Clinical trial: Oral Statins and Protection From Hearing Loss (NCT04826237)

Eligibility criteria:
Inclusion Criteria:

          -  Patient older than 18 years and younger than 81 years and

          -  Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical
             examination, history, audiology, speech interpretation tests and tinnitus evaluation
             and

          -  Seen in the clinic within the first 14 days after the onset of symptoms. and

          -  Mean hearing threshold equal to or worse than >30 dB averaged across three consecutive
             frequencies.

          -  Excellent English Speaking and Comprehension

        Exclusion Criteria:

          -  Children

          -  Prisoners

          -  Pregnant women

          -  Patients who have experienced similar prior events of SSNHL

          -  Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis,
             fungal infections,

          -  Autoimmune inner ear disease

          -  Middle ear inflammation or effusion

          -  Ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin, etc.

          -  Head Trauma, lead poisoning

          -  Genetic disorders affecting hearing

          -  Mitochondrial disorders, including MELAS (metabolic encephalopathy, lactic acidosis,
             and stroke-like episodes), stroke, Cogan's syndrome

          -  Neoplastic (neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous
             meningitis, intravascular lymphomatosis, others)

          -  Sarcoidosis

          -  Hyperviscosity syndrome

          -  Diabetes

          -  Use of statins within the last 12 months

          -  Allergy, hypersensitivity or intolerance to any components of the study medication

          -  Prior tinnitus

          -  Prior otologic surgery other than ventilation tubes

          -  History of drug abuse or alcoholism within the prior 2 years

          -  Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants,
             hypnotics or anxiolytics

          -  Severe systemic neurologic disease (epilepsy, Parkinson's, dementia/Alzheimers,
             multiple sclerosis

          -  Oral steroid treatment within the preceding 30 days

          -  Heart disease or TIAs

          -  Chronic kidney failure

          -  HIV, Hepatitis B or C

          -  Active shingles

          -  Skull, facial or temporal bone anomalies
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 80 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