NCT06085443

Safety and Effectiveness of an Auricular Spray

Clinical Study to Evaluate the Safety and Effectiveness of an Auricular Spray Medical Device Ear Hygiene

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: YSLab · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Excessive Ear Wax

Interventions

Type	Name	Description
OTHER	Ear Hygiene	2 sprays in each ear, every 3 days at home

Timeline

• Start date: 2024-02-06
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2023-10-17
• Last updated: 2025-07-10
• Results posted: 2025-07-10

Locations

1 site across 1 country: Poland