3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
Conditions: Ear Mold Impression Procedure
Sponsor: Sonova AG

Clinical Performance Evaluation of 3D Ear Canal Scanning 
Technology 
 
NCT05000047 
April 1, 2021

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 1/26 
 3D ear scanner – Workflow timing and 
preferences compared to traditional silicone earmold 
impressions 
Short Title of the clinical investigation 
(if available) 
 3D ear scanner – Workflow timing 
and preferences compared to traditional silicone 
earmold impressions 
Sonova StudyID 
371 
ID given by Ethics Committee / 
Investigational Review Board 
(if already available) 
20201845 (WIRB approval #) 
ID given by Competent Authority 
(if already available) 
ClinicalTrials.gov Identifier: NCT05000047 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 2/26 
Signature Page 
The Study Manager (Sonova employee representing the Sponsor and taking the practical 
tasks associated with the Sponsor) has approved the CIP version [2 (dated 04.01.2021), 
make sure this corresponds to the protocol version and date in the footer], and confirm 
hereby to conduct the investigation according to the CIP, current version of the World Med-
ical Association Declaration of Helsinki, ISO 14155 norm and the local legally applicable 
requirements. 
Name 
David Taylor, Au.D. 
Place, Date 
Phonak Audiology Research Center (PARC), 01.04.2021 
Signature 
Local Principal Investigator (PI) at investigation site: 
I have read and understood this CIP and agree to conduct the trial as set out in this inves-
tigation protocol, the current version of the World Medical Association Declaration of Hel-
sinki, ISO 14155 norm and the local legally applicable requirements. 
Investigation Site 
PARC 
Name (PI) 
Kevin Seitz-Paquette, Au.D. 
Place, Date 
PARC, 01.04.2021 
Signature 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 3/26 
Table of Contents 
1 
GENERAL ................................................................................................................................................. 5 
1.1 
SPONSOR .................................................................................................................................................. 5 
1.2 
PRINCIPAL INVESTIGATOR, COORDINATING INVESTIGATOR AND INVESTIGATION SITE(S)............................................. 5 
1.3 
OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION .......................................................................................... 6 
2 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE .................................................. 8 
2.1 
DESCRIPTION OF THE INVESTIGATIONAL DEVICE AND ITS INTENDED PURPOSE. ......................................................... 8 
2.2 
LEGAL MANUFACTURER OF THE INVESTIGATIONAL DEVICE. .................................................................................. 9 
2.3 
MODEL/TYPE, INCLUDING SOFTWARE VERSION AND ACCESSORIES ........................................................................ 9 
2.4 
TRACEABILITY DURING AND AFTER THE CLINICAL INVESTIGATION .......................................................................... 9 
2.5 
INTENDED PURPOSE OF THE INVESTIGATIONAL DEVICE IN THE PROPOSED CLINICAL INVESTIGATION. ............................. 9 
2.6 
POPULATIONS AND CLINICAL INDICATIONS ...................................................................................................... 9 
2.7 
DESCRIPTION OF THE MATERIALS USED ........................................................................................................... 9 
2.8 
SUMMARY OF THE NECESSARY TRAINING AND EXPERIENCE .................................................................................. 9 
2.9 
DESCRIPTION OF THE SPECIFIC MEDICAL PROCEDURES INVOLVED IN THE USE OF THE INVESTIGATIONAL DEVICE. ........... 10 
3 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION ....................................................... 10 
3.1 
PRECLINICAL EVIDENCE .............................................................................................................................. 10 
3.2 
CLINICAL EVIDENCE TO DATE ...................................................................................................................... 10 
3.3 
DESCRIPTION OF CLINICAL DEVELOPMENT STAGES ........................................................................................... 10 
4 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION ....................... 10 
4.1 
ANTICIPATED CLINICAL BENEFITS .................................................................................................................. 10 
4.2 
ANTICIPATED ADVERSE DEVICE EFFECTS ......................................................................................................... 10 
4.3 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL INVESTIGATION ............................................................. 10 
4.4 
POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS AS CONSIDERED UNDER THE RISK ANALYSIS ........ 11 
4.5 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS ....................................................................... 11 
4.6 
RISK/BENEFIT RATIONALE AND JUSTIFICATION OF THE SELECTION OF CLINICAL ENDPOINT(S). .................................... 11 
5 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION ......................................................... 12 
5.1 
PURPOSE OF THE CLINICAL INVESTIGATION CLAIMS FOR CLINICAL PERFORMANCE, EFFECTIVENESS OR SAFETY OF THE 
INVESTIGATIONAL DEVICE THAT ARE TO BE VERIFIED ...................................................................................................... 12 
5.2 
PRIMARY AND SECONDARY OBJECTIVES ........................................................................................................ 12 
5.3 
SCIENTIFIC JUSTIFICATION AND CLINICAL RELEVANCE FOR EFFECT SIZES, NON-INFERIORITY MARGINS OR EQUIVALENCE 
LIMITS 
12 
5.4 
SAFETY OBJECTIVES .................................................................................................................................. 12 
5.5 
HYPOTHESIS ............................................................................................................................................ 12 
6 
DESIGN OF THE CLINICAL INVESTIGATION ............................................................................................. 13 
6.1 
GENERAL ................................................................................................................................................ 13 
6.2 
INVESTIGATIONAL DEVICE(S) AND COMPARATOR(S) ......................................................................................... 14 
6.3 
PARTICIPANTS ......................................................................................................................................... 14 
6.4 
PROCEDURES ........................................................................................................................................... 15 
TIMING DETAILS ............................................................................................................................................ 15 
6.5 
MONITORING PLAN .................................................................................................................................. 17 
7 
STATISTICAL DESIGN AND ANALYSIS ...................................................................................................... 17 
7.1 
DETERMINATION OF SAMPLE SIZE ............................................................................................................... 17 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 4/26 
7.2 
STATISTICAL CRITERIA OF TERMINATION OF TRIAL ............................................................................................ 17 
7.3 
PLANNED ANALYSES ................................................................................................................................. 17 
7.4 
HANDLING OF MISSING DATA AND DROP-OUTS ............................................................................................... 18 
8 
QUALITY ASSURANCE AND CONTROL .................................................................................................... 18 
8.1 
DATA HANDLING AND RECORD KEEPING/ ARCHIVING ....................................................................................... 18 
8.2 
DATA MANAGEMENT ................................................................................................................................ 19 
9 
AMENDMENTS TO THE CIP .................................................................................................................... 19 
10 
DEVIATIONS FROM CLINICAL INVESTIGATION PLAN .............................................................................. 19 
10.1 
PROCEDURES FOR RECORDING, REPORTING AND ANALYZING CIP DEVIATIONS ....................................................... 20 
10.2 
NOTIFICATION REQUIREMENTS AND TIME FRAMES .......................................................................................... 20 
10.3 
CORRECTIVE AND PREVENTIVE ACTIONS AND PRINCIPAL INVESTIGATOR DISQUALIFICATION CRITERIA .......................... 20 
11 
DEVICE ACCOUNTABILITY ...................................................................................................................... 20 
11.1 
ACCOUNTABILITY FOR INVESTIGATIONAL DEVICE ............................................................................................. 20 
11.2 
RETURN OF INVESTIGATIONAL DEVICE ........................................................................................................... 20 
12 
STATEMENTS OF COMPLIANCE .............................................................................................................. 21 
13 
INFORMED CONSENT PROCESS.............................................................................................................. 21 
13.1 
PROCESS FOR OBTAINING INFORMED CONSENT............................................................................................... 21 
13.2 
PROCESS FOR OBTAINING INFORMED CONSENT IN EMERGENCY SITUATIONS.......................................................... 21 
14 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES .............................................. 21 
14.1 
DEFINITION AND ASSESSMENT OF ADVERSE EVENTS AND OTHER SAFETY RELATED EVENTS ...................................... 22 
14.2 
FORESEEABLE ADVERSE EVENTS AND ANTICIPATED ADVERSE DEVICE EFFECT .......................................................... 23 
14.3 
NON-REPORTABLE ADVERSE EVENTS............................................................................................................. 24 
14.4 
REPORTING OF ADVERSE EVENTS AND DEVICE DEFICIENCIES ............................................................................. 24 
14.5 
FOLLOW UP OF (SERIOUS) ADVERSE EVENTS .................................................................................................. 24 
15 
VULNERABLE POPULATION (IF APPLICABLE) .......................................................................................... 24 
15.1 
DESCRIPTION OF THE VULNERABLE POPULATION TO BE INCLUDED IN THE CLINICAL INVESTIGATION. ........................... 24 
15.2 
DESCRIPTION OF THE SPECIFIC INFORMED CONSENT PROCESS. ........................................................................... 24 
15.3 
DESCRIPTION OF THE EC'S SPECIFIC RESPONSIBILITY. ....................................................................................... 25 
15.4 
DESCRIPTION OF WHAT MEDICAL CARE, IF ANY, WILL BE PROVIDED FOR PARTICIPANTS AFTER THE CLINICAL INVESTIGATION 
HAS BEEN COMPLETED. ........................................................................................................................................... 25 
16 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION ................................... 25 
16.1 
CRITERIA AND ARRANGEMENTS FOR SUSPENSION OR PREMATURE TERMINATION OF THE WHOLE CLINICAL INVESTIGATION 
OR OF THE CLINICAL INVESTIGATION IN ONE OR MORE INVESTIGATION SITES. ..................................................................... 25 
16.2 
CRITERIA FOR ACCESS TO AND BREAKING THE BLINDING/MASKING CODE IN THE CASE OF SUSPENSION OR PREMATURE 
TERMINATION OF THE CLINICAL INVESTIGATION, IF THE CLINICAL INVESTIGATION INVOLVES A BLINDING/MASKING TECHNIQUE. .... 25 
16.3 
REQUIREMENTS FOR PARTICIPANT FOLLOW-UP. .............................................................................................. 25 
17 
PUBLICATION POLICY ............................................................................................................................ 25 
18 
BIBLIOGRAPHY ...................................................................................................................................... 25 
19 
TABLES .................................................................................................................................................. 26 
19.1 
TABLE OF TABLES ..................................................................................................................................... 26 
19.2 
TABLE OF FIGURES .................................................................................................................................... 26 
19.3 
ABBREVIATIONS ....................................................................................................................................... 26 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 5/26 
1 General 
1.1 Sponsor 
Name 
Sonova AG 
Audiology and Medicalization 
Audiological Care 
Address 
750 North Commons, Aurora, IL 60504 
1.2 Principal investigator, coordinating investigator and Investigation site(s) 
Principal Investigator 
Kevin Seitz-Paquette 
750 North Commons, Aurora, IL 60504 
kevin.seitz-paquette@sonova.com 
(630) 821-5000
Director PARC
Coordinating Investigator of a 
multi-center investigation 
(if applicable 
N/A 
[Investigation Site 1] 
Phonak Audiology Research Center (PARC) 
750 
[Investigation Site 2] (if 
applicable) 
N/A 
Third party (if applicable) (e.g. 
core laboratories, CROs, 
consultants, biostatisticians, 
monitoring institution or other 
contractors) 
N/A 
Further Staff 
 (studies coordinator), 
 (study 
monitor), 
 (research audiologist), 
 
