, Ambulation, Dexterity, Emotion, Cognition and Pain – each with 5 or 6 levels of 
ability/disability (12). The version in this clinical investigation uses a recall time of 1 week.  
The subjects will complete the HUI at the 12- and 24-months follow-up for the aided situation (with 
the Investigational device). 
The license to use the HUI questionnaire is purchased from Health Utilities Inc., 88 Sydenham Street, 
Dundas, ON, L9H 2V3 Canada.  

 
 
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7.3.2.2.4 
Questions regarding the satisfaction with the device 
At 12 and 24 months the subjects shall estimate the experience of the SP in relation to every-day 
situation, self-esteem, the easiness to use, durability of the device and sound quality using a Likert 
scale. It is a five- or seven-point scale which allows the individual to express how much they agree or 
disagree with a particular statement. The subjects shall also state if they are overall satisfied with the 
device, by answering yes or no. 
7.3.2.3 
Usability 
7.3.2.3.1 
Daily use 
At the 12- and 24-months visit, data regarding daily use of the sound processor will be collected. 
The estimated average hours of daily use (hours/day) during the last week before each follow up visit 
shall be recorded. 
7.3.2.3.2 
Daily streaming 
At the 12- and 24-months visit, data regarding daily streaming using the sound processor shall be 
collected. Streaming of for example phone calls or music, can be done directly from an iOS or 
Android phone, or by using the wireless accessories.  
Average hours of daily streaming (hours/day) during the last week before each follow-up visit shall be 
recorded. 
7.3.2.3.3 
Battery lifetime 
At the 12- and 24-months visit, data regarding battery lifetime for the sound processor will be 
collected. Average hours of the battery lifetime for a single battery during the last week before each 
follow up visit. Subjects will be encouraged to use each battery until the “low battery” is signaled by 
the SP. 
7.3.2.3.4 
Magnet choice 
There are 4 different magnet strengths, ranging from 1 to 4, strength 1 being the weakest. At the 12- 
and 24-months visit, the choice of SP magnet shall be checked and recorded. There may be a need 
to decrease or increase the strength depending on the subject’s preference. Every time a change 
occurs it is important to perform a new fitting procedure according to the OFS. 
7.3.2.3.5 
SoftWear Pad use 
At the 12- and 24-months visit, data regarding SoftWear pad use (Yes/No) for the sound processor 
will be collected. 
 
 

 
 
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7.3.2.3.6 
Sound Processor retention 
At the 12- and 24-months visit, the subjects shall estimate the experienced retention of the SP.  
The estimation shall be performed using the VAS scale (visual analogue scale 100mm) with 
insufficient retention to the left and excellent retention to the right.  
With regard to your Sound processor, please rate the overall retention by placing a single vertical line on the 
scale. 
 
 
 Insufficient 
 
 
 
                                    Excellent 
 retention 
 
 
 
 
 
          retention 
 
7.3.2.3.7 
Sound Processor wearing comfort 
At the 12- and 24-months visit, the subjects shall estimate the experienced wearing comfort of the 
SP.  
The estimation shall be performed using the VAS scale (visual analogue scale 100mm) with no 
comfort at all to the left and excellent comfort to the right. 
 
With regard to your Sound processor, please rate the overall comfort by placing a single vertical line on the 
scale. 
 
 
 Not comfortable 
 
 
 
                Most comfortable 
      at all 
 
 
 
 
 
