Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
Phase: NA
Conditions: Deafness, Hearing Loss, Hearing Loss, Conductive
Sponsor: Cochlear Bone Anchored Solutions

 
Cochlear Baha Attract System, CBAS5477  
 
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Clinical Investigation Plan (CIP) 
Investigation code  
CBAS5477 
Version  
Version date 
1.0 
22 NOV 2013 
 
 
 
 
Post-market clinical follow-up of a magnetic bone conduction 
implant (Cochlear Baha® Attract System) 
  
A multicentre, open, prospective clinical investigation.   
6 months investigation with an 18 months follow-up period.  
 
 
 
This document contains trade secrets and confidential commercial information, disclosure of which is 
prohibited without providing advance notice to Cochlear Bone Anchored Solutions AB and opportunity 
to object. 
 
 
 
 
 
 
 
 
Coordinating investigator  
Dr Emmanuel Mylanus 
Radboud University Nijmegen Medical Centre 
Nijmegen   
Netherlands 
 
 
Sponsor  
Cochlear Bone Anchored Solutions AB  
Konstruktionsvägen 14 
PO Box 82 
SE-435 22 Mölnlycke 
Sweden 
 

 
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Investigational sites  
Coordinating Investigator 
Dr Emmanuel Mylanus 
Radboud University Medical Centre 
Nijmegen   
Netherlands  
Principal Investigator  
Dr Myrthe Hol 
Radboud University Medical Centre 
Nijmegen   
Netherlands 
Principal Investigator  
Prof Dr Marco-Domenico Caversaccio 
Department of ENT, Head and Neck Surgery 
University Hospital Inselspital 
Bern 
Switzerland  
Principal Investigator 
Mr Kevin Green 
Manchester Royal Infirmary 
Manchester  
United Kingdom 
Principal Investigator 
Mr Peter Monksfield 
Queen Elizabeth Hospital 
Birmingham  
United Kingdom 
Principal Investigator  
Christina Runge, PhD 
Medical College of Wisconsin  
Milwaukee 
Wisconsin 
United States of America  
A change to this section is not a substantial protocol amendment. 
 
Clinical investigation management 
Director  
Mark Flynn, PhD 
Research & Applications   
Cochlear Bone Anchored Solutions 
Konstruktionsvägen 14, PO Box 82, 435 22 Mölnlycke 
Sweden 
Clinical Research Manager 
(CRM) 
Johan Blechert, MSc 
Research & Applications 
Cochlear Bone Anchored Solutions 
Konstruktionsvägen 14, PO Box 82, 435 22 Mölnlycke 
Sweden 
Statistician 
 
Nils-Gunnar Pehrsson 
Senior Biostatistician 
Statistiska Konsultgruppen 

 
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Stigbergsliden 5, level 4, Entry level 2  
SE-414 63 Göteborg 
Sweden 
Data manager  
 
Pascal Goenen, PhD 
Director Clinical Affairs and Data management 
Factory – CRO 
Professor Bronkhorstlaan 10-54 
3723 MB Bilthoven 
Netherlands  
A change to this section is not a substantial protocol amendment. 
 
 

 
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Synopsis 
 
Name of Sponsor  
Cochlear Bone Anchored Solutions AB  
Investigation code 
CBAS5477 
Investigational title 
Post-market clinical follow-up of a magnetic bone conduction 
implant (Cochlear Baha® Attract System) 
Design 
A multicentre, open, prospective clinical investigation. 6 months 
investigation with an additional 18 months follow-up period. 
Device tested in the 
investigation 
Cochlear Baha Attract System  
Rationale for conducting 
the investigation  
The rationale behind this post-market clinical follow-up investigation is 
to collect data regarding the usability and clinical performance of the 
Baha Attract System in subjects with hearing impairment that are 
candidates for Baha surgery: 
 
to evaluate the efficacy of the Baha Attract System in terms of 
hearing performance compared to the unaided situation and 
compared to a pre-operative test situation using the sound 
processor on a Baha Softband; 
 
to evaluate the mid- and long-term safety of the Baha Attract 
System. 
Primary objective  
To compare the hearing performance with the Baha Attract System 
(aided) and the unaided hearing performance. 
Secondary objective(s)  
 
To compare the hearing performance with the Baha Attract 
System and the hearing performance with the same sound 
processor on a Baha Softband. 
 
To compare health status and health-related quality of life and 
utility scores before and after use of the Baha Attract System.  
 
To compare self-reported assessment of hearing aid outcome 
before and after use of the Baha Attract System. 
 
To collect surgical information. 
 
To investigate if the Sound Processor Magnet strength and 
magnetic force required for retention changes over time. 
 
To collect information regarding pain, discomfort, numbness and 
soft tissue status. 
 
To monitor implant survival. 
 
To collect Adverse Events and device deficiencies. 
Duration of subject 
participation  
24 months  
Inclusion criteria  
 
Adult subject, i.e. ≥ 18 years of age 
 
Conductive or mixed hearing loss in the ear to be implanted:  

 
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o Bone conduction thresholds with a pure tone average PTA4 of 
< 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).  
OR 
Single-sided sensorineural deafness (SSD):   
o European sites: Bone conduction thresholds with a pure tone 
average PTA4 of < 30dB hearing level (mean of 500, 1000, 
2000 and 4000 Hz) in the good ear.  
o US sites: Air conduction thresholds with a pure tone average 
PTA4 of  20 dB hearing level (mean of 500, 1000, 2000 and 
3000 Hz) in the good ear OR Subject is indicated for an AC 
CROS but—for some reason—cannot or will not use an AC 
CROS. 
 
No previous bone conduction implant on the side of the skull to 
be implanted. 
 
Signed informed consent. 
Exclusion criteria  
 
Subjects that are scheduled for simultaneous bilateral implant 
surgery. The investigation is limited to subjects with unilateral use 
of the Baha Attract System (however, bilateral hearing loss is not 
an exclusion criterion). 
 
Suitable implant position for the BI300 Implant (4 mm or 3 mm) 
not found during surgery due to insufficient bone quality and/or 
bone thickness. 
 
Less than 3 mm soft tissue thickness at the planned implant site.  
 
Subjects that have received radiation therapy at the same side of 
the skull where the Baha Attract System will be positioned. 
 
Condition that could jeopardise osseointegration and/or wound 
healing as judged by the investigator (e.g. osteoporosis, 
psoriasis, use of corticosteroids).   
 
Uncontrolled diabetes as judged by the investigator.  
 
Condition that may have an impact on the outcome of the 
investigation as judged by the investigator.  
 
Unable to follow investigational procedures (e.g. to complete 
quality of life scales). 
 
Participation in another investigation with pharmaceuticals and/or  
medical device. 
Number of subjects  
52 
Primary assessment(s)  
Free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 
1000, 2000 and 4000 Hz) 
Secondary assessments 
 
Free-field hearing tests: 
- 
Threshold audiometry: 250, 500, 1000, 2000, 3000, 4000, 
and 6000 Hz 
- 
Adaptive speech recognition in noise (50% performance) 

 
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- 
Speech in quiet (50dB, 65dB and 80dB SPL) 
 
BC Direct thresholds 
 
Questionnaires: 
- 
Health Utility Index (HUI) 
- 
Abbreviated Profile of Hearing Aid Benefit (APHAB) 
- 
The Speech, Spatial and Qualities of Hearing Scale (SSQ) 
 
Surgical information:  
- 
Skin thickness  
- 
Surgery time 
- 
Soft tissue flap thinning  
- 
Bone removal/polishing 
- 
Implant stability quotient (ISQ) 
 
Sound processor selection 
 
SP Magnet selection 
 
Magnet retention force  
 
Questions regarding: 
- 
Daily use of sound processor (hours) 
- 
Magnetic retention 
- 
Change of Soft pad  
Safety evaluation  
 
Pain/discomfort 
 
Numbness  
 
Soft tissue status 
 
Loss/removal of Implant and/or Implant Magnet  
 
Device deficiency  
 
Concomitant medication 
 
Adverse Events and Adverse Device effect 
 
Serious Adverse Events and Serious  Adverse Device effect 
Flow chart  - see next page 
 
 
 
 
 
 
 
 
 
 
 
 
Flowchart 

 
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Procedures and timing  
Visit 1 
Softband 
test 
Visit 2 
Surgery 
Visit 3 
Suture 
removal 
Visit 4 
Fitting 
Visit  
5 
Visit  
6 
Visit  
7 
Visit 
8 
Visit 
9 
Day/Week/Month1 
Pre-op 
D 0 
D 10 
W 4 
W 6 
W 12 
M 6 
M 12 M 24 
Time window 
 
 
 5d 
 1w 
 1w  2w  4w  4w  4w 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
Nicotine use 
X 
 
 
 
 
 
 
 
 
Audiogram2 
X 
 
 
 
 
 
 
 
 
Eligibility criteria 
X 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
Soft tissue thickness  
X     or     X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Health Utility Index (HUI)3 
X4 
 
 
 
 
 
X 
 
X 
Abbreviated Profile of Hearing Aid 
Benefit (APHAB)3 
X4,5 
 
 
 
 
 
X6 
 
X6 
The Speech, Spatial and Qualities 
of Hearing Scale (SSQ)3 
X4,5 
 
 
 
 
 
X6 
 
X6 
 
 
 
 
 
 
 
 
 
 
BC Direct using BFS 
X7 
 
 
X8 
 
 
 
 
 
Selection of sound processor 
X 
 
 
 
 
 
 
 
 
Change of sound processor 
 
 
 
X9 
X9 
X9 
X9 
X9 
X9 
Fitting of sound processor  
X7 
 
 
X8 
 
 
 
 
 
Fine tuning of sound processor 
 
 
 