(research audiologist) 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 6/26 
1.3 Overall synopsis of the clinical investigation 
Background 
and Rationale 
 claims the 
 3D ear scanning solution to streamline clin-
cal processes. According to 
, with the 
, you can: 
•
save time and money on handling earmolds and hearing aids
•
secure digital patient records for easy storage, retrieval and
use
•
ensure a better fit and reduce remakes and returns,
•
enjoy a cleaner procedure
 
Previous research has been done at Sonova HQ to analyze the quality 
of 
 ear scans compared to traditional earmold impressions. 
However, to fully understand the value drivers, further data is needed 
exploring efficiency and preferences in comparison to traditional EMI 
methods. In addition, the department of Audiological Care is interested 
in finding out if this is a viable piece of equipment for their clinics. The 
results of previous research regarding quality of the 
 has war-
ranted a further look into efficiency and subjective preference. 
Investigation 
Objectives 
The primary objective of this study is to identify any significant differ-
ences in the time required for a clinician to complete the workflow of an 
 impression compared to traditional earmold impressions. 
The secondary objective of this study is to identify any significant pref-
erence for both the HCPs and patients when comparing the 
 
 to traditional EMI procedures. 
Outcome(s) / 
Endpoints: 
Time (mm:ss) will be recorded to quantify the duration of each impres-
sion procedure. 
Questionnaires will be administered to assess overall preferences of 
both the researchers and subjects. 
Investigation 
Design 
Interventional Study
Investigation Model 
Single Group
Parallel
Crossover
Factorial
Sequential
Masking 
single-blided
double-blinded
no masking
other:
Allocation 
N/A (for single-
Randomized
Nonrandomized

