Benefits of an Assistive Listening Device for Speech Intelligibility in Noise
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

Study Protocol and Statistical Analysis Plan 
 
 
Benefits of Roger for speech intelligibility 
 
 
Version 1 
11.26.2021 
 
NCT05072470 
 
 
 
 
 
 
 
 
 
 

Benefits of Roger for speech intelligibility 
 
1 Background 
While satisfaction with modern hearing aids is generally high, nearly one third of hearing aid 
users report that they continue to struggle with following conversations in noise (Picou, 
2020). For these listeners, or for particularly noisy listening situations, the use of a Roger 
device in addition to hearing instruments can further improve speech understanding, thereby 
mitigating residual difficulty in complex listening environments. For example, Thibodeau 
(2019) found that the use of a Roger microphone yielded significantly better speech 
recognition performance on the Hearing-in-Noise Test (HINT), compared with hearing aids 
alone. Further, the results of this study demonstrated that listeners received a greater benefit 
from a Roger microphone with multibeam technology (Roger Select) than from one lacking 
multibeam technology (Roger Pen) in the most difficult listening conditions tested (-5 and -10 
dB SNR). This would suggest that Roger technology that incorporates directionality - 
specifically, multibeam technology - is particularly beneficial for understanding speech in 
complex listening environments. The Roger On builds upon previous technology, 
implementing a spatial multibeam strategy. Briefly, the multibeam strategy available in the 
Roger Select uses three omnidirectional microphones to create six directional beams spaced 
60° apart; MultiBeam technology analyzes the signal-to-noise ratio (SNR) of each directional 
beam and automatically accentuates the signal in the beam with the highest SNR averaged 
over time (Gigandet et al., 2018). The spatial multibeam function in the Roger On advances 
this technology by applying head-related transfer function (HRFT) filters to each of the 
beams, such that the spatial cues are preserved in the amplified signal. The present study 
will investigate the benefit of the Roger On device as a whole for speech intelligibility, relative 
to hearing aids alone. It is expected that similar benefit for speech understanding in complex 
listening environments will be observed for the Roger On, relative to performance without the 
Roger One device, in the present study.  
2 Objectives 
The primary objective of this study is to demonstrate an improvement in speech intelligibility 
in noise with the use of a Phonak Roger On remote microphone system compared to the use 
of hearing aids alone for a group of adults with moderate to severe hearing loss. There is no 
secondary objective. 
3 Description of the investigational device 
The intended purpose of the investigational device (i.e., Roger On) in the proposed clinical 
investigation is to pick up the voice of a talker and send it directly to the listener’s ears. There 
are four main use cases for Roger On: (1) table mode, in which the Roger On device is 
placed on a table to hear the voices of people sitting around the microphone; (2) pointing 
mode, in which the listener holds the microphone in the direction of the person they want to 
hear; (3) presenter mode, in which the microphone is hung from a lanyard around the neck of 
(or clipped to the lapel of) a distant talker; and (4) TV/multimedia mode, in which the 
microphone is connected to a television or another audio source and the output is streamed 
directly into the listener’s ears. In the proposed clinical investigation, Roger On will be used 
only in table mode. 
 
The intended purpose of the Audéo P hearing aids (compatible devices to the Roger On) is 
to amplify and transmit sound to the ear and thereby compensate for impaired hearing. In 
this clinical investigation, the primary endpoint will be assessed with the compatible devices 
alone (Audéo P90 alone) and with the investigational device paired with the compatible 
devices (Audéo P90 + Roger On). When worn alone, the compatible devices amplify inputs 

