Clinical Study to Evaluate the Safety and Effectiveness of an Auricular Spray Medical Device Ear Hygiene
Phase: NA
Conditions: Excessive Ear Wax
Sponsor: YSLab

YSLAB 
Medical Device 
CIP #23E1670 
Final version 2.0 
Date: 09/11/2023 
Confidential 
Page 10/64 
 
 
PRM03-F-227_V6_EN  
Clinical investigational plan for MD 
 
1.5 
OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION 
Clinical 
investigation 
single 
identification #: 
Clinicaltrials.gov #NCT06085443 
Clinical investigation plan #: 
23E1670 
Title of the clinical investigation: 
CLINICAL 
STUDY 
TO 
EVALUATE 
THE 
SAFETY 
AND 
EFFECTIVENESS OF A AURICULARY SPRAY MEDICAL DEVICE 
 
Sponsor: 
YSLAB 
Le Forum 
 
29 000 Quimper 
FRANCE 
Development phase: 
Post market study 
Device used according to IFU 
Objectives: 
Principal aim: SAFETY 
The primary objective of the study is to confirm the safety of a 
marketed auricular spray with reverse and microdiffusion nozzle by 
clinical examination by ENT specialist and by the scoring of the 
irritation of the ear canal at D60 in comparison with basal scoring of 
irritation at D0 (scale 0 to 3) such as: 
- 0: no irritation,  
- 1: slight irritation (located slight erythema and/or dryness),  
- 2: moderate irritation (clear erythema or dryness which may be 
visible on the whole treated area),  
- 3: severe irritation (serious erythema with potential oedema and/or 
scar). 
Potential adverse events collection. 
 
Secondary aims: EFFICACY/PERFORMANCE PREVENTION for 
investigational device with reverse nozzle, investigational device with 
microdiffusion nozzle and for control group, in comparison to the 
baseline (D0) and between groups: 
 
scoring of the obstruction of ear canal by the Investigator 
0: no obstruction  normal and/or no significant presence of cerumen 
in the ear canal. The membrane is clearly visible. 
1: <25% minimal, very little and mostly insignificant impacted 
cerumen. The tympanic membrane is visible, but with still a little bit 
cerumen.  
2: 25-50% mild, some excessive impacted cerumen causing partial 
occlusion of the ear canal. The tympanic membrane is not entirely 
visible, quite difficult to see. 
3: 50-75% moderate, moderate and excessive impacted cerumen 
causing partial occlusion of the ear canal. Partial to very little of the
tympanic membrane is visible. 
4: 75-100% severe, severe and excessive impacted cerumen 
causing partial or complete occlusion of the ear canal.  Little if any of 
the tympanic membrane is visible. 
 
audiogram with classification of the loss or win hearing 
function using the following scale (only for subjects more 
than 6): 
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YSLAB 
Medical Device 
CIP #23E1670 
Final version 2.0 
Date: 09/11/2023 
Confidential 
Page 11/64 
 
 
PRM03-F-227_V6_EN  
Clinical investigational plan for MD 
 
No hearing function loss, hearing function loss between 5 to 10dB, 
hearing function >10dB (Subha et al.2006), hearing function win 
between 5 to 10 dB, hearing function win >10dB. 
Additionally, the secondary objective of this study will be to see if the 
investigational device is more efficient in children, adults or elderly 
subjects (for both nozzles - reverse or microdiffusion). 
 
Subject's self-evaluation using a questionnaire.  
 
Evaluation of the effect on the number of auricular affection 
(such as otitis) during the use period (daily log). 
Design: 
Open study, randomized, before / after treatment, with tested product 
versus control group, in parallel groups 
Planned Sample Size: 
99 included subjects and results delivered on 90 subjects. 
 
1 group of 72 included subjects in order to have results on 66 
subjects (33 subjects using product with the reverse diffuser
and 33 using the product with the microdiffusion diffuser  
 
1 group of 27 included subjects in order to have results on 24
subjects not using a spray (control group). (in case of discomfort 
or pain, they are allowed to use ear drops prescribed by a doctor 
after a medical examination)  
Number of investigational study 
sites: 
2 centers 
Inclusion criteria: 
1. Gender: female and/or male.  
2. Age:  
- 
30 to 40% having age between 3 to 12 yo,  
- 
30 to 40% between 13 to 65 yo,  
- 
30 to 40% more than 65 yo. 
3. Subjects able to use the tested product. 
4. Subjects having history of cerumen occlusion more than 
once a year with or without symptoms (reduction of hearing 
function, obstruction feeling of the ear canal,..). 
5. Subjects having ear help system or regular users of systems 
such as anti-noise plugs or headsets (only for the 13yo 
subjects and more). 
6. Subjects having a clinical score of ear canal obstruction of 2 
or 3 at D0. 
Exclusion criteria: 
1. 
 