 
X9 
X9 
X9 
X9 
X9 
Free field thresholds  
X5,7 
 
 
X8 
 
 
X8 
X8 
X8 
Speech recognition in noise  
X5,7 
 
 
X8 
 
 
X8 
X8 
X8 
Speech recognition in quiet   
X5,7 
 
 
X8 
 
 
X8 
X8 
X8 
Home test of sound processor on 
Softband 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Surgery  
 
X 
 
 
 
 
 
 
 
Surgery time  
 
X 
 
 
 
 
 
 
 
Soft tissue thinning 
 
X 
 
 
 
 
 
 
 
Bone polishing/removal 
 
X 
 
 
 
 
 
 
 
Implant stability quotient 
 
X 
 
 
 
 
 
 
 
Suture removal (if applicable) 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SP Magnet selection 
 
 
 
X 
 
 
 
 
 
Magnetic retention force 
 
 
 
X 
X 
X 
X 
X 
X 
Change of SP Magnet 
 
 
 
 
X9 
X9 
X9 
X9 
X9 
Questions regarding: 
 
Daily use of sound processor 
 
Magnet retention 
 
Change of Soft pad 
 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
Pain/discomfort 
 
 
 
 
X 
X 
X 
X 
X 
Numbness 
 
 
X 
X 
X 
X 
X 
X 
X 
Soft tissue status 
 
 
X 
X 
X 
X 
X 
X 
X 
Loss/removal of Implant or Implant 
Magnet  
 
 
X 
X 
X 
X 
X 
X 
X 
Device deficiency  
 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medication/treatment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Extra visit  
 
 
 
 
 
 
 
 
 
1 The time between visits will be calculated from Visit 2 (time 0); 2 Only if the last audiogram that was performed on the subject is older 
than 6 months; 3 To be completed by the subject; 4 Before Softband test; 5 Unaided; 6 Aided; 7 With sound processor on Softband; 8 With 
Baha Attract System; 9 If needed. 
 

 
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Table of Contents 
 
Investigational sites ............................................................................................................... 2 
Clinical investigation management ........................................................................................ 2 
Synopsis................................................................................................................................ 4 
Table of Contents .................................................................................................................. 8 
Abbreviations .......................................................................................................................11 
1 
Introduction ...................................................................................................................13 
1.1 
Background ............................................................................................................13 
1.2 
Rationale ................................................................................................................13 
1.3 
Objectives ..............................................................................................................14 
1.3.1 
Primary objective .............................................................................................14 
1.3.2 
Secondary objectives ......................................................................................14 
2 
Statement of compliance ..............................................................................................15 
2.1 
Ethical requirements for the conduct of the investigation ........................................15 
2.2 
Regulatory requirements for the conduct of the investigation .................................15 
2.3 
Updates ..................................................................................................................15 
2.4 
Quality standards ...................................................................................................16 
3 
Medical devices used during and after the investigation ...............................................17 
3.1 
Device tested in the investigation ...........................................................................17 
3.2 
Other devices used in the investigation ..................................................................18 
3.3 
Manufacturer of devices tested and used in the investigation .................................20 
3.4 
Treatment after the completion of the investigation ................................................20 
4 
Subjects and subject protection ....................................................................................21 
4.1 
Selection of subjects ..............................................................................................21 
4.1.1 
Inclusion criteria ..............................................................................................21 
4.1.2 
Exclusion criteria .............................................................................................21 
4.1.3 
Number of subjects .........................................................................................22 
4.2 
Subject enrolment and Informed consent ...............................................................22 
4.3 
Randomisation .......................................................................................................22 
4.4 
Discontinuation .......................................................................................................22 
4.5 
Replacement of subjects ........................................................................................22 
4.6 
Insurance ...............................................................................................................23 
5 
Design of the clinical investigation ................................................................................24 
5.1 
Rationale for the design of the clinical investigation................................................24 
5.2 
Variables ................................................................................................................24 
5.2.1 
Primary efficacy variable .................................................................................24 
5.2.2 
Secondary efficacy variables ...........................................................................24 
5.2.3 
Safety variables ...............................................................................................25 
5.2.4 
Demographics and baseline variables .............................................................26 
5.3 
Investigational flowchart .........................................................................................27 
6 
Procedures ...................................................................................................................28 
6.1 
Subject demographics ............................................................................................28 
6.2 
Medical history .......................................................................................................28 
6.3 
Nicotine use ...........................................................................................................28 
6.4 
Audiogram ..............................................................................................................28 
6.5 
Soft tissue thickness ...............................................................................................29 
6.6 
Health Utility Index (HUI) ........................................................................................29 
6.7 
The Abbreviated Profile of Hearing Aid Benefit (APHAB) .......................................29 
6.8 
Speech, Spatial, and Qualities of Hearing Scale (SSQ) ..........................................30 
6.9 
Sound processor selection .....................................................................................30 
6.10 
Bone Conduction (BC) Direct ..............................................................................31 
6.11 
Fine tuning of Baha sound processor ..................................................................31 
6.12 
Free field pure tone thresholds ...........................................................................31 
6.13 
Speech recognition of words in quiet ..................................................................32 

 
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6.14 
Adaptive sentence recognition in noise ...............................................................32 
6.15 
Test of Sound Processor on Softband ................................................................32 
6.16 
Surgery ...............................................................................................................33 
6.17 
Removal of sutures .............................................................................................33 
6.18 
Baha sound processor fitting on SP Magnet .......................................................33 
6.19 
SP Magnet selection ...........................................................................................34 
6.20 
Magnetic retention force .....................................................................................34 
6.21 
Daily use, retention, change of Soft pads ............................................................34 
6.22 
Pain/discomfort ...................................................................................................34 
6.23 
Soft tissue status ................................................................................................35 
6.24 
Numbness ..........................................................................................................35 
6.25 
Loss/Removal of Implant and/or Implant Magnet ................................................35 
6.26 
Device deficiency reporting .................................................................................35 
6.27 
Adverse Event (AE) and Serious Adverse Event (SAE) ......................................36 
6.27.1 
Definitions .......................................................................................................36 
6.27.2 
Handling and reporting of AEs .........................................................................37 
6.27.3 
Reporting of SAEs and device deficiency that could have lead to a SAE .........37 
6.27.4 
Reporting to ethics committees/investigational review boards .........................37 
6.28 
Concomitant medication and treatments .............................................................37 
6.29 
Extra visit(s) ........................................................................................................38 
7 
Risk and benefits of the devices and the clinical investigation ......................................39 
7.1 
Anticipated clinical benefits ....................................................................................39 
7.2 
Residual risks associated with the device and procedures .....................................39 
7.3 
Risks associated with participation in the clinical investigation ...............................40 
7.4 
Risk/benefit assessment ........................................................................................40 
8 
Statistical consideration ................................................................................................41 
8.1 
Statistical Design and Objectives ...........................................................................41 
8.1.1 
Primary statistical objectives ...........................................................................41 
8.1.2 
Secondary statistical objectives .......................................................................41 
8.2 
Sample size calculation ..........................................................................................41 
8.2.1 
Sample size calculation for the primary efficacy analysis: ...............................41 
8.2.2 
Sample size calculation for the for the secondary analysis ..............................42 
8.2.3 
Overall sample size considerations .................................................................42 
8.3 
Analysis sets – populations ....................................................................................42 
8.4 
General statistical methodology..............................................................................42 
8.5 
Efficacy analysis .....................................................................................................43 
8.5.1 
Primary efficacy analysis .................................................................................43 
8.5.2 
Secondary efficacy analyses ...........................................................................43 
8.6 
Adverse Event analyses .........................................................................................44 
8.6.1 
Analyses of Safety variables ...........................................................................44 
8.7 
Analyses of Surgical, Demographics and Baseline variables ..................................44 
8.8 
Analyses of concomitant medications and treatments ............................................44 
8.9 
Interim analysis ......................................................................................................44 
8.10 
Statistical Analysis Plan ......................................................................................45 
9 
Administrative Aspects .................................................................................................46 
9.1 
Training ..................................................................................................................46 
9.2 
Investigational data ................................................................................................46 
9.2.1 
Case Report Form (CRF) ................................................................................46 
9.2.2 
Source data .....................................................................................................46 
9.2.3 
Data management ...........................................................................................46 
9.3 
Archiving ................................................................................................................47 
9.4 
Device accountability ..............................................................................................47 
9.5 
Quality control ........................................................................................................47 
9.5.1 
Monitoring .......................................................................................................47 
9.5.2 
Audit ................................................................................................................47 
9.6 
Clinical Investigation Plan.......................................................................................47 

 
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9.6.1 
Deviations from Clinical Investigation Plan ......................................................47 
9.7 
Suspension or premature termination .....................................................................48 
9.8 
Publication policy ...................................................................................................48 
9.9 
Timetable ...............................................................................................................48 
10 
Bibliography ..................................................................................................................49 
11 
Signed agreement – Sponsor .......................................................................................50 
12 
Signed agreement – coordinating investigator ..............................................................51 
 
 
 
 
 

 
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Abbreviations 
 
 
ADE 
Adverse Device Effect 
AC  
Air conduction 
AE 
Adverse Event 
APHAB 
Abbreviated Profile of Hearing Aid Benefit 
Baha  
Bone anchored hearing system 
BC 
Bone Conduction 
BFS 
Baha Fitting Software  
BI 
Baha Implant 
BP 
Baha Processor 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form  
dB 
Decibel  
FDA 
Food and Drug Administration 
FS 
Fitting Software 
HRQL 
Health-Related Quality of Life 
HUI 
Health Utility Index 
Hz 
Hertz 
ICH 
International Conference on Harmonisation 
ITT 
Intention To Treat 
ISO 
International Organisation for Standardisation 
ISQ 
Implant Stability Quotient 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic Resonance Imaging 
PP 
Per Protocol  
PTA 
Pure Tone Average  
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event   
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SNR 
Speech to Noise Ratio 
SP 
Sound Processor  
SPL 
Sound Pressure Level 
SSD 
Single-sided Sensorineural Deafness 
SSQ 
The Speech, Spatial and Qualities of Hearing Scale 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
 
 
 
 
 

 
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Appendices 
 
Appendix 1 
Osstell ISQ Quick Guide 
 
 
 
 
 
 

 
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1 
Introduction  
 
1.1 Background 
 
Bone conduction implants such as the Baha® system were first clinically described in 1977 by 
Tjellström et al.1, and since then more than 100 000 patients have been treated with this technique. 
The traditional Baha system consists of a titanium implant, which connects to a sound processor via a 
skin-penetrating abutment. The sound processor transforms sound into vibrations that are transmitted 
via the abutment and titanium implant to the skull bone and then to the cochlea. Although Baha 
treatment has been proven to be a safe and effective treatment for patients with a mixed or conductive 
hearing loss or single-sided sensorineural deafness, a large proportion of Baha candidates refuse to 
undergo Baha surgery, mainly due to aesthetic concerns related to the percutaneous abutment. Other 
candidates may not be suitable for a percutaneous Baha due to being—for medical reasons or other—
unable to perform the daily cleaning that the percutaneous abutment requires. 
 
