Single Center Evaluation of a Sound Processor for a Transcutaneous System
Phase: NA
Conditions: Conductive Hearing Loss, Mixed Hearing Loss
Sponsor: Oticon Medical

CONFIDENTIAL
Issued by
Marianne 
Philipsson
Sign
Approved by
Sofia Jonhede
Sign
Date
2018-05-04
Page
1(27)
Title
Single center evaluation of a sound processor for a transcutaneous system
Document no.
35146
Revision
02
Clinical investigation plan
Title: Single center evaluation of a sound processor for a transcutaneous system
Version: 35146-02/2018-05-04
Synopsis
Study site:
ENT departement, Sahlgrenska University hospital
Investigation code:
C58
Principal investigators:
Måns Eeg Olofsson, MD Phd 
Sub-investigator
Ann-Charlotte Persson, certified audiologist, MSc
Sponsor:
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Monitor:
Oticon Medical representatives
Objective(s):
The primary objective of this study is to validate the performance of 
the externally worn sound processor named the Fusion sound 
processor (SP). In addition the study will evaluate magnet strength 
head, potential skin problems and retention in daily life. Focus will 
also be on user satisfaction, usability and performance compared to 
current SP. 
Methodology:
Prospective case study. 6-10 patients will be fitted with Oticon 
Medical Fusion SP
Product:
Fusion SP developed by Oticon Medical AB (Askim, Sweden).
Main inclusion/exclusion 
criteria:
Inclusion criteria

Subject implanted with BCI implant and using the BCI sound 
processor,
Exclusion criteria

Inability to participate in follow-ups
Intervention(s):
Fitting and evaluation of a sound processor to patient in daily life. 
Laboratory testing including speech in noise and aided thresholds 
measurements. 
Duration of study period:
7 months
Criteria for safety:
No complications is anticipated. Serious adverse events and adverse 
events will be monitored thorughout the study. 
Statistical methods:
Pairwise differences for continuous variables will be tested with 
Wilcoxon Signed Rank test and for ordered categorical variables with 
Sign test.
Investigation plan prepared 
by:
Marianne Philipsson, Clinical Trial Manager, MSc, Oticon Medical AB
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13.
Investigation administrative structure..................................................................................................19
13.1.
INFORMATION TO BE SUPPLIED TO THE CLINICAL INVESTIGATOR ......................................................... 19
13.2.
THE PATIENT’S MEDICAL RECORD ........................................................................................................ 19
13.3.
DATA HANDLING.................................................................................................................................. 20
13.4.
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION .................................... 20
14.
Data management ...................................................................................................................................20
14.1.1.
Data management procedures .................................................................................................... 21
14.2.
CONFIDENTIALITY................................................................................................................................ 21
15.
Statistical considerations........................................................................................................................21
16.
Amendments to the CIP .........................................................................................................................21
17.
Deviations from clinical investigation plan...........................................................................................21
18.
Device Accountability .............................................................................................................................21
19.
Statements of compliance .......................................................................................................................22
20.
Informed consent process.......................................................................................................................22
21.
Adverse events, adverse device effects and device deficiencies ...........................................................23
21.1.
ADVERSE EVENT (AE) ......................................................................................................................... 23
21.2.
SERIOUS ADVERSE EVENT (SAE)......................................................................................................... 23
21.3.
DEVICE DEFICIENCY............................................................................................................................. 23
21.4.
ADVERSE DEVICE EFFECT (ADE) ........................................................................................................ 23
21.5.
SERIOUS ADVERSE DEVICE EFFECT (SADE)........................................................................................ 24
21.6.
UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT (USADE).......................................................... 24
21.7.
REPORTABLE EVENTS .......................................................................................................................... 24
21.8.
REPORTING TIMELINES......................................................................................................................... 24
21.8.1.
Report by sponsor to the National Competent Authority............................................................ 24
21.8.2.
Report by the investigator to the sponsor ................................................................................... 24
22.
Publication Policy....................................................................................................................................24
23.
Results and reports .................................................................................................................................25
24.
References................................................................................................................................................26
25.
Signed agreements ..................................................................................................................................27
25.1.
SPONSOR .............................................................................................................................................. 27
25.2.
PRINCIPAL INVESTIGATOR.................................................................................................................... 27
2. Appendix
A. Case report forms 
3. Abbreviations
BAHS – Bone anchored hearing system
BBC – Bridge Bone Conductor 
BC – Bone Conduction 
BCI – Bone Conduction Implant
eCRF – electronic Case Report Form
dB – Decibel 
IPS - Infection/Irritation, Pain, Skin height/numbness - scale
N/PA – Newton Pascal
PTA – Pure Tone Average
SNR – Signal to Noise Ratio
SP – Sound Processor
SPL – Sound Pressure Level 
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SRS – Speech Recognition Score
SSQ – Speech, Spatial and Qualities of hearing
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replaced by the Oticon Medical Fusion SP.  
6. Identification and description of the investigational device
The Fusion SP (see Figure 3) is,
, intended for improvement of hearing 
for patients with conductive and mixed hearing losses by unilateral or bilateral fitting, as well as 
patients suffering from single sided deafness. The SP is 
worn on the side of the head and is daily placed attached 
and detached by patients themselves based on need and 
preference. 
 
