A Pivotal, Prospective, Single-centre, Randomized Test Order, Crossover, Open Label Study Comparing the Performance of a New Sound Processor With Unaided Hearing and Baha 5 in Adult Subjects With Conductive or Mixed Hearing Loss
Phase: NA
Conditions: Hearing Loss
Sponsor: Cochlear

Official Title: A pivotal, prospective, single‐centre, randomized test order, 
crossover, open label study comparing the performance of a new sound 
processor ‐ Baha 6 Max with unaided hearing and Baha 5 in adult subjects with 
conductive or mixed hearing loss. 
 
NCT Number: NCT04559282         
 
Document Date: 29 October 2020 

 
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Clinical Investigation Plan 
 
Investigation Title: 
 
A pivotal, prospective, single-centre, randomized test order, crossover, open label 
study comparing the performance of a new sound processor - Baha 6 Max with 
unaided hearing and Baha 5 in adult subjects with conductive or mixed hearing loss. 
 
Short Title: 
Baha 6 Max Home test 
CIP Number: 
CBAS5779 
Version Number: 
4.0 
Date:  
29-OCT-2020 
Sponsor 
Cochlear Bone Anchored Solutions AB (CBAS) 
Konstruktionsvägen 14 
SE-435 33 Mölnlycke 
Sweden 
Phone: +46 31 792 44 00 
 
 
 
 
 
 
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 (1). 
 
Confidential Information 
The information contained in this document is confidential and should not be copied or distributed to persons not involved 
in the conduct or oversight of the clinical investigation 
 

 
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Manufacturer 
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14  
Mölnlycke 435 33 
SWEDEN  
Sponsor Organisations 
 
Cochlear Bone Anchored Solutions AB  
Contact person: 
 
 
Konstruktionsvägen 14 
Mölnlycke 435 33  
SWEDEN  
Principal Investigator 
 
 
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14 
Mölnlycke 435 33  
SWEDEN 
Contract Services 
 
  
 
 
   
  
Safety Contact 
 
 
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14 
Mölnlycke 435 33  
SWEDEN 
 
 

 
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INVESTIGATOR AGREEMENT 
 
Principal 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 
 
Principal Investigator 
Signature 
Date 
 
 
 
 

 
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TABLE OF CONTENTS 
1 
Definitions and Abbreviations ......................................................................................................... 7 
2 
Clinical Investigation Synopsis ........................................................................................................ 8 
3 
Schedule of Events ....................................................................................................................... 12 
4 
Background Information and Rationale ........................................................................................ 14 
4.1 
Introduction ......................................................................................................................... 14 
4.2 
Findings of Previous Nonclinical and Clinical Studies ........................................................ 15 
4.2.1 
Nonclinical Data .................................................................................................... 15 
4.2.2 
Clinical Data .......................................................................................................... 15 
5 
Medical Device Information ........................................................................................................... 15 
5.1 
Identity and Description of the Investigational Medical Device (IMD) ................................ 15 
5.2 
Identity and Description of the Comparator ........................................................................ 16 
5.3 
Interfaces ............................................................................................................................ 16 
6 
Objectives and endpoints .............................................................................................................. 17 
7 
Design of the Clinical Investigation ............................................................................................... 18 
7.1 
General ............................................................................................................................... 18 
7.1.1 
Design Rationale ................................................................................................... 19 
7.2 
Subjects .............................................................................................................................. 19 
7.2.1 
Inclusion Criteria ................................................................................................... 19 
7.2.2 
Exclusion Criteria .................................................................................................. 19 
7.2.3 
Number of Subjects Required ............................................................................... 20 
7.2.4 
Vulnerable Populations ......................................................................................... 20 
7.2.5 
Enrolment & Study Duration ................................................................................. 20 
7.2.6 
Criteria for Subject Withdrawal ............................................................................. 20 
7.2.7 
Post-investigation Medical Care ........................................................................... 21 
7.3 
Performance Evaluations and Procedures ......................................................................... 21 
7.3.1 
Eligibility Evaluations and Procedures .................................................................. 21 
7.3.2 
Post-Enrolment Evaluations and Procedures ....................................................... 22 
7.3.3 
Adaptive Speech recognition in noise (Matrix test) .............................................. 22 
7.3.4 
Sound-field threshold ............................................................................................ 23 
7.3.5 
Speech recognition in quiet .................................................................................. 23 
7.3.6 
Sound scenarios ................................................................................................... 24 
7.3.7 
Diary ...................................................................................................................... 24 
7.4 
Safety Evaluations and Procedures ................................................................................... 24 
7.5 
Equipment Used for Evaluation of Performance and Safety .............................................. 24 
7.6 
Sponsor Role in Conduct of the Clinical Investigation ........................................................ 24 