to the hearing aid microphones and transmit sound to the ear and thereby compensate for 
impaired hearing. When paired with the investigational device, the compatible devices 
receive the input from the investigational device, combine it with the signal from the hearing 
aid microphones (using default gain settings and mixing ratio prescribed by Phonak Target 
software), and transmit this blended signal to the ear. 
4 Design of the clinical investigation 
This clinical investigation is a single-site, interventional study with a confirmatory design. 
Neither experimenters nor participants are blinded to the intervention (Audéo P90 + Roger 
On, Audéo P90 alone) as the display on the Roger On device indicates whether it is on or off. 
Covering the display would prevent the experimenter from confirming that the device is in the 
appropriate setting for each run. No control group is used for this investigation, as the 
objective is to quantify the benefit of remote microphone technology over hearing aids alone 
for individuals with moderate to severe hearing loss. Previous research conducted by 
Sonova has revealed that, under certain conditions, Phonak Roger technology may yield a 
benefit for speech understanding in noise and over distance beyond the performance of 
listeners with normal hearing. Thus, testing a normal-hearing control group would not 
necessarily indicate what level of performance should be expected. 
5 Risks and benefits of the investigational device and clinical 
Investigation 
It is unlikely that participants will have any direct benefit from taking part in this study, as the 
state-of-the-art investigational devices and compatible devices will be used only for a short 
amount of time during laboratory testing. However, this study has been approved by the 
study site IRB as a non-significant risk study. Thus, while the likelihood of benefiting from 
participating in this clinical investigation low, risks associated with study participation are also 
low. 
6 Endpoints 
Speech intelligibility in noise, measured using the AzBio Sentence Test in percent correct is 
the primary clinical endpoint of this clinical investigation for the comparison of the 
intervention conditions Audéo P90-R + Roger On vs. Audéo P90-R. This endpoint will be 
measured in three listening conditions of varying difficulty: -5, 0, and +5 dB SNR. 
This clinical endpoint was chosen to obtain clinical data that shows the clinical benefit of the 
Roger On device. The intended purpose of the investigational device (i.e., Roger On) is to 
pick up the voice of a talker and send it directly to the listener’s ears, in order to improve 
speech understanding in noise and over distance. The measurement of speech intelligibility 
in diffuse noise was selected as primary endpoint because this is one of the primary use 
cases for Roger technology. 
7 Inclusion and Exclusion Criteria 
Inclusion criteria for participant selection:  
1. Hearing impaired adults (minimum age: 18 years) who are experienced hearing aid 
users 
2. Hearing loss is symmetric (no more than a 15 dB difference between the right and left 
ears at three contiguous frequencies) and moderate to severe in degree (N3-N5 
standard audiogram) 
3. Good written and spoken English language skills 
4. Healthy outer ear (confirmed by otoscopy) 
5. Informed consent as documented by signature 
 
Exclusion criteria for participant selection: 

1. Contraindications to the medical device noted upon otoscopy (e.g., ear canal 
drainage) 
2. Known hypersensitivity or allergy to materials of the investigational device or 
compatible device 
3. Inability to produce reliable test results 
4. Known psychological problems 
5. Reported symptoms of vertigo and dizziness by participant 
8 Measurements and procedures 
Pure-tone audiometry 
Pure-tone audiometry is the gold standard measurement for assessing a person’s hearing 
status. This involves measuring the threshold of hearing (i.e., the lowest level of sound that 
can be detected at least 50% of the time) at the frequencies most important for 
understanding speech (.25-8kHz) and recording these thresholds on an audiogram. Bone 
conduction thresholds are measured using a bone oscillator, and provide information about 
the integrity of the cochlea (organ of permanent hearing) and retrocochlear pathway by 
bypassing the outer and middle ears. Air conduction thresholds are measured using 
headphones or insert earphones, and thus assess the entire auditory pathway. 
In this investigation, study candidacy will be determined based on potential participants’ 
audiograms from previous clinical appointments within the past one year prior to enrollment. 
Real Ear Measurement (REM) 
Real-Ear Measurement (REM) is a tool used to objectively measure the hearing instrument’s 
frequency response in a participant’s ear. In this clinical investigation, on-ear REM will be 
completed using the Verifit2. 
First, the participant’s hearing thresholds will be entered into the Verifit2 and the appropriate 
hearing aid fitting formula (DSL v5, NAL-NL1, NAL-NL2) will be selected. Based on these 
entries, the software will determine the appropriate amplification targets. In this clinical 
investigation, the fitting formula that the participant’s current hearing aids have been fit to will 
be selected. For most participants, this is the NAL-NL2 formula, as this is the most common 
fitting protocol used in a clinical adult population. 
Next, a soft silicone probe tube will be placed in the participant’s ear canal. The tip of the 
probe tube is placed in the participant’s ear canal, past the end of the hearing aid receiver or 
sound bore, ideally ~2mm away from the participant’s eardrum. The silicone probe tube is 
attached to a microphone that sits just outside the participant’s ear. 
The participant will be seated in front of a loudspeaker at a distance of 0.5-1 m. The 
International Speech Test Signal (ISTS) speech signal will be presented from the 
loudspeaker at 50 dB, 65 dB and 80 dB. This signal will be recorded with the probe tube 
placed in the participant’s ear, and the microphone just outside the participant’s ear. In this 
way, the measurement is used to validate a hearing aid fitting at the participant’s ear since it 
considers all relevant factors like direct sound, hearing aid output, and the individual anatomy 
of the participant’s ears. This method is also used indicate the quality of the hearing aid fitting 
i.e. if the hearing aid provides enough amplification in the specific frequencies, based on the 
targets prescribed by the fitting formula. 
Real ear measurement will be completed after hearing aid fitting and before the 
administration of study tasks. 
 