The 
Fusion SP intends to pick up the sound and convert to an 
electric signal that is processed to fit the patients hearing 
loss and specific needs though signal processing 
algorithms programmed to the SP’s digital chip. The signal 
is then converted to an electric magnetic signal 
transmitted from the transmitter coil in the SP to the 
receiver coil in the implant unit through the intact skin 
via a magnetic induction loop system. The Fusion SP 
includes a magnet, a microphone, battery, sound 
processing electronics and a radio frequency tuned 
switching power amplifier that drives the transmitter coil inductive link. The SP is placed above the 
implant which is located in the mastoid bone behind the ear, the SP is held in place by magnet forces 
and can easily be removed and reattached by the patient. All materials in contact is biocompatible 
[19]
 
 
 
Figure 3. The Fusion sound processor, to 
the left seen from the front and to the 
right seen from the side.
Figure 2 The BCI system with the BCI SP 
and BCC Transcutaneous direct drive 
bone conduction device
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7. Justification for the design of the clinical study
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To be consistent with earlier 
research on transcutaneous system comparison will be made primarily compared to the unaided 
condition. But since the subjects already have a device, the BCI SP, comparisons will also be made to 
this device. The duration of the study, 6 months, has been chosen to allow the patients to acclimatize
to the new SP as well as give a relevant time for evaluation of skin reactions and magnet retention 
forces. In addition a 7th month is added to the study to allow evalution of a new optimized setting.  
8. Risks and benefits of the investigational device and clinical
evaluation
A risk analysis have been performed according to ISO 14972 showing that the benefits of the Fusion
sound processor outweigh the residual risks [16]. It can be concluded that since the study only aims 
at fitting a new sound processor on already implanted subjects the risk of participating in the study is 
low and comparable to any SP change or upgrade within clinical practice
 
 
This will require an extra effort for the subjects, however generally the possibility to 
optimize ones sound experience is seen as something positive for people with hearing impairment.
The subjects will get access to a new SP with the latest technology and will have the opportunity to 
interact with the experts within the field of bone anchored hearing systems. The continued 
development of sound processors compatible with the subjects’ implanted system will grant the 
subjects access to continuous use of the system.
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We conclude that the risk of participation in this clinical study is minimal. The additional effort 
required of the participating subjects is deemed acceptable when weighted against the subject’s 
expected benefit in terms of trying a new sound processor with the latest technology and increasing 
the subject’s options of available hearing devices. This study will also provide input to the
development of, and help bring, a new bone conduction hearing device to market, which will provide 
the hearing impaired population with an additional treatment option.
9. Objectives and hypotheses
9.1. Primary Objective and hypothesis

The primary objective off this study is to validate the performance of the Fusion SP. 
Performance will be investigated in terms of improvement of aided sound field thresholds 
with the Fusion SP compared to the unaided condition. The hypothesis is that there will be a 
significant improvement in aided thresholds with the Fusion SP compared to unaided. 
9.2. Secondary Objectives and hypotheses

Magnet strength measured on the subjects’ head and potential skin problems when wearing 
the Fusion SP, where the hypothesis is that wearing the SP with the magnetic attachment to 
the skull will not cause any problem with adverse skin reactions.

Retention in daily life, where the hypothesis is that the Fusion SP can sustain the forces 
caused by daily movement eg. walking, walking up and down a stair and jogging. Extensive 
movement such as heavy exercising or physical work will require an extra holding option 
such as a safety line attached to the SP. 

Speech intelligibility performance compared to unaided. The hypothesize is a significant 
improvement for the Fusion SP compared to without SP.  

User satisfaction and usability focusing on evaluation and optimizing technical features. Our 
hypothesis is that satisfaction with the Fusion SP is as good as or better compared to the 
current solution.

 
 

Subjective evaluation of appearance of the SP, absolute and compared to their current SP as 
cosmetics is of great importance to users. We hypothesize that the appearance of the Fusion 
SP will be experienced as positive. 
9.3. Tertiary Objective
An additional objective of this study is also to use measurements from the fitting visit to increase our 
knowledge and to provide input to further development of transcutaneous solutions.
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10.1.
Endpoints
10.1.1.
Primary endpoints

Primary endpoint of this study will the difference between Fusion-aided and unaided sound 
field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
after six month use of the processor. 
10.1.2.
Secondary endpoints 

Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds 
at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) after seven months use of the processor.

Difference between Fusion-aided and unaided sound field Pure Tone thresholds at 
frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz after six months 
use of the processor.

Difference between Fusion-aided and unaided sound field Pure Tone thresholds at 
frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz after seven
months use of the processor.