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 7/26 
Number of Arms: [2] 
Observational Study
Investigation Model 
Cohort
Case-Control
Case-only
Case-crossover
Ecologic
Family-based
other:
Time Perspective 
Retrospective
Prospective
Cross-sectional
other:
Number of Groups/ Cohorts: [1] 
Type of design 
Exploratory
Confirmatory
Observational
Inclusion / Ex-
clusion criteria: 
External auditory canal must be present and medically unremarkable 
to facilitate impressions. Participants with surgical ears or without ex-
ternal auditory canals must be excluded. 
Measurements 
and proce-
dures: 
Three researchers will be facilitating these appointments to limit varia-
bility of researcher skill across the two conditions. Researchers will fa-
miliarize themselves with the 
 equipment through inde-
pendent practice prior to a training facilitated by 
(occuring April 
22nd) and will follow 
 training recommendations (perform scans 
on 10+ ears following in-person training) prior to data collection. Par-
ticipants will be seen for one appointment. The researcher will perform 
both traditional earmold impressions and 3D ear scans on both ears 
(conditions will be randomized and counterbalanced across partici-
pants). An additional researcher will use a stop watch to quantify the 
time (mm:ss) it takes for each condition, for both ears. At the end of the 
appointment, participants will also be asked to complete a subjective 
questionnaire regarding each condition, focusing on their perception of 
comfort and level of involvement throughout the impression taking. The 
resulting data will be compiled for all participants and analyzed using a 
T-test, to identify any significant differences in the time it takes to com-
plete each method of earmold impressions, in addition to any differ-
ences in subjective domains.
Intervention: 
 3D Ear Scanning Solution 
Control Inter-
vention (if ap-
plicable): 
Traditional silicone earmold impression material, administered by a 
cartridge impression gun. 
Number of Par-
ticipants with 
Rationale: 
N = 30 (10 participants per researcher). Both conditions will be meas-
ured for each participant. This sample population will provide an ade-
quately powered study under the assumption that time variance of each 
condition is within approximately 5 minutes. 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 8/26 
Investigation 
Duration: 
Approximately 1 month 
Investigation 
Schedule: 
Month/ Year of First-Participant-In (planned): MAY/2021 
Month/ Year of Last-Participant-Out (planned): JUN/2021 
Statistical Con-
siderations: 
Analysis of procedure time data will take place at the conclusion of the 
trial.  The intended analysis assumes a normally-distributed response 
variable.  As such, procedure times for each methodology will be tested 
for normality using a Shaprio-Wilk test 
Trial registra-
tion: 
U.S. National Library of Medicine – clinicaltrials.gov 
ClinicalTrials.gov Identifier: NCT05000047 
Investigation 
category and 
Rationale 
Non-significant Risk Investigation 
US FDA regu-
lated Device 
(applicable in 
the US) 
Yes
No
US FDA IDE 
(applicable in 
the US) 
Yes
, IDE Number: [xxx] 
No
Clinical Phase: 
Pre-market
[Exploration/ Confirmation] 
Post-Market
[Confirmation/ Observational] 
Good Clinical 
Practice (GCP) 
Statement: 
This investigation will be conducted in compliance with the protocol, the 
current version of the Declaration of Helsinki, ISO 14155 (as far as ap-
plicable) as well as all national legal and regulatory requirements.  
2 Identification and description of the investigational device 
2.1 Description of the investigational device and its intended purpose. 
 
 
 
 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 9/26 
The 
 is an alternative approach to traditional impression procedures. By creating a 3D 
digital scan, 
 claims that the 
 has potential to reduce shipping and procedural 
times in a cost effective manner. 
2.2 Legal manufacturer of the investigational device. 
 
 
 
 
 
 
 
 
 
2.3 Model/type, including software version and accessories 
 3D Ear Scanner 
SN: 
 
2.4 Traceability during and after the clinical investigation 
Participants will be assigned a non-identifying subject identification number. This number will 
be used to trace scans and impressions and will correspond to the respective participant. 
2.5 Intended purpose of the investigational device in the proposed clinical in-
vestigation. 
The 
 is an alternative approach to traditional impression procedures. By creating a 3D 
digital scan, 
claims that the 
 has potential to reduce shipping times and proce-
dural times in a cost effective manner. (See section 2.1) 
2.6 Populations and Clinical indications 
External auditory canals must be present and medically unremarkable to facilitate impressions. 
Participants with surgical ears or without external auditory canals must be excluded. 
2.7 Description of the materials used 
3D Ear Scanner- The 
is an alternative approach to traditional impression 
procedures. By creating a 3D digital scan, 
 claims that the 
 has potential to 
reduce shipping times and procedural times in a cost effective manner. (See section 2.1) 
Traditional silicone earmold impression material- Dreve Otoform A/flex 
• Shore Rating = 25 +/- 2 Shore A
*Used with 48ML Impression Gun
2.8 Summary of the necessary training and experience 
Researchers will familiarize themselves with the 
 equipment through independ-
ent practice prior to a training facilitated by 
 (occuring April 22nd) and will follow 
 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 10/26 
training recommendations (perform scans on 20+ ears following in-person training) prior to 
data collection 
2.9 Description of the specific medical procedures involved in the use of the 
investigational device. 
The 
 3D ear scanner is used to create a 3D mapping of the ear canal. This digital file 
is then used to produce an earmold. Traditional earmold impressions require an audiologist or 
HCP to place a dam to prevent impression material leakage, then fill the external auditory 
canal with silicone impression material. This material then has to set prior to being removed 
from the ear canal and then proceeds to production stages. 
3 Justification for the design of the clinical investigation 
3.1 Preclinical Evidence 
N/A – The 
3D ear scanner is a post market device. 
3.2 Clinical Evidence to date 
Previous research has shown comparable quality of impression between 
 3D ear 
scanner and traditional earmold impression procedures. However, it is unknown how 
 