Speech Intelligibility in Noise 
Participants will be seated 2 m away from a loudspeaker positioned at 0 azimuth; the Roger 
On device will be placed on a table in front of the participants, 1 m away from the same 
loudspeaker. 
AzBio sentences will be presented one at a time from the loudspeaker at a level of 65 dBA, 
measured at the location of the participant’s head (i.e., 2 m from the loudspeaker). 
Multi-talker babble noise will be presented from two loudspeakers in the front corners of the 
testing room. Speakers will be rotated away from the center of the room in order to create a 
background of diffuse noise. The noise will be calibrated at the same location as the speech, 

to the appropriate level for the given condition – that is, 60 dBA for the +5 dB SNR condition, 
65 dBA for the 0 dB SNR condition, and 70 dBA for the -5 dB SNR condition. 
Participants will be instructed to repeat as much of each sentence as they can understand. 
For each sentence, the investigator will indicate the number of words correctly repeated. 
Proportion/percent of words correctly repeated for each list of sentences indicates speech 
intelligibility in noise performance. 
Participants will complete this task in each intervention condition (Audéo P90 + Roger On, 
Audéo P90 alone) and in each listening condition (-5, 0, and +5 dB SNR). 
Speech intelligibility in noise will be completed following hearing aid fitting and REM. 
9 Statistical design and analysis 
Determination of Sample Size 
In a previous investigation of Roger technology (Thibodeau, 2019), significant benefit of 
Roger, compared to hearing aids alone, was observed for speech intelligibility performance 
in a cohort of 10 adults. Thus, 10 adults will be recruited to participate in this clinical 
investigation. Additional participants may be recruited if preliminary results of speech 
intelligibility reveal higher intersubject variability than observed in previous studies, or if 
participants withdraw or must be excluded. 
Statistical criteria of termination of trial 
No a priori statistical criteria will be used to determine the termination of the trial. However, 
the trial may be terminated prior to the completion of all planned data collection if a 
statistically significant effect of the intervention is observed and no additional participants are 
able to be recruited. 
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. 
Datasets to be analyzed, analysis population 
Speech intelligibility in noise performance will be recorded in proportion of words correctly 
repeated within each intervention condition (Audéo P90 + Roger On, Audéo P90 alone) in 
each listening condition (-5, 0, +5 dB SNR) for each anonymized participant. 
Primary Endpoint Analysis 
Primary analysis of study data will be completed at the conclusion of the data collection 
period by a representative of the sponsor (study manager). The results of the speech 
intelligibility task will be subjected to multivariate analyses of variance (MANOVA) to examine 
main and interaction effects of intervention. 
Secondary Endpoint Analysis 
If main or interaction effects are observed on MANOVA, post hoc tests will be used to 
examine differences in mean speech intelligibility performance across intervention for each 
listening condition. These post hoc tests will be completed at the conclusion of the data 
collection period by a representative of the sponsor (study manager). 
Interim Analysis 
Interim analysis (MANOVA) will be completed on a rolling basis by a representative of the 
sponsor (study manager). This will be done to monitor study results as participants are 
enrolled and tested to determine whether inclusion criteria should be adjusted to include 
more participants to ensure an adequately powered study. 
Safety Analysis 
All safety related events will be constantly monitored by the investigators and will 
immediately reported to the Principle Investigator and representative of the study sponsor 
(study manager). Evaluation of any SAE, SADE, or UADE will be conducted promptly by the 
study manager using Sonova’s standard medical device referral protocol. Confirmed UADEs 
will be reported to the IRB within 10 days after receiving notice of the event. If it is 
determined that an event or effect presents an unreasonable risk to subjects, this study, or 
those parts of the study presenting that risk, will be terminated no later than 5 working days 
after the determination is made and no later than 15 working days after Sonova USA first 
received notice of the event. 

