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

COVER PAGE 
CLINICAL INVESTIGATION PLAN 
 
Oﬃcial Ɵtle of the study: EvaluaƟon of a sound processor for a transcutaneous system 
NCT number: NCT05628285 
Document Date: 04-Jul-2023 

Title
Clinical Investigation Plan BC114
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Clinical Investigation Plan
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CONFIDENTIAL
Clinical Investigation Title
Evaluation of a sound processor for a transcutaneous system
Investigation Code
BC114
Investigational Device (s)
Sentio 1 sound processor
Principal Investigators:
Ann-Charlotte Persson
Habilitation & Health, Hearing organization
Södra Gubberogatan 6
416 63 Göteborg
E-mail: ann-charlotte.l.persson@vgregion.se (emergency contact)
Phone: +46 70 960 92 16 (emergency contact)
Sponsor
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Date
05-10-2022
Revision history:
Revision no
Date
Description 
0
05-07-2022
First version
1
05-07-2022
No changes to the document made. Only made Revision 
1 for consistency in the EDMS.
2
16-08-2022

Implementation of comments from the Swedish 
Medical Products Agency: 
o
Section 18 revised in accordance with MDR 
o
Visit 1 assessments updated 
o
PI contact details added 
o
Information on financial agreements added

Secondary endpoint E clarified

Additional minor clarifications
3
05-10-2022

Implementation of comments from Swedish MPA 
(LV) and Swedish Ethical Review Authority (EPM)
(2022-09-16)
4
04-07-2023

Amendment 1: Study prolongation (1 year)
o
A fourth visit is added in sections 6.2, 9.1, 9.4
o
Information added regarding future CE-
marked investigational device (Sentio 1) in 
section 9.1.
o
Timelines extended in section 9.3.5

Additional minor clarifications
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STATEMENT OF COMPLIANCE
This clinical investigation will be performed in consistency with the current versions of the Declaration of Helsinki, ISO 
14155, Regulation (EU) 2017/745 (MDR) and applicable regional or national regulatory requirements as well as any 
additional requirements imposed by the Ethical Committee’s.
This Clinical Investigation Plan contains privileged or confidential information, which is the property of the Sponsor. 
Information may not be disclosed to a third party without written authorization from the Sponsor
This document is the property of Oticon Medical AB and may not be distributed.
Referenced Documents, Regulations, Standards and Ethical principles
[A] Doc-00065319
C58 End of Trial Clinical Investigation Report (CIR)
[B] ISO 13485:2016 
Medical devices – Quality management systems –
Requirements for regulatory purposes
[C] Doc-00118033
Investigator's brochure BC114
[D] Doc-00119039
Audiological Manual Sentio 1 SP for BC114
[E] Doc-00062186
Clinical evaluation Plan Sentio system
[F] Doc-00067091
State of the art – BAHS
[G] Doc-00062127 
O1 Clinical investigation report, primary endpoint
[H] Doc-00063566
BC101 Clinical Investigation Plan
[I] EU MDCG 2020-10/2 
Clinical Investigation Summary Safety Report Form 1.0
[J] ISO 14971:2019
Medical devices – Application of risk management to medical devices
[K] Doc-00119094
Risk Management File study BC114
[L] ISO 14155:2020
Clinical investigation of medical devices for human subjects – Good clinical 
practice
[M] Doc-00117557
Clinical Investigation Report BC109 Investigation of an updated bone-
anchored sound processor
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SYNOPSIS
Clinical Investigation Title
Evaluation of a sound processor for a transcutaneous system
Investigation Code
BC114
Investigational Device (s)
Sentio 1 sound processor
Principal Investigator(s):
Ann-Charlotte Persson, certified audiologist, MSc
Habilitation & Health, Hearing organization
Södra Gubberogatan 6
416 63 Göteborg
E-mail: ann-charlotte.l.persson@vgregion.se (emergency contact)
Phone: +46 70 960 92 16 (emergency contact)
Sponsor:
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Methodology:
Prospective, single-center, comparative investigation with within-
subject control design. 
Inclusion/exclusion criteria:
Inclusion criteria:
1.
Signed Informed Consent Form
2.
Adult subjects (18 years or older)
3.
Subjects implanted with an I1 implant
4.
Fluent in Swedish
Exclusion criteria:
1.
Subjects who do not have the ability or are un-willing 
to follow investigational procedures/requirements, 
e.g., to complete questionnaires, according to 
investigator’s discretion. 
2.
Subject deemed unsuitable for any medical or other reason as 
judged by PI or medical responsible
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Objective(s):
Primary Objective

To assess the improvement of hearing with the Sentio1, 
PTA4
Secondary Objective (s)

To assess the improvement of hearing with the Sentio 1, 
across frequencies

To assess self-reported performance with the Sentio 1 
compared to previous sound processor after at least one 
month field usage of the Sentio 1

To assess the preference of sound processor.

To assess the degree to which Sentio 1 compensates for the 
BC hearing loss

To assess the difference between BC in-situ thresholds 
measured with Sentio 1 and conventional unmasked BC 
audiometry.

Assess safety with the Sentio 1 SP
Tertiary Objective (s)

 
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Endpoints
Primary Endpoint

Functional gain with Sentio 1, i.e., the difference in dB 
between unaided and aided sound field thresholds, 
calculated on average for frequencies 500, 1000, 2000 and 
4000 Hz (PTA4), at 1 month follow-up visit.
Secondary Endpoint(s)

Functional gain with Sentio 1, i.e., the difference in dB 
between unaided and aided sound field thresholds, for all 
measured frequencies.

Average SSQ12 scores with Sentio 1, current device and 
difference between the two for each question, sub-scales 
and in total.

Percentage (%) of subjects who prefer the Sentio 1 over 
current sound processor

Effective gain defined as the difference in dB between 
aided sound field thresholds with Sentio 1 and unmasked 
BC thresholds on the aided ear(s). The effective gain is 
calculated for PTA4 and for all measured frequencies.

Difference in dB between Sentio 1 BC in situ thresholds and 
BC thresholds measured with conventional unmasked BC 
audiometry for the frequencies 500, 1000, 2000, 3000 and 
4000 Hz

Tabulation of AEs occurred throughout the investigation and 
percentage of individuals with reported AEs
Tertiary Objective (s)
 