Difference between Fusion-aided sound field PTA 4 at
o
6 months and 1 months
o
6 months and 0 months
o
1 months and 0 months
o
6 months and 7 months use of the sound processor

Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 
1500, 2000, 3000, 4000, 6000 and 8000 Hz at
o
6 months and 1 months
o
6 months and 0 months
o
1 months and 0 months
o
6 months and 7 months use of the sound processor

Difference between Fusion-aided after 6 month of use and BCI-aided sound field PTA 4.

Difference between Fusion-aided 7 months of use and BCI-aided aided sound field PTA 4.

Difference between Fusion-aided after 6 month of use and BCI-aided sound field pure tones 
at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz

Difference between Fusion-aided 7 months of use and BCI-aided sound field pure tones at 
frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz

Difference between Fusion-aided and unaided speech intelligibility scores (in % correct) after 
six month use of the processor. 

Difference between Fusion-aided and unaided speech intelligibility scores (in % correct) after 
seven month use of the processor. 

Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR
after six months use of the processor.

Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR 
after seven months use of the processor.
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
Difference between Fusion-aided speech intelligibility scores (in % correct)
o
at 6 months and 1 months
o
6 months and 0 months
o
1 months and 0 months 
o
6 months and 7 months use of the sound processor

Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR
o
at 6 months and 1 months
o
6 months and 0 months
o
1 months and 0 months 
o
6 months and 7 months use of the sound processor

Difference between Fusion-aided after 6 month of use and BCI-aided speech intelligibility 
scores (in % correct)

Difference between Fusion-aided 7 months of use and BCI-aided sound speech intelligibility 
scores (in % correct)

Difference between Fusion-aided after 6 month of use and BCI-aided sound field speech 
intelligibility scores in SNR

Difference between Fusion-aided 7 months of use and BCI-aided sound speech intelligibility 
scores in SNR

Difference in magnet strength measured on the patient’s heads in Newton
o
after 6 and 1 months 
o
after 6 and 0 months
o
after 1 and 0 months
o
after 6 and 7 months use of the sound processor.

IPS (Infection/Irritation, Pain, Skin height/numbness - scale) score at baseline, one, six and 
seven months use of the sound processor.

Retention in daily life after one and six months of use as measured by questionnaire

User satisfaction and usability evaluation as measured by questionnaires after 1, 6 and 7
months of use.

Subjective performance as measured by SSQ (BCI at fitting, Fusion 1 & 6 months)

Difference in performance as measured by SSQ between Fusion-aided after 6 month of use 
and BCI-aided
10.1.3.
Tertiary endpoints

BC-insitu hearing thresholds for frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 
6000 and 8000 Hz

Unmasked BC-insitu on implanted ear for frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 
4000, 6000 and 8000 Hz

Gain curves evaluating feedback limits in dB N/Pa
10.2.
Outcome measures
10.2.1.
Test subject characteristics
We will collect the following subject characteristics (please refer to Form 1 in Appendix A for details).
•
Gender
•
Age
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At the first visit the patient information will be gone through together with the subject and the patient 
will have the possibility to ask questions on the study and study procedures. If the subject wishes to 
participate in the study, the informed consent is signed. The investigator will then perform a base line
skin evaluation.
Second visit, Fitting:

Fill out the questionnaire for BCI SP

Perform conventional BC-threshold measurements through audiometer and BC71 vibrator.  

Fitting of the Fusion sound processor including BC-insitu and feedback manager.

Skull simulator measurements on the Fusion SP and BCI SP

Sound field thresholds and speech intelligibility measurements on the BCI SP and Fusion SP

Magnet force measurement

Photo of the sound processor on the head

Hand out of questionnaires for evaluation of Fusion SP

The subject will start by filling out the questionnaire to evaluate the BCI SP. After that the fitting of the 
Fusion SP will be performed, a part of the fitting is to measure BC-insitu and feedback manager. As a 
reference for the BC- insitu thresholds conventional audiometric BC thresholds will also be measured 
at the second visit. The subjects’ initial opinion about the sound will indicate if there is a need for fine
tuning or not. The subject will be given the possibility to walk around with the SP in place and evaluate 
the sound.
Sound field thresholds and speech intelligibility measurements will be performed both on Fusion SP
and on BCI SP and photos will be taken with the sound processor on the head. To check the retention
force of the magnet a magnet force measurement will be performed together with an evaluation of 
magnet strength and potential shift of magnet to a stronger or weaker if deemed necessary by the
sub-investigator. At last questionnaires used for Fusion SP evaluation will be handed out.
 
