Sudden Deafness Treatment Trial

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