 
Duration of investigation
period:
Expected investigation start: 15 November 2022
Expected investigation end: 15 February 2025
Number of screened subjects: 16
Estimated number of enrolled 
subjects:
12-14
Estimated number of subjects 
completing the investigation:
11
Investigation plan prepared 
by:
Marianne Philipsson, Sr. Clinical Trial Manger, Oticon Medical AB
Åsa Nilsson, Sr. Clinical Trial Manager, Oticon Medical AB
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TABLE OF CONTENTS
SYNOPSIS..................................................................................................................................3
TABLE OF CONTENTS...........................................................................................................6
LIST OF ABBREVIATIONS ...................................................................................................8
INTRODUCTION......................................................................................................................9
BACKGROUND.......................................................................................................................9
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE ...10
INVESTIGATIONAL DEVICE DESCRIPTION ............................................................................10
MANUFACTURER.................................................................................................................10
IDENTIFICATION OF THE INVESTIGATIONAL DEVICE ...........................................................10
TRACEABILITY....................................................................................................................11
INTENDED PURPOSE ............................................................................................................11
POPULATION AND INDICATIONS ..........................................................................................11
TRAINING AND EXPERIENCE................................................................................................11
INSTALLATION AND USE .....................................................................................................11
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION ..........12
SUMMARY OF COMPARABLE DEVICES (STATE-OF-THE-ART)................................................12
JUSTIFICATION OF THE INVESTIGATION DESIGN AND OUTCOME MEASURES.........................12
BENEFITS AND RISKS OF THE INVESTIGATIONAL DEVICE, CLINICAL 
PROCEDURE AND CLINICAL INVESTIGATION..................................................................14
ANTICIPATED CLINICAL BENEFITS.......................................................................................14
RESIDUAL RISKS AND ANTICIPATED ADVERSE DEVICE EFFECTS...........................................14
7.2.1
Residual risks Sentio 1 sound processor........................................................................14
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL INVESTIGATION (6.2.3 IN 
ISO14155)......................................................................................................................................15
POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS AS CONSIDERED 
UNDER RISK ANALYSIS ....................................................................................................................15
7.4.1
Medications/pharmaceuticals........................................................................................15
7.4.2
Medical treatments.........................................................................................................15
RISK CONTROL AND/OR MITIGATION ...................................................................................15
RATIONALE FOR BENEFIT-RISK RATIO .................................................................................15
OBJECTIVES AND HYPOTHESES.....................................................................................16
PRIMARY OBJECTIVE...........................................................................................................16
8.1.1
Primary hypothesis ........................................................................................................16
SECONDARY OBJECTIVE(S).................................................................................................16
TERTIARY OBJECTIVES........................................................................................................17
DESIGN OF THE CLINICAL INVESTIGATION..............................................................17
GENERAL ............................................................................................................................17
INVESTIGATIONAL DEVICE(S) AND COMPARATOR(S)...........................................................18
SUBJECTS............................................................................................................................18
9.3.1
Inclusion criteria............................................................................................................18
9.3.2
Exclusion criteria...........................................................................................................18
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9.3.3
Criteria and procedures for subject withdrawal or lost to follow up............................19
9.3.4
Subject Follow-up and Care ..........................................................................................19
9.3.5
Number of Subjects ........................................................................................................19
9.3.6
Information on vulnerable, pregnant and breastfeeding population, if applicable.......20
CLINICAL INVESTIGATION FLOW CHART..............................................................................20
9.4.1
Clinical Investigation visits............................................................................................21
CLINICAL INVESTIGATION PROCEDURES.............................................................................22
9.5.1
Fitting and adjustment of Sentio 1.................................................................................22
9.5.2
Clinical assessments ......................................................................................................22
9.5.3
Performance Assessments..............................................................................................23
9.5.4
Patient Related Outcomes (PRO) ..................................................................................23
MONITORING........................................................................................................................24
MONITORING PLAN.............................................................................................................24
STATISTICAL DESIGN AND ANALYSIS .........................................................................25
SAMPLE SIZE .......................................................................................................................25
TIMING FOR DATA ANALYSIS...............................................................................................25
MISSING DATA HANDLING...................................................................................................25
REPORTING DEVIATIONS FROM THE ORIGINAL STATISTICAL ANALYSIS PLAN ......................26
SUBGROUPS FOR ANALYSIS .................................................................................................26
DATA MANAGEMENT.........................................................................................................26
AMENDMENTS TO THE CIP ..............................................................................................28
DEVIATIONS FROM CLINICAL INVESTIGATION PLAN...........................................29
DEVICE ACCOUNTABILITY..............................................................................................29
STATEMENTS OF COMPLIANCE.....................................................................................29
INSURANCE .........................................................................................................................30
INFORMED CONSENT PROCESS......................................................................................30
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES
30
DEFINITIONS .......................................................................................................................30
18.1.1
Adverse Event (AE)....................................................................................................30
18.1.2
Adverse Device Effect (ADE).....................................................................................31
18.1.3
Serious Adverse Event (SAE).....................................................................................31
18.1.4
Serious Adverse Device Effect (SADE)......................................................................31
18.1.5
Device deficiency (DD)..............................................................................................31
18.1.6
Unanticipated Serious Adverse Device Effect (USADE)...........................................31
18.1.7
Serious public health threat.......................................................................................32
METHODS FOR DISCOVERING AND DOCUMENTING AE/ADE AND DD.................................32
18.2.1
Severity.......................................................................................................................32
18.2.2
Causality ....................................................................................................................33
REPORTING OF SAFETY EVENTS TO COMPETENT AUTHORITY BY SPONSOR.........................34
18.3.1
Reporting of SAE/SADE and Device Deficiencies with SADE potential...................34
18.3.2
Reporting of Serious public health threats ................................................................35
REPORTING OF SAFETY EVENTS TO SPONSOR BY INVESTIGATION SITE ................................35
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18.4.1
Reporting of AE/ADE and DD...................................................................................35
18.4.2
Reporting of SAE/SADE/USADE and DD with SADE potential ...............................35
REPORTING OF SAFETY EVENTS TO EC BY INVESTIGATION SITE..........................................35
NON-REPORTABLE EVENTS..................................................................................................35
SAFETY EVENT FOLLOW-UP.................................................................................................36
SAFETY RELATED CONTACTS ..............................................................................................36
DATA MONITORING COMMITTEE ........................................................................................36
VULNERABLE POPULATION (IF APPLICABLE)..........................................................36
SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION36
PUBLICATION POLICY.......................................................................................................37
CLINICAL INVESTIGATION AGREEMENTS ................................................................37
SIGNED AGREEMENTS.......................................................................................................38
SPONSOR.............................................................................................................................38
PRINCIPAL INVESTIGATOR...................................................................................................38
BIBLIOGRAPHY....................................................................................................................39
LIST OF ABBREVIATIONS
AE
Adverse Event
ADE
Adverse Device Effect
BAHS
Bone Anchored Hearing System
CIP
Clinical Investigation Plan
DD
Device Deficiency
EC
Ethical Committee
eCRF
Electronic Case Report Form
GCP
Good Clinical Practice
GDPR
General Data Protection Regulation
ISF
Investigator Site File
IRB
Institutional Review Board
ISO
International Organization for Standardization
LMV
Läkemedelsverket (Swedish Medical Products Agency)
MDCG
Medical Device Coordination Group
OM
Oticon Medical
OSN
Open Sound Navigator
PI
Principal Investigator
PRO
Patient Reported Outcomes
SAE
Severe Adverse Event
SADE
Serious Adverse Device Effect
SSQ
Speech, Spatial and Qualities of hearing
USADE
Unanticipated Serious Adverse Device Effect
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Traceability
During and after the investigation the investigational device, Sentio 1, will be traceable by a unique 
identification code/serial number. The serial numbers will be recorded in the electronic Case Report Forms 
(eCRF), and in the 'Investigational device accountability log' (for further details, see section 15).
Intended Purpose
The Sentio 1 is, together with an active transcutaneous implant, intended for improvement of hearing for 
patients
 
Population and indications
 
 
 
 
 
 
 
 
 
 
Training and Experience
Prior to the initiation of the investigation, the hearing care professionals will be trained in all procedures 
related to handling and fitting the Sentio 1. Training and training content will take the assessment from the 
risk management process into account.
 
 
Installation and Use
Fitting of the Sentio 1 in will be conducted as per standard clinical routine for BAHS as described in the 
Audiological Manual from Oticon Medical [D]. The Sentio 1 will be fitted (adapted) to the subject’s need by 
hearing care professionals.
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JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION
A clinical evaluation including an assessment and analysis of clinical data concerning safety and performance 
of the Sentio system is summarized in the IB [C]. Finalized pre-clinical and clinical studies on earlier design 
iterations of the Sentio system demonstrates that the systems perform as anticipated. A pivotal, pre-market 
clinical investigation on the final design of the Sentio system is currently [H] ongoing to collect sufficient 
evidence of the safety and performance of the system. 
The current investigation will focus on the performance with Sentio 1 on patients previously implanted with 
the I1 as a part of a planned upgrade of these patients to the latest Sentio sound processor. 
Summary of comparable devices (state-of-the-art)
A systematic literature review of alternative treatment options for patients with the indication of Sentio 
system has been performed and is summarized in the IB [C]
 
 
 
 
 
 
 
The literature review showed that although the performance measures used varies between studies, the data 
on the active transcutaneous devices consistently showed performance improvement over the unaided 
condition on all outcome measures. The most commonly used performance measure are sound field 
thresholds (typically presented as the difference between unaided and aided thresholds hereafter denoted 
as functional gain), speech intelligibility test in quiet and noise and self-reported outcome questionnaires. 
 
