Sudden Deafness Treatment Trial
Sudden Deafness Treatment Trial
This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected
 into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing
 loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).
Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous
 improvement is seen in approximately 20% of subjects. Improvement is seen in approximately
 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and
 uncontrolled case series have suggested the intratympanic corticosteroids may work as well or
 better than oral treatment. The risks of oral prednisone are well-known. In theory,
 intratympanic treatment should achieve a higher drug concentration at the target (inner ear)
 with less risk of systemic side effects. This study is a head-to-head comparison of oral
 prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden
 deafness. The study is designed as a non-inferiority trial testing that hypothesis that
 intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects
 assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day)
 followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4
 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary
 outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include
 word recognition hearing levels and safety issues of local vs. systemic steroid side-effects
 and pain.
Inclusion Criteria:

 -  Men/women 18 years and older in good health

 -  Unilateral sensorineural hearing loss developing within 72 hours (SSNHL)

 -  Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with
 the affected ear >/= 30 dB worse than contralateral ear in at least one of the four
 frequencies

 -  Symmetric hearing prior to onset of SSNHL

 -  Hearing loss must be idiopathic

 -  Hearing loss must have occurred within the past 14 days

 -  Must be able to read or write English or Spanish

 Exclusion Criteria:

 SYSTEMIC DISEASE

 -  >21 days prior oral steroid treatment within preceding 30 days

 -  History of tuberculosis (TB) or positive PPD

 -  Insulin-dependent diabetes mellitus

 -  History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc.

 -  Serious psychiatric disease or psychiatric reaction to corticosteroids

 -  History of heart disease or transient ischemic attacks (TIAs)

 -  Prior treatment with chemotherapeutic or immunosuppressive drugs

 -  Pancreatitis

 -  Active peptic ulcer disease or history of gastrointestinal bleeding

 -  History of HIV, Hepatitis B or C

 -  Chronic kidney failure

 -  Alcohol abuse

 -  Active shingles

 -  Severe osteoporosis or non-surgical aseptic necrosis of the hip

 OTOLOGIC DISEASE

 -  Prior history of SSNHL

 -  History of fluctuating hearing loss

 -  History of Meniere's disease

 -  History of chronic ear infection

 -  History of otosclerosis

 -  History of ear surgery (except childhood pressure equalization [pe] tubes)

 -  History of congenital hearing loss

 -  History of trauma immediately preceding onset of SSNHL

 -  History of syphilitic hearing loss

 -  History of genetic/hereditary hearing loss

 -  Skull, facial, or temporal bone anomalies