The clinical investigation outlined in this Clinical Investigation Plan (CIP) will assess the usability and 
clinical performance of a magnetic bone conduction implant, Cochlear Baha Attract System. The 
device aims to reduce the perceived barriers for Baha candidates by providing a non-skin penetrating 
bone anchored hearing device. This gives Baha candidates a treatment option with improved cosmetic 
outcomes and minimal aftercare. In the Baha Attract System, the sound processor connects to a non-
percutaneous implant through a transcutaneous coupling. The transcutaneous coupling consists of an 
implanted magnet, which is fixated to the osseointegrating titanium implant underneath the soft 
tissues, and an external magnet placed on top of the skin. The sound processor attaches to the 
external magnet via a snap coupling. The transducer of the sound processor transforms sound into 
vibrations which are conducted through the soft tissues and via the titanium implant to the skull and 
onwards to the cochlea.  
 
The Baha Attract System is intended for patients (adults and children) with conductive or mixed 
hearing loss or single-sided sensorineural deafness. Patients should have sufficient bone quality and 
quantity to support successful implant placement.  
 
The Baha Attract System is CE marked and has been in clinical use in Europe since September 2013, 
and received FDA clearance in the US in November 2013. This post-market clinical follow-up 
investigation aims to evaluate the usability and the mid- to long-term performance of the Baha Attract 
System in terms of hearing outcomes and safety. The investigation will also provide input to future 
product developments in the area of transcutaneous bone conduction hearing.  
 
 
 
 
1.2 Rationale  
The rationale behind this post-market clinical investigation is to collect data regarding the usability and 
clinical performance of the Baha Attract System in subjects with hearing impairment that are 
candidates for Baha surgery: 
 
to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to 
the unaided situation and compared to a pre-operative test situation using the sound processor on 
a Baha Softband; 
 
to evaluate the mid- to long term safety of the Baha Attract System. 

 
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1.3 Objectives  
 
1.3.1 
Primary objective 
 
To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing 
performance. 
 
 
1.3.2 
Secondary objectives 
  
 
To compare the hearing performance with the Baha Attract System and the hearing performance 
with the same sound processor on a Baha Softband. 
 
To compare health status, health-related quality of life and utility scores before and after use of 
the Baha Attract System.  
 
To compare the self-reported assessment of hearing aid outcome before and after use of the 
Baha Attract System. 
 
To collect surgical information. 
 
To investigate if the Sound Processor Magnet strength and magnetic force required for retention 
changes over time. 
 
To collect information regarding pain, discomfort, numbness and soft tissue status. 
 
To monitor implant survival. 
 
To collect Adverse Events and device deficiencies. 
 
 

 
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2 
Statement of compliance 
 
2.1 Ethical requirements for the conduct of the investigation  
 
The investigation will be conducted in accordance with the ethical principles as described in the latest 
version of the Declaration of Helsinki adopted by the World Medical Association. 
 
The Clinical Investigation Plan (CIP), the informed consent form and any other written information that 
will be given to subjects will be submitted to the appropriate ethics committee/institutional review 
board.   
 
 
 
2.2 Regulatory requirements for the conduct of the investigation  
 
The investigation does not need approval from regulatory authorities within EU since the devices used 
in the investigation are CE marked for the intended use described in this CIP. 
 
In the US, the devices used in the investigation are registered as 510(k) medical devices in 
accordance with the Food, Drug, and Cosmetic Act for the intended use described in this CIP. Hence, 
the investigation does not need to be approved by the FDA in accordance with the premarket 
notification process.  
 
The investigation will be conducted in accordance with applicable local regulations, e.g. data 
protection legislation. 
 
 
 
2.3 Updates  
 
The appropriate ethics committee/institutional review board shall after initial approval of the 
investigation receive the following information, when applicable: 
 
 
Status reports and written summary of the investigation as required by the ethics 
committee/institutional review board 
 
Documentation required in order to apply for an extension 
 
Documentation required in order to apply for a substantial amendment to the CIP or the 
informed consent form 
 
Report(s) with new information that may affect the safety of the subjects or the conduct of 
the investigation  
 
Protocol amendments must be approved by concerned ethics committee/investigational review board 
and regulatory authorities (if applicable). 
 
 
 
 
 

 
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2.4 Quality standards  
 
The staff at the investigational site and the Sponsor shall follow the guidelines provided in the ISO 
standard 14155:2011 ‘Clinical investigation of medical devices for human subjects – Good clinical 
practice’.  
 
In the US, the FDA recognise ISO 14155:2011 with the following exceptions: 
 
Sections 4.5.2-5, 7.1.2: Institutional review board membership and procedures must follow US 
regulations 
 
Sections 4.7.3.4, 4.7.4-5: Informed consent content and procedures must follow US 
regulations 
 
Sections 6.4.1, 8.2.4.5.j-k, 8.2.5, 9.7-8. Annex A.14, Annex F: Adverse event reporting 
procedures must be consistent with US regulations 
 
 

 
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3 
Medical devices used during and after the investigation 
 
3.1 Device tested in the investigation 
 
The device tested in the investigation is the Cochlear Baha Attract System. The device is CE 
marked in the EU and registered as a 510(k) device in the US for the intended use described in this 
CIP. 
 
The Cochlear Baha Attract System incorporates implantable and external parts as illustrated in Figure 
1. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended 
to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP 
Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP 
Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute 
the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap 
coupling.  
  
Figure 1.  From left to right: BI300 Implant, BIM400 Implant Magnet, SP Magnet with Soft pad, and sound processor. 
 
 
The different parts of the Cochlear Baha Attract System are described in more detail below: 
 
 
BI300 Implant (Article # 92128, 92129) 
The BI300 Implant is a screw-shaped titanium implant with a titanium dioxide-blasted surface 
(TiOBlast). The implant has a diameter of 4.5 mm and is available in two different lengths, 4 
mm and 3 mm. The implant is intended to be fixated and become osseointegrated in the skull 
bone. The BI300 Implant is delivered sterile for single-use. 
 
 
BIM400 Implant Magnet (Article # 93550) 
The BIM400 Implant Magnet comprises an implantable hermetically sealed titanium casing 
(round shape, diameter: 27 mm, surface area: 5.7 cm2) including two magnets (north and 
south pole) in half ring shape. The Implant Magnet is fixated to the BI300 Implant with a 
fixation screw and lies completely under the skin. The Implant Magnet is delivered sterile for 
single-use. 
  
 
Figure 2.  Implant Magnet 
 

 
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 
SP Magnet (Article # 93561, 93562, 93563, 93564, 93565, 935661)  
The SP Magnet consists of a plastic casing (round shape, diameter: 30 mm, surface area: 7 
cm2), which holds two magnets (north and south pole) in half ring shape. The SP Magnet is 
intended to hold the sound processor in place over the Implant Magnet. The sound processor 
attaches to the SP Magnet by means of a snap connection. The SP Magnet is available in six 
different strengths to suit different soft tissue thicknesses and patient life style. The soft tissue 
facing portion of the SP Magnet is covered by a soft material, the Soft pad. The SP Magnet is 
delivered unsterile; sterilisation is not necessary.  
 
     
    
Figure 3. SP Magnet  
 
 
Soft pad (Article # 94175) 
The part of the SP Magnet that is in contact with the skin is covered by a Soft pad. The 
intention of the Soft pad is to better distribute the pressure and improve the comfort for the 
patients. The Soft pad is disposable and can be easily removed and replaced by the patient 
when it becomes worn or dirty. 
 
 
 
Figure 4. Soft pad  
 
 
Sound Processor  
The Baha Sound Processor attaches to the SP Magnet via a snap coupling. The Cochlear 
Baha 4 Sound Processor, BP110 Sound Processor or future generation regulatory approved 
Cochlear Baha sound processors shall be used in the investigation. Sound processor fitting 
shall be performed using Cochlear Baha Fitting Software 4.0 or future generation Baha 
Fitting Software. 
 
 
 
3.2 Other devices used in the investigation 
 
 
Indicator for Baha Attract (Article # 93571) – Used during surgery to identify the correct 
positioning of the Implant, SP Magnet and sound processor before surgery. 
                                               
 
 
1 93566 SP Magnet 6 is pending regualtory approval/clearance in Europe and US. The device will be regulatory 
approved before use in the investigation.   

 
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 
Implant Magnet template (Article # 94071) – Used during surgery to ensure correct positioning 
of the Implant Magnet in relation to the bone, i.e. to assess size, position and angulation of the 
Implant Magnet in the bone.  
 
Bone bed indicator (Article # 93572) – Used during surgery to determine if polishing of the 
bone is required. The Bone bed indicator is used to identify any uneven bone parts around the 
BI300 Implant that could interfere with the implant casing. The instrument is placed into the 
BI300 Implant and then turned around a full circle. A lever arm will then identify any uneven 
bone surface that could interfere with the Implant Magnet casing when attached. Any such 
uneven part (bump) should be removed before placing the Implant Magnet.  
 