 
 
 
 
Justification of the investigation design and outcome measures
In order to answer the proposed hypothesis, that there will be a significant improvement in aided thresholds 
with the Sentio 1 compared to unaided, a prospective, within subject controlled clinical investigation will be 
performed.
The single-arm design and the primary endpoint evaluation of performance reflects a typical clinical 
investigation design in the field. 
Thus, this investigation will be a pre-market, confirmatory investigation with the purpose to confirm the 
performance of the Sentio 1 sound processor on users previously implanted with the I1 implant. The 
investigation includes four visits and three field trial periods. On the first visit the subjects will be fitted with 
the Sentio 1 according to the audiological manual [D]. The first field trial period will allow the subjects to get 
adapted to the sound in the Sentio 1. After one month (visit window +4 weeks) a follow up visit is conducted 
to evaluate the Sentio 1 sound processor. The investigation design in regards of fitting of and adaptation time
to the Sentio 1 corresponds to standard clinical practice. A field period is conducted after the second and 
third visit with the purpose to monitor the safety of the Sentio 1 to assure long term safety data. The follow 
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up visit after one and two years will be conducted as a physical or remote meeting depending on subjects’
preference.
6.2.1
Outcome measures
To ensure a holistic understanding of the Sentio 1, the current investigation combines audiological 
assessments in the laboratory and subjective self-reported outcomes collected during and after field trial 
periods. 
In the sections below, the justification and rational for using each outcome measure is outlined.
6.2.1.1
Ability to hear sounds – Functional gain and sound field-hearing thresholds
Outcome with sound field hearing threshold results can be presented as the absolute measured aided 
threshold level [dB HL], as the difference between unaided and aided thresholds [dB] (“functional gain”) or 
in relation to the cochlear loss, defined by BC thresholds (”BC/effective gain”). Functional gain is the most 
common way of expressing benefit (improvement of hearing) in the state-of-the art literature [F]. Overall 
sound field thresholds are a reliable and language independent outcome typically included as part of clinical 
practice for bone conduction devices and is therefore included in this investigation. 
6.2.1.2
Patient reported outcomes
Patient reported outcomes are commonly used in the state-of-the art literature [F]. In this investigation
patient reported outcomes (PRO) will be used to evaluate subjective performance of the Sentio 1 compared 
to current sound processor. In addition, patient reported outcome will be used to evaluate the preference 
between Sentio 1 and current sound processor for further confirmatory assessment of the performance of 
the Sentio 1. 
6.2.1.2.1 SSQ12
The Speech, Spatial and Qualities of Hearing scale (SSQ; Gatehouse and Noble [3]), and its abbreviated scale 
SSQ12 [4], are validated questionnaires useful for evaluating self-reported performance with a hearing device
and have therefore been deemed suitable to use in this investigation. 
6.2.1.2.2 Preference
To systematically assess the preference of the Sentio 1 compared to subject’s current sound processor a 
preference scheme previously used for BAHS [M] will be used in this investigation.
6.2.1.3
 
 
 
 
 
 
 
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BENEFITS AND RISKS OF THE INVESTIGATIONAL DEVICE, CLINICAL PROCEDURE AND CLINICAL 
INVESTIGATION
The risk assessment and analysis has been conducted according to internal procedures established in 
accordance with ISO 14971:2019 [J]. In addition, risk assessment and analysis for conduct of investigation
has been conducted according to internal procedures [K] established in accordance with ISO 14155:2020 [L].
Anticipated clinical benefits
Together with an active transcutaneous implant, the Sentio 1 is expected to improve hearing 
 
 
 
 
 
 
 
 
Residual risks and anticipated adverse device effects
The risk assessment and analysis has been conducted according to internal procedures established in 
accordance with ISO 14971:2019 [J]and qualitative and quantitative aspects of clinical safety of risks have 
been examined and documented as part of the process. All identified hazardous situations in combination 
with harm have been evaluated for the probability of occurrence and the severity of harm. Based on this 
evaluation the risks have been categorized and control measures have been implemented to control and 
reduce the risks as far as possible. The identified risks have been mitigated as far as possible and all residual 
risks are acceptable according to the Sponsor’s risk acceptability criteria. 
The residual risks summarized below, including the characterization of their nature (hazards), incidence 
(occurrence), severity and outcome (harms), are disclosed in the IB [C] together with references to the 
complete risk management files. 
7.2.1
Residual risks Sentio 1 sound processor
 
 
 
 
 
 
 
 
 
 
 
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Risks associated with participation in the clinical investigation (6.2.3 in ISO14155)
The proposed clinical investigation has been designed to minimize the risks as far as possible. During the 
development of the CIP, systematic clinical investigation risk assessments according to internal procedures 
and ISO14155 have been performed. The inclusion of subjects has been limited to adults already implanted 
with an I1 implant. Exclusion criterion no. 2 has been set to exclude potential subjects with any medical or 
other condition, as judged by the PI or other medically responsible person, which could increase the risk 
associated with investigation participation to unacceptable levels. No procedures, measurements or 
assessments in the investigation add additional risks to the subjects. Since the investigation only aims at 
fitting a new sound processor on already implanted subjects the risk of participating in the investigation is 
considered low and comparable to any sound processor change or upgrade within clinical practice.
There is a minimal risk to the subject by means of violation of the General Data Protection Regulation (GDPR)
by study personnel. Violations may include the accidental disclosure of personal identifiable information to 
unauthorized personnel or improper use of personal identifiable identification by authorized personnel. 
Possible interactions with concomitant medical treatments as considered under risk analysis 
7.4.1
Medications/pharmaceuticals
If medication is considered necessary for the subjects’ safety and well-being during the clinical investigation, 
the investigator can refer to a physician according to normal clinical practice.
7.4.2
Medical treatments

The sound processor contains a magnet and caution should be taken with subjects that have active 
implants (e.g., implantable defibrillators, CSF shunts, pacemakers).

If the subject needs to undergo MRI, the sound processor must be removed. 
Risk control and/or mitigation
The identified risks related to the use of the device have been mitigated as far as possible through verified 
design considerations, process validation and information and warnings disclosed in the instructions for use. 
In addition, the Sponsor will provide sufficient training on the specifics of the device prior investigation
enrollment to minimize the risks associated with the devices. 
The risk of violation of the GDPR is mitigated through the selection of a qualified site and investigator reduce 
the risk of unqualified study personnel. Additionally, at the site initiation visit, study personnel will undergo 
GDPR training by the Sponsor representative. This training will emphasize the violation of GDPR as a protocol 
deviation, which requires reporting to the Sponsor.
Rationale for benefit-risk ratio
Potential hazards associated with the use of the Sentio 1 have been through a comprehensive risk 
management process in accordance with ISO 14971:2019[J]. The identified risks have been mitigated as far 
as possible and no unacceptable residual risks have been identified according to the Sponsor’s acceptability 
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3.
Difference in SSQ12 scores between Sentio 1 and 
current sound processor for each question, sub-
scales and in total.
D.
To assess the preference of sound 
processor.
1.
Percentage (%) of subjects who prefer the Sentio 
1 over current sound processor 
9.5.4.2
E.
To assess the degree to which Sentio 
1 compensates for the BC hearing 
loss
1.
Effective gain defined as the difference in dB 
between aided sound field thresholds with 
Sentio 1 and unmasked BC thresholds on the 
aided ear(s). The effective gain is calculated for 
all measured frequencies.
2.
Effective gain with Sentio 1, see definition above, 
calculated in average for frequencies 500, 1000, 
2000 and 4000 Hz (PTA4).
9.5.3.2.2
F.
To assess the difference between BC 
in-situ thresholds measured with 
Sentio 1 and conventional 
unmasked BC audiometry.
1.
Difference in dB between Sentio 1 BC in situ 
thresholds and BC thresholds measured with 
conventional unmasked BC audiometry for the 
frequencies 500, 1000, 2000, 3000 and 4000 Hz
9.5.3.1
9.5.1
G.
Assess safety with the Sentio 1 
sound processor
1.
Tabulation of AEs occurred throughout the 
investigation and percentage of individuals with 
reported AEs.
18
Tertiary objectives
Tertiary objective
Corresponding tertiary endpoint/outcome 
variable(s)
Section
 
 

I.
 
