LANDMARK: Oral versus Intratympanic corticosteroid treatment for SSNHL

AOral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial

Rauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ

Rauch SD, Halpin CF, Antonelli PJ, et al. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011;305(20):2071-9.

Take Home Points:

  • Intratympanic steroid treatment (IT) was noninferior to oral steroid treatment with 30.7 dB and 28.7 dB PTA improvements in oral and intratympanic treatment groups, respectively
  • Oral steroid treatment may be superior in patients with PTA > 90 dB, dizziness, presenting within 7 days of onset, and without prior steroid use. Intratympanic steroid may be better in the patient population that does not meet the above criteria.
  • There were no differences in serious adverse effects between the two-groups
  • IT was associated with ear pain and dizziness/vertigo
  • Oral treatment was associated with mood change, blood glucose problems, appetite changes, dry mouth/thirst, and weight change

The Details:

  • This was a prospective, randomized, non-inferiority trial.
  • 250 patients with unilateral, sudden-onset sensorineural hearing loss (SNHL)
  • Sudden-onset was defined as presenting with 14 days of onset of a 50 dB or higher PTA hearing threshold as tested by air- and bone- conducted PTA and speech audiometry
  • Exclusion: Patients with previous ear-related conditions or a genetic/family history of hearing loss
  • 121 patients received 60 mg/day of oral prednisone for 14 days with a 5-day taper
  • 129 patients received four 40 mg/mL doses of middle-ear methylprednisolone injections administered over 14 days
  • Hearing-thresholds were retested after 1 and 2 weeks of treatment and at 2 and 6 months after conclusion of treatment
  • Noninferiority was defined as a less than 10 dB post-treatment difference in the intratympanic group compared to the oral steroid group
  • This study does not address those patients who present with symptoms after the 14 day window tested