Soft tissue gauge 6mm (Article # 950702) – A tool used during surgery to ensure that the soft 
tissue thickness does not exceed the recommended maximum of 6 mm and, when applicable, 
identify the need for surgical soft tissue thinning.   
 
 
       
  
 
 
Figure 5. Surgical tools. From left to right: Indicator for Baha Attract, Implant Magnet template, Bone bed 
indicator, Soft tissue gauge. 
 
 
 
Surgical instruments for the BI300 Implant 4mm and 3mm – Used for the implantation of the 
implant. 
For more information regarding tools needed for surgery, see the Surgery Guide for the Cochlear 
Baha Attract System, and the Baha Attract System Product catalogue insert.  
 
 
Baha Softband – Used to fixate the sound processor to the skull during the 1-2 weeks test 
period before surgery and for pre-operative aided hearing tests. 
 
Safety Line – Used to secure the sound processor and the SP Magnet in case of loss of 
magnetic retention. 
 
Cochlear Baha Fitting Software 4.0 – Used to customise the sound processor to an individual 
subject. 
 
All the above devices are CE marked in the EU and registered as 510(k) devices in the US for the 
intended use described in this CIP. 
 
In addition, a new Force Measuring Tool will be used in the investigation to measure the magnetic 
retention force of the SP Magnet. The device will be CE marked in the EU as a Class I product and 
listed as a Class I medical device in the US before use in the investigation.  
 
 
                                               
 
 
2 95070 Soft tissue gauge 6 mm is pending regualtory approval/clearance in Europe and US. The device will be 
regulatory approved before use in the investigation.   

 
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3.3 Manufacturer of devices tested and used in the investigation 
 
Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden. 
 
 
 
3.4 Treatment after the completion of the investigation 
 
The subjects will be able to continue with the Baha Attract System after the investigation.  
 
 
 
 
 
 

 
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4 
Subjects and subject protection 
 
4.1 Selection of subjects  
 
4.1.1 
Inclusion criteria 
 
A subject will be eligible for inclusion in the investigation if he/she meets all of the criteria below: 
 
Adult subject, i.e. ≥ 18 years of age 
 
Conductive or mixed hearing loss in the ear to be implanted:  
o Bone conduction thresholds with a pure tone average PTA4 of < 30 dB hearing level (mean 
of 500, 1000, 2000 and 4000 Hz).  
OR 
Single-sided sensorineural deafness (SSD):   
o European sites: Bone conduction thresholds with a pure tone average PTA4 of < 30dB 
hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.  
o US sites: Air conduction thresholds with a pure tone average PTA4 of  20 dB hearing 
level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for 
an AC CROS but—for some reason—cannot or will not use an AC CROS. 
 
No previous bone conduction implant on the side of the skull to be implanted. 
 
Signed informed consent. 
 
4.1.2 
Exclusion criteria   
 
A subject will be excluded from participation in the investigation if he/she meets any of the criteria 
below: 
 
Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is 
limited to subjects with unilateral use of the Baha Attract System (however, bilateral hearing 
loss is not an exclusion criterion). 
 
Suitable implant position for the Baha BI300 Implant (4 mm or 3 mm) not found during surgery 
due to insufficient bone quality and/or bone thickness.  
 
Less than 3 mm soft tissue thickness at the planned implant site.  
 
Subjects that have received radiation therapy at the same side of the skull where the Baha 
Attract will be positioned. 
 
Condition that could jeopardise osseointegration and/or wound healing as judged by the 
investigator (e.g. osteoporosis, psoriasis, use of corticosteroids). 
 
Uncontrolled diabetes as judged by the investigator.  
 
Condition that may have an impact on the outcome of the investigation as judged by the 
investigator. 
 
Unable to follow investigational procedures (e.g. to complete quality of life scales). 
 
Participation in another investigation with pharmaceuticals and/or medical device. 
 
 

 
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4.1.3 
Number of subjects  
 
52 subjects will be included in the investigation.  
 
 
 
4.2 Subject enrolment and Informed consent  
 
Before a subject is asked to sign an informed consent form, an investigator must explain the following 
to the potential investigational subject: 
 
The rationale, aims and objectives of the investigation 
 
Risks and benefits 
 
Alternative treatments 
 
Extent of the subject’s involvement  
 
That the subject can withdraw his/her consent at any time  
 
That the confidentiality of subject data will be maintained at all time 
 
The subject will be given time for consideration and must have the possibility to ask any questions 
before signing the informed consent form. Signed and dated informed consent from potential subjects 
must be obtained before any investigational procedure can be performed. The subject will receive a 
copy of the signed informed consent. The investigator will (after informed consent has been obtained) 
assign a unique enrolment number to the subject.  
 
 
 
4.3 Randomisation  
 
Not applicable  
 
 
 
4.4 Discontinuation 
 
 
Subjects are free to discontinue their participation in the investigation at any time. 
 
Subjects may be discontinued from the investigation at any time at the discretion of the 
investigator. 
 
Subjects who themselves discontinue from the investigation should always be asked about the 
reason(s) for the discontinuation and the presence of any Adverse Events. If possible, the subject 
should always be seen and assessed by an investigator. Any Adverse Event should be followed up.  
 
 
 
4.5 Replacement of subjects 
 
If a subject discontinues participation in the investigation, he/she will not be replaced.  
 

 
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4.6 Insurance  
 
In case of any damage or injury occurring during the participation in the investigation, the Sponsor has 
contracted an insurance company (Willis), which will cover the liability of the Sponsor, the investigators 
and other persons involved in the investigation. The Sponsor may use a local insurance company, 
where applicable, according to national legislation. 
 
 
 
 

 
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5 
Design of the clinical investigation  
 
The investigation is designed as an international multicentre, open, prospective clinical investigation.  
The investigation comprises a 6-month investigation with an additional 18-month follow-up period. 
 
 
5.1 Rationale for the design of the clinical investigation 
 
This investigation is designed to collect data regarding the usability and clinical performance of the 
Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery.  
 
The investigation will be performed in an open design since it is not possible to perform the 
investigation in a blinded fashion. The main evaluations of the investigation, i.e. free-field hearing 
tests, are relevant and objective methods. 
 
This investigation is expected to demonstrate that the Baha Attract System performs within its 
intended use and is a suitable treatment for patients with a conductive or mixed hearing loss or single-
sided sensorineural deafness.  
 
While the Baha Attract System is approved for use in both adults and children, this investigation is 
limited to adult subjects. The paediatric population constitutes an inhomogeneous patient group (age-
related), and currently there are no audiological tests that are suitable for comparisons across age 
ranges and across multiple countries/languages. Performance evaluation of the Baha Attract System 
in children should be performed as separate investigations. 
 
 
 
5.2 Variables 
 
5.2.1 
Primary efficacy variable   
 
Free-field hearing tests: Thresholds audiometry – Pure Tone Average PTA4 (Mean of 500Hz, 1000Hz, 
2000Hz and 4000Hz). 
 
 
5.2.2 
Secondary efficacy variables   
 
The secondary efficacy variables will be evaluated as follows: 
 
 
Free-field hearing tests: 
- 
Threshold audiometry (pure tones): 250, 500, 1000, 2000, 3000, 4000 and 6000Hz 
- 
Adaptive speech recognition in noise (50% performance) 
- 
Speech in quiet (50dB, 65dB and 80dB SPL) 
 
 
BC Direct thresholds 
 
Questionnaires: 

 
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- 
Generic quality of life scale: Health Utility Index (HUI):  
o 
Health related quality of life score for overall health 
o 
Vision score 
o 
Hearing score 
o 
Speech score 
o 
Ambulation/mobility score 
o 
Dexterity score 
o 
Self-care score 
o 
Emotion score 
o 
Cognition score 
 
- 
Abbreviated Profile of Hearing Aid Benefit (APHAB): 
o 
Ease of Communication 
o 
Reverberation 
o 
Background Noise 
o 
Aversiveness  
o 
Global score 
 
- 
The Speech, Spatial and Qualities of Hearing Scale (SSQ) 
 
 
Surgical information:  
- 
Skin thickness  
- 
Surgery time 
- 
Soft tissue flap thinning  
- 
Bone polishing/removal 
- 
Implant stability quotient (ISQ) 
 
 
Sound processor selection 
 
 
Choice of SP Magnet  
 
 
Magnetic retention force (dynamometer) 
 
 
Questions regarding: 
- 
Daily use of sound processor (hours) 
- 
Magnetic retention 
- 
Change of Soft pad 
 
 
 
5.2.3 
Safety variables 
 
 
Pain/discomfort 
 
Numbness  
 
Soft tissue status 

 
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 
Loss/removal of Implant and/or Implant Magnet  
 
Device deficiency  
 
Concomitant medication 
 
Adverse Events and Adverse Device Effect 
 
Serious Adverse Events and Serious Adverse Device Effects 
 
 
 
5.2.4 
Demographics and baseline variables 
 
 
Demographics  
 
Medical and surgical history  
- 
Type of hearing loss 
- 
Aetiology of hearing loss 
- 
Current conventional hearing aid  
- 
Current/previous medications and treatments 
 
Nicotine use 
 
Audiogram 
 
Skin thickness 
 
 
 
 
 

 
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5.3 Investigational flowchart 
 
Procedures and timing  
Visit 1 
Softband 
test 
Visit 2 
Surgery 
Visit 3 
Suture 
removal 
Visit 4 
Fitting 
Visit  
5 
Visit  
6 
Visit  
7 
Visit 
8 
Visit 
9 
Day/Week/Month1 
Pre-op 
D 0 
D 10 
W 4 
W 6 
W 12 
M 6 
M 12 M 24 
Time window 
 
 
 5d 
 1w 
 1w  2w  4w  4w  4w 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
Nicotine use 
X 
 
 
 
 
 
 
 
 
Audiogram2 
X 
 
 
 
 
 
 
 
 
Eligibility criteria 
X 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
Soft tissue thickness  
X     or     X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Health Utility Index (HUI)3 
X4 
 
 
 
 
 
X 
 
X 
Abbreviated Profile of Hearing Aid 
Benefit (APHAB)3 
X4,5 
 
 
 
 
 
X6 
 
X6 
The Speech, Spatial and Qualities 
of Hearing Scale (SSQ)3 
X4,5 
 
 
 
 
 
X6 
 
X6 
 
 
 
 
 
 
 
 
 
 
BC Direct using BFS 
X7 
 
 
X8 
 
 
 
 
 
Selection of sound processor 
X 
 
 
 
 
 
 
 
 
Change of sound processor 
 
 
 
X9 
X9 
X9 
X9 
X9 
X9 
Fitting of sound processor  
X7 
 
 
X8 
 
 
 
 
 
Fine tuning of sound processor 
 
 
 
 
X9 
X9 
X9 
X9 
X9 
Free field thresholds  
X5,7 
 
 
X8 
 
 
X8 
X8 
X8 
Speech recognition in noise  
X5,7 
 
 
X8 
 
 
X8 
X8 
X8 
Speech recognition in quiet   
X5,7 
 
 
X8 
 
 
X8 
X8 
X8 
Home test of sound processor on 
Softband 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Surgery  
 
X 
 
 
 
 
 
 
 
Surgery time  
 
X 
 
 
 
 
 
 
 
Soft tissue thinning 
 
X 
 
 
 
 
 
 
 
Bone polishing/removal 
 
X 
 
 
 
 
 
 
 
Implant stability quotient 
 
X 
 
 
 
 
 
 
 
Suture removal (if applicable) 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SP Magnet selection 
 
 
 
X 
 
 
 
 
 
Magnetic retention force 
 
 
 
X 
X 
X 
X 
X 
X 
Change of SP Magnet 
 
 
 
 
X9 
X9 
X9 
X9 
X9 
Questions regarding: 
 
Daily use of sound processor 
 
Magnet retention 
 
Change of Soft pad 
 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
Pain/discomfort 
 
 
 
 
X 
X 
X 
X 
X 
Numbness 
 
 
X 
X 
X 
X 
X 
X 
X 
Soft tissue status 
 
 
X 
X 
X 
X 
X 
X 
X 
Loss/removal of Implant or Implant 
Magnet  
 
 
X 
X 
X 
X 
X 
X 
X 
Device deficiency  
 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medication/treatment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Extra visit  
 
 
 
 
 
 
 
 
 
1 The time between visits will be calculated from Visit 2 (time 0); 2 Only if the last audiogram that was performed on the subject is older 
than 6 months; 3 To be completed by the subject; 4 Before Softband test; 5 Unaided; 6 Aided; 7 With sound processor on Softband; 8 With 
Baha Attract System; 9 If needed. 
 

 
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6 
Procedures  
 
6.1 Subject demographics 
 
The following demographic data will be recorded at the baseline visit, Visit 1: 
 
Date of birth (month and year) 
 
Gender  
 
Ethnic background 
 
Weight and height 
 
 
 
6.2 Medical history 
 
The following subject characteristics will be recorded at the baseline visit, Visit 1:  
 
Type of hearing loss 
 
Aetiology of hearing loss 
 
Current conventional hearing aid  
 
Relevant medical and surgical history during the past five years as judged by the investigator  
 
Current concomitant medication and treatments  
´ 
 
 
6.3 Nicotine use 
 
Use of nicotine should be assessed using the following scale:  
0 
Does not smoke 
 
1 
Less than 10 cigarettes/day 
Low consumption 
2 
Between 11 and 20 cigarettes/day 
Medium consumption 
3 
Between 21 and 40 cigarettes/day 
High consumption  
4 
More than 40 cigarettes/day  
Very high consumption 
 
 
 
6.4 Audiogram  
 
Unaided audiometric threshold measures (including both air- and bone conduction thresholds) should 
demonstrate that the subject has a conductive or mixed hearing loss or single-sided sensorineural 
deafness. An existing audiogram may be used as long as it has been completed during the last six 
months. The subject’s pre-operative Pure Tone Average PTA4 (mean of 500, 1000, 2000 and 4000Hz) 
should be recorded to ensure the subject meets the inclusion criteria.  
 
 
 
 
 

 
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6.5 Soft tissue thickness 
 
At Visit 1 or Visit 2, the surgeon should measure the soft tissue thickness at the planned implant site. 
A hypodermic needle, a clamp and a ruler should be used. Topical anaesthetic may be used at the 
discretion of the investigator. Local anaesthetic given as a subcutaneous injection should not be used 
prior to soft tissue thickness measurement since the thickness will be affected. In order to obtain a 
correct measurement, care must be taken to not depress the skin with the needle, fingers and/or 
clamp.  
 
Subjects with a soft tissue thickness of less than 3 mm should be excluded from the 
investigation. Subjects with a soft tissue thickness exceeding 6 mm at the planned location of 
the Implant Magnet will require surgical thinning of the soft tissue flap.  
 
 
Figure 6. Measuring soft tissue thickness  
 
 
 
 
6.6 Health Utility Index (HUI) 
 
The Health Utilities Index (HUI®) is a generic preference-based system for measuring comprehensive 
health status and health-related quality of life (HRQL). HUI provides descriptive evidence on multiple 
dimensions of health status, a score for each dimension of health, and a HRQL score for overall 
health. Health dimensions include vision, hearing, speech, ambulation/mobility, pain, dexterity, self-
care, emotion and cognition. Each dimension has 3-6 levels.  
 
The subjects will complete the HUI Mark 3 (HUI3) at Visit 1, 7 and 9.  
 
At Visit 1, the subjects will complete the HUI3 questionnaire prior to the Softband test.  
 
 
 
6.7 The Abbreviated Profile of Hearing Aid Benefit (APHAB) 
 
The APHAB is a 24-item self-assessment inventory that evaluates the benefit experienced by the 
subject when using hearing amplification compared to the unaided situation. The APHAB produces a 
global score and scores for four subscales: ease of communication (EC), reverberation (RV), 
background noise (BN), and aversiveness (AV).  
 
The subjects will complete the APHAB questionnaire at Visit 1, 7 and 9.  
 
At Visit 1, the subjects shall complete the questionnaire prior to the Softband test. At Visit 1, the 
questionnaire shall be answered with respect to the subject’s unaided hearing.  
 

 
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At Visit 7 and 9, the subjects shall complete the questionnaire for the aided situation (with the Baha 
Attract System). 
 
 
 
6.8 Speech, Spatial, and Qualities of Hearing Scale (SSQ)  
 
The Speech, Spatial, and Qualities of Hearing (SSQ) questionnaire is designed to measure self-
reported auditory disability across a wide variety of domains, reflecting the reality of hearing in the 
everyday world. 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 at Visit 1, 7 and 9. 
 
At Visit 1, the subjects shall complete the SSQ questionnaire prior to the Softband test. At Visit 1, the 
SSQ shall be answered with respect to the subject’s unaided hearing, even for subjects with a 
previous hearing device.  
 
At Visit 7 and 9, the subjects shall complete the questionnaire for the aided situation (with the Baha 
Attract System). 
 
 
 
6.9 Sound processor selection  
 
Based on results from BC Direct tests (see section 6.10 for details) performed with the sound 
processor on a Baha Softband at Visit 1, the audiologist will select an appropriate Baha sound 
processor for the subject. The Baha BP110 Sound Processor, the Baha 4 Sound Processor or future 
generation regulatory approved sound processors shall be used. If deemed necessary, the audiologist 
shall adjust the sound processor gain until satisfied, as judged by the investigator and subject.  
 
During the selection process all the three free-field tests must be performed on the selected sound 
processor and the chosen setting, i.e: 
 
Threshold audiometry – free field  
 
Adaptive speech recognition in noise 
 
Speech recognition in quiet 
 
The selected sound processor should be used during the Softband testing period and then attached to 
the SP Magnet at Visit 4. The subject will receive a user manual for the selected sound processor. 
 
If the subject is unsatisfied or experiences extensive feedback noise, the audiologist may switch to a 
more powerful sound processor. 

 
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6.10 Bone Conduction (BC) Direct 
 
BC Direct is a tool in the Cochlear Baha Fitting Software to establish the unmasked bone condition 
threshold with tones presented through the sound processor. At Visit 1, BC Direct data shall be 
collected with the selected sound processor on a Baha Softband and shall be used to calculate the 
fitting (settings) of the sound processor for the Softband test period (see section 6.15). BC Direct and 
the fitting procedure will also be performed at Visit 4 when the subject will start to use the sound 
processor connected to the SP Magnet. 
 
Baha Fitting Software 4.0 or future generation Baha Fitting Software will be used. Feedback 
management (part of Fitting Software) should be used when fitting the device. 
 
     
Figure 7. Performing BC Direct on Softband. 
 
 
 
6.11 Fine tuning of Baha sound processor  
 
If the subject experiences problem with the performance of the sound processor (e.g. feedback, 
loudness, poor sound quality) the audiologist should change the sound processor settings utilising 
Baha Fitting Software 4.0 or future generation Baha Fitting Software. BC Direct should be performed 
and the sound processor should be re-prescribed. The same procedure shall also be performed 
each time a subject requires a change of the SP Magnet. 
 
 
 
6.12 Free field pure tone thresholds 
 
The purpose of this test is to establish the hearing thresholds for pure tones presented in free field 
through a speaker in front position (0 degrees azimuth) according to the so-called ascending or 
modified Hughson-Westlake method. During the test, the signal processing of the sound processor 
shall be set to omnidirectional mode. The test shall be performed with the non-test ear blocked (in 
case or normal or near-normal hearing or a large assymetry with the non-test ear having significantly 
better hearing thresholds). 
 