 
9.5.3.3
DESIGN OF THE CLINICAL INVESTIGATION
General 
The investigation is prospective, single-center, comparative investigation with within-subject control 
design. It is estimated that 12-14 subjects previously implanted with the I1 implant will be fitted with 
Oticon Medical Sentio 1 sound processor.
The investigation includes two laboratory visits at the research unit at Chalmers tekniska högskola
(Hörsalsvägen 9, vån 7, 41258 Göteborg), with a field trial period between. Both visits will take between 2-3 
hours including breaks. At the first visit the subject’s current device is evaluated and Sentio 1 is fitted 
according to the audiological manual [D]. Audiological measurements will be conducted. If needed,
finetuning will be applied according to the subject’s preference. Retention will be assessed and the magnet 
in the sound processor will be adjusted according to the investigator judgement and subject needs and 
preference. The subjects will wear the Sentio 1 in their daily life for 1 month (visit window +1 month). During 
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the field trial the subjects will fill out one questionnaire. At the second visit, any AE that occurred in the field 
trial will be evaluated. Audiological measurements will be conducted. If needed, finetuning will be applied 
according to the subject’s preference. Retention will be assessed and the magnet in the sound processor will 
be adjusted according to the investigator judgement and subject needs and preference. A preference 
questionnaire will be filled out during the visit. A third and fourth visit are scheduled after one and two years 
respectively of using the device, with the main purpose to monitor safety using the device. Visit 3 can be 
conducted at Chalmers or at the Hearing clinic in Gothenburg or as a telephone visit. Visit 4 will take place at 
the Hearing clinic in Gothenburg. 
 
 
 
 
Due to the nature of the end points (comparisons between aided and unaided, and Sentio 1 and current 
sound processor) there is no possibility to blind the investigation as the conditions are obvious for the subject.
Enrollment of subjects is expected to occur in the second half of 2022, after approvals from the Ethical 
Committee (EC) and Regulatory Authority (Läkemedelsverket, LMV). The investigation will be considered 
completed when the last subject has completed the last visit.
Investigational device(s) and comparator(s) 
The investigational device is the Sentio 1, which has been described in section 5. For secondary objectives 
A1-3 and B1 the subject’s own device will be the comparator device. 
 
 
Each subject will receive one investigational device. Additional spare devices will be available with the 
investigator in case of subjects losing or breaking a device. 
 
 
Subjects
Subject previously implanted with the I1 implant will be asked to take part in the study. Recruitment of the
patients will be the responsibility of the Principal Investigator (PI). 
 
 
9.3.1
Inclusion criteria
Patients meeting following criteria may be included in the investigation:
1.
Signed Informed Consent Form
2.
Adult subjects (18 years or older)
3.
Subjects implanted with an I1 implant
4.
Fluent in Swedish
9.3.2
Exclusion criteria
Subjects meeting any of following criteria will not be permitted to participate in the investigation:
1.
Subjects who do not have the ability or are un-willing to follow investigational 
procedures/requirements, e.g., to complete questionnaires, according to investigator’s
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discretion. 
2.
Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible
9.3.2.1
Relationship of investigation population to target population.
The target population for the Sentio 1 is patients with either a mixed/conductive hearing loss (MHL/CHL) or 
SSD. In the investigation on the S1 and I1 implant [G] only patients with mixed/conductive losses were 
included, thus only patients with MHL/CHL will be included in this investigation. No children will be included 
in this investigation. 
9.3.3
Criteria and procedures for subject withdrawal or lost to follow up
Subjects are free to discontinue participation in the investigation at any time and are not required to give a 
reason for their decision. This will not affect the future treatment / medical care of the subject.  However, 
subjects who discontinue the investigation should be asked about the reasons(s) for their discontinuation, 
and about the presence of any adverse event (AE) / adverse device effect (ADE) and if possible, be assessed 
by an investigator. If such withdrawal is due to problems related to the investigational device safety or 
performance, the investigator shall ask for the subject's permission to follow his/her status/condition outside 
the clinical investigation.
Subjects may be withdrawn from further participation in the investigation if the investigator judges that this 
is in the subject's best interest, or for safety reasons. 
Other reasons for premature discontinuation may be severe non-compliance to the CIP as judged by the 
investigator and/or the Sponsor, or incorrect enrolment, i.e., a subject did not meet the required 
inclusion/exclusion criteria for the investigation.
Should a subject fail to show up on agreed visits the site personnel should use all reasonable efforts to get in 
contact with the subject to prevent anyone from being 'lost-to follow-up'. The contact attempts should be 
properly documented in the subject’s medical record.
The investigator will be thoroughly informed at the site initiation training that missing data should be avoided 
to the farthest extent reasonably possible as it could have deleterious effects on trial integrity and credibility. 
Due to the prerequisites for participating in the investigations, subjects withdrawing, discontinuing or being 
lost to follow-up from the investigation will not be replaced. Collected data will be considered as far as 
possible in analyses.
9.3.4
Subject Follow-up and Care
After the investigation, the subjects will be receiving follow-up and care according to clinical standard 
procedures for patients with bone anchored implants and may be asked to participate in follow-up 
investigations. 
 
 
 
 
9.3.5
Number of Subjects
It is planned to screen 16 subjects to reach enrollment of 12-14 subjects in this investigation. The sample 
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9.4.1
Clinical Investigation visits
9.4.1.1
Visit 1 (screening/baseline visit)
Following procedures will be carried out during the first visit. The flow below is a suggested flow, based on 
convenience for subject and investigator the order may be changed. Information, informed consent and 
screening will always be carried out before any investigation related procedures are conducted. 

The subject is thoroughly informed about the investigation including all investigation related visits. 
Time will be given for consideration and answering any questions the subject might have. 

Consent form is signed.

Screening according to inclusion and exclusion criteria.

The subject’s demographical data as well as their personal data and subjects’ characteristics are 
registered.

Audiometry is performed

Fitting and adjustment of the Sentio 1 is performed 
o
Including BC in-situ and feedback management measurement. 
o
Strength of retention magnet is considered and potentially changed according to the 
subject’s needs and preference. 
o
Finetuning is considered and Sentio 1 is adjusted according to the subject’s needs and 
preference.

 

Questionnaire for evaluation the subject’s current hearing solution is filled out. 

Questionnaires for evaluation of the Sentio 1 is handed out and instructions to fill them out prior to 
next visit is given. 

AEs are assessed.
9.4.1.2
Visit 2 follow up (1 month)
Following procedures will be carried out at visit 2. The flow below is a suggested flow, based on convenience 
for subject and investigator the order may be changed.

AEs are assessed.

Questionnaires is handed in and checked for completeness. 

Aided and unaided sound field thresholds are performed.

Preference questionnaire is filled out.

Adjustment of the Sentio 1 is considered.
o
Strength of retention magnet is considered and potentially changed according to the 
subject’s needs and preference. 
o
Finetuning is considered and Sentio 1 is adjusted according to the subject’s needs and 
preference.
9.4.1.3
Visit 3 follow up (1 year)
Following procedures will be carried out at visit 3. The flow below is a suggested flow, based on convenience 
for subject and investigator the order may be changed. Based on subject needs and preference the visit might 
be a remote visit. 

AEs are assessed.

Adjustment of the Sentio 1 is considered
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o
Strength of retention magnet is considered and potentially changed according to the
subject’s needs and preference. 
o
Finetuning is considered and Sentio 1 is adjusted according to the subject’s needs and 
preference.
9.4.1.4
Visit 4 follow up (2 years)
Following procedures will be carried out at visit 4. The flow below is a suggested flow, based on convenience 
for subject and investigator the order may be changed. 

AEs are assessed.

Change and adjustment of the Sentio 1 as applicable
o
Strength of retention magnet is considered and potentially changed according to the 
subject’s needs and preference. 
o
Finetuning is considered and Sentio 1 is adjusted according to the subject’s needs and 
preference.

Study termination
9.4.1.5
Unscheduled visit(s)
If need for extra adjustment of the Sentio 1 or if other aspects arise that requires the attention of the 
investigator the subject’s will be booked for an extra appointment. 
Clinical Investigation Procedures
9.5.1
Fitting and adjustment of Sentio 1
The fitting of the Sentio will follow clinical practice for bone anchored devices and will be made following the 
fitting procedure described in the Audiological manual [D]. 
 
The fitting procedure includes measurement of 
feedback limit and BC In-situ threshold for the frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 
and 8000 Hz. If needed, the sound in Sentio 1 can be finetuned according to the patient’s needs and 
preference. Also, the retention and comfort in relation to the magnet connection between the Sentio 1 and 
implant will be assessed, and if needed the magnet in the sound processor will be exchanged to a weaker or 
stronger magnet. At follow up visits further adjustment regarding finetuning and magnet retention is 
assessed. 
9.5.2
Clinical assessments
9.5.2.1
Demographic Data and Baseline Measurements
Following subject characteristics will be collected upon enrollment:

Gender

Age

Indication (MHL/CHL/SSD)

Implanted side (L/R)

Type of hearing loss on the non-implanted side (MHL/CHL, SSD, normal hearing, sensorineural 
hearing loss)

Hearing solution on the non-implanted side (BAHS, conventional hearing aid, no hearing solution, 
other)

Usage hours with current device
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will be used in this investigation. The SSQ12 was developed and validated by Noble, Jensen [4] and contains 
12 questions that reflect the perceived performance in speech intelligibility, spatial abilities, and sound 
quality. Each item is scored from 0 to 10, with larger values always indicating greater ability. The SSQ12 will 
be assessed at visit 1 (own device) and at visit 2 (Sentio 1).
9.5.4.2
Preference questionnaire
The preference scheme is developed by Oticon Medical and has often been used when comparing two 
devices. 
 