        imaginable 
 
7.3.2.4 
Device exposure 
Device exposure is information about for how long the subject is exposed to the Osia 2 Implant and 
the Osia 2 Sound Processor. Data is summarized from other data fields in the same case report 
form. 
7.4 Safety Evaluations and Procedures 
Subjects will be carefully monitored during the investigation for possible adverse events and 
appropriate treatment of the subject will be initiated. Any adverse events observed will be fully 
investigated by the investigator and documented in the CRF including assessment of seriousness, 
severity (mild, moderate or severe) and relationship to the medical device.The risks and anticipated 
ADEs for Osia 2 System, as identified in Section 8.2 of the CIP, will be assessed in the clinical 
investigation via reporting of all AEs/ADEs from the time of first subject first visit until last subject last 
visit. The Sponsor will be notified by automatic eCRF alerts when events are judged as device 
related or serious. A safety monitor, appointed by the Sponsor, will be contacted regarding events 
that are uncertain, serious or unexpected. 
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regarding all AEs and DDs reported. This evaluation will be performed by the team responsible for 
the clinical investigation, including the Safety contact/monitor. The interim safety evaluation will be 
documented in a report. 
7.4.1 
Concomitant Medication and Therapies 
Relevant Medications and treatments, as judged by the Investigator, that are given to the subjects should be 
entered in the eCRF. 
Prohibited therapies are the following: 
• 
ototoxic drugs 
If a subject receives a prohibited therapy each situation will be evaluated case by case and judged by 
the responsible investigator. 
7.4.2 
Client Service Receipt Inventory (CSRI) 
CSRI is a research instrument developed to collect socio-economic information on service utilisation, 
income, accommodation and other cost-related variables (13). Its primary purpose is to allow 
resource use patterns to be described and support costs to be estimated using an appropriate unit 
cost. It is free to use and allows users to exclude questions not relevant for the investigation in which 
it is to be used. 
The adapted version of CSRI will, in this investigation, collect data referent to the 12 months before 
each visit regarding demographics (marital status, cohabitation, usual place of residence, education 
level), employment status and healthcare utilisation and hearing rehabilitation. 
7.5 Equipment Used for Evaluation of Performance and Safety 
All tests shall be performed in a sound insulated room. Equipment used for audiological testing shall 
be calibrated in accordance the local procedures at each clinic. A work instruction will be provided by 
the time of the Site Initiation Visit. 
The OFS and CDI tool together with a user manual or work instruction for the software according to 
current released version will be provided by the sponsor. 
7.6 Sponsor Role in Conduct of the Clinical Investigation 
The test set-up regarding speaker placement, sound room facility and software used at each clinic 
were checked and approved by the Sponsor at the previous CBAS5751 investigation. Equipment 
used for audiological testing shall be calibrated according to the clinic’s normal standard before 
initiation of the investigation. Calibration certificates will be asked for by the Sponsor as part of the 
investigation documentation. 
If needed, technical expertise will be provided in the study, for example for installation of 
programming software, provision of training on the software or troubleshooting with the performance 
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8 RISKS AND BENEFITS OF THE INVESTIGATIONAL MEDICAL DEVICE AND 
CLINICAL INVESTIGATION 
8.1 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.  
Compared to treatment according to standard practice at the clinic, the participants in this 
investigation will be more closely monitored regarding the IMD and also get the opportunity to meet 
and interact more with the audiology team and other medical staff at the clinic. The participation will 
lead to better knowledge on long term performance and safety which might be beneficial for future 
Osia System Recipients. 
8.2 Anticipated Adverse Device Effects 
The Investigational device has been designed and manufactured to ensure that all risks have been 
reduced as far as possible. However, certain adverse device effects (ADEs) may occur even after all 
state-of-the-art risk control measures have been implemented and verified. 
As per section 4.2.2, the subjects were implanted and provided with the Osia 2 System in the 
previous prospective, multicentre clinical investigation CBAS5751 where safety and performance of 
the Osia 2 System were tested in short term, at 3 and 6 months. 
The CBAS5751 clinical investigation on the Osia 2 System showed no serious adverse events or 
device deficiencies related to the Implant (OSI200). 
The following adverse device effects were reported in relation to the procedure; infected wound (6), 
muscular neck pain in region inferior to operation site (2), pain (1), ear pain (1), crust on wound (1) 
and hair follicle caught in wound (1). 
In addition, the following adverse device effects related to the device or both the device and the 
procedure have been reported (to date). Pain at implant site (4), itchiness and discomfort around 
incision (4), infection (1), tender skin at sound processor site (1), increased tinnitus (1), discomfort 
due to sound processor heating up (1), prominence of the edge of the Osia implant (1), distress (1) 
and frustration (1). In the CBAS5751 clinical investigation numbness was evaluated separately, not 
reported as an AE. Around 50% of the subjects reported numbness in the implant area during the 
investigation. 
In a clinical investigation with the first generation Osia implant and Osia Sound Processor (16) the 
same kind of adverse device effects were reported. In addition, headache, vertigo, neuropathic pain 
and three cases of warm skin when using the device were reported. The issues were transient and 
did not cause any suffering to the subjects. In a clinical investigation with the first generation Osia 
implant, but the current Osia Sound Processor (17) one adverse device event was reported; skin 
irritation under the SP which was resolved after a few days of not using the device and adding a 
SoftWear pad. 
More information and details with regards to any risks with the use of the Investigational device is 
provided in the Investigator´s Brochures (3) (4). 

