Earol Madrid Study

Inclusion criteria

• Subject must be willing to provide written informed consent prior to any clinical investigation related procedure;
• Male or female patients over 18-year-old;
• Presence of ear wax in both ear canals with a minimum of > 50% ear wax blockage in at least one ear (level 4) and > 25% blockage in the contralateral ear (level 3) as assessed using the TMVSS;
• Subject must be willing and able to perform all the visits, follow the PI instructions and complete the follow-up of the study.

Exclusion criteria

• Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study;
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period;
• Presence of other anatomic or comorbid conditions (e.g. ear eczema or seborrhea), or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness;
• Presence or history of a tympanic membrane perforation or tympanostomy tubes at any time during the previous 6 months;
• Presence or history of a known or suspected ear infection (i.e. otitis externa or otitis interna) in the previous 2 months;
• Presence of a known or suspected chronic suppurative otitis media;
• Presence or history of a known or suspected keratosis obturans;
• Presence of known or suspected mastoiditis;
• Use of any ototopical drug or OTC product or ear wax-removal product (except for water or physiologic saline) during the preceding 3 days;
• Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions;
• Temporal bone neoplasm.