 
 
The preference scheme will be filled out by the subjects at the final visit (Visit 2).
MONITORING
During the investigation, representatives from Oticon Medical will have regular contacts with the 
investigational site with the purpose to oversee the investigation. Monitoring activities, including on-site 
visits, will be performed by appointed monitors according to applicable standards (i.e., ISO 14155) and 
internal guidance documents. The overall purposes of the monitoring are to ensure that:

The rights, safety and well-being of human subjects are protected.

Reported data are accurate, complete, and verifiable from source documents.

The conduct of the clinical investigation complies with the approved CIP, subsequent amendments 
(if any), applicable standards (i.e., ISO 14155), and applicable regulatory and ethics committee 
requirements.
The monitor or other Sponsor personnel will be available between visits if the PI or other site personnel needs 
information and/or advise.
Authorized representatives of the Sponsor and/or Regulatory Authority may visit the site to perform 
audits/inspections, including source data verification.
The PI should guarantee access to source documents for the monitor and auditors as well as for inspection 
by appropriate Regulatory Authority and Ethics Committee, if required. 
Source documents are further described in section 12. Data Management.
Monitoring Plan
The extent and nature of the monitoring activities (e.g., review of data entered in the eCRF, source data 
verification, review of investigator’s site file etc.) will be described in an investigation specific Monitoring 
Plan. The monitoring strategy will be based on a risk-based approach according to ISO 14155:2020.
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STATISTICAL DESIGN AND ANALYSIS
The statistical analysis of all efficacy variables will be performed according to the study Statistical Analysis 
Plan. The general methodology for the analysis of primary, secondary, and tertiary endpoints is described 
below. Wilcoxon signed-rank test will be used to test hypotheses. The decision of the hypothesis test is done 
at the 5% significance level. Pearson’s correlations (or Spearman’s if the data is not normally distributed) will 
be used to test correlations.
The distribution of continuous variables will be given as Mean, 95% confidence interval (CI) of the mean, 
standard deviation (SD), Minimum and Maximum (Mean (SD), (Min; Max)). The distribution of categorical 
and dichotomous variables will be given as number and percentage (n = (%)). 
All subjects that consented to the investigation will be included in the safety population; all subjects enrolled
and treated in the investigation will be included in the Intent-to-Treat (ITT) population. All subjects included 
in the investigation with no major protocol deviations will be included in the Per-Protocol (PP) population. 
The final decisions regarding the PP population will be taken after investigation completion, at the Clean File 
meeting before the database lock. All efficacy analyses will be performed on the PP population as main 
analysis. Complementary analysis for all efficacy variables will also be performed on the ITT population.
Details will be described in the Statistical Analysis Plan.
Sample size
The complete population implanted with I1 (N = 16) will be screened for participation in the investigation 
and the estimated sample size will be 12-14 patients enrolled, about 15% drop-out, and approximately 11 
patients completing the study. Data from 11 patients will enable detection of a statistically significant 
difference between aided and non-aided functional gain of 9 dB or higher (based on normal approximation), 
with 90% power, 5% two-sided level of significance, and an estimated variability (SD) for the difference of 8 
dB. This is considered well within the clinically relevant detection levels for functional gain as described by 
the systematic literature review on comparable devices [F]. The proposed sample size is also considered to 
ensure clinically relevant data for conclusions on the secondary end-point SSQ12, where the previous study 
on the I1 and S2 [A] has used a sample size of 10 patients, and 11 patients would enable detection of 
statistically significant differences in mean scores of 1 or higher (based on normal approximation), with 90% 
power, 5% two-sided level of significance, and an estimated variability (SD) for the difference of 0.9.
Timing for data analysis
One interim data analysis will be performed when all subjects have completed the second visit. The interim 
data analysis will include all investigation end-points at that time point. A final analysis will be made after all 
subjects have finalized the last visit and conclude on the safety assessment. 
Data cleaning and database lock of the applicable data will be performed both before the interim analysis 
and prior to the final data analysis. Data cleaning activities and database lock procedures will be defined in a 
data management plan prior to investigation start. 
Missing data handling
Missing data (e.g., single questions, experimental repetitions) will be treated as Not A Number (NANs) and 
will be disregarded from the analysis. A detailed description of missing data will be given in the Statistical 
Analysis Plan. Missing data will be handled in the same way for PP and ITT population.
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Reporting deviations from the original statistical analysis plan
Any deviations discovered throughout the investigation from the original SAP, will be described with 
justification in a CIP amendment to the final report, as deemed appropriate.
Subgroups for analysis
No analysis on subgroups will be performed in the investigation.
DATA MANAGEMENT
Data management will be conducted according to the investigation specific Data Management Plan (DMP). 
Any deviations, i.e., discrepancies and additions from the process defined in the DMP will be described in an 
investigation specific database lock meeting minutes.
All personal data collected and processed concerning the subjects participating in the investigation are 
protected under the Regulation (EU) 2016/679 (GDPR) and will be handled accordingly. Further, professional 
secrecy regarding subject information and data applies to all involved personnel, including Sponsor
representatives.
Names and/or other explicit personal identification information will not be collected or recorded for 
investigational purposes, with one crucial exception: it is the responsibility of the investigator to keep a 
‘Subject Identification Log’ up to date, where personal identification information matches the Subject 
Identification Number (see below). The ’Subject Identification Log’ must be kept up to date and stored in the 
Investigator Site File (ISF) in a secure location with restricted access. This log will not, at any time during and 
after the investigation, be available to any unauthorised party, nor available in the Sponsor files.  
All subjects enrolled in the investigation will be provided with a Subject Identification Number (i.e.,
pseudonymization), consisting of a digit code, where the leading digit represents the investigation site 
number, for this single-site investigation all subject ID number will start with 100 and the two following 
numbers represents the consecutive subject number (e.g. 101 for the first enrolled subject 102 for the second 
enrolled subject.
Source documents
Source documents shall be created and maintained by the investigation site team as per clinical routine 
throughout the investigation. Source documents are the original records, including but not limited to 
worksheets (e.g., printouts of eCRF forms), physician or nursing notes, subject questionnaires etc. During 
each visit where printouts or copies of the source documentation are used for the investigation, these shall 
be signed and dated (i.e., certified) by a member of the investigation site team.
For investigation-specific variables, a possibility to use a combined worksheet/checklist will be made 
available to the investigation site. These worksheets will then, if used, constitute the source for the data 
noted in the worksheets. The site will store the worksheets in the ISF. The Sponsor may request a copy for 
remote monitoring. For variables entered directly into the eCRF, the eCRF is considered the source. To ensure 
consistency in the recording of source data, the use of worksheets versus entering data directly into the eCRF 
will be defined based on the preferred workflow of the site (if not directly entered into the medical record).
A source data agreement list will be created at each investigation site to define which are the source 
documents for the data gathered in the study and the location of them. This document will be completed at 
the first interim monitoring visit at the latest.
The Principal Investigator will provide direct access to source data during and after the clinical investigation 
for monitoring, audits, and regulatory authority review and inspections, if applicable. Permission for this 
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direct access to source documents needs to be obtained by the investigator from the subjects, hospital 
administration and local regulatory authorities as applicable, before starting the clinical investigation.
Case Report Form recording and processing
Data captured will be recorded, by the investigator and/or delegated site staff, in eCRFs by means of an EDC-
system (SMART-TRIAL), provided/hosted by an external party (MEDEI ApS, Copenhagen, Denmark). The 
system has built-in features that enables users to be GCP and GDPR compliant. All data in relation to SMART-
TRIAL is stored on secured Microsoft Azure hardware located in the EU, i.e., Dublin, Ireland. All users of the 
EDC system have personal accounts, accessed by two-factor authentication, allowing tracking of all data 
entries and changes in the system (i.e., audit trail).
The set-up, build and maintenance of the eCRF, incl. corresponding content (forms, events, data checks etc.), 
and testing/validation of the system, is performed by trained Sponsor representatives.