 
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8 
Risks and Benefits of the Investigational medical device and Clinical Investigation .................... 25 
8.1 
Anticipated Clinical Benefits ............................................................................................... 25 
8.2 
Anticipated Adverse Device Effects .................................................................................... 25 
8.3 
Risks Associated with Participation in the Clinical Investigation ........................................ 25 
8.4 
Risk Mitigation .................................................................................................................... 26 
8.5 
Risk-to-Benefit Rationale .................................................................................................... 26 
9 
Statistical Considerations .............................................................................................................. 29 
9.1 
General Statistical Considerations ..................................................................................... 29 
9.2 
Endpoints ............................................................................................................................ 30 
9.2.1 
Primary Endpoints................................................................................................. 30 
9.2.2 
Secondary Endpoints ............................................................................................ 30 
9.3 
Hypotheses ......................................................................................................................... 31 
9.3.1 
Primary Hypothesis ............................................................................................... 31 
9.4 
Sample Size Determination ................................................................................................ 31 
9.5 
Analysis Populations ........................................................................................................... 32 
9.5.1 
Full Analysis Set ................................................................................................... 32 
9.5.2 
Per Protocol Population ........................................................................................ 32 
9.6 
Primary Endpoint Analyses ................................................................................................. 32 
9.7 
Secondary Endpoint Analyses ............................................................................................ 32 
9.8 
Safety Analyses .................................................................................................................. 32 
9.9 
Demographics and Baseline Characteristics ...................................................................... 32 
9.10 Interim Analyses ................................................................................................................. 32 
9.11. Statistical Analysis Plan ...................................................................................................... 33 
10 Informed Consent Process ........................................................................................................... 33 
11 Adverse Events and Device Deficiencies ..................................................................................... 33 
11.1 Definitions ........................................................................................................................... 33 
11.1.1 
Adverse Event ...................................................................................................... 33 
11.1.2 
Adverse Device Effect .......................................................................................... 33 
11.1.3 
Serious Adverse Event ......................................................................................... 34 
11.1.4 
Serious Adverse Device Effect ............................................................................. 34 
11.1.5 
Unanticipated Serious Adverse Device Effect ...................................................... 34 
11.1.6 
Adverse Events of Special Interest ....................................................................... 34 
11.1.7 
Device Deficiency ................................................................................................. 34 
11.2 Recording and Handling of Adverse Events ....................................................................... 35 
11.2.1 
Assessment of Severity ........................................................................................ 35 
11.2.2 
Assessment of Causality ...................................................................................... 35 

 
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11.2.3 
Assessment of Seriousness ................................................................................. 37 
11.2.4 
Assessment of Expectedness .............................................................................. 37 
11.3 Recording and Handling of Device Deficiencies................................................................. 37 
11.4 Reporting Responsibilities .................................................................................................. 37 
11.4.1 
Investigator Reporting of Serious Adverse Events ............................................... 37 
11.4.2 
Sponsor Notification of Events ............................................................................. 38 
11.5 Independent Data Monitoring Committee ........................................................................... 38 
12 Device Accountability .................................................................................................................... 39 
13 Deviations from the Clinical Investigation Plan ............................................................................. 39 
14 Data Management ........................................................................................................................ 39 
15 Confidentiality ................................................................................................................................ 40 
16 Ethics Committee and Regulatory Authority Approval .................................................................. 40 
17 Suspension or Premature Termination ......................................................................................... 41 
17.1 Reporting to regulatory authority ........................................................................................ 41 
18 Amendments to the Clinical Investigation Plan ............................................................................. 41 
19 Record Keeping and Retention ..................................................................................................... 41 
20 Publication Policy .......................................................................................................................... 42 
21 Statements of compliance ............................................................................................................. 42 
22 Quality Control and Assurance ..................................................................................................... 42 
22.1 Monitoring ........................................................................................................................... 42 
22.2 Audits .................................................................................................................................. 42 
22.3 Trademarks and Copyright ................................................................................................. 43 
23 Bibliography .................................................................................................................................. 44 
Change History ..................................................................................................................................... 45 
 
 
 

 
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 a Reprogram the first randomised device (Baha 5 SP or Baha 6 Max) 
b Should be performed, if needed 
c Only applicable to Baha 6 Max.  
d Instruction on how to complete Diary 
e Randomised order 
 
 
 
 

 
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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 Investigator’s 
Brochure (3). 
4.2.2 
Clinical Data 
The previously released and comparator device Baha 5 SP has similar characteristics as Baha 6 Max 
SP (3). The clinical data for Baha 5 SP appraised and analysed from systematic literature review and 
exploratory clinical investigations demonstrate good objective hearing outcomes, with consistently 
improved sound-field thresholds (PTA4, mean of 0.5, 1, 2 and 4 kHz), speech recognition in quiet 
and in noise as compared to the unaided condition. There are no high risks relating to the use of the 
Baha SPs or accessories (section 3 in IB, (3)). 
 
5 MEDICAL DEVICE INFORMATION 
5.1 Identity and Description of the Investigational Medical Device (IMD) 
The Baha 6 Max SP is a fully programmable, head-worn, SP with support for direct audio, data 
streaming and wireless connection to Cochlear Wireless Accessories, among other features. It has 
been developed to meet the needs of patients with CHL, MHL or SSD (3). 
 
 
 
Figure 2. The Baha 6 Max SP 
The Baha 6 Max SP receives sound from its two microphones. Digital audio can be received through 
wireless streaming from the wireless accessories or from a compatible iPhone. 
The SP processes the received information and generates a mechanical signal, i.e. a force output 
that is transferred to the skull of the patient via the implant system. The vibration is generated by an 
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The SP contains signal processing features to enhance the patient’s hearing experience. These are 
further described in the IB (section 1.2, (3)). 
The material used in the Baha 6 Max SP is described in the Investigator Brochure (section 1.2, table 
2, (3)).  
Research subject that will participate in the investigation are experienced SP users. They will be 
provided with an Instructions for Use (IFU) (4). 
The manufacturer of Baha 6 Max SP is CBAS.  
5.2 Identity and Description of the Comparator 
The Cochlear Baha 5 SP is the predecessor to Baha 6 Max SP.  
The Baha 5 SP uses bone conduction to transmit sounds to the cochlea (inner ear). It is indicated for 
people with conductive hearing loss, mixed hearing loss and single sided sensorineural deafness 
(SSD). Furthermore, it is indicated for bilateral and paediatric recipients. Fitting range up to 45 dB 
SNHL (2). 
Baha 5 SP is CE-marked. 
 