 
 
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8.3 Risks Associated with Participation in the Clinical Investigation 
The subjects are already implanted with the investigational device and using the Sound Processor, 
no additional risk is therefor expected for participation. The long-term risk of using the Osia System is 
unknown, which will be followed in this investigation in a controlled way until 24 months post 
implantation. 
Due to the current COVID-19 pandemic it could be a potential risk for the subjects to visit the clinics 
in case of increased outbreaks in the respective regions. 
8.4 Risk Mitigation 
All reported ADEs and DDs will be reviewed regularly by the Sponsor for the duration of the clinical 
investigation to facilitate early detection and appropriate intervention if events are unanticipated with 
respect to incidence, severity, or outcome. 
Respective clinic will handle the Covid-19 situation according to local regulations and instructions.  
8.5 Risk-to-Benefit Rationale 
The long-term risks using this Osia 2 System is still unknown. In relation to the individual benefit to be 
more closely monitored regarding the IMD and also get the opportunity to meet and interact more 
with the audiology team and other medical staff at the clinics the benefits are considered to 
overweight the risks. Participation in this clinical investigation could lead to increased risk for the 
subject to be infected by COVID-19 when visiting the clinic but is judged as limited as long as the 
subjects and clinics follow local regulations. 
9 STATISTICAL CONSIDERATIONS 
9.1 General Considerations 
The distribution of continuous variables as well as change in continuous variables will be given as n, 
mean, SD, SEM, Median, Min and Max and the distribution of dichotomous and categorical variables 
will be given as number and percentages. Mean changes over time will be presented along with 95% 
CI. 
All data will be presented in summarized tables and figures along with listings of individual data. The 
last non-missing measurement from the CBAS5751 investigation (3- and 6-months visits) will serve 
as the baseline reference in this follow up analysis for each subject. Changes from this baseline 
measurement will be evaluated statistically using a paired statistical methodology, each subject 
serves as his/her own control. Data collected at 12 and 24 months will be presented by visit where 
applicable. Data which are of collected continuously over time such as Adverse event and Device 
deficiency will be presented as Number of events and Number of subjects with events, and not by 
visits. Efficacy audiology measurements will be compared to the subjectively evaluation of the 
satisfaction with the system in order to find out if there are any useful clinical audiological cut-offs 
where a subject is satisfied or not. 
Analyses at 12 months will be based on subjects attending the 12 months visit and analyses at 24 
months analyses will be based on subjects attending the 24 months visit. No per protocol analyses 
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Pass/fail criteria to be applied to the results: 
• 
The objective is considered as fail if more than two of the subjects have experienced a related 
serious adverse event with the same root cause within the first 24 months from surgery. 
• 
The objective is considered as fail if more than two of the subjects have an increase in PTA-4 
Sound field threshold >15 dB at 24 months compared to the last obtained aided PTA value in 
CBAS5751 (3 or 6 months).  
• 
The objective is considered as fail if more than two of the subjects have an increase in SNR 
field threshold >1 unit at 24 months compared to the last obtained aided SNR value in 
CBAS5751 (3 or 6 months). 
If a failed result regarding PTA-4 or SNR is obtained a root cause analysis will be performed to 
confirm that the failed value depends on declined performance and not on other factors such as 
impaired unaided hearing, incorrectly performed tests or other causes. 
If any of the criteria are failed the investigation is considered as fail. 
No formal hypothesis testing will be performed in this long term follow up study. 
No termination of the study will be made on statistical grounds. 
Protocol deviations will be listed in listing appendix. 
No Statistical Analysis Plan (SAP) is planned to be produced. 
9.2 Endpoints 
9.2.1 
Safety Endpoints 
• 
Adverse events (including explantations, revision surgery) 
o AEs,  
o ADEs,  
o SAEs,  
o SADEs and  
o AESIs. 
• 
Device deficiencies 
• 
Use of concomitant medication 
• 
Compare baseline audiogram before implantation with audiogram at follow up visits to 
investigate if the thresholds have been constant over time. Bone- and air conduction 
thresholds, masked and unmasked, at 12 and 24 months. 
• 
Socio-economic health care data will be collected at 12- and 24 months. It will be estimated 
and used at a later stage together with data from other sources. 
o 
Demographics: marital status, cohabitation, usual place of residence, education level 
o Employment status 
o Healthcare utilisation 