All data, subject- and product-related, must be accurately recorded in a timely manner (i.e., within 5 working 
days) into the EDC system by the delegated site staff.
NB. For Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE) stricter timelines applies, see 
Section 18.4 for further reference.
The person entering the data into the database is not allowed to make any personal interpretation or to 
make any decisions on the data than self-evident corrections as listed in the data entry instructions or data 
handling report. All entered data must be consistent with the source documents, and if any discrepancies are 
found they must be corrected or explained in writing where applicable. The Principal Investigator is 
responsible for the data entered in the EDC-system and for signing the eCRF at the end of the clinical 
investigation.
The patient reported outcome (PRO) instrument used in this investigation will be completed on paper forms 
by the subjects themselves. The forms (i.e., source documents), marked with the Subject ID, will then be 
transferred by manual data entry to the corresponding form in the EDC-system by an authorized member of 
the investigation site team.
For screening failures following data will be recorded: reason for failure with reference to IE criteria and 
patient characteristics. 
Data Management
To ensure data validity and accuracy, manual data cleaning and query handling will be performed remotely 
on a regular basis within the EDC-system. In addition, computerized edit checks will be utilised for identifying 
data values that are outside the allowed range, incomplete or inconsistent, and CIP deviations. The Data 
Validation Plan (DVP) specifies the checks that are to be performed on subject data for the clinical 
investigation. 
Once all data has been captured and entered into the eCRF by the investigation site team, verified and 
validated by the appointed Sponsor representatives, and all reconciliation with the reported events and 
events reported to Oticon Medical Research and Development department, the clinical investigation 
database will be locked and the data will be analysed.
Storage of data
The investigator should retain clinical investigation records for at least 15 years after completion (or 
premature termination) of the investigation, or, in the event that the device is subsequently placed on the 
market, at least 15 years after the last corresponding device has been placed on the market. However, it is 
the responsibility of the investigator to make sure that the investigation record of clinical investigation 
subjects is retained in accordance with local legislation and in accordance with the maximum period of time 
allowed by the hospital. The investigator will continue having ‘view access’ to the study database even after 
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study closure.
The Principal Investigator must take measures to prevent accidental or premature destruction of these 
documents and at the end of the storage period, acquire a confirmation from the Sponsor before proceeding 
with the destruction of the documentation.
If the principal investigator leaves the investigation site, he/she will provide the Sponsor with the name and 
address of the person who will resume responsibility for the ISF. If the ISF will be transferred to another party 
(e.g., external archive, service provider etc.) this shall be discussed, agreed and documented in beforehand 
between the investigation site and the Sponsor.
The complete study database, which is a part of the TMF, will be securely stored at Oticon Medical, with 
restricted access. The TMF will be retained for 15 years after completion (or premature termination) of the 
investigation, or in the event that the device is subsequently placed on the market, at least 15 years after the 
last corresponding device has been placed on the market.
Missing data
Handling of missing data will be described in the SAP. In order to minimize missing data, the importance of 
complete follow up data sets will be emphasized to investigators and investigation site staff, as will the 
importance of recruiting subjects who are motivated to undergo treatment and participate in the 
investigation. The investigation site is leading in the field of bone conduction devices, thus familiar with the 
outcomes of the treatment, and what level of treatment compliance that can be expected from patients 
considering undergoing treatment with a device. The sites will also have experience in conducting clinical 
investigations and recruiting investigation subjects. The patient information will give the subjects a clear 
understanding of the design of the investigation and the visit schedule. The latter has been carefully 
considered to mimic the standard practice of treatment with a bone conduction device, but also to be feasible 
in relation to the burden on the investigation subjects as a mitigation measure to avoid drop-outs and/or 
missing appointments. In addition, subjects will be given the opportunity to complete out PROs at the 
applicable site visits if they have forgotten to bring them or to complete them on beforehand. 
Monitoring through the electronic data capturing system will be performed all through the investigation 
period. Early and close monitoring of the eCRFs will enable the Sponsor to take action and get back to site if 
missing data and/or deviations are found. The Sponsors representatives will be in close contact to site to give 
support and training for general quality assurance of the data captured in the investigation
Audits and inspections
Audits of the clinical investigation may be conducted by the Sponsor or third parties designated by the 
Sponsor to evaluate compliance with the CIP, written procedures, this International Standard and the 
applicable regulatory requirements. These audits may cover all involved parties, systems and facilities and 
are independent of, and separate from, routine monitoring or quality control functions.
AMENDMENTS TO THE CIP
If changes to the CIP are needed, proposed amendments to the CIP shall be agreed upon between the 
Sponsor and Principal Investigator, and/or the coordinating investigator. Substantial amendments should be 
approved by the EC and Competent Authority (CA), as applicable, before incorporated. 
In addition, substantial amendments to the Subject Information and Consent Form and/or other applicable 
documents previously approved by the EC/CA must be approved by the EC/CA before they will come into 
effect. For non-substantial amendments, local regulations regarding notifications to EC/CA should be 
followed.
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DEVIATIONS FROM CLINICAL INVESTIGATION PLAN
A CIP deviation is an intentional or unintentional failure to follow the requirements of the CIP. Every effort 
should be made to comply with the requirements of the CIP and the Investigator, and other representatives 
of the investigational site team, is not allowed to deviate from the CIP, unless needed to protect the rights, 
safety and well-being of the subjects (i.e., emergencies). Under these circumstances, deviations from the CIP 
may proceed without prior approval by the Sponsor and favourable opinion from EC. Such cases should be 
documented and reported to the EC, as per local requirements, and to the Sponsor as soon as possible, but 
in no event later than 5 working days after the emergency occurred.
If other deviations occur, the Investigator should inform the monitor/clinical trial manager and make a record 
in the CIP Deviation Log provided in the EDC system.  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 systematic 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 investigation. If serious or repeated deviations occur, the Sponsor has the right to 
initiate early termination of the investigation.
At the end of the investigation, or in connection to a predefined interim analysis, protocol deviations will be 
re-categorized as minor or major and their consequence on analysis populations will be determined.
DEVICE ACCOUNTABILITY
The devices will be shipped or delivered by a Sponsor representative, as applicable, and kept in a locked area
at the site. The Sponsor will keep records of the shipped / delivered investigational devices. A device 
accountability log will be held on site including date of reception, unique serial number, expiry date, subject 
identification, date of fitting and date of return of unused products (if applicable).  The serial number will be 
noted in the eCRF at the fitting visit. If any devices are exchanged for any reason during the investigation the 
new unique serial number will be noted together with date of exchanging the device (both on the 
investigational device log and in the subjects eCRF).
All unused investigational devices must be returned to the Sponsor when treatment of the last subject has 
been completed. Return of devices by the end of investigation will be logged by Sponsor in Sponsor records.
The monitor will verify the accountability process at the monitoring visits.
STATEMENTS OF COMPLIANCE
The clinical investigation will be performed in consistency with the current version of the Declaration of 
Helsinki, ISO 14155, Regulation (EU) 2017/745 (MDR) and applicable regional or national competent 
authority regulations and requirements as well as any additional requirements imposed by the EC. 
The final clinical investigation plan, including the final version of the patient Information and Consent Form 
must be approved in writing by an Ethics Committee (EC), and Competent Authorities (CA) if applicable, 
before enrolment of any subject into the investigation. The Principal Investigator is responsible for informing 
the Ethics committee of any amendment to the investigation plan as per local requirements. 
The clinical investigation will not be commenced until approvals from the applicable Ethics Committee (EC) 
and Competent Authority (CA) have been received.
Any additional requirements imposed by the EC or national Competent Authorities shall be followed.
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Insurance
The Sponsor will be responsible for ensuring adequate insurance covering any injuries to the subject caused 
by the investigational device.
 