 
Figure 3. The Baha 5 SP 
 
The manufacturer of Baha 5 SP is CBAS.  
5.3 Interfaces 
An audiologist uses programming software—Fitting Software—to modify hearing profiles in order to 
provide comfortable and usable gain for the sound processor for each user (Baha Connect System 
recipient). Communication between the computer-based software and the sound processor is 
achieved using a Noahlink Wireless programming unit. Baha Fitting Software is used in clinic by 
audiologists or similar trained hearing healthcare professionals e.g. research audiologists (section 1.3 
in IB, (3)). 
 
 

 
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7.1.1 
Design Rationale 
The primary purpose with this investigation is to test the Baha 6 Max SP versus unaided hearing in 
order to achieve regulatory approval and to investigate which device (Baha 6 Max versus Baha 5) the 
subjects prefer. 
The second primary objective is to compare hearing performance between Baha 6 Max SP and Baha 
5 SP in a home (normal) hearing environment. The subjects will test the two SPs during a week at 
home in a cross-over design (randomised test order). Based on their experiences with the SPs the 
subject will be asked which of them they prefer. Because all subjects are prescribed and used to 
amplified sound through bone conduction, one weeks testing at home is regarded as sufficient time 
to evaluate the performance of a SP. The investigation must be performed in an open fashion since it 
is not possible to blind the investigation due to differences in design.  
After fitting of the test device several listening tests (adaptive speech in noise, thresholds audiometry 
and speech in quiet) will be performed in a sound booth. 
The evaluation of sound quality and listening effort through sound clips (visit 3) will be performed in a 
blinded fashion, i.e. the subject will not know which SP that is tested. The test order will be 
randomised   
7.2 Subjects 
Written, informed consent must be obtained from the subject before any study procedures are 
initiated. 
7.2.1 
Inclusion Criteria 
Subjects must meet all the inclusion criteria described below to be eligible for this clinical 
investigation.  
1. Adult subject (18-<70 years of age)  
2. At least 12 months experience from using a Baha Connect system (percutaneous Baha) 
3. Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from 
improved hearing from bone conduction devise as judged by the research audiologist 
4. 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. 
Signs of infection around the implant site 
2. 
Unable to follow investigational procedures 
3. 
Unable or unwilling to comply with the requirements of the clinical investigation as 
determined by the Investigator 
4. 
Investigator site personnel directly affiliated with this investigation and/or their 
immediate families; immediate family is defined as a spouse, parent, child, or sibling. 

 
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5. 
Cochlear employees  
6. 
Currently participating, or participated within the last 30 days, in another interventional 
clinical investigation/trial involving an investigational drug or device. 
7.2.3 
Number of Subjects Required 
In order to meet the sample sizes calculations for both primary analyses, 16 subjects will be included.  
As this is an internal Cochlear investigation, patients will be recruited until the number of required 
patients are enrolled. Hence, no dropouts are expected. 
7.2.4 
Vulnerable Populations 
No applicable  
7.2.5 
Enrolment & Study Duration 
The following subject status definitions apply: 
Screened: A consented subject who is being assessed for eligibility according to the Screening 
requirements. 
Screen Fail: A consented subject that has been determined to not meet all eligibility criteria for 
enrolment. 
Enrolled: First use of the IMD or comparator following completion of screening activities and 
confirmation of eligibility 
The expected duration of each subject’s participation in the clinical investigation is 3 weeks, from the 
time of informed consent to the End of Study visit.  
The enrolment period for the clinical investigation is anticipated to be 6 weeks from the time of first 
subject consent to enrolment of the last subject.  
The anticipated total duration of the clinical investigation is therefore 8-9 weeks.  
Clinical Investigation completion is last subject last visit. In the event of an ongoing SAEs/SADEs at 
the time of this last visit, the clinical investigation completion will be extended for a further 30 days, or 
until resolution or stabilisation of the event, whichever comes first. 
7.2.6 
Criteria for Subject Withdrawal 
Subjects can decide to withdraw from the investigation at any time. The Investigator shall ask the 
reason(s). The reason for withdrawal should be documented in the subject’s source files and the 
case report form (CRF). 
The Investigator or Sponsor may also decide to withdraw a subject from the clinical investigation if it 
is considered to be in their best interests. 
Subject withdrawal may be for any of the following reasons: 
 
Adverse Event (AE) 
 
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 
CIP or GCP deviation 
 
Subject lost to follow-up 
 
Subject withdrew consent 
 
Subject death 
 
Sponsor decision 
 
Investigator decision 
 
Other (specify) 
If subject withdrawal is due to problems related to the IMD or comparator safety or performance, the 
Investigator shall ask for the subject's permission to continue in safety follow up (i.e., adverse events) 
until their scheduled End-of-Study visit. 
If a subject is lost to follow-up, every possible effort must be made by the study site personnel to 
contact the subject and determine the reason for discontinuation. At least 3 separate attempts taken 
to contact the subject must be documented. 
Enrolled subjects who are withdrawn/discontinued will not be replaced. Randomisation Procedures 
The test order between the two SPs will be randomised based on a computer-generated 
randomisation schedule prepared by the Sponsor. 
7.2.6.1 
Blinding Procedures 
Blinding of the SPs during the home test is not possible due to the differences in design.  
When performing the subjective evaluation of sound clips the subjects will be blinded to which SP 
(Baha 6 Max SP or Baha 5 SP) currently tested, i.e. single-blind. This is possible since the 
investigator will place the SP on the abutment without showing the subject.   
7.2.7 
Post-investigation Medical Care 
After the investigation a subject will continue to use the SP currently prescribed to him/her. 
 