 
 
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o Hearing rehabilitation 
9.2.2 
Performance Endpoints 
• 
The hearing performance at 12- and 24-months post-surgery when using the Investigational 
device compared to the hearing performance at of 3- and 6-months in the CBAS5751 
investigation assessed as: 
o The change in Thresholds audiometry, sound-field [PTA4, mean of 0.5, 1, 2 and 4 
kHz] 
o The change in Thresholds audiometry, sound-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 
4.0, 6.0 and 8.0 kHz]. 
o The change in Adaptive speech in noise [signal-to-noise ratio, 50% speech 
understanding].  
• 
BC Direct [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz] will be performed using the 
Investigational device at 12- and 24-months post-surgery. 
9.2.3 
Patient Reported Endpoints  
• 
The benefit in self-reported hearing outcome when using the Investigational device at 12- and 
24-months post-surgery compared with the benefit at 3- and 6-months post-surgery in the 
CBAS5751 investigation assessed by:  
o The change in scores using the Abbreviated Profile of Hearing Aid Benefit (APHAB). 
o The change in scores using the Speech, Spatial and Qualities of Hearing Scale 
(SSQ). 
• 
The benefit in health-related quality of life (HRQoL) when using the Investigational device at 
12- and 24-months post-surgery compared with the benefit at 3- and 6-months post-surgery in 
the CBAS5751 investigation. 
• 
Usage information at 12 and 24 months: 
o Magnet choice 
o Sound Processor retention 
o Sound Processor wearing comfort 
o Use of SoftWear pad 
o Daily use 
o Daily streaming 
o Battery lifetime 
o Retention 
o 
Comfort 
• 
Subjective questions at 12 and 24 months: 
o Every-day situation 
o Self-esteem 
o Sound quality 

 
 