t
 
INFORMED CONSENT PROCESS
The Principal Investigator will ensure that the potential subject is given full and adequate oral and written 
information about the nature and purpose of the investigation, including possible benefits and risks involved. 
Alternatives to the treatment suggested in the CIP must be discussed to allow the potential subject to have 
an informed choice. Potential subjects must also be notified that they are free to decline participation in the 
investigation, and that they are free to discontinue at any time, without any consequences to their future 
care. Sufficient time will be given for consideration and the opportunity to ask questions before signing the 
informed consent form will be provided. The signed informed consent must be obtained before conducting 
any procedures specific for the investigation. 
By signing the informed consent form, the subject agrees to participate in the investigation and that the 
results obtained may be used in authority assessments, and/or submissions for presentation or publication 
in scientific meetings and/or journals, with the condition that privacy and confidentiality are preserved.
The informed consent will be signed and dated by the subject and investigator who gave the verbal and 
written information. A copy of the patient information sheet including the signed informed consent form 
should be given to the patient and the original of the consent form must be filed in the ISF.
If any new information becomes available during the investigation that possibly could influence the subjects’ 
willingness to participate, they will be informed and asked to sign a revised informed consent, if applicable.
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES
Definitions 
The definitions and procedures for reporting Adverse Events (AE), Adverse Device Effects (ADE), 
Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), Device Deficiencies (DD), 
Unanticipated Serious Adverse Device Effects (USADE) and Serious public health threats are 
presented in the subsections below. It is of outmost importance that all staff involved in the 
investigation is familiar with the definitions and procedures and it is the responsibility of the 
Principal Investigator to ensure this. 
18.1.1 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, in the context of a clinical investigation, 
whether or not related to the investigational device.
Note:
a. This definition includes events that are anticipated as well as unanticipated events
b. This definition includes events occurring in the context of a clinical investigation related to the 
investigational device, the comparator or the procedures involved. For the purpose of safety reporting all 
activities related to the use of a medical device may be considered procedures.
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18.1.2 Adverse Device Effect (ADE)
An adverse device effect is an adverse event related to the use of an investigational medical device.
Note 1: 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.
Note 2: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device.
Note 3: This includes ‘comparator’ if the comparator is a medical device
18.1.3 Serious Adverse Event (SAE)
Any adverse event that led to any of the following: 
(a) death, 
(b) serious deterioration in the health of the subject, that resulted in any of the following: 
(i) life-threatening illness or injury, 
(ii) permanent impairment of a body structure or a body function, 
(iii) hospitalisation or prolongation of patient hospitalisation, 
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
(v) chronic disease, 
(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
Note: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse event.
18.1.4 Serious Adverse Device Effect (SADE)
A serious adverse device effect is an adverse device effect that has resulted in any of the consequence 
characteristics of a serious adverse event.
18.1.5 Device deficiency (DD)
Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational 
device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.
18.1.6 Unanticipated Serious Adverse Device Effect (USADE)
An Unanticipated Serious Adverse Device Effect is an effect which by its nature, incidence, severity 
or outcome has not been identified in the current risk assessment. Procedures associated with the 
use of a device should be addressed in the risk assessment, which makes it possible to determine 
whether the procedure related SAEs are Unanticipated Serious Adverse Device Effect or not. SAEs 
related to procedures imposed by the clinical investigation plan but not with the use of the device 
should not be considered Serious Adverse Device Effects.
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Note: Anticipated Serious Adverse Device Effect (ASADE) is an effect which by its nature, incidence, severity 
or outcome has been identified in the risk assessment.
18.1.7 Serious public health threat
An event which could result in imminent risk of death, serious deterioration in a person's state of health, or 
serious illness, that may require prompt remedial action, and that may cause significant morbidity or 
mortality in humans, or that is unusual or unexpected for the given place and time. 
Methods for discovering and documenting AE/ADE and DD
All subjects will be asked about the occurrence of AEs from the first day and until completion of the 
investigation. Events prior to enrolment will be considered medical history. The Principal Investigator (PI) or 
delegate will collect safety information using a non-leading question “have you experienced any new health 
problems or worsening of any existing condition?”. Events directly observed or spontaneously reported by 
the subjects will also be recorded throughout the investigation 
All AEs falling into any of the previously defined definitions must be recorded as an AE in the eCRF. Clearly 
related signs, symptoms and abnormal diagnostic procedure results should be grouped together and 
reported as a single diagnosis or symptom whenever possible.
All AEs, but not limited to events reported by the subject or reported in response to an open question by the 
PI or member of the investigation team, which fall into any of the previously defined definitions must be 
recorded as an AE in the eCRF and should include the following information:

Brief description of the event(diagnosis)

Date of event onset (and time, if relevant)

Date of event resolution (and time, if relevant)

Severity

Seriousness

Causality assessment (i.e., relationship to medical device and/or procedure)

Event treatments

Event outcome
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance shall be reported as a device deficiency (DD) without unnecessary delay to the Sponsor by using 
the device deficiency form. It is the PI’s responsibility to record every observed device deficiency together 
with an assessment. The Sponsor shall review all device deficiencies and determine and document in writing 
whether they could have led to a SADE. Device Deficiencies that are assessed to or have SADE potential 
should be subjected to expedited reporting as described in Section 18.4.
AEs/ADEs and DDs should be reported to Sponsor as described in section 18.4.1. SAEs/SADEs/USADEs and 
DDs with SADE potential should be subject to expedited reporting according to section 18.4.2.
18.2.1 Severity
Severity describes the intensity of an AE and will be assessed as:

Mild: does not interfere with subject’s usual function.

Moderate: interferes to some extent with subject’s usual function

Severe: interferes significantly with subject’s usual function
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18.2.2 Causality
The relationship between the use of the medical device (including the medical - surgical procedure) and the 
occurrence of each adverse event shall be assessed and categorized. 
During the causality assessment activity, clinical judgement shall be used and the relevant documents, such 
as the Investigator’s Brochure, Clinical Investigation Plan and risk analysis report shall be consulted, as all of 
the foreseeable serious adverse events and the potential risks are listed and assessed there. The presence of 
confounding factors such as concomitant medication/treatment, the natural history of the underlying disease 
other concurrent illness or risk factors should also be considered.
The investigator and Sponsor will use the following definitions to assess the relationship of the serious 
adverse event to the investigational device, the comparator or the investigation procedure:
1.
Not related: Relationship to the device, comparator or procedures can be excluded when:
o
the event has no temporal relationship with the use of the investigational device, or the
procedures related to application of the investigational device;
o
the serious adverse event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible;
o
the discontinuation of medical device application or the reduction of the level of
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious adverse event;
o
the event involves a body-site or an organ that cannot be affected by the device or procedure;
o
the serious adverse event can be attributed to another cause (e.g. an underlying or concurrent 
illness/ clinical condition, an effect of another device, drug, treatment or other risk factors);
o
the event does not depend on a false result given by the investigational device used for diagnosis, 
when applicable;
In order to establish the non-relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious adverse event.
2.
Possible: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely. Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of another 
device, drug or treatment). Cases where relatedness cannot be assessed, or no information has been 
obtained should also be classified as possible.
3.
Probable: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be reasonably explained by 
another cause.
4.
Causal relationship: the serious adverse event is associated with the investigational device, 
comparator or with procedures beyond reasonable doubt when:
o
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;
o
the event has a temporal relationship with investigational device use/application or
procedures;
o
the event involves a body-site or organ that

the investigational device or procedures are applied to;

