The goal of this clinical trial is to test the safety and efficacy of a medical device in subjects with cerumen in excess. The main questions it aims to answer are: * Does the medical device induce skin irritation in the ear canal? * Does the medical device reduce obstruction of ear canal induced by excessive cerumen? Participants will use the device in each ear, once a day, every 3 days at home. Researchers will compare the medical device group to a control group who will not use the medical device.
Ocean Bio Actif Hygiène de l'oreille is a medical device class IIa indicated for the prevention of the formation of earwax plugs and consequently the pathologies linked to the accumulation of earwax (hearing loss and infection/affection of the external auditory canal). This clinical investigation is designed to improve the quality and quantity of data available on both the safety and the efficacy of Ocean Bio-Actif, in order to confirm the safety and the efficacy of the product in a post-market environment. The objective of the current clinical investigation is to confirm the efficacy and safety of topical application to the ear canal of Ocean Bio-Actif.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
99
2 sprays in each ear, every 3 days at home
Eurofins Dermscan Poland
Gdansk, Ul. Matuszewskiego 12, Poland
Skin Irritation
To confirm the safety of the device by clinical examination by ENT specialist and scoring of the irritation of the ear canal at Day90 in comparison with basal scoring of irritation at Day0 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).
Time frame: Day0 and Day90
Ear Canal Obstruction Due to Excessive Earwax
To confirm the efficacy/performance of the device for the prevention of ear obstruction in comparison to baseline (Day0) and between groups using the 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.
Time frame: Day0 and Day90
Hearing Function
Secondary aims: EFFICACY/PERFORMANCE PREVENTION for investigational device and for control group, in comparison to the baseline (Day0) using an audiogram (only for subjects more than 6). Hearing function was assessed in patients on day 0 (D0) and day 90 (D90). The mean difference in hearing function (D90 - D0), expressed in decibels (dB), was reported in a data table. A mean difference greater than +5 dB is considered a gain in hearing function, while a mean difference less than -5 dB is considered a loss in hearing function. A difference in hearing function within the range \[-5 dB; +5 dB\] is considered to indicate no effect on hearing function.
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Time frame: Day0 and Day90