At Visit 1, free-field thresholds shall be measured for the unaided situation and with the selected 
sound processor on a Baha Softband. At Visit 4, 7, 8 and 9, the same test shall be performed with the 
selected sound processor and selected SP Magnet. 
 

 
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Figure 8. Free field front speaker position. 
 
 
 
6.13 Speech recognition of words in quiet  
 
The purpose of this test is to establish the test subject’s maximum speech recognition in quiet. The 
speech test in quiet shall be performed using phonetically balanced words presented from the front (0 
degrees azimuth). The test material shall be single syllable words and presented at 50, 65 and 80 dB 
sound pressure level (SPL) and scores shall be recorded as % correct words at each presentation 
level. During the test, the signal processing of the sound processor shall be set to omnidirectional 
mode. The test shall be performed with the non-test ear blocked (in case or normal or near-normal 
hearing or a large assymetry with the non-test ear having significantly better hearing thresholds). 
 
At Visit 1, the speech in quiet test shall be performed for the unaided situation and with the selected 
sound processor on a Baha Softband. At Visit 4, 7, 8 and 9, the same test shall be performed with the 
selected sound processor and selected SP Magnet. 
 
 
 
6.14 Adaptive sentence recognition in noise  
 
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 from the front (0 degrees azimuth) and noise 
from the back (180 degrees azimuth). The noise shall be kept constant at 65 dB SPL, and the speech 
shall be adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of 
understanding. During the test, the signal processing of the sound processor shall be set to 
omnidirectional mode. The test shall be performed with the non-test ear blocked (in case or normal or 
near-normal hearing or a large assymetry with the non-test ear having significantly better hearing 
thresholds). 
 
At Visit 1, the speech in noise test shall be performed for the unaided situation and with the selected 
sound processor on a Baha Softband. At Visit 4, 7, 8 and 9, the same test shall be performed with the 
selected sound processor and selected SP Magnet.  
 
 
 
6.15 Test of Sound Processor on Softband  
 
Between Visit 1 and Visit 2 (pre-operatively), the subjects will use the Baha Softband to test the sound 
processor during 1-2 weeks in different daily listening situations in order to get an impression of the 
hearing improvement he/she might anticipate post-surgery with the sound processor connected to the 
SP Magnet. The subject will use the selected sound processor as described in section 6.9. Instructions 
regarding use of the Baha Softband are described in the user manual for the product.  

 
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6.16 Surgery 
 
Surgery will be performed at Visit 2 in accordance with the procedure described in the Surgery Guide 
for the Baha Attract System. Surgery may be performed under general anaesthesia or by using local 
anaesthetic at the discretion of the investigator. The following information will be collected: 
 
Surgery time  
The surgery time is measured from the time from first incision to suture closure. 
 
 
Soft tissue thinning performed  
Surgical thinning of the soft tissue flap must be performed if the thickness exceeds 6 mm. If 
soft tissue thinning is performed, the extent of flap thinning (in mm) shall be recorded.  
 
 
Bone polishing/removal performed  
Any use of bone polishing to accommodate the Implant Magnet shall be recorded.  
 
 
Implant stability quotient (ISQ) 
Implant stability shall be measured during surgery using resonance frequency analysis. The 
measurement renders an implant stability quotient (ISQ) value between 1 and 100. The 
measurement shall be performed at the implant level after inserting the BI300 Implant and 
before attaching the Implant Magnet to the Implant. The highest and lowest ISQ value out of 
two perpendicular measurements shall be recorded, ISQ High and ISQ Low. The Osstell ISQ 
instrument and SmartPeg Type 30 (Osstell, Gothenburg, Sweden) shall be used. The 
procedure for obtaining ISQ values is described in Appendix 1.  
 
After surgery, the subject will receive instructions as for how to take care of the skin in accordance 
with local practice. The subject will also receive a Magnetic Resonance Imaging (MRI) card, which 
contains information to professional health care providers regarding the implanted magnet. 
 
 
 
6.17 Removal of sutures  
 
The sutures shall be removed at Visit 3 (i.e. 10 days after surgery), if applicable. The surgeon/surgical 
nurse will determine if the wound requires further wound dressings, and if so, extra visit(s) will be 
scheduled, until the wound is considered healed.   
 
 
 
6.18 Baha sound processor fitting on SP Magnet 
 
The Baha sound processor that was selected during the initial sound processor selection at Visit 1 
(see Section 6.9) will be fitted with the SP Magnet to the implant at Visit 4 (i.e. 4 weeks after surgery). 
A suitable SP Magnet shall be selected as described in Section 6.19. Sound processor fitting shall be 
performed in accordance with the information in the Fitting Guide (Baha Fitting Software 4.0 or later 
generation). If the wound is not considered sufficiently healed, as judged by the surgeon/surgical 
nurse, the installation shall be delayed to a scheduled subsequent visit or extra visit, when the site is 
considered sufficiently healed.  

 
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The subject will receive a User Guide, which contains important information regarding the device.  
 
 
 
6.19 SP Magnet selection  
 
Initial SP Magnet selection shall be performed at the time of fitting the Baha sound processor to the 
SP Magnet at Visit 4 (see Section 6.18). During follow-up, a change to a stronger or weaker SP 
Magnet may be required. A decision regarding SP Magnet strength shall be made at Visit 4-9 and at 
any extra visit. SP Magnet selection shall be performed in accordance with the procedure described in 
the SP Magnet Selection Guide for the Baha Attract System. When selecting an SP Magnet it is 
important to choose the SP Magnet that provides the best possible retention while still being 
comfortable for the subject.  
 
If a subject requires an SP Magnet change, BC Direct shall be performed with the new SP 
Magnet and the device shall be re-prescribed.  
 
 
 
6.20 Magnetic retention force   
 
The magnetic retention force of the SP Magnet shall be measured at Visit 4-9 and at any extra visits 
including a change of SP Magnet. A specific Force Measuring Tool (dynamometer) shall be used. The 
measurement will be repeated three times. For each measurement the SP Magnet should be placed 
on the skin above the Implant Magnet and the measurement should be performed after one minute in 
order for the Soft pad to be compressed. 
 
 
 
6.21 Daily use, retention, change of Soft pads 
 
At Visits 5-9 subjects will be asked about the following topics: 
 
Daily use of sound processor  
Average hours of daily use (hours/day) during the last week before Visit 5, and during the last 
month before Visit 6-9.  
 
Insufficient retention (number of episodes) 
Number of times the device fell off during the last week before Visit 5-9? 
 
Change of Soft pads (frequency) 
Number of times the subject changed the Soft pad during the last week before Visit 5, and 
during the last month before Visit 6-9? 
 
 
 
6.22 Pain/discomfort 
 
The subject will be asked about the level of discomfort and/or pain at Visits 5-9 using the following 
scale:  
 

 
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 
Which of the following alternatives corresponds best to the subject’s experience with the Baha 
Attract System?  
0 =  No discomfort and/or pain. Normal daily use of sound processor.  
1 =  Slight discomfort and/or pain, not significantly affecting daily use of sound processor.  
2 =  Discomfort and/or pain, reducing daily use of sound processor.  
3 =  Excessive discomfort and/or pain, preventing use of sound processor. 
 
 
 
6.23 Soft tissue status 
 
At Visit 3-9, the investigator will examine the soft tissue at the implant site. In case of signs of e.g. 
inflammation, infection, skin necrosis or scar hypertrophy, the event shall be reported on the Adverse 
Event page in the CRF. If any treatment is provided, it shall also be recorded on the Concomitant 
medication page in the CRF.  
 
 
 
6.24 Numbness 
 
Subjects will be assessed for any presence of numbness around in the implant area at Visits 3-9. The 
following scale will be used: 
 
1. No numbness  
2. Numbness within 2 cm from the implant (center of the inner magnet)  
3. Numbness within and beyond 2 cm from the implant (center of the inner magnet) 
 
Numbness will be assessed by means of a pin and a cotton swab. Randomly picked locations in and 
around the implant area (within and beyond 2 cm from the centre of the implant magnet) will be tested 
by gently touching the skin with the pin and the cotton swab. The scale above shall be used to score 
the subject’s sensation to stimulus with the pin and with the cotton swab. 
 
 
 
6.25 Loss/Removal of Implant and/or Implant Magnet  
 
Any loss or removal of the BI300 Implant and/or BIM400 Implant Magnet should be recorded on the 
Adverse Events page in the Case Report Form (CRF), together with the reason for the loss or 
removal. 
 
 
 
6.26 Device deficiency reporting  
 
The definition of a device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 

 
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A device deficiency should be reported to the Sponsor. A device deficiency that could have lead to a 
Serious Adverse Event (SAE) should be reported immediately (see next section). 
 
 
 
6.27 Adverse Event (AE) and Serious Adverse Event (SAE)  
 
6.27.1 Definitions 
 
Term 
Definition  
Adverse Event (AE) 
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 used in the investigation*. This definition includes events related 
to the procedures involved. 
Adverse Device Effect 
(ADE) 
Adverse event related to the use of medical device used in the 
investigation*.  
 
This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
 
This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device. 
Serious Adverse Event 
(SAE) 
A SAE** is an adverse event that: 
 
results in death 
 
is life-threatening 
 
requires inpatient hospitalisation or prolongation of existing 
hospitalisation 
 
results in persistent or significant disability/incapacity 
 
is a congenital anomaly/birth defect 
 
has led to a important medical event that may have 
jeopardised the subject or may have required an 
intervention to prevent one of the above characteristics/ 
consequences. These can include complaints that might 
have led to a medical occurrence if  
o 
suitable action had not been taken or  
o 
intervention had not been made or  
o 
if circumstances had been less fortunate. 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not considered a 
serious adverse event. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious Adverse Event 
Unanticipated Serious 
Serious adverse device effect which by its nature, incidence, severity or 

 
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Adverse Device Effect 
(USADE) 
outcome has not been identified in the current version of the risk 
analysis report 
 
 
Device deficiency 
 
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. 
*  The definition is broader than the definition in ISO14155:2011 since it includes all clinical investigations 
regardless if the medical device(s) is an investigational device or not. 
**  The definition is broader than the definition in ISO14155:2011 since it includes important medical event as a 
reportable event (see 6.26.3). 
 