 
If convenient for the subject, visit 1 and visit 2 can be carried out at the same day. 
Phone call and potential extra visit

Adverse events during the test period

Evaluate need for fine tuning and conduct fine tuning

Skull simulator on Fusion SP after fine tuning

After approximately one week of usage the test subjects will be contacted by phone and interviewed 
about the usage of the Fusion SP. The purpose with the phone call is to in an early stage address 
potential issues using the Fusion SP as the setting potentially could differ somewhat compared to what 
the test subjects have been used to. If deviations are judged to be severe and affect the usage of the 
SP the test subject will be offered to come in for an additional fine tuning. At the extra visit fine tuning 
of the Fusion SP will be performed. The fine tuning will be verified through skull simulator 
measurements.
Third visit, one month after fitting:

Adverse events during the test period
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
Hand in questionnaire and interview about sound processor

Magnet force measurement and skin evaluation

Fine tuning if needed 

If fine tuning: skull simulator measurement with Fusion SP after fine tuning

Sound field thresholds and speech intelligibility measurements Fusion SP and unaided

Photo of the area under the sound processor.

Hand out of questionnaires for evaluation of Fusion SP 

At the third visit after one month the test subjects hand in questionnaires on Fusion SP and magnet 
forces are measured again. Sound field thresholds and speech intelligibility measurements on Fusion
will be performed. A photo of the area under the SP will be taken to help with evaluation of skin 
condition. If needed fine tuning will be performed with skull simulator measurement after. In the 
beginning of the visit eventual adverse events during the test period will be noted.
Fourth visit, six months

Adverse events during the test period

Hand in questionnaires

Magnet force measurement and skin evaluation

Sound field thresholds and speech intelligibility measurements on Fusion SP

Fine tuning to apply additional setting

Skull simulator on Fusion SP after fine tuning

Adverse events during the visit. 


Go through information about adding on an extra visit 

Signing informed consent for adding an extra visit 
Fifth visit, seven months

Adverse events during the test period

Hand in questionnaires 

Sound field thresholds and speech intelligibility measurements on Fusion SP 


If finetuning: Skullsimulator simulator on Fusion SP after fine tuning
On the fourth visit the magnet force measurements and pictures of the skin under the SP will be 
repeated. Sound field thresholds and speech intelligibility measurements will be conducted, this time 
for the Fusion SP and unaided. There is also a possibility for extra fine tuning if needed. In the beginning 
of the visit adverse events during the test period will be noted.
Unscheduled visits
If any problems arise under the trial, the subjects are advised to contact the sub-investigator. The sub-
investigator will evaluate and confer with the investigator if needed. If the problems are SP related (eg. 
need for fine tuning, loss of SP or malfunctioning SP) appointment with the sub-investigator or if of 
medical character (eg. skin problem or pain the area under the SP) refer to investigator who will 
schedule an extra visit. 
10.4.
Investigational device and comparator
The investigational device is described in Sec. 6. Exposure time of the investigational device is 
expected to be somewhere from a minimum of 5 hours up to a full day’s use, 16 hours. The usage is 
expected to be the same as the usage of patient’s current device, the BCI SP. 
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10.5.1.
Sample size calculation
The sample size calculation is based on the primary end-point. With Wilcoxon Rank test (compare 
Sec. 15. Statistical considerations) we need a minimum of 6 patients to reach statistical significance if 
all show improvements. Results from the BCI study on 6 patients [21] and studies on Bonebridge 
(another transcutaneous system with similar intended use and population, please refer to Sec. 5) 
show an average difference between aided and unaided free-field thresholds of 31dB (Sec. 5). Based 
on knowledge in the field and the primary end-point of this study, the minimum sample size is 
therefore 6 patients.
This sample size, although limited, will also provide valuable data on more general performance and 
satisfaction with the device, as described in the secondary objectives of the study. We therefore 
conclude that the minimum of six included patients is an adequate sample size. 
11.
Study Procedures
11.1.
Fitting
 
 
 
 
 
11.2.
Measurements
11.2.1.
Magnet force measurement
To measure the pull off force in Newton a digital force gauge will be used together with a measuring 
adaptor with a magnet corresponding to the magnet in the SP. Both axial and parallel forces will be 
measured. For parallel force the force gauge is pulled straight up while the patient sits with the head 
straight. For axial forces, the force gauge is pulled straight up while the patient tiles the head to the 
side.
11.2.1.
Skull simulator measurement 
To measure the output of the Fusion sound processor a skull simulator is used. The skull simulator 
simulates the mechanical impedance of the head when a bone anchored sound processor is attached 
to it.
 