A s af et y a n al y si s of t h e r el e v a nt d at a will b e c o m pl et e d at t h e c o n cl u si o n of t h e d at a 
c oll e cti o n p eri o d.  
D e vi ati o n( s) fr o m t h e ori gi n al st ati sti c al pl a n  
D e vi ati o n s t o t h e st ati sti c al pl a n will b e c a pt ur e d a n d r e p ort e d i n a n u p d at e t o t hi s d o c u m e nt,  
wit h j u stifi c ati o n.  
H a n dli n g of mi s si n g d at a a n d dr o p -o ut s  
S h o ul d p arti ci p a nt s wit h dr a w fr o m t h e st u d y or b e l o st t o f oll o w u p pri or t o c o m pl eti o n of all  
st u d y t a s k s a n d/ or c o n diti o n s, n o eff ort will m a d e t o c o m p ut e w h at t h eir p erf or m a n c e w o ul d  
h a v e b e e n i n t h e i n c o m pl et e t a s k s/ c o n diti o n s. R at h er, t hi s will b e tr e at e d a s mi s si n g d at a.  
Dr o p -o ut s will n ot b e r e pl a c e d, h o w e v er, a d diti o n al p arti ci p a nt s m a y b e r e cr uit e d/ e nr oll e d, 
d e p e n di n g o n a v ail a bilit y of v ol u nt e er s.  
1 0  I n v esti g ati o n D ur ati o n  
T ot al e x p e ct e d d ur ati o n of t h e cli ni c al i n v e sti g ati o n: 2 m o nt h s  
E x p e ct e d d ur ati o n of e a c h p arti ci p a nt’ s p arti ci p ati o n: ≤ 2 h o ur s  
1 1  D at a H a n dli n g a n d M a n a g e m e nt  
C a s e R e p ort F or m s ( C R F)  
Cli ni c al i n v e sti g ati o n d at a will b e r e c or d e d b ot h wit h p a p er C a s e R e p ort Fr o m ( p C R F) a n d  
el e ctr o ni c C a s e R e p ort F or m ( e C R F). A C R F will b e m ai nt ai n e d f or e a c h e nr oll e d cli ni c al 
i n v e sti g ati o n p arti ci p a nt. All C R F s will b e k e pt c urr e nt t o r efl e ct t h e p arti ci p a nt’s st at u s at 
e a c h p h a s e d uri n g t h e c o ur s e of t hi s cli ni c al i n v e sti g ati o n. P arti ci p a nt s will b e i d e ntifi e d i n  t h e 
C R F b y a n a p pr o pri at e c o d e d i d e ntifi c ati o n ( p arti ci p a nt I D). All cli ni c al i n v e sti g ati o n t e a m 
m e m b er s ar e a ut h ori z e d f or t h e C R F e ntri e s a n d it will b e a s s ur e d t h at a n y a ut h ori z e d 
p er s o n c a n b e i d e ntifi e d b ot h f or p C R F s a n d e C R F s. If p C R F s will b e u s e d , t h e i n v e sti g at or’s 
i d e ntifi er a s w ell a s t h e p arti ci p a nt I D will b e fill e d i n a n d d at a ar e e nt er e d i nt o a n el e ctr o ni c 
fil e f or a n al y si s b y t h e r e s p e cti v e i n v e sti g at or. D at a will b e m o nit or e d b y t h e a s si g n e d 
m o nit or. P arti ci p a nt s ar e all o w e d t o s elf -c orr e ct. I n v e sti g at or s d o n ot m a k e a n y c orr e cti o n s 
wit h o ut d o c u m e nt ati o n (i. e., fr o m el e ctr o ni c r e c or d s fr o m s oft w ar e o ut p ut).  
S p e cifi c ati o n s of s o ur c e d o c u m e nt s  
S o ur c e d at a ar e a v ail a bl e at t h e i n v e sti g ati o n sit e t o d o c u m e nt t h e e xi st e n c e of t h e cli ni c al  
i n v e sti g ati o n p arti ci p a nt s. T h e s o ur c e d at a ar e d o c u m e nt e d i n t h e f oll o wi n g s o ur c e 
d o c u m e nt s:  
 P arti ci p a nt i nf or m ati o n i n cl u di n g I nf or m e d C o n s e nt F or m  
 A u di o m etri c d at a ( el e ctr o ni c d o c u m e nt o n p a s s w or d -pr ot e ct e d cli ni c al d at a b a s e)  
 L at er ali z ati o n a n d s p ati al  h e ari n g t a s k r e s ult s  
 S u bj e cti v e c o m m e nt s r e g ar di n g i n v e sti g ati o n al d e vi c e (if a n y)  
 C o m p e n s ati o n R e c or d F or m  
 A d v er s e E v e nt a n d D e vi c e D efi ci e n c y F or m  
S o ur c e d at a w hi c h ar e c oll e ct e d o n p a p er C R F s ar e tr a n sf err e d t o e C R F s b y t h e r e s p e cti v e  
i n v e sti g at or. T h e p C R F s s o ur c e d o c u m e nt s ar e st or e d i n t h e i n v e sti g at or sit e fil e (I S F). 
R e c or d k e e pi n g/ ar c hi vi n g  
A n y h ar d c o pi e s of t h e s o ur c e d o c u m e nt ati o n will b e st or e d i n a l o c k e d c a bi n et a n d k e pt f or a  
mi ni m u m of 3 y e ar s aft er r e g ul ar or pr e m at ur e t er mi n ati o n of t h e cli ni c al i n v e sti g ati o n. 
El e ctr o ni c d at a fil e s will r e si d e o n a n et w or k dri v e or s e c ur e s er v er t h at i s a c c e s si bl e t o t h e 
cli ni c al i n v e sti g ati o n t e a m. S er v er s ar e l o c at e d i n U S. H e n c e, o nl y e n c o d e d d at a will b e 
st or e d o n s er v er s, w hi c h will n ot i n cl u d e p er s o n al d at a i n a n y m e a n s. N o t hir d p art y will b e 
a bl e t o tr a c e b a c k t h e e n c o d e d d at a t o p er s o n al i nf or m ati o n of t h e p arti ci p a nt s. All i d e ntif yi n g 
d at a will b e st or e d at t h e st u d y sit e.  
 