7.3 Performance Evaluations and Procedures 
7.3.1 
Eligibility Evaluations and Procedures  
Demographics 
The following demographic data will be recorded at Screening and Baseline: 
 
Age collected as date of birth (month and year) 
 
Gender 
 
 
 

 
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Hearing history 
During Screening and Baseline a number of baseline characteristics will be recorded:  
 
Type of hearing loss 
 
Etiology of hearing loss: (chronic) infection, tumor, trauma, malformation, otosclerosis, other 
 
Current hearing aid 
 
Treatment ear 
Audiogram 
Unaided audiometric threshold measures (including both air- and bone conduction thresholds) should 
demonstrate whether the subject has a conductive or mild to moderate mixed hearing loss and meets 
the audiological inclusion criteria.  
An existing audiogram may be used as long as it has been completed during the last twelve months 
and contains all the required relevant frequencies. Frequencies required for air and bone conduction 
thresholds are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000Hz.  
If an audiogram is older than 12 months or does not contain the required frequencies, a new 
audiogram shall be performed at Screening/Baseline. Frequencies required for air and bone 
conduction thresholds are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000Hz. 
Contralateral masking should be used if needed. The site staff shall always measure both the 
unmasked thresholds, as well as and the masked thresholds, if applicable.  
 
7.3.2 
Post-Enrolment Evaluations and Procedures 
7.3.3 
Adaptive Speech recognition in noise (Matrix test)  
The purpose of this test is to establish the test subject’s ability to recognise speech in the presence of 
background noise. The adaptive speech test in noise shall be conducted using validated lists of 
phonetically balanced sentences, with speech presented in sound-field from the front (0 degrees 
azimuth) and noise will also be presented from the front (figure 4). 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 speech-to-noise ratio (SNR) providing a 50% level of understanding.  
 
Software and speech material to be used is the Matrix test in language specific versions as 
applicable.  
 
The test 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). 
 

 
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The speakers should be at the height of the test subjects head and more than 1 metre away from the 
test subject. There should preferably be more than 1 metre of free space around the test subject in all 
directions. This is in accordance with the current standard. 
    
         
FRONT 
Figure 5: Speech in noise speaker position 
 
     
 
At Visit 1 and 2, the speech in noise test will be performed for the aided situation with Baha 6 Max SP 
or Baha 5 SP depending on the randomisation order.  
At visit 3 the test will be performed unaided. 
7.3.4 
Sound-field threshold 
The purpose of this test is to establish the hearing thresholds in sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 
4.0, 6.0, 8.0 9.0 and 10.0 kHz] through a speaker in front position (0 degrees azimuth) according to 
the so-called ascending or modified Hughson-Westlake method (Figure 10). The test 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). The signal to be used 
should be warble tones.   
At Visit 1 and 2, the sound-field thresholds will be measured in the aided situation with Baha 6 Max 
SP or Baha 5 SP depending on the randomisation order. 
At visit 3 the test will be performed unaided.      
7.3.5 
Speech recognition in quiet 
The purpose of this test is to establish the test subject’s word recognition score in quiet. The speech 
test in quiet shall be performed using phonetically balanced words presented in sound-field through a 
speaker from the front (0 degrees azimuth) (figure 10). The test material shall be monosyllabic words 
and presented at 65 dB sound pressure level (SPL) and scores shall be recorded as % correct 
words. The test 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). 

 
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At Visit 1 and 2, the speech recognition in quiet test will be performed for the aided situation with 
Baha 6 Max SP or Baha 5 SP depending on the randomisation order.  
At visit 3 the test will be performed unaided. 
7.3.6 Sound scenarios  
Subjective rating of sound, i.e. loudness, sound quality, speech understanding, own voice, artefacts 
and feedback after listening to sound clips in the following sound scenarios: 
 
Female voice in a noisy restaurant environment at 65 dBSPL 
 
Music at 70 dBSPL 
 
7.3.7 
Diary  
Subject will complete daily the diary which covers the following items: 
 
Daily use of the SP (hours) 
 
Change of battery 
 
Switch to their own SP and reason for change  
 
7.4 Safety Evaluations and Procedures 
The risks and anticipated ADEs for Baha 6 Max SP or Baha 5 SP, as identified in Sections 7.2 and 
8.3 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. 
 
Safety data adjudication may be conducted by the Sponsor’s Medical Officer in accordance with the 
Sponsor’s standard operating procedures. 
 
7.5 Equipment Used for Evaluation of Performance and Safety 
All tests shall be performed in the sound insulated room at CBAS. Equipment used for audiological 
testing will be calibrated in accordance with CBAS internal procedures before initiation of the 
investigation. No changes to the setup will be done during the investigation. 
 
7.6 Sponsor Role in Conduct of the Clinical Investigation 
The investigation will be conducted by audiologist employed by CBAS and the investigation will be 
conducted at CBAS facilities.  
 

 
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 
Always keep a distance of 1.5 meters between yourself and your colleagues  
 
No handshaking 
 
Do not come into the office if you have any of the following symptoms (based on the list of symptoms 
provided by The Public Health Agency, Folkhälsomyndigheten, Sweden): 
 
Cough 
 
Fever 
 
Difficulty breathing 
 
Runny nose/blocked nose 
 
Sore throat 
 
Headache 
 
Nausea 
 
Muscle and joint pain 
 
Loss of taste/smell 
Everyone must be symptom-free in order to enter the facility. We ask you to reflect upon your health 
status each day and confirm that you are symptom-free before entering the facility in order to protect 
each other. When entering the facility, you need to: 
1. Sign your name in the ledger to confirm that you are Covid-19 symptom free 
2. Sanitize your hands at the hand sanitizer station (pump the bottle three times) 
3. Walk directly to your workstation 
 
To further decrease the risk of infection, the CBAS guidelines also state that colleagues should have 
a social distance when sharing cars for lunch, avoid rush hour if using public transport to/from the 
workplace, meeting rooms can only be used with a limited number of participants (depending on the 
size of the meeting room) and meeting owners are responsible for sanitizing used equipment  when 
the meeting ends prior to leaving the room. When working in labs and/or sound booths, all equipment 
used must be sanitized before leaving the lab/sound booth and face masks must be used if two or 
more employees are in the lab at the same time. The following guidelines for the use of face masks 
are:  
 
Face masks should cover both your nose and mouth 
 
Do not touch the face mask while being worn to avoid contamination 
 
When leaving the room for a longer period throw away your face mask and use a new one 
when reentering 
 
When removing a face mask, you should use the band/ties to remove it (i.e. do not touch the 
material covering your mouth/nose) 

 
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Currently, visitors are not allowed into the CBAS facility. Exceptions must be approved by a member 
of the executive team. Hosts receiving approved visitors must ask visitors to confirm they do not have 
any Covid-19 symptoms. The host is also responsible for ensuring their visitors upholds the 
measures set out in these guidelines.  
 
For study participants, most of the above listed guidelines will apply such as being symptom-free 
when asked about interest in study participation during the recruitment process and in all study visits, 
sanitize their hands when entering the CBAS facility, keeping a social distance of 1.5 meters to all 
employees in the facility, no handshaking and covering mouth/nose when coughing/sneezing. 
However, it should be noted that some exceptions to the above listed guidelines must apply. For 
example, when entering the CBAS facility, none of the study participants will have to sign their name 
on a ledger (in order to certify that they are symptom-free) to protect their privacy as study 
participants.  A social distance of 1.5 meters between the clinical research audiologist and the test 
subject will be kept as much as possible during all visits. An exception is during implant inspection as 
the audiologist has to rule out infection around the implant area before the start of the study. During 
the implant inspection, the audiologist will use disposable plastic gloves and a face shield visor. The 
face shield visor will be worn by the audiologist during the whole session for each study visit. The 
primary reason for using a face shield visor and not face masks during study visits or in the lab is 
because face masks make lipreading impossible. Hard of hearing people rely highly on facial 
expressions and visual cues in order to compensate for missing verbal information. Thus, it is of 
crucial importance that we ensure all test subjects understand all information provided to them during 
the study, both for their own safety and the validity of the study results.  
To further minimize the risk of infection for the participant and CBAS employees, the participants will 
either take their own car to the CBAS facility or we will book a taxi where they will be placed in the 
backseat (i.e. distance to the driver). Public transport to/from the CBAS facility will not be allowed. 
Between each visit, the audiologist will sanitize all equipment used such as technical equipment, 
chairs, tables, door handles, etc.   
It is essential for CBAS to conduct the planned study in due time because the previous generation of 
Baha Sound Processor (i.e. the Baha 5 SP) was introduced in 2015 and the regulatory approved 
product lifetime for this device is five years. Thus, CBAS prefer to certify the investigational device 
and enable patients to benefit from all the technical improvements and new features introduced in the 
new generation of Baha, i.e. the Baha 6 Max sound processor. For more information about technical 
improvements and new features in Baha 6 Max, see section 1.2 The investigational medical device in 
the Investigator’s Brochure. 
In summary, a wide range of measures to prevent Covid-19 transmission have already been applied 
for all employees at the CBAS facility and will be applied to all study participants to minimize the risk 
of infection. Face shield visors instead of face masks will be used during all visits by the audiologist 
as we believe that face masks will cause communication difficulties which in turn will negatively affect 
the safety of the participants and the validity of the study results. We believe that the benefits of 
performing the current study (with all preventive measures taken for both employees and study 
participant) outweigh the risks as this study will enable the next generation Baha sound processor to 

 
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be released to the market in due time and with that give current and future Baha users access to all 
the technical benefits that comes with it.  
 
9 STATISTICAL CONSIDERATIONS 
9.1 General Statistical Considerations 
The investigation will have two primary analyses, one regarding Adaptive speech in noise between 
Baha 6 Max SP and unaided hearing (alpha = 0.005) and one regarding preference between Baha 6 
Max SP and Baha 5 SP (alpha = 0.045).  These endpoints will be evaluated using the decision rules 
of the Holm’s test. (Ref NEJM2). With these procedures we will have a total type I error <0.05. 
For the comparison between the Baha 6 Max SP and unaided the design don’t take care of period 
effect so the statistical analyses will be paired. For the comparison between Baha 6 Max SP and 
Baha 5 SP a cross over design was applied and the statistical analyses will be adjusted for period 
effect. 
The main results for all outcome variables are the estimate of mean differences with 95% confidence 
interval (CI) with a descriptive p-value. The p-value will only have a confirmatory value for the two 
primary analyses. 
For comparison between the Baha 6 Max SP and unaided Fisher’s non-parametric permutation test 
for paired observations will be used for continuous variables and Sign test for dichotomous variables 
and ordered categorical variables. 
For the comparison between Baha 6 Max SP and Baha 5 SP the following period adjusted analysis 
should be performed for continuous variables: For each subject take the difference between the 
measurement in second period and the measurement in first period. Then analyse these differences 
between the subjects randomised to Baha 6 Max SP in the first period and the subjects randomised 
to Baha 5 SP in the first period with Fisher’s two-sided non-parametric permutation test. The Fisher’s 
permutation test is preferable because it is non-parametric and gives consistent 95% CI. 
For the comparison between Baha 6 Max SP and Baha 5 SP the following period adjusted analysis 
should be performed for dichotomous and ordered categorical variables: For each subject take the 
difference as, improved no change and worsened, between the measurement in second period and 
the measurement in first period. Then analyse these ordered categorical differences between the 
subjects randomised to Baha 6 Max SP in the first period and the subjects randomised to Baha 5 SP 
in the first period with Mantel-Haenszel chi-square test.  
For comparison of preference of device between Baha 6 Max SP and Baha 5 SP the Sign test will be 
used. 
The distribution of continuous variables will be given as mean, standard deviation, median, Q1, Q3, 
minimum and maximum and of categorical variables as numbers and percentages.  
If a subject completes the cross over part but not the final visit, he will be included in the comparison 
between Baha 6 Max SP and Baha 5 SP but not in the comparison Baha 6 Max SP vs unaided in 
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The investigation will be completed when there are as many available subjects that are needed in the 
primary analyses.  
The main analyses will be on the full analysis set (FAS) and complementary analyses on the Per 
protocol population. No imputation of missing data will be performed. 
9.2 Endpoints 
• 
Adaptive speech in noise [signal-to-noise ratio, 50% speech understanding] 
 
• 
Preference of device. Only Baha 6 Max SP and Baha 5 SP. 
 