11.3.
Clinical assessments
11.3.1.1.
Photo
Photos should be taken of the Fusion SP on the test subject’s head from a 0° and 90° angle with the 
sound processor on and from 90° without the SP on to assess the physical appearance and fit of the
device together with the potential skin reactions. The pictures will be taken with the SP or the area 
under the SP in center and without being able to identify the subject.  
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11.3.1.2.
BC-thresholds
Detection of thresholds through audiometer and using a BC71 vibrator as used for measuring 
conventional audiometry. Pure tone signal at 250 Hz, 500Hz, 750Hz, 1kHz, 1.5kHz, 2 kHz, 3kHz, 4kHz, 
6kHz, 8kHz.
11.3.1.3.
Aided Sound field thresholds
Detection thresholds with/without BAHS. Warble tone signal presentation via loudspeaker. 250 Hz, 
500Hz, 750Hz, 1kHz, 1.5kHz, 2 kHz, 3kHz, 4kHz, 6kHz, 8kHz
11.3.2.
Speech to noise thresholds (Hagerman). 
Speech recognition test using five word matrix sentences. The material is based on a list of ten 
spoken Swedish sentences computer edited to obtain new lists with exactly the same words but put 
together into new sentences [1]. Speech level kept constant at an average level of 63 dB SPL and 
noise adapts to find the signal to noise ratio where the test subject repeats 50% of the words correct.
The order of testing the BCI SP and Fusion SP on visit 1 and Fusion SP and Unaided on visit 2 will be 
altered not favor any of the conditions due to either learning or fatigue effects. Also the speech list 
used for testing will be balanced avoiding the same list to be used too many times. 
11.3.3.
Speech recognition score in noise (SRS) using monosyllabic words
A list of 50 Swedish monosyllabic words is presented to the patient at a level of 68 dB SPL with a 
constant speech shaped noise present. The signal to noise ratio is 4 dB and the number correct 
words in percent is obtained. The order of testing the BCI SP and Fusion SP on visit 1 and Fusion SP 
and Unaided on visit 2 will be altered not favor any of the conditions due to either learning or fatigue 
effects. Also the speech list used for testing will be balanced avoiding the same list to be used too 
many times.
11.3.4.
Skin assement evaluation
Used for skin assessment is the recently developed IPS scale consisting of three parts: I 
(Infection/Irritation-scale) ranging from 0-4, P (Pain-Scale) ranging from 0-2 and S (Skin 
height/numbness-scale) ranging from 0-2. A higher score on either of the subscales reflects a more 
severe complication [20]. 
12.
Monitoring plan
During the investigation, representatives from Oticon Medical will have regular contact with the 
investigation site. According to Good Clinical Practice (GCP) guidelines, the main task of the clinical 
trial monitor is to oversee the progress of a clinical study and to ensure that:

The rights and well-being of human subjects are protected

Reported trial data are accurate, complete and verifiable from source documents

The conduct of the trial is in compliance with the currently approved protocol, SOPs, GCP and
applicable regulatory requirements
Authorized representatives of the sponsor will therefore visit the centre to perform inspections as 
well as monitor the data captured in the electronic data system throughout the study. 
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13.
Investigation administrative structure 
 
 
 
 
 
 
 
 
 
 
 
