Safety and Effectiveness of an Auricular Spray

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.

Inclusion criteria

• Gender: female and/or male.
• 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.

• Subjects able to use the tested product.
• 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,..).
• Subjects having ear help system or regular users of systems such as anti-noise plugs or headsets (only for the 13yo subjects and more).
• Subjects having a clinical score of ear canal obstruction of 2 or 3 at D0.

Exclusion criteria

• Subjects who had chirurgical act on the mastoïde.
• Subjects who had severe troubles of the internal ear (severe dizziness, desorientation, nausea).
• Subjects using regularly a ear spray for washing his/her ears.
• Subjects having a score of ear canal obstruction at 4 at D0.
• Pregnant or nursing woman or planning a pregnancy during the study;
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
• Subject in a social or sanitary establishment;
• Subject suspected to be non-compliant according to the investigator's judgment;
• Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
• Subject suffering from a severe or progressive disease.