claims of increased efficiency applies to the workflow of Sonova’s retail facilities. In particular, 
Audiological Care has the need for supportive data in deciding whether or not the 
 3D 
ear scanner adds value to their businesses. These value drivers of interest include procedural 
time, and subjective comfort and overall preference for patients and providers. 
3.3 Description of clinical development stages 
Post Market – Observational  
•
Registry
•
Post Market Clinical Investigation
4 Risks and benefits of the investigational device and clinical 
investigation 
4.1 Anticipated clinical benefits 
Better understanding of the value drivers behind 
 3D Ear Scanners. This data will 
support the decision making process for incorporating these products into Audiological Care 
clinics. 
4.2 Anticipated adverse device effects 
The devices used in this investigation are post-market devices, and are to be used as recom-
mended by the manufacturers. For these reasons, there are no anticipated adverse device 
effects. 
4.3 Risks associated with participation in the clinical investigation 
The investigatory procedure and comparator procedure both carry risks typical to the standard 
of care of earmold impression procedures. When placing an object in the auditory canal, there 
is risk of discomfort to the participant. In addition, when equipment is placed too deep into the 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 11/26 
auditory canal, there is risk for damage or perforation of the tympanic membrane. There are 
risks of skin sensitivity to material of the devices inserted into the auditory canal, as well as 
risk for abrasions or irritation while placing these devices during the procedure. 
4.4 Possible interactions with concomitant medical treatments as considered 
under the risk analysis 
Exclusion criteria of this investigation removes the possibility of interactions with concomitant 
medical treatments. 
4.5 Steps that will be taken to control or mitigate the risks 
Researchers will be trained in accordance with the manufacturer’s 
 recommendations 
specific to this product prior to data collection. The control condition (Silicone earmold impres-
sion procedure) is within the scope of practice of the research audiologists. The research au-
diologists are licensed by the state of Illinois and the procedures performed are within their 
scope of practice as defined by the licensing body. 
Table 1: Summary of all controls taken to mitigate the risks of the product related residual risks. 
Polarion Risk-ID –Auditory Canal Discomfort 
Risk Control 
Researchers are trained in both procedures to limit this risk 
as much as possible. This training has been provided by the 
manufacturers of equipment. Performing this procedure com-
plies with the scope of practice of their licensing body. 
Polarion Risk-ID – Tympanic Membrane Perforation 
Risk Control 
Researchers are trained in both procedures to limit this risk 
as much as possible. This training has been provided by the 
manufacturers of equipment. Performing this procedure com-
plies with the scope of practice of their licensing body. 
Polarion Risk-ID – Skin Sensitivity 
Risk Control 
Researchers are trained in both procedures to perform them 
as safely and efficiently as possible. This allows the time of 
contact with equipment to be as limited as possible for partic-
ipants, minimizing the risk of skin sensitivity occurances. 
Polarion Risk-ID – Skin Abrasions and Irritation 
Risk Control 
Researchers are trained in both procedures to limit this risk 
as much as possible. This training has been provided by the 
manufacturers of equipment. Performing this procedure com-
plies with the scope of practice of their licensing body. 
4.6 Risk/benefit rationale and justification of the selection of clinical end-
point(s). 
The risks of this study are minimal as the procedures are within the scope of practice of the 
research audiologists, and manufacturer training recommendations are to be followed for the 
 3D ear scanner. These limited risks are accompanied by the benefit of understanding 
whether or not the 
 3D ear scanner will be beneficial to Audiological Care Clinics, 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 12/26 
particularly in terms of procedural timing and preferences for both patients and providers. To 
satisfy the primary objective, the entirety of the procedural workflow will be captured using a 
stop watch (mm:ss) for both conditions, in order to have a direct measure of the timing com-
ponent of the investigation. To satisfy the secondary objective, subjective questionnaires will 
be administered to answer questions relevant to incorporating this product into clinics. Ques-
tion domains will include, but are not limited to, patient comfort, patient’s perceived level of 
involvement, researcher’s ease of use, and both patient/provider confidence in the scan/im-
pression producing an appropriate earmold.  
5 Objectives and hypotheses of the clinical investigation 
5.1 Purpose of the clinical investigation claims for clinical performance, ef-
fectiveness or safety of the investigational device that are to be verified 
The purpose of this study is to better understand the value drivers behind the 
. 
The study intends to find any significant difference in the time it takes to complete the workflow 
of the 
 3D ear scanner impressions, compared to a traditional silicone earmold 
impression (EMI). A secondary purpose of this study is to identify preferences between the 
 and traditional methods, for both patients and providers. This information will allow 
us to find out whether this is a viable piece of equipment for Audiological Care clinics. 
5.2 Primary and Secondary Objectives 
The Primary objective is to identify any significant differences in the time required for a provider 
to complete the workflow of an 
 3D ear scanner, compared to traditional silicone ear-
mold impression procedures. The secondary objective is to identify any significant preferences 
for both providers and patients. 
5.3 Scientific justification and clinical relevance for effect sizes, non-inferior-
ity margins or equivalence limits 
This is an exploratory trial, and as such, no specific effect size, non-inferiority margin, or equiv-
alence limit is applicable. 
5.4 Safety Objectives  
There are no risks or anticipated adverse device effects to be assessed for this investigation. 
5.5 Hypothesis 
The study is exploratory in nature and will be used to further develop further hypotheses. The 
purpose of this study is to better understand the value drivers behind the 
. The 
study intends to find any significant difference in the time it takes to complete the workflow of 
the 
 3D ear scanner impressions, compared to a traditional silicone earmold 
impression (EMI). A secondary purpose of this study is to identify preferences between the 
 and traditional methods, for both patients and providers. This information will allow 
us to find out whether this is a viable piece of equipment for Audiological Care clinics. 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 13/26 
6 Design of the clinical investigation 
6.1 General 
6.1.1 Design Type 
This observational study will have two conditions (
 3D ear scanner and a control con-
dition - traditional silicone impression procedure) across a sample population of 30 human 
subjects. The order of conditions will be counterbalanced and blinding is not applicable. 
6.1.2 Measures for minimizing bias 
Conditions will be counterbalanced across participants. In addition, three research audiolo-
gists will be involved in data collection in order to better represent the skill level of an average 
provider. 
6.1.3 Endpoints with rationale for their selection and measurement 
To satisfy the primary objective, the entirety of the procedural workflow will be captured using 
a stop watch (mm:ss) for both conditions, in order to have a direct measure of the timing 
component of the investigation. To satisfy the secondary objective, subjective questionnaires 
will be administered to answer questions relevant to incorporating this product into clinics. 
Question domains will include, but are not limited to, patient comfort, patient’s perceived level 
of involvement, researcher’s ease of use, and both patient/provider confidence in the scan/im-
pression producing an appropriate earmold. 
6.1.4 Methods and timing for assessing, recording, and analyzing variables 
To satisfy the primary objective, the entirety of the procedural workflow will be captured using 
a stop watch (mm:ss) for both conditions, in order to have a direct measure of the timing 
component of the investigation. To satisfy the secondary objective, subjective questionnaires 
will be administered to answer questions relevant to incorporating this product into clinics. 
Question domains will include, but are not limited to, patient comfort, patient’s perceived level 
of involvement, researcher’s ease of use, and both patient/provider confidence in the scan/im-
pression producing an appropriate earmold. 
6.1.5 Equipment to be used for assessing the clinical investigation variables 
and arrangements for monitoring maintenance and calibration. 
To satisfy the primary objective, the entirety of the procedural workflow will be captured using 
a stop watch (mm:ss) for both conditions, in order to have a direct measure of the timing 
component of the investigation. To satisfy the secondary objective, subjective questionnaires 
will be administered to answer questions relevant to incorporating this product into clinics. 
Question domains will include, but are not limited to, patient comfort, patient’s perceived level 
of involvement, researcher’s ease of use, and both patient/provider confidence in the scan/im-
pression producing an appropriate earmold. 
6.1.6 Any procedures for the replacement of participants (not applicable to ran-
domized clinical investigations  
In the event of attrition, a rolling recruitment approach may take place in order to maintain 
adequate power of the investigation.  
6.1.7 Clinical investigation sites  
PARC, 750 North Commons Drive, Aurora, IL 60504 
6.1.8 Definition of completion of the clinical investigation 
The clinical investigation is considered complete when the study report has been reviewed 
and approved by the appropriate authorities. 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 14/26 
6.2 Investigational device(s) and comparator(s) 
Description of the exposure 
to the investigational de-
vice(s)  
For each subject, the investigational device (
 3D ear 
scanner) will have an exposure time of approximately 15 mi-
nutes, or the length of time it takes to complete a 3D ear scan 
in its entirety. 
Description of the exposure 
to the comparator(s), if used. 
For each subject, the comparator (silicone earmold impres-
sion procedure) will occur for approximately 15 minutes, or 
the length of time it takes to complete a traditional silicone 
earmold impression.  
List of any other medical de-
vice to be used during the 
clinical investigation (if appli-
cable) 
N/A 
Number of investigational 
devices to be used, and jus-
tification 
1 – The investigational device can be reused and sanitized 
between subjects in accordance with the manufacturer rec-
ommendations. 
6.3 Participants 
Inclusion criteria for partici-
pant selection 
Adult aged (18+ years) and any degree of hearing loss. 
Exclusion criteria for parti-
cipant selection 
External auditory canal must be present and medically unre-