13.1.
Information to be supplied to the clinical investigator
Before initiating the clinical investigation, the principal investigator and sub investigator will receive 
all written study and device related information.
13.2.
The patient’s medical record
The subjects’s participation in the clinical investigation will be documented in the patient’s medical 
record along with test subject code, title of the investigation and investigation code. This will be done 
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by the investigator at the first visit. It will also be documented that the patient has been informed 
about the study and that the patient has signed the informed consent form. The date of inclusion 
into the study will be recorded together with the study code. When leaving the study that date will 
be recorded. Note that if AEs warrants follow-up the date that the last activity to follow the AE up is 
the last date in the study and not the last visit date. The last date of AE follow-up may have the status 
ongoing, not recovered or unknown. Ongoing will be used only when a status quo have been 
reached. Unknown may be used when the subject has been lost to follow-up.
13.3.
Data handling
All data concerning trial subjects is protected under the Personal Data Act (Personuppgiftslagen
(1998:204)) and the Health and Medical Service Act (Hälso- och sjukvårds lagen) and will be handled 
accordingly. After 25 May 2018 the data for the trial subjects is protected under the General Data 
Protection Regulation (GDPR)All information about the subjects is under professional secrecy. All 
information about the subjects outside the clinic will be anonymized and the subjects identity will 
not be known for anyone outside the clinic. 
The sub-investigator will, during the study, hold the appointments with the subjects at an external 
location outside the hospital at Chalmers Technical University where the appropriate measurement 
facility is located. No personnel from Chalmers will be involved in the study visits besides acting as 
technical support for the measurement facilities. No patient data will be shared with the personnel 
and they will get no access to any information about the patient. 
13.4 Suspension or premature termination of the clinical investigation
If the investigation is terminated prematurely or suspended, the sponsor will promptly inform the 
clinical investigation centre of the termination or suspension and the reason(s) for this. The 
competent authorities and the ethical committee will also be informed promptly in writing and 
provided with the reason(s) for the termination or suspension by the sponsor. The sponsor may at 
any time terminate the clinical investigation due to circumstances related to the product or company 
that preclude ongoing patient treatment.  
14.
Data management
Data captured will be recorded in the electronic Case Report Forms (eCRF). In appendix A the content 
of the eCRFs are specified. All data, subject and product related, must be accurately recorded in the 
eCRF by the investigator and/or delegated site staff, in this case the sub-investigator All patient related 
questionnaires will be filled out anonymously and will only be identified by the subject code. The 
patient code on all questionnaries and CRFs will ensure tracebility of data. All data gathered by 
questionnaire will be added in the eCRF by the sub-investigator.
All users of the eCRF system have personal, password protected accounts allowing tracking of all data 
entry in the system. Data management and data cleaning will be continuously performed in the eCRF 
using the queries function to ensure traceability of all data entry and changes by the assigned data 
manager. Data management is performed by the Sponsor. Monitoring will be performed against 
source data in patient journals. The monitor will have access to the subject’s identity and will sign an 
agreement in accordance with the hospital practice to ensure patient confidentiality. All subjects will 
be given a code that will make the subject’s identity unknown to external parties such as the sponsor. 
It is the responsibility of the investigator to make sure that subject identification listings with subject 
code and identity are kept. These lists, source data and a copy of the eCRF data shall be retained for 5 
years after the study has been completed.
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14.1.1.
Data management procedures
Database lock will be agreed by data manager, principal and sub investigator, and study project 
leader in a clean file meeting before any data analysis. Database lock will be done at the end of the 
study, when all six month data is available. 
14.2.
Confidentiality
At all times throughout the clinical investigation confidentiality will be observed by all parties 
involved. All data will be secured against unauthorized access.
15.
Statistical considerations
To evaluate the differences between the unaided and Fusion SP aided threshold at 6 months 
(primary end-point) a non-parametric test (Wilcoxon Signed Rank test) will be used.
A detailed statistical analysis plan (SAP) will developed prior to database lock by an independent bio-
statistician (compare Sec. 13). In general, pairwise differences for continuous variables will be tested 
with Wilcoxon Signed Rank test and for ordered categorical variables with Sign test. Last value 
carried forward will be used for potential drop-out subjects. If imputation is used, sensitivity analysis 
will be performed for the primary outcome, and selected additional outcome variables as defined in 
the statistical analysis plan.
16.
Amendments to the CIP
In case of changes to the clinical trial protocol are needed, an amendment should be made. 
Substantial amendments should be approved by the competent authorities and ethical committee 
before incorporated.
17.
Deviations from clinical investigation plan
The investigator should not deviate from the clinical investigational plan except if needed to protect 
the rights, safety and well-being of the subjects. Such cases such be documented and reported to the 
EC and the Sponsor as soon as possible.
If deviations (other than mentioned above) occur, the Investigator should inform the monitor/clinical 
study manager and recorded in the protocol deviation log provided in the study site file.  The 
implications of the deviation must be reviewed and discussed between the Sponsor and the 
Investigator. If deviations are found during monitoring visits, they should also be documented in the 
monitoring report and handled as above. This should be done as soon as possible after detection to 
avoid repetitive deviations. Continuous review of protocol deviations during monitoring visits aim to 
detect systematic errors and to identify retraining needs at the site. Frequency of monitoring is
