Clinical trial: Earol Madrid Study (NCT04653662)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction