Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.

Brief Summary

The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands and apocrine glands. Cerumen is part of the external ear defense mechanisms against foreign bodies and infectious agents, lubricating and cleaning the ear canal. Cerumen production is a normal and protective process for the ear canal. Cerumen is naturally removed through the renewal of the skin in the external auditory meatus, and through the chewing movements of the jaw. Nonetheless, earwax plug - defined as an accumulation of cerumen - is a frequent occurrence across all age groups, with notably higher rates in vulnerable populations. Causes of earwax plug comprise attempts to remove wax, as well as ear canal deformity. It also has been suggested that ear cleaning with cotton buds, particularly when the external ear canal is wet, might be one of the important causes of cerumen impaction. Earwax plug leads to hearing loss that is easily treatable but can have significant cognitive and social consequences. They can also delay the diagnosis of certain ear conditions, such as ear infections, which can lead to medical complications and have economic implications. Effective treatment options for earwax plug include cerumenolytic agents (water-based agents, oil-based agents, surfactant-based agents), irrigation with or without cerumenolytic pre-treatment, and manual removal. Inappropriate treatment options include cotton-tipped swabs, ear candling, olive oil drops or sprays, and non-chewing diets. A-CERUMEN® devices correspond to cerumenolytic agents' products composed of surfactant-based agents. Although all the available data points towards a good performance and safety profile of the devices under evaluation, the clinical data surrounding the devices under evaluation is based on only one or two studies and there is currently no data available on A-CERUMEN® devices for the pediatric patient population, or on pregnant and breastfeeding women. To address this gap, LABORATOIRES GILBERT plans in the Clinical Evaluation Report (CER) a confirmatory clinical trial to collect further data in the adult population and data in the pediatric population, pregnant and breastfeeding women for the devices under evaluation. The Instructions for Use (IFU) should be updated in accordance with the findings of this study. In this context, LABORATOIRES GILBERT promotes a Post-Market Clinical Follow-Up (PMCF) study to assess independently performance, safety and patient satisfaction of A-CERUMEN® Spray and A-CERUMEN® Unidose devices. This PMCF study must include pediatric population and pregnant/breastfeeding women.