described in the monitoring plan and should be increased if systemic deviations are identified.
All protocol deviations must be documented stating the reason, date, the action(s) taken, and the 
impact for the subjects and/or the study. 
If serious or repeated deviations occurs, the Sponsor has the right to initiate early termination of the 
study.
At the end of the study, protocol deviations will be categorized as minor or major and their 
consequence on analysis populations will be decided. 
18.
Device Accountability 
Each device prepared for the clinical study will get a unique serial number that will be marked on the 
device and on the box of the device. The devices will be brought by sponsor representative for each 
of the fittings as the sponsor responsible also will assist with the fitting. The device serial number will 
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be noted in the eCRF at the fitting visit. The sponsor will also keep a  log of the device number and 
subject number. If any SPs are exchanged during the study the new number will be noted down 
together with date of exchanging the SP. 
19.
Statements of compliance
The clinical investigation will not be commenced until approval from both applicable regulatory 
authority and ethical committee has been received.
Ethical conduct of the investigation
The clinical investigation will be performed in consistency with the current version of the Declaration 
of Helsinki (Washington 2002), ISO 14155-2011 and applicable regulatory requirements and any 
additional requirements imposed by the EC.
Regulatory authorities
The clinical study will be submitted to and approved, in writing, by the Swedish regulatory authorities 
(MPA) prior to commencing the study. Any substantial changes to the investigational plan will be 
submitted for review. In case of any serious adverse events (SAE) the regulatory authority will be 
informed.
Ethics review
The investigation plan, including the final version of the patient Information and Consent Form must 
be approved in writing by an Independent Ethics Committee (IEC) before enrolment of any subject
into the investigation. Substantial amendments to the Clinical Investigation Plan must be approved 
by the IEC if they influence the risk for the subject. Non-substantial amendments will be notified to 
the ethics committee.
Insurance
The subjects are covered by The Swedish Pharmaceutical Insurance and the Patient Injury Act. In 
addition the subjects are covered by insurance from the sponsor covering the use of the Fusion 
sound processor. This insurance covers use of the Fusion sound processor both during enrolment in 
this study but also use after study completion.
20.
Informed consent process
The clinical investigator will ensure that the subject is given full and adequate oral and written 
information about the nature, purpose, possible risks and benefits involved. In this study this will be 
given over the telephone but also in written sent home to the subject. Subject will be notified that 
they are free to discontinue participation in the investigation at any time. The subject will be given 
time for consideration and the opportunity to ask questions before signing the informed consent 
form. This can be done by the subject contacting the investigator prior to the study or time will also 
be set aside on the first visit as the first thing on the visit. The subject signed informed consent must 
be obtained before conducting any procedures specifically for the investigation. 
If any new information becomes available during the course of the trial that could influence the 
subjects’ willingness to participate, the subject will be informed and asked to sign a revised informed 
consent.
The subject will consent in writing that the results obtained in the investigation may be used in 
authority assessment or submissions for publications in scientific journals with the condition that 
privacy and confidentiality is preserved. Subject will also consent in writing that concerned 
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personnel, sponsor representatives and concerned authorities may have access to the subject’s 
medical record to perform source data verification.
The signed original of the consent form must be filed by the clinical investigator. A copy of the 
patient Information including the signed consent form should be given to the subject. 
21.
Adverse events, adverse device effects and device 
deficiencies
Any adverse events or serious adverse events, as described in Sec. 21.1 and Sec. 21.2, will be 
reported in this study as well as the parallel Osseofon study 
. Any 
ongoing (S)AE at the conclusion of this study will be resolved in the Osseofon study. Any new AE’s or 
SAE’s that occur after the conclusion of this study but within the frame of the Osseofon study will be 
reported in the Osseofon study. An agreement to share relevant safety reporting data has been 
reached between the sponsors of the two studies to ensure adequate safety follow-up of the device.
21.1.
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in subjects, users or other persons whether or not related 
to the investigational medical device. 
NOTE 1: This definition includes events related to the investigational device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
21.2.
Serious Adverse Event (SAE) 
Adverse event that: 
a) led to a death, injury or permanent impairment to a body structure or a body function. 
b) led to a serious deterioration in health of the subject, that either resulted in: 
- a life-threatening illness or injury, or 
- a permanent impairment of a body structure or a body function, or 
- in-patient hospitalization or prolongation of existing hospitalization, or 
- in medical or surgical intervention to prevent life threatening illness 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect. 
NOTE 1: Planned hospitalization for pre-existing condition, or a procedure required by the Clinical 
Investigation Plan, without a serious deterioration in health, is not considered a serious adverse 
event. 
21.3.
Device deficiency
Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, 
safety or performance. This may include malfunctions, use error, or inadequacy in the information 
supplied by the manufacturer. 
21.4.
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device. 
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NOTE 1- This includes any adverse event resulting from insufficiencies or inadequacies in the 
instructions for use, the deployment, the implantation, the installation, the operation, or any 
malfunction of the investigational medical device.
NOTE 2- This includes any event that is a result of a use error or intentional abnormal use of the 
investigational medical device. 
21.5.
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