• 
Diary. Only Baha 6 Max SP and Baha 5 SP. 
 - Daily use of sound processors (hours) 
 - Change of battery 
 - Switch to their own sound processor and the reason for change 
 
• 
Thresholds audiometry, sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz] 
 
• 
Speech in quiet [% correctly perceived words at 65dB SPL] 
 
• 
Evaluation of sound quality and listening effort through sound clips. Only Baha 6 Max SP 
and Baha 5 SP. 
 
9.2.1 
Primary Endpoints 
• 
Primary endpoint for comparison between Baha 6 Max SP and unaided.  
 
Adaptive speech in noise [signal-to-noise ratio, 50% speech understanding] 
 
• 
Primary endpoint for comparison between Baha 6 Max SP and Baha 5 SP. 
 
Preference of device. 
 
9.2.2 
Secondary Endpoints 
• 
Daily use of sound processors (hours) from Diary, Only Baha 6 Max SP vs Baha 5 SP 
• 
Change of battery from Diary, Only Baha 6 Max SP vs Baha 5 SP 
• 
Switch to their own sound processor and the reason for change from Diary 
, 
Only Baha 6 Max SP vs Baha 5 SP 
• 
Adaptive speech in noise [signal-to-noise ratio, 50% speech understanding] Baha 6 Max SP 
and Baha 5 SP 
• 
Thresholds audiometry, sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz] 

 
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• 
Speech in quiet [% correctly perceived words at 65dB SPL] 
• 
Evaluation of sound quality and listening effort through sound clips. Only Baha 6 Max SP and 
Baha 5 SP. 
 
9.3 Hypotheses 
9.3.1 
Primary Hypothesis 
The first primary efficacy analysis is the comparison regarding adaptive speech in noise [signal-to-
noise ratio, 50% speech understanding] between Baha 6 Max SP and unaided using a two-sided 
Fisher’s non-parametric permutation test for paired observations on significance level 0.005. 
H0: µBaha 6 Max SP = µunaided 
H1: µBaha 6 Max SP  > µunaided   or  µBaha 6 SP  < µunaided    
 
The second primary efficacy analysis is the comparison regarding preference of device between 
Baha 6 Max SP and unaided using a two-sided Sign test on significance level 0.045. 
 
          H0 : Probability preference of Baha 6 Max SP before Baha 5 SP =0.5, given preferred any. 
          H1 : Probability preference of Baha 6 Max SP before Baha 5 SP >0.5, given preferred any or 
          Probability preference of Baha 6 Max SP before Baha 5 SP <0.5, given preferred any. 
 
9.4 Sample Size Determination 
First primary analysis: Baha 6 Max SP vs unaided regard Adaptive speech in noise 
Assuming an individual mean difference (aided Baha 6 Max SP minus unaided) in speech recognition 
in noise of 16 dB SNR with a standard deviation (SD) of 12.5 (Busch et al, 2015), a total sample of 15 
eligible subjects are required to provide 90% power to reject the null hypothesis for the statistical test 
for the primary objective (change in dB SNR) using a two sided, alpha 0.005, with Two-sided Fisher’s 
non-parametric permutation test for paired observations.  As this is an internal Cochlear investigation, 
patients will be recruited until the number of required patients are obtained. Hence, no dropouts are 
expected (8).  
 
Second primary analysis: Baha 6 Max SP vs Baha 5 SP regarding preference of device. 
Assuming that 86% prefer Baha 6 Max SP, then 16 subjects are needed for 80% power with two-
sided Sign test on significance level 0.045. 
In order to satisfy both sample sizes for the primary analyses 16 subjects will be randomised into the 
investigation. 
. 

 
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9.5 Analysis Populations 
9.5.1 
Full Analysis Set 
The Full Analysis Set will consist of randomized subjects that have at least one measurement on two 
of the periods Baha 6 Max SP, Baha 5 SP and unaided. 
9.5.2 
Per Protocol Population 
The Per protocol population will consist of all randomized patients that have measurements on all 
primary and secondary variables on all three periods and have no major protocol violations. 
9.6 Primary Endpoint Analyses 
The first primary endpoint analysis will be the comparison of adaptive speech in noise [signal-to-
noise ratio, 50% speech understanding] between the Baha 6 Max SP and unaided with two-sided  
Fisher’s non-parametric permutation test for paired observations on significance level 0.005 on the 
FAS population. Mean difference with 99.5% confidence interval will be given together with the 
distribution of the difference. 
The second primary endpoint analysis will be the comparison between Baha 6 Max SP and Baha 5 
SP regarding preference of device with two-sided Sign test on significance level. Proportion of 
preferences for Baha 6 Max SP with exact 95 % CI will be calculated. 
If one of the two primary efficacy analyses are significant but not the other, the other can be retested 
at the 5% significance level according to the decision rule of the Holms test (9). 
9.7 Secondary Endpoint Analyses 
All the secondary endpoints in section 8.2.2 will be analysed according to the statistical methods 
given in section 8.1 General Statistical Considerations on both the FAS population and the Per 
Protocol population. The two primary efficacy analyses will also be performed on the Per Protocol 
population 
9.8 Safety Analyses 
The Adverse Event will be analysed descriptively for the Safety population. 
Adverse Events and Serious Adverse Events will be coded with the MeDRA dictionary and tabulated 
by Preferred Term-code and System Organ Class-code and treatment. 
9.9 Demographics and Baseline Characteristics 
Demographics and baseline characteristic will be descriptively summarised 
9.10 Interim Analyses 
N/A 