the investigational device or procedures have an effect on;
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o
the serious adverse event follows a known response pattern to the medical device (if the 
response pattern is previously known);
o
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious adverse event (when clinically feasible);
o
other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out;
o
harm to the subject is due to error in use;
o
the event depends on a false result given by the investigational device used for diagnosis10, 
when applicable;
In order to establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious adverse event.
The sponsor and the investigators will distinguish between the serious adverse events related to the 
investigational device and those related to the procedures (any procedure specific to the clinical 
investigation). An adverse event can be related both to procedures and the investigational device. 
Complications caused by concomitant treatments not imposed by the clinical investigation plan are 
considered not related.
Any AE’s that are assessed as possibly, probably or causally related will be classified as an ADE, which entails 
further information to be recorded, as specified in the corresponding eCRF.
Particular attention shall be given to the causality evaluation of USADE, since the occurrence of USADE could 
suggest that the clinical investigation places subjects at increased risk of harm than was expected 
beforehand. 
In case of disagreement between the Sponsor and the Principal Investigator assessments of the AE, both 
opinions shall be communicated to concerned parties. 
Reporting of safety events to Competent Authority by Sponsor
18.3.1 Reporting of SAE/SADE and Device Deficiencies with SADE potential
In accordance with MDR (EU) 2017/745, the following events are considered reportable events: 
(a) any serious adverse event that has a causal relationship with the investigational device, the comparator 
or the investigation procedure or where such causal relationship is reasonably possible; 
(b) any device deficiency that might have led to a serious adverse event if appropriate action had not been 
taken, intervention had not occurred, or circumstances had been less fortunate; 
(c) any new findings in relation to any event referred to in points (a) and (b). 
The period for reporting shall take account of the severity of the event. Where necessary to ensure timely 
reporting, the Sponsor may submit an initial report that is incomplete followed by a complete report. 
For clinical investigations performed in line with the requirements of the Regulation (EU) 2017/745-Medical 
Device Regulation (MDR) Sponsor shall immediately, but no later than 2 calendar days after awareness report 
to CA events 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. For any 
other reportable events, Sponsor shall immediately but not later than 7 calendar days report the event to 
CA.
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In the absence of a fully functional EUDAMED database the MDCG template ‘Summary Reporting Form’ [I].
shall be used. 
18.3.2 Reporting of Serious public health threats
Report of Serious public health threat shall be sent immediately to CA, but not later than 2 calendar days 
after awareness by Sponsor of new reportable event or of new information in relation with an already 
reported event. 
Reporting of safety events to Sponsor by investigation site
18.4.1 Reporting of AE/ADE and DD
Any AE/ADE or DD shall be reported to the Sponsor via the eCRF within 5 working days after investigation 
site study personnel’s awareness. 
For device deficiencies that fulfil the SADE definition, the Investigator must provide Oticon Medical with 
detailed information and perform the steps described for SAE/SADE reporting section 18.4.2.
18.4.2 Reporting of SAE/SADE/USADE and DD with SADE potential
Any AE or ADE that is classified as serious, and any DD judged to have SADE potential shall be reported to the 
Sponsor via the eCRF, complemented with any additional information of the event as it become available. 
The signed report will trigger a system-generated e-mail notification to the Sponsor.
The report shall be registered in the eCFR immediately, but not later than 3 calendar days after investigation 
site study personnel’s awareness of the event. 
All SAEs/SADEs and DDs that could have led to a SADE should contain as much information as possible. In 
addition to information already collected and recorded for AEs/ADEs there is more detailed information 
required for SAEs/SADEs/USADs as specified in eCRF.
The occurrence of USADEs could suggest that the clinical investigation places subjects at increased risk of 
harm than was to be expected beforehand. Oticon Medical will handle and report USADEs to applicable 
authorities.
Reporting of safety events to EC by investigation site
It is the responsibility of the Principal Investigator to ensure that the local safety reporting requirements are 
adhered to regarding the extent of information and timing of reporting to the concerned EC.
Investigation study personnel shall provide Sponsor with all SAE/SADE/USADE related documentation and 
correspondence to the EC.
When the opinion on seriousness/causality differs between the PI and the Sponsor, the PI will be informed 
and is responsible for communicating both opinions to the EC, as required and agreed between Sponsor and 
PI. 
Non-reportable events
Not applicable
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Safety event follow-up
Medical follow-up of any type of safety event will continue until the symptoms/disease resolves, or an 
adequate medical explanation is apparent.
Documentation of all follow-up information regarding the AEs must be provided in the eCRF and, in 
accordance with the reporting requirements described above.
If the subject is withdrawn from investigation treatment due to an AE, the AE and the reason for withdrawal 
from the investigation is to be documented clearly in the eCRF.
Safety related contacts
Should the need for further guidance on safety-related issues and/or reporting be evident, the following 
contact details applies:
Oticon Medical
Phone:
+46 31 748 61 70 (vigilance)
Postal address:
Oticon Medical
Datavägen 37,
SE-436 32 Askim, Sweden
Mail:
QA@oticonmedical.se
Data Monitoring Committee 
Based on the risk assessment, it has been concluded that a DMC is not needed for this open label, single arm, 
single center clinical investigation. The investigation will be conducted by experienced hearing aid 
professionals that are used to working with similar devices, with similar risk profiles. 
VULNERABLE POPULATION (IF APPLICABLE)
Not applicable for this investigation
SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION
The investigator or Sponsor may at any time terminate the clinical investigation due to circumstances related 
to the rights, safety and welfare of the subjects enrolled, or conduct of the investigator/investigational site 
or company that preclude ongoing subject treatment.
If the investigation is suspended or terminated prematurely, the investigator will promptly inform the 
Sponsor and provide the reason(s) thereof (and vice versa). The applicable regulatory authorities and 
ECs/IRBs concerned will also be informed promptly in writing by the investigator. In case of suspension or 
terminated prematurely, subject included in the clinical investigation will fall under standard clinical care 
provided by the hospital. 
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PUBLICATION POLICY
A final report of the clinical investigation (CIR) (accompanied by a summary) will be completed, even if the 
investigation is prematurely terminated. The report will be prepared by the sponsor as referred to in 
Regulation (EU) 2017/745 (MDR) Chapter III of Annex XV, and Annex D of ISO 14155:2020. Irrespective of the 
outcome of the clinical investigation, the sponsor will within one year of the end of the clinical investigation 
or within three months of the early termination or temporary halt submit the CIR to the competent authority. 
The results obtained in the investigation may be submitted for publication in scientific journals by the 
investigators, in cooperation with the Sponsor. Privacy and confidentiality of information about each subject 
will be preserved in any reports and any publications of the clinical investigation data. 
Annual progress reports and final clinical investigation report will be submitted to the EC as applicable.
The clinical investigation will be registered in a publicly accessible database (www.clinicaltrials.gov) before 
recruitment of the first subject. Results will be registered once the clinical investigation and final investigation 
report have been completed.
CLINICAL INVESTIGATION AGREEMENTS
This is a sponsored investigation financed by Oticon Medical AB. The site ‘Habilitation & Health, Hearing 
organization, Södra Gubberogatan 6, 416 63 Göteborg’ will receive compensation 
 
 
 
A clinical investigation agreement will be signed between Oticon Medical AB and 
‘Habilitation & Health, Hearing organization, Södra Gubberogatan 6, 416 63 Göteborg’ before the 
investigation starts.
In addition, as the subject visits will be conducted at the site Chalmers University of Technology, a separate 
contract between Sponsor and Chalmers University of Technology will be fully executed before study start. 
Chalmers University of Technology will receive compensation
 
 
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SIGNED AGREEMENTS
Sponsor
On behalf of Oticon Medical AB I approve this clinical investigation plan.
Date and signature: 
Name and title
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 versions of the declaration of Helsinki and ISO 14155 
Clinical investigation of medical devices for human subjects — Good clinical practice. 
Date and signature: 
Name and title
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BIBLIOGRAPHY
1.
Reinfeldt, S., et al., New developments in bone-conduction hearing implants: a 
review. Med Devices (Auckl), 2015. 8: p. 79-93.
2.
Persson, A.C., et al., Three-Year Follow-Up with the Bone Conduction Implant.
Audiol Neurootol, 2020: p. 1-13.
3.
Gatehouse, S. and W. Noble, The Speech, Spatial and Qualities of Hearing Scale 
(SSQ). Int J Audiol, 2004. 43(2): p. 85-99.
4.
Noble, W., et al., A short form of the Speech, Spatial and Qualities of Hearing scale 
suitable for clinical use: the SSQ12. Int J Audiol, 2013. 52(6): p. 409-12.
5.
Ryall, A., Jenstad L. M, Pumford, J, Howe, T, Grosjean, G, Counseling During Real 
Ear Measurements: The Clients' Perspective. Journal of the American Academy of 
Audiology, 2020. 32(2): p. 107-115.
6.
Hodgetts, W., et al., Development of a Novel Bone Conduction Verification Tool 
Using a Surface Microphone: Validation With Percutaneous Bone Conduction 
Users. Ear Hear, 2018.
7.
Persson, A.C., Håkansson, B; Mechanda, M.C, Hodgetts, W.B, Fréden Jansson, K, 
Eeg-Olofsson, M, Reinfeldt, S, A novel method for objective in-situ measurment of 
audibility in bone conduction hearing devices - a pilot study using a skind drive 
BCD. International Journal of Audiology, 2022.
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