Pr o c e d ur e s t o m ai nt ai n a n d pr ot e ct p arti ci p a nt pri v a c y.  
T h e S p o n s or a n d Pri n ci p al i n v e sti g at or affir m a n d u p h ol d t h e pri n ci pl e of t h e p arti ci p a nt' s 
ri g ht t o pri v a c y a n d t h at t h e y s h all c o m pl y wit h a p pli c a bl e pri v a c y l a w s. E s p e ci all y, a n o n y mit y 
of t h e p arti ci p a nt s s h all b e g u ar a nt e e d w h e n pr e s e nti n g t h e d at a at s ci e ntifi c  m e eti n g s or 
p u bli s hi n g t h e m i n s ci e ntifi c j o ur n al s. I n di vi d u al p arti ci p a nt m e di c al i nf or m ati o n o bt ai n e d a s a 
r e s ult of t hi s cli ni c al i n v e sti g ati o n i s c o n si d er e d c o nfi d e nti al a n d di s cl o s ur e t o t hir d p arti e s i s 
pr o hi bit e d. P arti ci p a nt c o nfi d e nti alit y will b e f urt h er e n s ur e d b y utili zi n g p arti ci p a nt 
i d e ntifi c ati o n c o d e n u m b er s t o c orr e s p o n d t o tr e at m e nt d at a i n t h e c o m p ut er fil e s a s b el o w 
d e s cri b e d f urt h er. F or d at a v erifi c ati o n p ur p o s e s,  a ut h ori z e d r e pr e s e nt ati v e s of t h e S p o n s or 
or t h e st u d y sit e I n stit uti o n al R e vi e w B o ar d (I R B) m a y r e q uir e dir e ct a c c e s s t o p art s of t h e 
d at a r e c or d s r el e v a nt t o t h e i n v e sti g ati o n.  
A cti o n s t a k e n t o g u ar a nt e e p arti ci p a nt pri v a c y:  
 I n g e n er al, S o n o v a f oll o w s t h e r e q uir e m e nt s fr o m G e n er al D at a Pr ot e cti o n R e g ul ati o n 
( G D P R). 
 P art i ci p a nt n a m e s a n d d et ail s, a c c e s si bl e b y t h e st u d y m o nit or, a p pr o pri at e i n v e sti g at or s 
a n d Pri n ci pl e I n v e sti g at or, ar e d o c u m e nt e d i n t h e P arti ci p a nt I d e ntifi c ati o n L o g.  
T h er e i s n o di s cl o s ur e of p er s o n al i nf or m ati o n t o a n y o n e el s e a si d e fr o m t h e i n v e sti g ati o n 
t e a m. 
 P arti ci p a nt p a p er -b a s e d fil e s will b e l o c k e d i n c a bi n et s at t h e st u d y sit e; k e y s t o t h e  
c a bi n et ar e pl a c e d i n a l o c ati o n t o w hi c h o nl y t h e i n v e sti g at or s h a v e a c c e s s.  
 El e ctr o ni c al d at a i s u pl o a d e d i n pr oj e ct fil e s o n S h ar e P oi nt; a c c e s s i s p er mitt e d t o  
m o nit or, pri n ci p al i n v e sti g at or, a n d i n v e sti g at or s o nl y.  
1 2  A m e n d m e nts t o t h e CI P  
A m e n d m e nt s t o t h e CI P, if n e c e s s ar y, will b e u p d at e d wit h j u stifi c ati o n i n t hi s d o c u m e nt.  