markable to facilitate impressions. Participants with surgical 
ears or without external auditory canals must be excluded. 
Criteria and procedures for 
participant withdrawal or 
lost to follow up 
During the consent process, participants agree to their in-
volvement being completely voluntary and they may withdraw 
at any time. A participant is immediately withdrawn if reques-
ted to be removed from the investigation. In addition, in the 
event of an adverse event, the investigation will be paused 
until the event is reviewed and it is deemed safe to continue 
the investigation. 
Attrition will be documented in an excel spreadsheet contai-
ning all collected data. 
In the event of attrition, a rolling recruitment may take place in 
order to maintain adequate statistical power of the investiga-
tion. 
Point of enrollment 
Following the manufacturer recommended training protocol 
for the investigatory device for all researcher involved in data 
collection. 
Point 
of 
randomization 
(if applicable). 
N/A, conditions will be counterbalanced during enrollment. 
Total expected duration of 
the clinical investigation 
Approximately 1 month 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 15/26 
Expected duration of each 
participant's participation 
Approximately 30 minutes 
Number of participants re-
quired to be included in the 
clinical investigation, and 
where needed anticipated 
distribution of enrolment 
among the participating 
clinical sites. 
30 subjects seen at PARC 
Estimated time needed to 
select this number (i.e. en-
rolment period). 
Approximately 2 weeks 
Relationship of investiga-
tion population to target 
population 
Investigation population will contain a variety of external audi-
tory canal sizes and shapes, relatable to the average patient 
without any external auditory canal anomalies. 
Information on vulnerable, 
pregnant and breastfeed-
ing population, if applica-
ble. 
N/A 
6.4 Procedures 
6.4.1 Investigation-related Procedure 
Three researchers will be facilitating these appointments to limit variability of re-
searcher skill across the two conditions. Researchers will familiarize themselves with 
the 
 equipment through independent practice prior to a training facili-
tated by 
(occuring April 23rd) and the researchers will follow 
training rec-
ommendations (perform scans on 20+ ears following in-person training) prior to data 
collection. Participants will be seen for one appointment. REUR/REUG, RECD, tym-
panometry, and reflex thresholds will be collected. The researcher will perform both 
traditional earmold impressions and 3D ear scans on both ears (conditions will be ran-
domized and counterbalanced across participants). An additional researcher will use 
a stop watch to quantify the time (mm:ss) it takes for each condition, for both ears. 
After each procedure, participants and the clinician will also be asked to complete a 
questionnaire regarding each condition, focusing on their perception of comfort and 
level of involvement throughout the impression taking. In the event that a clinician feels 
as though a silicone impression needs to be remade, this will be recorded on the clini-
cian questionnaire. Timing will be recorded for all attempts, but only the time recorded 
for the final impressions will be used in the data analysis. The resulting data will be 
compiled for all participants and analyzed using a T-test, to identify any significant dif-
ferences in the time it takes to complete each method of earmold impressions, in ad-
dition to any differences in perceptual comfort.  
The step by step processes for each procedure and corresponding time record-
ing are as follows: 
TIMING DETAILS 
Silicone EMI 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 16/26 
•
Introduction – “I will be taking some impressions of your ear canals. I will place this
foam block in each ear, before filling your canals with the silicone impression mate-
rial. It will take a few minutes to harden before I remove them. Due to the nature of
this study, I am going to ask you to hold any questions until after the procedure is
done, but do not hesitate to let me know if you are experiencing any discomfort
throughout the procedure.”
•
Have materials out and ready to go (impression cartridge in impression gun, box
folded together, but do not put a tip on the impression gun)
•
Otoscopy
•
Cerumen management if needed
•
Start timer
•
Tie off otoblocks
•
Place otoblocks bilaterally
•
Confirm otoblock placement with otoscopy
•
Put tip on impression gun
•
Administer impression material bilaterally
•
Check hardness of silicone every 30 seconds
•
Remove impressions when set
•
Inspect impressions for landmarks
•
Perform otoscopy
•
Put impressions in box
•
End timer
•
Administer questionnaires
•
Introduction – “I will be using this camera to take some scans of your ear canals. I will
place a headset on you and this probe will be inserted into your canal. You will be
able to view the procedure on the TV in front of you. Due to the nature of this study, I
am going to ask you to hold any questions until after the procedure is done, but do
not hesitate to let me know if you are experiencing any discomfort throughout the
procedure.”
•
Otoscopy
•
Start timer
•
Sanitize
tip and headset
•
Enter patient info
•
Hair management
•
Headset placement
•
Perform scans bilaterally
•
Inspect scans for landmarks
•
Press power button on screen to save scans
•
End timer
•
Administer questionnaires
IN THE EVENT THAT A CLINICIAN FEELS AS THOUGH THE IMPRESSION/SCAN IS UN-
SATISFACTORY TO SEND IN FOR A CUSTOM PRODUCT, THE PROCEDURE WILL BE 
REPEATED. THE TIMING OF ALL PROCEDURES WILL BE RECORDED ON THE TIMING 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 17/26 
RECORDS, AND REASON FOR REPEAT WILL BE CAPTURED IN THE CLINICIAN QUES-
TIONNAIRE. 
These timing details do not include setting up equipment (removing from drawers/cabinets, 
etc.), sending a silicone impression order through the eStore, or sending 
 scans to a 
manufacturer. One researcher (David) will take a one-time time recording of these processes 
and others that may be of interest, separate from data collection. 
6.4.2 Sponsor activities 
N/A 
6.4.3 Outcome comprising factors 
Inclusion/exclusion criteria, limiting bias with multiple researchers, uncertainty of how HL may 
influence subjective preferences, etc. 
Exclusion criteria has been designed to limit comprising factors due to participant anatomy. 
Multiple researchers will be administering appointments to limit researcher bias.  
6.5 Monitoring plan 
The extent and nature of monitoring appropriate for the clinical investigation including the 
strategy for source data verification (SDV) are based on considerations such as the objective, 
design, complexity, size critical data points and endpoints of the clinical investigation. A de-
tailed plan for monitoring arrangements is provided separately from this CIP (TPL-160). 
7 Statistical design and analysis 
The description of and justification for the statistical design and analysis of this clinical 
inves-tigation is in line with Chapters 5 and 6. 
7.1 Determination of Sample Size 
A priori sample size estimation was not performed for this investigation, as the investigation is 
exploratory and does not aim to confirm any effect with statistical significance and power. 
7.2 Statistical criteria of termination of trial 
This is an exploratory trial and will not have statistical criteria for termination. 
7.3 Planned Analyses 
The statistical analysis plan includes the methods and types of the analysis, the variables the 
data sets and the timeframe when the (interim) analysis is planned.  
7.3.1 Datasets to be analyzed, analysis population 
Total procedure time will be recorded in seconds. Each procedure time will be recorded along 
with the audiologist, the anonymous participant ID, the procedure methodology (i.e., scanning 
or traditional silicone impressions), and the ordinal number of the procedure for the given 
methodology by the respective audiologist. Qualitative data will be collected as a question, 
response, methodology, and anonymous participant ID. 
7.3.2 Primary Analysis 
Analysis of procedure time data will take place at the conclusion of the trial.  The intended 
analysis assumes a normally-distributed response variable.  As such, procedure times for 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 18/26 
each methodology will be tested for normality using a Shaprio-Wilk test.  If the data are nor-
mally distributed, additional analysis will proceed immediately.  If data are not normally distrib-
uted, transformation(s) may be performed on the data, as appropriate, to achieve an approxi-
mately normal distribution of the response data for further analysis.   
Data (raw or transformed, per above) will then be subjected to analysis via linear mixed effects 
modeling.  The model will be constructed to regress (raw or transformed) procedure time on 
a dummy variable of methodology (fixed effect), with a random effect of audiologist.  This 
model will allow the investigators to evaluate the relative difference in procedure time between 
the methodologies, while removing and separately evaluating the variance contributed by the 
audiologist undertaking the procedure.  
7.3.3 Secondary Analysis 
Qualitative data acquired via questionnaires will not be statically analyzed.  A cursory (i.e., 
visual) analysis of the “learning curve” for each audiologist may also be performed, but will not 
be included as a statistical analysis.  
7.3.4 Interim Analysis 
No interim analysis is planned during this trial. 
7.3.5 Safety Analysis 
No safety analysis is necessary as the procedures performed are within the scope of practice 
of the researchers and utilize publicly available equipment.  
7.3.6 Deviation(s) from the original statistical plan 
Deviations to the statistical plan will be captured and reported in an update to this document, 
with justification.  
7.4 Handling of missing data and drop-outs 
Participants with missing procedure time data for either or both methodologies will be excluded 
from statistical analysis entirely.  Missing qualitative data will not impact statistical analysis (as 
no statistical analysis is planned for qualitative data).  Drop-outs will not be replaced during 
this study.  Achieved statistical power will be calculated and documented if the planned sample 
size is not achieved.   
8 Quality Assurance and Control 
8.1 Data Handling and record keeping/ archiving 
Study data is recorded both with paper and with electronic Case Report Forms (p/eCRF). For 
each enrolled study participant a CRF is maintained. All CRFs are kept current to reflect the 
subject’s status at each phase during the course of study. Participants cannot be identified in 
the CRF by name or initials and birth date but an appropriate coded identification is used. All 
study team members are authorized for the CRF entries and it is assured that any authorized 
person can be identified both for pCRFs and eCRFs. If pCRFs are used, the investigator’s 
acronym as well as the subject ID is filled in and data are entered into an electronic file for 
analysis by the respective investigator and data get monitored by the assigned monitor. In 
case of a self-evident corrections, either the subject does it by himself or the investigator un-
dertakes the correction by crossing out the word/sentence with a single horizontal line and by 
adding the correction including his personal identifier and the date. 