 
6.27.2 Handling and reporting of AEs  
 
Subjects will be carefully monitored during the investigation for possible AEs and appropriate 
treatment of the subject will be initiated.  
 
Any AE observed will be fully investigated by the investigator and documented in the case report form 
(CRF) including assessment of severity (mild, moderate or severe) and relationship to the medical 
device.  
 
 
6.27.3 Reporting of SAEs and device deficiency that could have lead to a SAE 
 
An investigator should report within 24 hours, after being aware of the event, an SAE or a device 
deficiency that could have lead to a SAE. The report should be sent as an e-mail attachment to 
Cochlear Bone Anchored Solutions AB. Instructions and contact information is available on the SAE 
form.   
 
 
6.27.4 Reporting to ethics committees/investigational review boards 
 
SAEs/SADEs/USADEs and device deficiencies that could have led to a SAE should be reported to 
ethics committees/investigational review boards in accordance with local requirements. 
 
 
 
6.28 Concomitant medication and treatments 
 
All medications and treatments given, whether or not to treat AEs/ADEs, must be recorded in the 
appropriate section of the CRF. 
 
 
 
 
 

 
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6.29 Extra visit(s) 
 
Extra visit(s) may be a scheduled visit in order to change wound dressing or to follow-up any 
complications. These visits will be recorded on extra pages in the CRF. The following information will 
be recorded: 
 
Date  
 
Reason for extra visit 
 
Procedures and/or treatment used 
 
Staff that conducted the visit (surgeon, surgical nurse or audiologist) 
 
 
 

 
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7 
Risk and benefits of the devices and the clinical investigation 
 
7.1 Anticipated clinical benefits 
 
The Baha Attract System is regulatory approved/cleared for the intended use in the present 
investigation. With the Baha Attract System, the subjects will be able to benefit from the Baha sound 
processor without an abutment penetrating the skin, thus providing cosmetic advantages compared 
to a traditional Baha. In addition, with the Baha Attract System, there is reduced need for daily 
cleaning to maintain a healthy implant site compared to a percutaneous Baha, and risk of adverse 
tissue reactions related to the percutaneous passage are eliminated.   
 
It is expected that the audiological performance of the Baha Attract System will be similar to, or 
somewhat better than, Baha on a Softband. The performance in the high frequency range are likely 
to be slightly lower for subjects with the Baha Attract System compared to the percutaneous 
solution, due to transcutaneous attenuation of the vibrations through the skin.  
 
Participation in the investigation requires slightly more frequent follow-up visits for the subject than 
what is normally required, and the duration of the visits will be slightly longer than normal. The more 
frequent visits will provide the subject the opportunity to more frequently interact with the treating 
physician. Subjects will receive compensation for travelling expenses made for extra visits to the 
clinic. 
 
 
 
7.2 
Residual risks associated with the device and procedures 
Risks associated with the transcutaneous coupling that cannot be completely eliminated include 
magnetic retention difficulties, pressure-related skin complications and pain/discomfort. The system 
has been designed to minimise these risks. For example:  
 
The SP Magnet has been designed with a Soft pad on the soft tissue facing surface to evenly 
distribute the pressure, thus minimising the occurrence of peak pressure areas. 
 
To minimise the risk of pressure-related complications, the transcutaneous coupling has been 
designed such that the average pressure over the skin should not exceed 0.4 N/cm2 (capillary 
blood pressure) and peak pressures should not exceed 0.6 N/cm2 (diastolic blood pressure).  
 
The surgeons are instructed to carefully thin the soft tissue flap during surgery if the skin 
thickness exceeds 6 mm, to ensure good magnetic retention.  
 
Subjects with a soft tissue flap thickness of less than 3 mm are not included in the 
investigation. 
 
Sound processor loading shall be performed at 4 weeks post surgery. However, if the wound 
is not sufficiently healed, loading should be delayed.  
 
The investigators and the subjects will be instructed to carefully select an appropriate SP 
Magnet by balancing the magnet retention to avoid any skin problems. 
 
The surgical procedure associated with the Baha Attract System is described in the Surgery Guide for 
the Baha Attract System. The guide has been developed by the Sponsor together with a group of 
experienced Baha surgeons.  
 

 
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Tests have demonstrated that the Implant Magnet in combination with the BI300 Implant is MRI 
conditional for up to 1.5 Tesla. Subjects that receive the Baha Attract System will receive an MRI card, 
for use by radiologists to evaluate and plan any MRI examination. Subjects that have received 
radiation therapy at the same side of the skull where the Baha Attract will be positioned are excluded 
from the investigation.  
 
 
 
7.3  Risks associated with participation in the clinical investigation 
 
As with any surgical products, there is a risk that unanticipated Adverse Events may occur. The 
subjects will be closely monitored in the investigation and instructed to contact the responsible 
investigator if they experience any untoward effect. 
    
 
 
7.4 
Risk/benefit assessment 
 
The risks are acceptable when weighed against the benefits of the intended performance of the 
devices used in the investigation.  
 

 
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8 
Statistical consideration  
 
8.1 Statistical Design and Objectives 
 
8.1.1 
Primary statistical objectives  
 
To compare the Baha Attract System to unaided hearing, via measurement of the following variables 
in free-field hearing tests: 
 
Threshold audiometry: PTA4 (mean of 500, 1000, 2000 and 4000Hz) 
 
 
8.1.2 
Secondary statistical objectives 
 
 
To compare the Baha Attract System to unaided hearing, via measurement of the following 
variables: 
- 
Thresholds audiometry: 250, 500, 1000, 2000, 3000, 4000, and 6000 Hz 
- 
Adaptive speech recognition in noise (50% performance) 
- 
Speech perception in quiet (50dB, 65dB and 80dB SPL) 
- 
HUI Mark 3 
- 
APHAB 
- 
SSQ 
 
 
To compare the Baha Attract System to the situation where the same sound processor is worn on 
a Baha Softband, via measurement of the following variables: 
- 
Threshold audiometry: PTA4 (mean of 500, 1000, 2000 and 4000Hz) 
- 
Threshold audiometry: 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz 
- 
Adaptive speech recognition in noise (50% performance) 
- 
Speech perception in quiet (50dB, 65dB and 80dB) 
 
 
Description of all Adverse Events, device deficiencies, surgical variables, demographics, baseline 
variables, pain, numbness, soft tissue status, implant loss and questions. 
 
 
To investigate if the choice of SP Magnet and magnetic retention force changes over time. 
 
 
 
8.2 Sample size calculation  
 
8.2.1 
Sample size calculation for the primary efficacy analysis:  
 
In order to achieve 90 % power to detect a clinically significant difference of 10 dB in free-field hearing 
thresholds between the unaided situation and the Baha Attract System at the 6 months visit with 
Fisher’s non-parametric permutation test for paired observation, two-sided test with significance level 
0.05, on the ITT population 20 evaluable subjects are needed assuming a within subject standard 
deviation (SD) of 13.0 dB. The within subject SD for change in PTA4 has been estimated to 12.3 dB in 
a previous study within Cochlear comparing unaided hearing with a BP100 sound processor on a 

 
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Softband versus unaided hearing2. To compensate for a 10% drop out rate in the study 22 subjects 
should be included in the investigation. 
 
 
8.2.2 
Sample size calculation for the for the secondary analysis  
 
In order to achieve 90 % power to detect a clinically significant change of 1.5 dB in free-field hearing 
thresholds from Softband to the Baha Attract System at the 6 months visit with Fisher’s non-parametric 
permutation test for paired observation, two-sided test with significance level 0.05, on the ITT 
population 46 evaluable subjects are needed assuming a within subject SD of 3 dB. The within subject 
SD for change in PTA4 has been estimated to 2.89 dB in a previous study within Cochlear  comparing 
outcomes with a BP100 sound processor on a Softband versus on an abutment2. 
 
 
8.2.3 
Overall sample size considerations 
 
In order to achieve 90% power both for the primary analysis (PTA4, Baha Attract vs. unaided) and the 
secondary analysis of the primary variable (PTA4, Baha Attract vs. Softband), 46 evaluable subjects 
are needed. To compensate for a 10% drop out rate in the study 52 subjects will be included in the 
investigation.  
 
 
 
8.3 Analysis sets – populations 
 
The Intention-to-Treat population (ITT) will include all subjects who have received the surgical 
intervention.  
 
The Per Protocol population (PP) will include subjects that have completed the investigation according 
to the protocol. Subjects that were incorrectly included or were considered major protocol violators 
should be removed from the PP population. 
 
The Safety population consists of all surgically treated subjects. 
 
The final definition of the analysis sets (ITT, PP and Safety) will be taken at the clean file meeting 
before database lock. 
 
 
 
8.4 General statistical methodology 
 
Since all included subjects will have measurements of the primary and important secondary efficacy 
variables for unaided hearing, with the sound processor on a Softband and with the Baha Attract 
System, all statistical analyses will be paired. All statistical analyses will be non-parametric. In order to 
choose the most powerful test, the Fisher’s non-parametric permutation test for paired observations3 
will be used for all paired analyses of continuous variables. The permutation tests use the measured 
values and not only the ranks in the calculations. For paired analysis of dichotomous and ordered 
categorical variables the Sign test will be used.  
 