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o Easy to use 
o Durability 
o Overall satisfaction (Yes/No) 
9.2.4 
Exploratory Endpoint 
• 
High frequency thresholds [6.0, 7.0, 8.0, 9.0 and 9.5 kHz] will be collected with the CDI tool, 
using the Investigational device at 12- and 24-months post-surgery.  
9.3 Hypotheses 
No hypothesis testing will be made in the study. Confidence limits and p-values presented in the 
analyses are considered to be exploratory. 
9.4 Sample Size Determination 
This is a long term follow up study of the CBAS5751 study and no specific sample size calculation 
will be made here. 
9.5 Analysis Populations 
Subjects attending the 3- and/or the 6-months visit in the original CBAS5751 study who accept to 
participate in this long term follow up investigation and attends the 12- or 24 months visit will be 
analysed. No per protocol population will be defined.  
9.6 Safety Endpoint Analyses 
Separate tabulations of AEs, ADEs, SAEs, SADEs and AESIs will be produced. AEs, ADEs and 
AESIs will also be produced by severity (mild, moderate or severe) and relationship (related defined 
as Possibly, Probably and Definitely related). Number of events, number of subjects and percent of 
subjects with events will be presented by System Organ Class (SOC) and term in the CTCAE or 
IMDRF. Which system to be used will be decided and documented before the database is locked 
Device deficiency will be summarized and presented as number and percentage. Device deficiencies 
will be presented totally and by relationship (Sound Processor, Implant, OFS or Accessories). 
Concomitant medications will be presented in patient individual listings. 
Descriptives for the socio-economic data, demographics and information on service utilisation related 
to hearing rehabilitation will be summarized for all patients. 
9.7 Performance Endpoint Analyses 
All performance variables will be presented by visit and changes where applicable according to 
paragraph 9.1. Wilcoxon signed rank test will be performed for changes in continuous variables over 
time, for changes in dichotomous outcomes Sign test will be used to evaluate better/equal/worse. 
Analyses of PTA-4 thresholds and SNR vs overall satisfaction at 24 months will be made in order to 
find if there is any cut off point on these variables which predicts if a patient is satisfied or not. This 
will be made using logistic regression and c, ROC-curve and effect plot of predicted probability by 
PTA-4 and SNR will be presented. 

 
 
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9.8 Patient Reported Outcomes Endpoint Analyses 
All patient recorded variables will be presented by visit and changes where applicable according to 
paragraph 9.1. Wilcoxon signed rank test will be performed for changes in continuous variables over 
time, for changes in dichotomous outcomes Sign test will be used to evaluate better/equal/worse. 
9.9 Exploratory Endpoint Analyses 
High frequency thresholds [at 6.0, 7.0, 8.0, 9.0 and 9.5 kHz] will be presented by visit, both individual 
and mean values.  
9.10 Interim Analyses 
An interim safety analysis will be performed when all subjects have completed their 12-months visit. 
A compilation of all AEs and DDs that occurred between the 6-months visit in CBAS5751 and the 12-
months visit in this investigation will be performed. In addition, follow-up of any unresolved AEs at the 
6-month visit in CBAS5751 will be done. 
10 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject using an approved ICF prior 
to any clinical investigation-related examination or activity. The rationale of the clinical investigation, 
as well as the risks and benefits, what participation will involve, and alternatives to participation will 
be explained to the subject. Ample time will be provided for the subject to enquire about details of the 
clinical investigation and to decide whether to participate. 
All questions about the clinical investigation shall be answered to the satisfaction of the subject or the 
subject’s legally acceptable representative. Subjects shall not be coerced or unduly influenced to 
participate or to continue to participate in a clinical investigation. 
Each subject (or their legally authorised representative) and the person who conducted the informed 
consent discussion, shall sign and date the Informed Consent Form (ICF). Where required, a witness 
shall sign and personally date the ICF. A copy of the signed ICF shall be given to the subject. The 
original signed ICF shall be archived in the Investigator’s Site File or subject file at the investigational 
site. 
The subject, or the subject’s legally authorised representative, shall be informed in a timely manner if 
new information becomes available that may be relevant to the subject’s willingness to continue 
participation in the clinical investigation. The communication of this information must be documented 
as an update to the ICF and re-consent of the subject. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 Definitions 
11.1.1 Adverse Event  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons 
whether or not related to the medical device or the procedures required for implant or use. 

 
 
