Clinical trial: AM-111 in the Treatment of Acute Inner Ear Hearing Loss (NCT02561091)

Eligibility criteria:
Inclusion Criteria:

          1. Unilateral ISSNHL with onset within 72 hours prior to study treatment;

          2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most
             affected contiguous air conduction audiometric pure tone frequencies ("pure tone
             average", PTA);*

          3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air
             conducted PTA frequencies compared with the unaffected contralateral ear or reference
             values from a pre-existing audiogram or ISO 7029;2000 norm values in case of
             asymmetric hearing prior to the ISSNHL incident;

          4. Age ≥ 18 and ≤ 65 years on the day of screening;

        Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          1. Bilateral ISSNHL;

          2. Acute hearing loss from noise trauma, barotrauma or head trauma;

          3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic
             hydrops or Menière's disease in the affected ear;

          4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the
             affected ear;

          5. History of acoustic neuroma or other retrocochlear damage in the affected ear;

          6. History of otosclerosis in the affected ear;

          7. Suspected perilymph fistula or membrane rupture in the affected ear;

          8. Congenital hearing loss;

          9. History of ISSNHL in the past 2 years;

         10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study
             treatment;

        Other protocol-defined exclusion criteria may apply.
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