 
ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 19/26 
 
8.1.1 Specifications of source documents 
Timing measures will be recorded for both procedures and any additional attempts. Data from 
questionnaires will be compiled, but not statistically analyzed. Other data includes source in-
take form and Noah packages containing tympanometry and reflex thresholds, RECD, and 
REUR data. 
8.1.2 Record keeping/ archiving 
All paper data will be stored in a locked filing cabinet at the Phonak Audiology Research Cen-
ter (PARC). All electronic data files will be encrypted and stored on secure research computers. 
All identifying data will be stored at PARC. De-identified data will be shared with production to 
cross-check the quality of scans/impressions, and with partners at Sonova Switzerland.  
8.2 Data management 
8.2.1 Procedures data review, database cleaning, queries 
During data collection of the investigation, physical copies of the data will be compiled and 
digitized by the study manager on a daily basis. Data will be reviewed for mis-entries or inac-
curacies as each data set is entered.  
The extent and nature of monitoring appropriate for the clinical investigation including the 
strategy for source data verification (SDV) are based on considerations such as the objective, 
design, complexity, size critical data points and endpoints of the clinical investigation. A de-
tailed plan for monitoring arrangements is provided separately from this CIP (TPL-160). 
8.2.2 Procedures for verification, validation and securing of EDC system 
Not applicable for this investigation. 
8.2.3 Procedures to maintain and protect participant privacy. 
The identifiable data kept at PARC will be destroyed as soon as the final analyses have been 
completed. The de-identified data will be kept for seven years after the publication of results. 
When the data are destroyed, paper records will be shredded by services provided at PARC. 
Electronic data will be encrypted as de-identified NOAH packages, where applicable, to be 
shared with Sonova Switzerland. 
8.2.4 Procedures for data retention. 
Digital records of anonymized data will be stored on company network drive. 
8.2.5 Specified retention period. 
Digital records will be archived for 7 years from date of acquisition. 
8.2.6 Other aspects of clinical quality assurance, as appropriate. 
Refer to LoESD for licensure, insurance status, and appropriate qualifications of researchers. 
9 Amendments to the CIP 
Amendments to the CIP, if necessary, will be updated with justification in this document. 
10 Deviations from clinical investigation plan 
Deviations from the CIP to protect the rights, safety and well-being of human participants un-
der emergency circumstances may proceed without prior approval of the sponsor and the EC 