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NOTE 1: This definition includes events related to the medical device or the comparator device. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users and other persons, this definition is restricted to events related to medical 
devices. 
11.1.2 Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of a medical device. 
NOTE 1: This includes any AE resulting from insufficiencies or inadequacies in the instructions for 
use, the deployment, the implantation, the installation, the operation, or any malfunction of the 
medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the 
medical device. 
11.1.3 Serious Adverse Event 
A serious adverse event (SAE) is any AE that: 
a) led to a death,  
b) led to a serious deterioration in the health of the subject that either resulted in: 
• a life-threatening illness or injury, or 
• a permanent impairment of, or damage to, a body structure or a body function, or 
• in-patient hospitalisation or prolonged hospitalisation, or 
• medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment or damage to a body structure or a body function, or 
• Chronic disease. 
c) led to foetal distress, foetal death or a congenital physical or mental abnormality, or birth 
defect 
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a SAE. 
11.1.4 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an ADE that has resulted in any of the consequences 
characteristic of a SAE. 
11.1.5 Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is a SADE, which by its nature, incidence, 
severity, or outcome has not been identified in the current version of the Investigator’s Brochures (3) 
(4). 
NOTE: An anticipated serious adverse device effect is an effect, which by its nature, incidence, 
severity, or outcome has been identified in the Investigator’s Brochure.  

 
 
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c) circumstances had been less fortunate 
All DDs will be documented in the source notes and the DD page of the CRF. 
All explanted implants shall be sent to Device Analysis according to company procedures. Implants 
and Sound Processors should be sent to CLTD. 
In case of any DD and/or explantation of an implant, site should contact the sponsor, whom will then 
provide the site with a RETRIEVED DEVICE KIT for return of the implant and further instructions on 
the return process. In case of any DD of a Sound Processor the site should contact the sponsor for 
further return details.  
11.4 Reporting Responsibilities 
The Investigator is responsible for reporting all AEs and DDs in the CRF.   
11.4.1 Investigator Reporting of Serious Adverse Events 
All AEs meeting the criteria for an SAE, or DD that could have led to a SADE, and AESI, must be 
reported to the Sponsor within 24 hours after awareness. 
Reporting is achieved through completion of the events details in the Adverse Event page of the 
eCRF 
The Investigator shall always provide an assessment of causality at the time of the initial report, as 
described in section 11.2.2 ‘Assessment of Causality’. If data obtained after reporting indicates that 
the assessment of causality is incorrect, then the SAE form may be appropriately amended, signed, 
dated, and resubmitted to the Sponsor. 
If the Investigator does not have all other information regarding an SAE, he/she will not wait to 
receive additional information before reporting the event.  The reporting forms shall be updated when 
additional information is received. 
The Investigator is responsible for reporting of safety events to their local EC using the applicable 
report form, in accordance with local regulations. 
11.4.2 Sponsor Notification of Events 
The Sponsor is responsible for reviewing all safety data to evaluate potential causality and 
anticipation of all ADEs. 
The Sponsor is also responsible for reporting all reportable events according to the requirements and 
timelines of the regulatory authorities relevant to this clinical investigation, and shall conduct an 
expedited assessment of all SAEs, unanticipated ADEs, DDs that could have led to an SADE and 
AESI. 
The Safety Monitor for AE/DD assessment and any AE/DD related queries is: 

 
 
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comprehensive audit trail for all data entered, including updates and queries, and documents the time 
that each entry occurred and who made the entry. 
Principal Investigators will affirm that the data for each subject at their site is accurate and complete 
by way of an electronic signature. 
In addition, de-identified electronically generated data will be collected from the OFS. The 
unamended data file shall be regarded as the source. 
15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance 
with governing data privacy regulations [such as the EU GDPR regulations]. 
Data will be reported to the Sponsor on CRFs or related documents (for example, questionnaires). 
Subjects will be identified on CRFs and other related documents only by a unique subject 
identification code and shall not include the subject’s name or other personal identifiable information. 
Completed CRFs or related documents are confidential and will only be available to the Investigator 
and site staff, the Sponsor and their representatives, and if requested to the Ethics Committee. 
Publications or submission to an EC shall not disclose the identity of any subject. 
16 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
The clinical investigation will not commence prior to the written favourable opinion or approval from 
the EC is obtained. 
The final Sponsor-approved version of the CIP, Informed Consent Form, and other necessary 
documents shall be submitted to the EC. A copy of the EC opinion/approval shall be provided to the 
Sponsor. 
The Investigator shall forward to the Sponsor, for review and approval, any amendment made to the 
approved ICF and any other written information to be provided to the subject prior to submission to 
the EC. 
The Sponsor and Principal Investigator will continue communications with the EC, as required by 
national regulations, the clinical investigational plan, or the responsible regulatory authority. 
Any additional requirements imposed by the EC 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. 