 
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9.11. Statistical Analysis Plan 
A statistical analysis plan (SAP) with detailed statistical analyses specified for all variables will be 
written and signed off before the database lock. 
10 INFORMED CONSENT PROCESS 
The Investigator shall obtain written informed consent from the subject using an approved ICF prior 
to any clinical investigation-related examination or activity. The rationale of the clinical investigation, 
as well as the risks and benefits, what participation will involve, and alternatives to participation will 
be explained to the subject. Ample time will be provided for the subject to enquire about details of the 
clinical investigation and to decide whether to participate. 
All questions about the clinical investigation shall be answered to the satisfaction of the subject or the 
subject’s legally acceptable representative. Subjects shall not be coerced or unduly influenced to 
participate or to continue to participate in a clinical investigation. 
Each subject and the person who conducted the informed consent discussion, shall sign and date the 
Informed Consent Form (ICF). A copy of the signed ICF shall be given to the subject. The original 
signed ICF shall be archived in the Investigator’s Site File or subject file at the investigational site. 
The subject shall be informed in a timely manner if new information becomes available that may be 
relevant to the subject’s willingness to continue participation in the clinical investigation. The 
communication of this information must be documented as an update to the ICF and re-consent of 
the subject. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 Definitions 
11.1.1 Adverse Event  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons 
whether or not related to the medical device or the procedures required for implant or use. 
NOTE 1: This definition includes events related to the medical device or the comparator device. 
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. 

 
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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 Brochure 
 
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.  
11.1.6 Adverse Events of Special Interest 
N/A 
11.1.7 Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. 
NOTE: Device Deficiencies include malfunctions, use errors, and inadequate labelling or information 
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12 DEVICE ACCOUNTABILITY 
Supply of investigational medical devices will be recorded using the Sponsor Device Tracking Form 
(1295388). Investigational medical device(s) will be quarantined at the investigational site and clearly 
labelled to identify exclusively for use in a clinical investigation. 
Subject level device supply will be tracked in the CRF.  
13 DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
The Investigator(s) must not deviate from the CIP, except in case of an emergency to protect the 
safety and well-being of the subject(s). Such deviations will be documented by the site personnel in 
the source documentation for the subject and reported to the relevant EC as per institutional 
requirements and to the Sponsor as soon as possible, but not later than 24 hours from the date of the 
emergency. 
If there is a deviation from CIP-defined assessments or parts thereof are omitted or completed 
incorrectly, the deviation will also be documented by the site personnel in the source documentation 
for the subject. Depending on the type or severity of the deviation the Investigator may be required to 
notify the EC, particularly if the deviation potentially impacts subject safety, performance of IMD 
and/or comparator, or data integrity. 
All CIP deviations will be documented in the eCRF to enable analysis and reporting by the Sponsor in 
the Clinical Investigation Report, or to the relevant regulatory authority(s), if applicable. 
Gross misconduct on behalf of an Investigator, such as intentional non-compliance with CIP or GCP 
requirements or fraud, will result in disqualification of the Principal Investigator and/or Investigational 
Site from participation in the investigation. Data provided by the Principal Investigator or 
Investigational Site will be excluded from the per-protocol analysis group. 
14 DATA MANAGEMENT 
The CRF will capture subject status according to the following criteria: 
 
Consented: Signed consent and eligibility evaluations underway 
 
Screen Fail: Subject determined not to be eligible to proceed for participation 
 
Enrolled: First use of the IMD or comparator 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 End of Study visit. Withdrawn subjects may continue in safety follow up until 
their scheduled End of Study visit.  
 
Complete: Enrolled subjects who complete the planned follow up schedule and End of Study 
visit.  
Source data will be captured in clinic notes, paper-based source data worksheets, or printed directly 
from testing software.  
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 

 
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to obtaining access to the system and will have their own Login/Password. Access to clinical study 
information will be based on an individual’s role and responsibilities. 
 uses role-based user permissions for data entry, viewing, and reporting options. All 
communications between users and the EDC server are encrypted. Web servers are protected by a 
managed firewall. This application is designed to be in compliance with applicable regulations 
including 21 CFR Part 11. 
The application will include programmed data consistency checks and supports manual generation of 
data clarifications/queries, including documentation of site responses. The application maintains a 
comprehensive audit trail for all data entered, including updates and queries, and documents the time 
that each entry occurred and who made the entry. 
Principal Investigators will affirm that the data for each subject at their site is accurate and complete 
by way of an electronic signature. 
15 CONFIDENTIALITY 
The investigator and site staff will collect and process personal data of the subjects in accordance 
with governing data privacy regulations [such as the EU GDPR regulations]. 
Data will be reported to the Sponsor on CRFs or related documents (for example, questionnaires). 
Subjects will be identified on CRFs and other related documents only by a unique subject 
identification code and shall not include the subject’s name or other personal identifiable information. 
Completed CRFs or related documents are confidential and will only be available to the Investigator 
and site staff, the Sponsor and their representatives, and if requested to the Ethics Committee and 
national regulatory authorities. Publications or submission to a regulatory authority shall not disclose 
the identity of any subject. 
16 ETHICS COMMITTEE AND REGULATORY AUTHORITY APPROVAL 
The clinical investigation will not commence prior to the written favourable opinion or approval from 
the EC and or regulatory authority (if appropriate) is obtained. 
The final Sponsor-approved version of the CIP, Informed Consent Form, and other necessary 
documents shall be submitted to the EC. A copy of the EC opinion/approval shall be provided to the 
Sponsor. 
The Investigator shall forward to the Sponsor, for review and approval, any amendment made to the 
approved ICF and any other written information to be provided to the subject prior to submission to 
the EC. 
The Sponsor and Principal Investigator will continue communications with the EC, as required by 
national regulations, the clinical investigational plan, or the responsible regulatory authority. 
Any additional requirements imposed by the EC or regulatory authority will be implemented by the 
Sponsor. 
The Investigator shall submit the appropriate documentation if any extension or renewal of the EC 
approval is required.  Substantial amendments to the CIP, the ICF, or other written information 
provided to subjects will be approved in writing by the EC. 