 
ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 20/26 
 
– such deviations will be documented and reported to the sponsor representative (Investiga-
tion Manager) and the EC as soon as possible. Apart from that the investigator is not allowed 
to deviate from this CIP unless that deviation does not influence the investigation data. 
10.1 Procedures for recording, reporting and analyzing CIP deviations 
Each deviation from the CIP will be documented including date of protocol deviation, name of 
investigator, participant ID, affected visit (if applicable), reason for deviation and anticipated 
influence on investigation data. 
10.2 Notification requirements and time frames 
Each deviation needs to be reported to the Sponsor (= Study Manager) and depending on the 
severity, also to the IRB 
For locations under WCG IRB approval (Canada/US): For protocol deviations, reporting to 
WCG IRBs (including WIRB) is required only for deviations that harmed a subject or placed 
subject at risk of harm or a deviation made without prior IRB approval to eliminate an immedi-
ate hazard to a subject within 5 days. 
(Source: WCG IRB Investigator Guidance: Prompt Reporting Requirements (HRP-071)) 
10.3 Corrective and preventive actions and principal investigator disqualifica-
tion criteria 
The Sponsor may disqualify a clinical investigator if the clinical investigator has repeatedly or 
deliberately failed to comply with applicable regulatory requirements or the clinical investigator 
has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to 
the Ethics Review Board or Competent Authority, in any required report. 
11 Device accountability 
 
11.1 Accountability for investigational device 
The PI or authorized designee keep records documenting the following in a written process: 
• 
Names of participants who received, used, returned, or disposed of device 
• 
Date of receipt, identification, and quantity of each investigational device (batch/serial 
number or unique code) 
• 
Expiry date (if applicable) 
• 
Date(s) of use 
• 
Participant identification 
11.2 Return of investigational device 
The PI or authorized designee keep records documenting the following in a written process: 
• 
Date on which the device was returned (if applicable) 
• 
Date of return of unused, expired, or malfunctioning investigational devices (if applica-
ble) 

 
ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 21/26 
 
• 
Date and documentation of disposal of devices as per sponsor instructions (if applica-
ble) 
12 Statements of compliance 
The clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki (Declaration of Helsinki, 2018). 
The Clinical investigation will be in compliance with the ISO 14155 (ISO_14155, 2020) and 
the following national and regional (if applicable) regulations: N/A 
The clinical investigation will not begin until the required approval/ favorable opinion from the 
EC and regulatory authority (if applicable) have been obtained, (To be checked, if appropriate). 
Any additional requirements imposed by the EC or regulatory authority will be followed. (To 
be checked, if appropriate). 
• 
This clinical investigation is covered with the following insurance:  
 
 
• 
Professional liability insurance from HPSO 
o 
 
 
This investigation is solely financed by Sonova AG and will be conducted internally. 
13 Informed consent process 
13.1 Process for obtaining informed consent  
At the beginning of the first appointment, investigators will hand the consent form to the par-
ticipant in a private setting and grant sufficient time to read the whole form. The consent form 
contains detailed information about incentives and reimbursement. Any questions will be an-
swered and the participant will be given sufficient time to decide whether or not they want to 
participate in the study. After the participant signed two copies of the consent form, the re-
searcher will sign both copies as well and provide one copy to the participant. 
In case of changes to the procedures described in the consent form, the participant will be 
informed at the beginning of an appointment. 
13.2 Process for obtaining informed consent in emergency situations 
 
This Chapter is not applicable for this investigation. Informed Consent will only be obtained by 
investigation participants who can provide informed consent themselves before enrollment.  
14 Adverse events, adverse device effects and device deficiencies 
Device deficiencies and all adverse events (AE) including all serious adverse events (SAE) 
are collected, fully investigated and documented in the source document and appropriate case 
report form (CRF) during the entire investigation period, i.e. from participant’s informed con-
sent until the last protocol-specific procedure, including a safety follow-up period (ISO_14155, 

 
ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 22/26 
 
2020). Documentation includes dates of event, treatment, resolution, assessment of serious-
ness and causal relationship to device and/or investigation procedure. 
Information on AEs is systematically collected during the regular investigation visits, and 
phone calls (if applicable). 
14.1 Definition and Assessment of Adverse Events and other safety related 
events 
14.1.1 Adverse Events (Definition) 
An adverse event is an untoward medical occurrence, unintended disease or injury, or unto-
ward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device (ISO_14155, 2020) 
• 
Note1: this definition includes events related to the investigational medical device or the 
comparator. 
• 
Note2: This definition includes events related to the procedures involved. 
• 
Note3: For users or other persons, this definition is restricted to events related to the use 
of investigational medical device 
14.1.2 Serious Adverse Event 
A SAE is an AE that led to any of the following 
a) death 
b) serious deterioration in the health of the subject, users or other persons as defined by one 
or more of the following 
• 
life-threatening illness or injury, or 
• 
permanent impairment to a body structure or a body function including chronic dis-
eases, or 
• 
in-patient hospitalization or prolongation hospitalization, or 
• 
medical or surgical intervention to prevent life-threatening illness or injury or perma-
nent impairment to a body structure or a body function 
c) foetal distress, foetal death or a congenital abnormality or birth defect 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the Clin-
ical Investigation Plan, without serious deterioration health, is not considered a serious ad-
verse event (ISO_14155, 2020) 
14.1.3 Adverse Device Effect 
An adverse device effect, is an adverse event related to the use of an investigational medical 
device (ISO_14155, 2020) 
• 
Note: This definition includes AEs resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or preparation, or any malfunction of the inves-
tigational medical device. 
• 
Note: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device  