The analyses will be performed in the following priority: 

 
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1. Baha Attract System vs. Unaided 
2. Baha Attract System vs. the sound processor on a Baha Softband  
 
The main efficacy analysis will be performed on the ITT population and complementary efficacy 
analyses will be performed on the PP population. The main analysis will be performed after the 6 
month visit. A complementary analysis will be performed 18 months after the main analysis (24-month 
visit). All significance tests will be two-sided and performed at the 5% significance level. 
 
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. 
 
Adverse Events, Device deficiencies, Surgical variables, Demographics Baseline, Questions, Magnetic 
force and Magnet strength variables will only be analysed descriptively.  
 
 
 
8.5 Efficacy analysis 
 
8.5.1 
Primary efficacy analysis 
 
Primary efficacy analysis will be determined by analysis of change in free-field threshold audiometry: 
PTA4 (mean of 500, 1000, 2000 and 4000Hz), from unaided versus Baha Attract System at the 6 
months visit for the ITT population, using Fisher’s two-sided non-parametric permutation test for paired 
observations at a significance level of 0.05.  
 
 
8.5.2 
Secondary efficacy analyses 
 
Comparison regarding change from unaided hearing to Baha Attract System will be done according to 
the general methodology with Fisher’s non-parametric permutation test for paired observations for the 
following variables: 
 
Threshold audiometry: PTA4 (Mean of 500, 1000, 2000 and 4000 Hz) at 4 weeks, 12 and 24 
months 
 
Threshold audiometry: 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz at 4 weeks, 6, 12 and 
24 months 
 
Adaptive speech recognition in noise (50% performance) at 4 weeks, 6, 12 and 24 months  
 
Speech in quiet (50dB, 65dB and 80dB) at 4 weeks, 6, 12 and 24 months 
 
HUI3 at 6 and 24 months 
 
APHAB at 6 and 24 months 
 
SSQ  at 6 and 24 months 
 
Comparison of the Baha Attract System with the same sound processor worn on a Softband will be 
done according to the general methodology with Fisher’s non-parametric permutation test for paired 
observations for the following variables: 

 
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 
Threshold audiometry: PTA4 (Mean of 500, 1000, 2000 and 4000 Hz) at 4 weeks, 6, 12 and 
24 months  
 
Threshold Audiometry: 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz at 4 weeks, 6, 12 and 
24 months 
 
Adaptive speech recognition in noise (50% performance) at 4 weeks, 6, 12 and 24 months 
 
Speech in quiet (50dB, 65dB and 80dB SPL) at 4 weeks, 6, 12 and 24 months 
 
All secondary efficacy analyses will be two-sided and conducted at the 0.05 significance level. 
 
All secondary efficacy analyses will be performed for both the ITT population and PP population. 
 
 
 
8.6 Adverse Event analyses 
 
Adverse Events will be analysed descriptively for the Safety population. Implant survival will be 
analysed and illustrated with a Kaplan-Meier survival curve. 
 
Adverse Events and Serious Adverse Events will be coded with the MedDRA dictionary and tabulated 
by Preferred Term-code and System Organ Class-code and treatment. 
 
 
8.6.1 
Analyses of Safety variables 
 
All safety variables will be analysed descriptively for the Safety population. 
 
 
 
8.7 Analyses of Surgical, Demographics and Baseline variables 
 
The Surgical, Demographics and Baseline variables will be analysed descriptively for the ITT 
population and PP population. 
 
 
 
8.8 Analyses of concomitant medications and treatments 
 
Concomitant medications will be coded and tabulated by treatment. 
 
 
 
8.9 Interim analysis  
 
No interim analyses are planned. In addition to the main analysis at 6 months, only a follow-up 
analysis after 24 months is planned. 
 
 

 
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8.10 Statistical Analysis Plan  
 
A statistical analysis plan (SAP) with detailed statistical analyses specified for all variables and time 
points will be written and signed before the database lock. 
 
 
  
 
 

 
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9 
Administrative Aspects 
 
9.1 Training  
 
The Sponsor will organise an initiation visit before study start. The visit will cover: the CIP, 
investigational procedures including the informed consent process, instructions regarding CRF 
completion and any other matters or queries related to running the investigation at the site.  
 
The principal investigator will ensure that appropriate training relevant to the investigation is given to 
the medical, nursing and other staff involved at the clinic and that new information of relevance to the 
performance of this investigation is forwarded to the staff involved. 
 
 
 
9.2 Investigational data  
 
9.2.1 
Case Report Form (CRF) 
 
Data Collection will be done by using a paper document (pCRF) or electronic system (eCRF) for each 
subject on which information will be reported. Specific instructions on how to complete the CRF will be 
provided to the investigator and other site staff. Completed CRFs will be reviewed and signed by an 
investigator.   
 
 
9.2.2 
Source data  
 
Source data is defined as all the information in original records, certified copies of original records of 
clinical findings, observations, or other activities in a clinical investigation, necessary for the 
reconstruction and evaluation of the clinical investigation. 
 
The CRF could be source data and before the initiation of the investigation the principal investigators 
should together with the monitor complete the template ‘Origin of source data’ stipulating where 
source data should be recorded at the investigational site. 
 
 
9.2.3 
Data management 
 
A data management plan will be written that describes the overall data handling process including 
data validation, clarification of data and the clean file process. 
 
The database management system iDataFax will be used. It will allow automated CRF tracing, 
facilitate data entry, provide easy data export into SAS and to Sponsor. It meets all the FDA (21 
CFR§11) and ICH requirements.  
 
All outstanding questions regarding data should be handled during the clean file meeting. After 
declaring clean file the data will be locked.  
 
 
 

 
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9.3 Archiving  
 
The Sponsor and principal investigator shall maintain the investigation documents as required by the 
applicable regulatory requirements.  
 
 
 
9.4 Device accountability  
 
Access to the devices used in the investigation shall be controlled and the devices shall be used 
according to this CIP. 
 
The principal investigator or authorised designee shall keep records documenting the device identity 
(batch number/serial number or unique code), use of the device and disposal of the device (if 
applicable) in accordance with standard procedures at the hospital and in accordance with local 
regulations. 
 
 
 
9.5 Quality control  
 
9.5.1 
Monitoring  
 
The Sponsor will appoint a monitor that will visit sites during the investigation. The monitor will be 
appropriately trained and informed about the nature of the investigation, ISO 14155:2011 and 
applicable regulatory requirements. 
 
The monitor will verify the informed consent of participating subject, that the investigational team is 
adhering to the protocol and that data are accurately recorded in the CRF. 
 
The monitor must have direct access to source data.  
 
 
9.5.2 
Audit  
 
Audits of the clinical investigation may be conducted by the Sponsor or third party designated by the 
Sponsor to evaluate compliance with the CIP, written procedures, ISO-14155:2011 and applicable 
regulatory requirements.  
 
 
 
9.6 Clinical Investigation Plan  
 
9.6.1 
Deviations from Clinical Investigation Plan 
 
Any deviation from the CIP will be recorded together with an explanation of the deviation. Deviations 
will be reported to the Sponsor, who is responsible for analysing them and assessing their 

 
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significance. The appropriate ethics committee/institutional review board and regulatory authorities (if 
applicable) will be informed of any significant protocol deviations. 
 
 
 
9.7 Suspension or premature termination  
 
The Sponsor may suspend or prematurely terminate either an individual investigation site or the entire 
clinical investigation for significant and documented reasons. A principal investigator may suspend or 
prematurely terminate participation in the clinical investigation at the investigational site for which 
he/she is responsible.  
 
 
 
9.8 Publication policy 
 
The result of this study will be published. Authors of the primary publication based on this study must 
fulfil the criteria defined by the International Committee of Medical Journal Editors (ICMJE). 
 
The primary publication must be published before any secondary publications are submitted for 
publication.  
 
 
 
9.9 Timetable 
 
First subject in:  
Q1 2014 
Last subject in: 
Q3 2014 
Last subject out:  
Q3 2016 
 
End of investigation is defined as ‘last subject last visit’. 
  
 

 
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10 
Bibliography 
 
1. Tjellström A, Håkansson B, Lindström J, et al. Analysis of the mechanical impedance of bone-
anchored hearing aids. Acta Otolaryngol 1980;89:85-92 
2. Hedin A, Flynn M. Investigation of potential impact of TBaha passive regarding hearing 
performance, Sweden: Cochlear Bone Anchored Solutions AB; 2013, 615077. 
3. Good P. Permutation Tests. A Practical Guide to Resampling Methods for Testing Hypotheses. 
Springer, Inc New York (2000), page 51-52. 
 
 
 
 
 

 
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11 
Signed agreement – Sponsor 
 
 
Title  
Post-market clinical follow-up of a magnetic bone conduction implant 
(Cochlear Baha® Attract System) 
A multicentre, open, prospective clinical investigation. 
6 months investigation with an 18 months follow-up period 
 
Investigation code 
CBAS5477 
 
Version   
1.0 
 
Version date  
22 NOV 2013 
 
 
 
 
Signature of Cochlear Bone Anchored Solutions  
 
I agree to the terms of this clinical investigation protocol, including all appendices. 
 
 
Signature:   
 
 
____________________ 
 
 
___________________ 
Mark Flynn 
 
 
 
Date (dd-MMM-yyyy) 
Director of Research and Applications  
 

 
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12 
Signed agreement – coordinating investigator  
 
 
Title  
Post-market clinical follow-up of a magnetic bone conduction 
implant (Cochlear Baha® Attract System) 
A multicentre, open, prospective clinical investigation. 
6 months investigation with an 18 months follow-up period 
 
Investigation code 
CBAS5477 
 
Version   
1.0  
 
Version date 
 
 
 
22 NOV 2013 
 
 
 
 
Signature of Coordinating investigator 
 
I agree to the terms of this clinical investigation protocol, including all appendices. 
 
 
Signature:   
 
 
_________________________ 
 
___________________ 
Dr Emmanuel Mylanus 
 
 
Date (dd-MMM-yyyy) 
Radboud University Nijmegen Medical Centre 
Nijmegen   
Netherlands