Audiology in the sudden hearing loss clinical trial.
OBJECTIVE
To report the pretreatment and posttreatment population characteristics and the overall stability of the audiologic outcomes found during the Sudden Hearing Loss Clinical Trial (ClinicalTrials.gov: Identifier NCT00097448).


METHODS
Multicenter, prospective randomized noninferiority trial of oral versus intratympanic (IT) steroid treatment of sudden sensorineural hearing loss (SSNHL).


METHODS
Fifteen academically based otology practices.


METHODS
Two hundred fifty patients with unilateral SSNHL presenting within 14 days of onset with 50 dBHL or greater pure tone average hearing threshold in the affected ear.


METHODS
Either 60 mg/d oral prednisone for 14 days with a 5-day taper (121 patients) or 4 IT doses for 14 days of 40 mg/ml methylprednisolone (129 patients).


METHODS
Primary end point was change in hearing [dB PTA] at 2 months after treatment. Noninferiority was defined as less than 10 dB difference in hearing outcome between treatments. In this article, pretreatment and posttreatment hearing findings will be reported in detail.


RESULTS
A general (and stable) effect of treatment and a specific effect of greater improvement at low frequencies were found in both treatment groups.


CONCLUSIONS
Hearing improvements are stable, and a significantly greater improvement occurs with lower frequency after either oral or IT steroid treatment of SSNHL.
Department of Audiology, Massachusetts Eye and Ear Infirmary, USA. chris_halpin@meei.harvard.edu
Chris
C
Halpin
Helen
H
Shi
Domenic
D
Reda
Patrick J
PJ
Antonelli
Seilesh
S
Babu
John P
JP
Carey
Bruce J
BJ
Gantz
Joel A
JA
Goebel
Paul E
PE
Hammerschlag
Jeffrey P
JP
Harris
Brandon
B
Isaacson
Daniel
D
Lee
Chris J
CJ
Linstrom
Lorne S
LS
Parnes
William H
WH
Slattery
Steven A
SA
Telian
Jeffrey T
JT
Vrabec
Steven
S
Rauch
D000284:Administration, Oral; D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001301:Audiometry, Pure-Tone / Q000379:methods*; D002986:Clinical Trials as Topic; D003639:Hearing Loss, Sudden / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D008775:Methylprednisolone / Q000008:administration & dosage / Q000627:therapeutic use; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D021641:Recognition, Psychology; D012107:Research Design; D013067:Speech Perception; D013256:Steroids / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D013256:Steroids; D011241:Prednisone; D008775:Methylprednisolone