 
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The Investigator shall report to the EC any new information that may affect the safety of the subjects 
or the conduct of the clinical investigation. The Investigator will send written status summaries of the 
investigation to the EC regularly, as per local EC requirements. 
Upon completion of the clinical investigation, the Investigator shall provide the EC with a brief report 
of the outcome of the clinical investigation, as per local EC requirements. 
The clinical investigation is covered by clinical trial insurance, meeting the requirements of the 
participating countries. 
17 SUSPENSION OR PREMATURE TERMINATION 
The Sponsor will discontinue the clinical investigation site if: 
1) major non-adherence to the CIP or GCP principles is occurring 
2) it is anticipated that the subject recruitment will not be adequate to meet the objectives of the 
clinical investigation 
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 
 
17.1  Reporting to regulatory authority  
If this investigation is suspended or terminated prematurely, the Swedish Medicines Agency shall be 
informed within 24 hours whether it is for safety reasons that the trial is terminated or cancelled, 
otherwise within 15 calendar days. When a trial is completed according to plan, the Swedish 
Medicines Agency must be informed within 15 calendar days after the trial has ended (last subject 
last visit). 
18 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
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, if applicable). 
19 RECORD KEEPING AND RETENTION 
Data generated from the clinical investigation will be stored in a limited-access file area and be 
accessible only to representatives of the study site, the Sponsor and its representatives, and relevant 
health authorities/regulatory agencies.  All reports and communications relating to study subjects will 
identify subjects only by subject unique identification code.  Complete subject identification will be 
maintained by the Investigator. This information will be treated with strict adherence to professional 
standards of confidentiality. 

 
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The investigator must retain study-related records for a period of at least 15 years after completion of 
the investigation or after the last device was placed on the market, if the IMD has market 
authorisation. 
20 PUBLICATION POLICY 
This clinical investigation will be prospectively registered at a public clinical trial registry, i.e. 
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 (8) (9) may also be disseminated as 
conference presentations (e.g., abstract and poster session). Manuscript authorship and 
responsibilities will be discussed and agreed upon prior to investigation start and in accordance with 
guidelines and recommendations provided by the International Committee of Medical Journal Editors 
(ICMJE) to enable communication in a timely manner. All contributors who do not meet the criteria for 
authorship will be listed in an acknowledgments section of the publication. 
21 STATEMENTS OF COMPLIANCE 
This clinical investigation shall be conducted in accordance with ethical principles that have their 
origin in the Declaration of Helsinki (11), International Standard ISO 14155 Clinical investigation of 
medical devices for human subjects - Good Clinical Practice (1), 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 study procedures and documentation are consistently conducted and compliant with the ISO 
14155 Standard, Good Clinical Practice (GCP) (1), 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 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 
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22.3 Trademarks and Copyright 
ACE, Advance Off-Stylet, AOS, AutoNRT, Autosensitivity, Beam, Button, CareYourWay, Carina, 
Cochlear, 科利耳, コクレア, Cochlear SoftWear, Codacs, ConnectYourWay, Contour, Contour 
Advance, Custom Sound, ESPrit, Freedom, Hear now. And always, HearYourWay, Hugfit, Hybrid, 
Invisible Hearing, Kanso, MET, MicroDrive, MP3000, myCochlear, mySmartSound, NRT, Nucleus, 
Off-Stylet, Slimline, SmartSound, Softip, SPrint, True Wireless, the elliptical logo, WearYourWay and 
Whisper are either trademarks or registered trademarks of Cochlear Limited. Ardium, Baha, Baha 
SoftWear, BCDrive, DermaLock, EveryWear, Vistafix, and WindShield are either trademarks or 
registered trademarks of Cochlear Bone Anchored Solutions AB.  © Cochlear [2020] 
 
 

 
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23 BIBLIOGRAPHY 
1. International Organization for Standardization. ISO 14155:2011 Standard: Clinical investigation of 
medical devices for human subjects – Good clinical practice. 2011. Available at: 
https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-2:v1:en.  
2. D1667159_Global Clinical Evaluation Report Baha Connect System.  
3. CBAS5779_Investigator’s Brochure (IB).  
4. D1710779_SV Baha 6 Max User Manual - IMD.  
5. D1623400_Acoustics_SP_Cleaning,_Summary_Report.  
6. D1698384_Baha_6_Max_-_Cleaning___Disinfecting_v1.  
7. D1798254_TR_Cleaning_and_Disinfection_record_v1.  
8. Busch S, Giere T, Lenarz T, Maier H. Comparison of audiologic results and patient satisfaction for two 
osseointegrated bone conduction devices: results of a prospective study. Otol Neurotol. 2015;36(5):842–
848.  
9. Dmitrienko A, D’Agostini R.B. “ Multiplicity Considerations in Clinical Trials”, N ENGL J MED 378 and 2018, 
22 may.  
10. MEDDEV 2.7/3, revision 3, May 2015, CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING 
UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC.  
11. (8)World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving 
Human Subjects. 2013. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-
ethical-principles-for-medical-research-involvin.