1 3  D evi ati o ns fr o m cli nic al i n v esti g ati o n pl a n  
D e vi ati o n s fr o m t h e CI P t o pr ot e ct t h e ri g ht s, s af et y a n d w ell -b ei n g of h u m a n p arti ci p a nt s 
u n d er e m er g e n c y cir c u m st a n c e s m a y pr o c e e d wit h o ut pri or a p pr o v al of t h e s p o n s or a n d t h e 
E C – s u c h d e vi ati o n s will b e d o c u m e nt e d a n d r e p ort e d t o t h e s p o n s or r e pr e s e nt ati v e ( St u d y 
M a n a g er) a n d t h e E C a s s o o n a s p o s si bl e. A p art fr o m t h at t h e i n v e sti g at or i s n ot all o w e d t o 
d e vi at e fr o m t hi s CI P u nl e s s t h at d e vi ati o n d o e s n ot i nfl u e n c e t h e i n v e sti g ati o n d at a.  
1 4  D evic e acc o u nt a bilit y  
A s t h er e i s n o h o m e tri al c o m p o n e nt t o t h e  st u d y, i n v e sti g ati o n al d e vi c e s a n d c o m p ati bl e 
d e vi c e s will b e k e pt at t h e i n v e sti g ati o n sit e f or t h e d ur ati o n of t h e st u d y a n d will b e r et ur n e d 
t o t h e s p o n s or u p o n c o n cl u si o n of t h e st u d y. Tr a c ki n g i nf or m ati o n will b e s h ar e d b et w e e n t h e 
st u d y sit e a n d s p o n s or.  
H o w e v er, c o m p ati bl e d e vi c e s eri al n u m b er s will b e s a v e d i n t h e fitti n g s oft w ar e, all o wi n g f or  
tr a c e a bilit y d uri n g l a b t e sti n g s e s si o n s (i. e., w hi c h d e vi c e s w er e w or n b y e a c h p arti ci p a nt 
d uri n g e a c h s e s si o n).  
If a n i n v e sti g ati o n al d e vi c e m u st b e r e pl a c e d d u e t o a d e vi c e d efi ci e n c y, r e c or d of t h e n e w 
s eri al n u m b er, d e vi c e i d e ntifi er, d at e of r e c ei vi n g t h e r e pl a c e m e nt, d at e of r et ur n of t h e d ef e ct  
i n v e sti g ati o n al d e vi c e, et c. will b e m ai nt ai n e d b y t h e St u d y M a n a g er. 
R e pr e s e nt ati v e s of t h e s p o n s or ( St u d y M a n a g er) will m ai nt ai n r e c or d s of s hi p m e nt/r e c ei pt of  
i n v e sti g ati o n al d e vi c e s a n d r el at e d st u d y s u p pli e s b et w e e n t h e s p o n s or a n d st u d y sit e, 
i n cl u di n g t h e r et ur n of d e vi c e s t o t h e s p o n s or o n c e t h e cli ni c al i n v e sti g ati o n h a s b e e n 
fi n ali z e d. 
1 5  I nf or m e d c o ns e nt pr oc ess  
T h e i n v e sti g at or s will e x pl ai n t o e a c h p arti ci p a nt t h e n at ur e of t h e st u d y, it s p ur p o s e, a n d t h e  