2. Subjects who had severe troubles of the internal ear (severe 
dizziness, desorientation, nausea). 
3. Subjects using regularly a ear spray for washing his/her ears.
4. Subjects having a score of ear canal obstruction at 4 at D0. 
5. Pregnant or nursing woman or planning a pregnancy during 
the study; 
6. Subject who had been deprived of their freedom by 
administrative 
or 
legal 
decision 
or 
who 
is 
under 
guardianship; 
7. Subject in a social or sanitary establishment; 
8. Subject suspected to be non-compliant according to the 
 
9. Subject with a condition or receiving a medication which, in 
 
10. Subject suffering from a severe or progressive disease. 
 
Investigational device: 
Name / code 
 
 
OCEAN BIO-ACTIF Ear Hygiene (reverse nozzle) 
OCEAN BIO-ACTIF Ear Hygiene (microdiffusion nozzle) 
Bag on valve spray, with ergonomic nozzle 
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YSLAB 
Medical Device 
CIP #23E1670 
Final version 2.0 
Date: 09/11/2023 
Confidential 
Page 12/64 
 
 
PRM03-F-227_V6_EN  
Clinical investigational plan for MD 
 
Galenic form 
Dosage 
Duration 
Administration route 
2 sprays in ear, every 3 days at home 
90 days 
Topical to ear canal 
Endpoints: 
Primary endpoints: 
 
Clinical evaluation, 
 
Clinical score of the irritation with structured scale, 
 
Record of the possible adverse reactions. 
Secondary endpoints: 
 
Clinical score of the obstruction of ear canal, 
 
Results of audiogram with classification of the loss or win 
hearing function 
 
Subject satisfaction survey 
 
The number of auricular affection (such as otitis) during the 
use period 
 
Study Procedures: 
D0, D90 
Statistical methods: 
The analysis of the primary endpoint will be performed on the ITT and 
population. 
The analysis of the secondary endpoint will be performed on the 
population. 
The analysis of the safety/tolerance parameters will be performed on 
 
 
Primary endpoint: 
 
The irritation is assessed by the Laryngologist using a 4-point 
D0 and D90. 
 
For each product, a paired t-test will be used to test whether the 
change from baseline (D90-D0) differ significantly from 0. The 
normality assumption will be checked using a Shapiro-Wilk test 
( =0.01), in case of rejection, a Wilcoxon signed ranks test will be 
used. 
 
To test whether the products differ statistically in terms of change 
from baseline (D90-D0), a two-sided t-test is used. If the normality 
assumption is not met, a non-parametric approach is used with a 
Wilcoxon signed rank test.   
 
Secondary endpoints: 
 
For each secondary parameter: 
 
 
Clinical score of the irritation with structured scale 
 
Clinical score of the obstruction of ear canal 
 
Results of audiogram with classification of the loss or win hearing 
function. 
 
The number of auricular affection (such as otitis) during the use 
period 
 
For each product, a paired t-test will be used to test whether the 
change from baseline (D90-D0) differ significantly from 0. The 
normality assumption will be checked using a Shapiro-Wilk test 
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YSLAB 
Medical Device 
CIP #23E1670 
Final version 2.0 
Date: 09/11/2023 
Confidential 
Page 13/64 
 
 
PRM03-F-227_V6_EN  
Clinical investigational plan for MD 
 
( =0.01), in case of rejection, a Wilcoxon signed ranks test will be 
used. 
 
To test whether the products differ statistically in terms of change 
from baseline (D90-D0), a two-sided t-test is used. If the normality 
assumption is not met, a non-parametric approach is used with a 
Wilcoxon signed rank test.   
 
For the subjective evaluation questionnaire: 
 
For each item of the subjective questionnaire, the raw data will be 
summarized in frequency (N) and percentage (%) by group of 
product. 
 
All statistical tests will be assessed at  = 5% level of significance in 
a bilateral approach.  
 
 
 
 
Foreseen study duration: 
Clinical investigation beginning: Q4 2023  
Clinical investigation end: Q3 2024 
Clinical investigation global duration:8 months 
Duration by subject: 90 days 
 
 
 
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YSLAB 
Medical Device 
CIP #23E1670 
Final version 2.0 
Date: 09/11/2023 
Confidential 
Page 14/64 
 
 
PRM03-F-227_V6_EN  
Clinical investigational plan for MD 
 
FLOW-CHART 
 
Procedure (time-points)
V1 
V2 
Intervals 
D0 
 
D90 
(+/-3) 
Informed Consent
Medical exam 
 
Medical background and previous 
treatment 
 
 
Clinical scoring including irritation  
of the ear canal 
 
 
Audiogram 
Dispense product and daily log 
 
Collect product and daily log 
 
Subjective evaluation questionnaire 
 
Adherence control, record of AE, 
concomitant treatments 
 
 
End of study form
 
 
 
 
 
 
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