21.6.
Unanticipated Serious Adverse Device Effect (USADE) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
NOTE: Anticipated SADE (ASADE): an effect which by its nature, incidence, severity or outcome 
has been previously identified in the risk analysis report 4. 
21.7.
Reportable Events
In accordance with the applicable regulatory guidelines and directives, the following events are 
considered reportable events;
- any SAE, 
- any Device Deficiency that might have led to a SAE if: 
a) suitable action had not been taken or
b) intervention had not been made or 
c) if circumstances had been less fortunate 
- new findings/updates in relation to already reported events. 
21.8.
Reporting Timelines
21.8.1.
Report by sponsor to the National Competent Authority
Oticon Medical must report to the NCA (the Swedish MPA):
- all reportable events as described in 21.7 which indicate an imminent risk of death, serious 
injury, or serious illness and that requires prompt remedial action for other patients/subjects, users 
or other persons or a new finding to it: immediately, but not later than 2 calendar days after 
awareness by sponsor of a new reportable event or of new information in relation with an already 
reported event. 
- any other reportable events as described in 21.7 or a new finding/update to it: immediately, 
but not later than 7 calendar days following the date of awareness by OM of the event.
21.8.2.
Report by the investigator to the sponsor 
Reportable events should be reported to Oticon Medical within 24 hours from when Investigator is 
first made aware of the event. Reporting to the ethical committee is done according to local 
regulation and is the responsibility of the Investigator.
22.
Publication Policy
Prior to enrollment this study will be registered on ClinicalTrials.gov
When the primary clinical investigation is completed, even if prematurely terminated, a final report 
will be compiled. 
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23.
Results and reports
When the clinical investigation is completed, even if prematurely terminated, a final report will be 
compiled. An interims analysis of the primary endpoint at 1 month will be compiled.
The results may also be used as basis for authority assessment. Privacy and confidentiality of 
information about each subject will be preserved in the report and any publication of the clinical 
investigation data. 
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24.
References
1.
Hagerman, B. “Sentences for testing speech intelligibility in noise,” Scand Audiol. (1982)
11:79 87 
2.
Reinfeldt, S. et al. “New developments in bone-conduction hearing implant: a review,”
Medical devices: Evidence and Research (2015) 
3.
Snik A. F. et al, “Consensus statements on the BAHA system: where do we stand at 
present?”, Annals of Otology Rhinology & Laryngology Suppl.. (2005) 195:1-12
4.
Oticon Medical document 35125-00 “Test Report for Clinical Study C58”
5.
L. Lassaletta, M. Calvino, M. Zernotti, and J. Gavilán, “Postoperative pain in patients 
undergoing a transcutaneous active bone conduction implant (Bonebridge),” Eur. Arch. Oto-
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Laryngol. - Head Neck Surg., Mar. 2016.
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F. Hassepass et al., “The bonebridge as a transcutaneous bone conduction hearing system: 
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Laryngol. - Head Neck Surg., Jun. 2014.
7.
G. Sprinzl et al., “First European Multicenter Results With a New Transcutaneous Bone 
Conduction Hearing Implant System: Short-Term Safety and Efficacy,” Otol. Neurotol., vol. 
Publish Ahead of Print, p. 10.1097/MAO.0b013e31828bb541, 2013.
8.
R. D. Laske, C. Röösli, F. Pfiffner, D. Veraguth, and A. M. Huber, “Functional Results and 
Subjective Benefit of a Transcutaneous Bone Conduction Device in Patients with Single-Sided 
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Neurotol., Jun. 2015.
9.
F. Ihler, L. Volbers, J. Blum, C. Matthias, and M. Canis, “Preliminary functional results and 
quality of life after implantation of a new bone conduction hearing device in patients with 
conductive and mixed hearing loss,” Otol Neurotol, vol. 35, no. 2, pp. 211–5, Feb. 2014.
10. T. Rahne et al., “Functional results after Bonebridge implantation in adults and children with 
conductive and mixed hearing loss,” Eur. Arch. Oto-Rhino-Laryngol. Off. J. Eur. Fed. Oto-
Rhino-Laryngol. Soc. EUFOS Affil. Ger. Soc. Oto-Rhino-Laryngol. - Head Neck Surg., Nov. 2014.
11. W.-D. Baumgartner et al., “A New Transcutaneous Bone Conduction Hearing Implant: Short-
Term Safety and Efficacy in Children,” Otol. Neurotol. Off. Publ. Am. Otol. Soc. Am. Neurotol. 
Soc. Eur. Acad. Otol. Neurotol., May 2016.
12. K. E. Eberhard, S. Ø. Olsen, H. Miyazaki, M. Bille, and P. Caye-Thomasen, “Objective and 
Subjective Outcome of a New Transcutaneous Bone Conduction Hearing Device: Half-year 
Follow-up of the First 12 Nordic Implantations,” Otol. Neurotol. Off. Publ. Am. Otol. Soc. Am. 
Neurotol. Soc. Eur. Acad. Otol. Neurotol., vol. 37, no. 3, pp. 267–275, Mar. 2016.
13. M. E. Zernotti, M. F. Di Gregorio, P. Galeazzi, and P. Tabernero, “Comparative outcomes of 
active and passive hearing devices by transcutaneous bone conduction,” Acta Otolaryngol. 
(Stockh.), pp. 1–3, Mar. 2016.
14. M. Manrique, I. Sanhueza, R. Manrique, and J. de Abajo, “A New Bone Conduction Implant: 
Surgical Technique and Results,” Otol. Neurotol., vol. 35, no. 2, p. 216–220 
10.1097/MAO.0000000000000253, 2014.
15. T. Gerdes, R. B. Salcher, B. Schwab, T. Lenarz, and H. Maier, “Comparison of Audiological 
Results Between a Transcutaneous and a Percutaneous Bone Conduction Instrument in 
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Acad. Otol. Neurotol., Apr. 2016.
16. Oticon Medical document 34815-00 Risk mangement file Fusion SP
17. B Håkansson, "Personal communication"
18. Gatehouse, S. & Noble, W. (2004). "The speech, spatial and qualities of hearing scale 
(SSQ)," International Journal of Audiology, 43, 85-99
19. Oticon Medical Doc 35203 "Hardware Platform Biological Evaluation Report for Fusion SP"
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20. Kruyt I J. "The IPS-scale: A new soft tissure assessment scale for percutaneous and 
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25.
Signed agreements
25.1.
Sponsor 
On behalf of Oticon Medical AB I agree to the terms of this investigation plan. 
Date and signature: 
Name and title
25.2.
Principal Investigator
I agree to the terms of this investigation plan. I will conduct the investigation according to the 
procedures specified herein and in consistency with the current version of the declaration of Helsinki 
and ICH Guideline for Good Clinical Practice (GCP). 
Date and signature: 
Name and title
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