procedures, involving the expected duration, the potential risks and benefits and any 
discomfort it may entail. Each participant will be informed that the participation in the study is 
voluntary and that they may withdraw from the study at any time, and that withdrawal of 
consent will not lead to consequences for the participant. The participant must be informed 
that their medical records may be examined by authorized individuals. 
The formal consent of a participant, using the approved consent form, must be obtained 
before the participant is submitted to any clinical investigation procedure. The participant 
should be given the opportunity to read and consider the statement before signing and dating 
the informed consent form and should be offered a copy of the signed document. The 
consent form must also be signed and dated by the investigator (or their designee) and it will 
be retained as part of the study records. 
 
Informed Consent will only be obtained by investigation participants who can provide 
informed consent themselves before enrollment. 
16 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 consent until the last protocol-specific procedure, including a safety 
follow-up period (ISO-14155,2020). Documentation includes dates of event, treatment, 
resolution, assessment of seriousness and causal relationship to device and/or investigation 
procedure. 
 
The causality assessment of the SAE will be conducted according to MDCG 2020-10/1 
Safety Reporting in Clinical Investigations of Medical Devices under Regulation (EU) 
2017/745. 
The reporting of Serious Adverse Events and Device Deficiencies follows the Regulation 
(EU) 2017/745 and the MDCG 2020-10/1 Safety Reporting in Clinical Investigations of 
Medical Devices under Regulation (EU) 2017/745. 
17 Vulnerable Populations 
Not applicable; this clinical investigation does not involve any vulnerable populations. 
18 Suspension or premature termination of the clinical investigation 
The clinical investigation will be suspended or prematurely terminated if the feature and/or 
investigative device malfunctions or 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. The trial will be suspended within 5 days of determination that the 
study or device puts subjects at an unreasonable risk (per 21 CFR 812). 
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, because the clinical investigation does not involve a blinding/masking 
technique. 
Requirements for participant follow-up. 
According to the FDA, follow-up is required for participants who experience serious adverse 
events. Follow-up will be conducted by the study manager until the nature of the event is 
resolved. 

19 Publication policy 
The clinical investigation will be registered in clinicaltrials.gov, a publicly accessible 
database, as required by US law. 
The results of the clinical investigation will be documented internally in a study report, 
authored by the study manager.