 
ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 23/26 
 
14.1.4 Health hazards 
Health hazards are findings in the trial that may affect the safety of investigation participants 
and, which require preventive or corrective measures intended to protect the health and safety 
of investigation participants SAE 
14.1.5 Device Deficiencies (Definition) 
A Device Deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety or performance (ISO_14155, 2020) 
• 
Note: Device deficiency include malfunctions, use errors, and inadequacy in the infor-
mation supplied by the manufacturer including labelling 
• 
Note: This definition includes device deficiencies related to the investigational medical de-
vice or the comparator  
14.1.6 Causal relationship of SAE 
A causal relationship towards the medical device or investigation procedure should be rated 
as follows: 
Not related: The relationship to the device or procedures can be excluded. 
Unlikely: The relationship with the use of the device seems not relevant and/or the event can 
be reasonably explained by another cause, but additional information may be obtained. 
Possible: The relationship with the use of the investigational device is weak but cannot be 
ruled out completely. Alternative causes are also possible. 
Probable: The relationship with the use of the investigational device seems relevant and/or 
the event cannot be reasonably explained by another cause. 
Causal relationship: The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt. 
Device deficiencies that might have led to an SAE are always related to the medical device. 
14.2 Foreseeable adverse events and anticipated adverse device effect 
 
Table 2: List of foreseeable adverse events and anticipated adverse device effects 
Polarion 
[Risk ID] 
Foreseeable AE 
Anticipated 
ADE 
Likely incidence 
Mitigation 
or 
treatment 
N/A 
Patient 
Discom-
fort 
N/A 
Likeliness is limited 
Training 
N/A 
Tympanic Memb-
rane Perforation 
N/A 
Unlikely 
Training, within 
scope of practice 
of researchers 
N/A 
Skin Sensitivity 
N/A 
Unlikely 
Training to limit 
time of contact 
with equipment 
N/A 
Skin Abrasion and 
Irritation 
N/A 
Unlikely 
Training, within 
scope of practice 
of researchers 
 

 
ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 24/26 
 
No serious adverse event that could be related to the investigational device or investigation 
procedures are expected during this clinical investigation. 
14.3 Non-reportable adverse events 
Table 3: List of all non-reportable AEs including rational 
Non-reportable AEs 
Rationale 
N/A 
The investigation is a one time appointment 
lasting approximately an hour. An event that 
happens during this investigation would not 
be reported if it is deemed unrelated. If in 
event does occur, it is likely unrelated due to 
the short timeframe of the investigation. 
 
14.4 Reporting of Adverse Events and Device Deficiencies 
14.4.1 Reporting time frame 
Table 4: Overview of time period in which the PI reports AEs and Device Deficiencies to Investigation Manager, 
Ethics Commission and Competent Authority 
 
Investigation 
Manager 
Ethics Commission Competent Authority 
Adverse Events 
1-2 Days 
5 Days 
N/A 
Serious 
Adverse 
Events 
1-2 Days 
5 Days 
N/A 
Health hazards that 
require measures 
1-2 Days 
5 Days 
N/A 
Device 
Deficien-
cies 
1-2 Days 
5 Days 
N/A 
 
14.4.2 Reporting Procedure 
In the event of an adverse event, the investigation manager will make contact with the principal 
investigator within 24 hours to align on reporting procedures, as outlines above in 14.4.1, and 
to evaluate the relationship of the investigational device and the related procedure.  
In the event of a serious adverse event, this will be reported to the FDA using Reporting Form 
FDA 3500, or by telephone at 1-800-FDA-1088. 
14.5 Follow up of (Serious) Adverse Events 
The investigation manager will follow up as recommended by the FDA. 
15 Vulnerable population (if applicable) 
15.1 Description of the vulnerable population to be included in the clinical in-
vestigation. 
The investigation does not include any vulnerable populations. 
15.2 Description of the specific informed consent process. 
Not applicable, as this investigation does not include any vulnerable populations. 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 25/26 
15.3 Description of the EC's specific responsibility. 
Not applicable, as this investigation does not include any vulnerable populations. 
15.4 Description of what medical care, if any, will be provided for participants 
after the clinical investigation has been completed. 
Not applicable, as this investigation does not include any vulnerable populations. 
16 Suspension or premature termination of the clinical 
investigation 
16.1 Criteria and arrangements for suspension or premature termination of the 
whole clinical investigation or of the clinical investigation in one or more 
investigation sites. 
The clinical investigation will be suspended or prematurely terminated if the participants or 
researchers are exposed to safety risks other than those outlined in this document. These 
events may include but are not limited to – natural disaster, widespread outbreak of illness, 
compromised structure of the investigation site, etc.  
16.2 Criteria for access to and breaking the blinding/masking code in the case 
of suspension or premature termination of the clinical investigation, if the 
clinical investigation involves a blinding/masking technique. 
Not applicable to this investigation, as there is no blinding/masking code. 
16.3 Requirements for participant follow-up. 
Due to the short nature of this investigation, there are no requirements for participant follow-
up. 
17 Publication policy 
The clinical investigation will be registered in clinicaltrials.gov, a publicly accessible database, 
as required by United States national law. 
The results of the clinical investigation will be published internally in the format of a study 
report. 
The investigation will be published June 2021 by David Taylor, Au.D. 
18 Bibliography 
Declaration of Helsinki. (2018, July 9). Retrieved September 17, 2020, from www.wma.net: 
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
medical-research-involving-human-participants/ 
ISO_14155. (2020, 07). ISO 14155 Clinical Investigation of medical devices for human 
participants -Good clinical practice. ISO 14155 Clinical Investigation of medical 
devices for human participants -Good clinical practice. International Organization for 
Standardization. 

ID: PDL-8319 
Version: <Do not edit> 
Clinical Investigation Plan (CIP) 
SRF-371 
Confidential and proprietary. 
This document and its contents are confidential and proprietary to Sonova and shall not be reproduced or otherwise disclosed 
to anyone other than Sonova employees without written authorization from Sonova. 
This printout is an uncontrolled copy. The original is stored in the Document Management System 
Template: TPL-368 [2] 
Page 26/26 
19 Tables 
19.1 Table of Tables 
Table 1: Summary of all clinically relevant residual risks. .....................................................11 
Table 2: Summary of all controls taken to mitigate the risks of the product related residual 
risks. ................................................................................................................................... 11 
Table 4: List of foreseeable adverse events and anticipated adverse device effects ........... 23 
Table 5: List of all non-reportable AEs including rational ..................................................... 24 
Table 6: Overview of time period in which the PI reports AEs and Device Deficiencies to 
Investigation Manager, Ethics Commission and Competent Authority ................................. 24 
19.2 Table of Figures 
No table of figures entries found. 
19.3 Abbreviations 
CIP 
Clinical Investigation Plan 
e.g.
EMI
Example given 
Earmold Impression 
FDA
Food and Drug Association 
GCP
Good Clinical Practice 
ISO
International Organization for Standardization 
N/A
PARC
Not applicable 
Phonak Audiology Research Center 
PI
Principal Investigator 
TPL
Template 
US
United States