 
 
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Notification to Therapeutics Goods Administration (TGA) is needed in Australia before commencing 
the study. 
17 SUSPENSION OR PREMATURE TERMINATION 
The Sponsor will discontinue the clinical investigation site if: 
1) major non-adherence to the CIP or GCP principles is occurring 
2) it is anticipated that the subject recruitment will not be adequate to meet the objectives of the 
clinical investigation 
An ongoing clinical investigation may be discontinued in case of: 
1) device failure 
2) serious or intolerable ADE, leading to the explant or discontinued use of the device 
3) subject’s death 
Should the Sponsor discontinue the clinical investigation, the Sponsor will continue to support those 
subjects who were already implanted with the device under investigation until the IMD is approved by 
national regulatory authority. 
18 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
No changes in the CIP or investigational procedures shall be made without mutual agreement of the 
Coordinating 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. 
19 RECORD KEEPING AND RETENTION 
Data generated from the clinical investigation will be stored in a limited-access file area and be 
accessible only to representatives of the investigation site, the Sponsor and its representatives, and 
relevant health authorities/regulatory agencies.  All reports and communications relating to 
investigation 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. 
The investigator must retain investigation-related records after completion of the investigation. 
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 investigation documentation. 
20 PUBLICATION POLICY 
This clinical investigation will be prospectively registered at a public clinical trial registry for example 
ClinicalTrials.gov. 

 
 
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A joint peer-reviewed publication authored by the clinical investigator(s) and Sponsor will be 
prepared. In addition, the results of the clinical investigation may also be disseminated as conference 
presentations (e.g., abstract and poster session). Manuscript authorship and responsibilities will be 
discussed and agreed upon prior to clinical investigation start and in accordance with guidelines and 
recommendations provided by the International Committee of Medical Journal Editors (ICMJE) to 
enable communication in a timely manner. All contributors who do not meet the criteria for authorship 
will be listed in an acknowledgments section of the publication. 
21 STATEMENTS OF COMPLIANCE 
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki, International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice, and any regional or national 
regulations, as applicable. 
22 QUALITY CONTROL AND ASSURANCE 
In accordance with Cochlear’s Quality Management System, all clinical investigations shall be 
conducted according to internationally recognised ethical principles for the purposes of obtaining 
clinical safety and performance data about medical devices. 
The Sponsor employees (or designee) shall use standard operating procedures (SOP) to ensure that 
clinical investigation procedures and documentation are consistently conducted and compliant with 
the ISO 14155 Standard, Good Clinical Practice (GCP), and applicable local regulations. 
22.1 Monitoring 
The Sponsor will perform on-site and remote monitoring visits as frequently as necessary to oversee 
conduct, data collection and record keeping by sites. The clinical investigation monitoring plan is a 
separate document describing all the activities performed during site qualification, initiation, 
monitoring, and close out. 
22.2 Audits 
An Investigator must, in reasonable time, upon request from a relevant health authority or regulatory 
agency, permit access to requested records and reports, and copy and verify any records or reports 
made by the Investigator. Upon notification of a visit by a regulatory authority, the Investigator will 
contact the Sponsor immediately.   
The Investigator will grant the Sponsor representatives the same access privileges offered to relevant 
health authority or regulatory agents, officers, and employees. 
23 TRADEMARKS AND COPYRIGHT 
Cochlear, Baha, Osia, Carina, the elliptical logo, and marks bearing an ® or ™ symbol, are either 
trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB.  © Cochlear [2020]. 

 
 
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24 REFERENCES 
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ethical-principles-for-medical-research-involving-human.  
2. International Organization for Standardization. ISO 14155:2011 Standard: Clinical investigation of 
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https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-2:v1:en.  
3. D1577642, Investigator's Brochure OSI200.  
4. D1503289, Investigator's Brochure Osia 2 SP.  
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