Audiology in the sudden hearing loss clinical trial

Chris Halpin, Helen Shi, Domenic Reda, Patrick J. Antonelli, Seilesh Babu, John P Carey, Bruce J. Gantz, Joel A. Goebel, Paul E. Hammerschlag, Jeffrey P. Harris, Brandon Isaacson, Daniel Lee, Chris J. Linstrom, Lorne S. Parnes, William H. Slattery, Steven A. Telian, Jeffrey T. Vrabec, Steven Rauch

Research output: Contribution to journalArticle

Abstract

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). Study Design: Multicenter, prospective randomized noninferiority trial of oral versus intratympanic (IT) steroid treatment of sudden sensorineural hearing loss (SSNHL). Setting: Fifteen academically based otology practices. Patients: 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. Intervention: 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). Main Outcome Measure: 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. Conclusion: Hearing improvements are stable, and a significantly greater improvement occurs with lower frequency after either oral or IT steroid treatment of SSNHL.

Original languageEnglish (US)
Pages (from-to)907-911
Number of pages5
JournalOtology and Neurotology
Volume33
Issue number6
DOIs
StatePublished - Aug 2012

Fingerprint

Audiology
Sudden Hearing Loss
Hearing
Clinical Trials
Sensorineural Hearing Loss
Steroids
Unilateral Hearing Loss
Therapeutics
Methylprednisolone
Otolaryngology
Population Characteristics
Prednisone
Multicenter Studies
Ear
Outcome Assessment (Health Care)

Keywords

  • Audiometry
  • Sudden hearing loss
  • Word recognition

ASJC Scopus subject areas

  • Otorhinolaryngology
  • Clinical Neurology
  • Sensory Systems
  • Medicine(all)

Cite this

Halpin, C., Shi, H., Reda, D., Antonelli, P. J., Babu, S., Carey, J. P., ... Rauch, S. (2012). Audiology in the sudden hearing loss clinical trial. Otology and Neurotology, 33(6), 907-911. https://doi.org/10.1097/MAO.0b013e31825d9a44

Audiology in the sudden hearing loss clinical trial. / Halpin, Chris; Shi, Helen; Reda, Domenic; Antonelli, Patrick J.; Babu, Seilesh; Carey, John P; Gantz, Bruce J.; Goebel, Joel A.; Hammerschlag, Paul E.; Harris, Jeffrey P.; Isaacson, Brandon; Lee, Daniel; Linstrom, Chris J.; Parnes, Lorne S.; Slattery, William H.; Telian, Steven A.; Vrabec, Jeffrey T.; Rauch, Steven.

In: Otology and Neurotology, Vol. 33, No. 6, 08.2012, p. 907-911.

Research output: Contribution to journalArticle

Halpin, C, Shi, H, Reda, D, Antonelli, PJ, Babu, S, Carey, JP, Gantz, BJ, Goebel, JA, Hammerschlag, PE, Harris, JP, Isaacson, B, Lee, D, Linstrom, CJ, Parnes, LS, Slattery, WH, Telian, SA, Vrabec, JT & Rauch, S 2012, 'Audiology in the sudden hearing loss clinical trial', Otology and Neurotology, vol. 33, no. 6, pp. 907-911. https://doi.org/10.1097/MAO.0b013e31825d9a44
Halpin, Chris ; Shi, Helen ; Reda, Domenic ; Antonelli, Patrick J. ; Babu, Seilesh ; Carey, John P ; Gantz, Bruce J. ; Goebel, Joel A. ; Hammerschlag, Paul E. ; Harris, Jeffrey P. ; Isaacson, Brandon ; Lee, Daniel ; Linstrom, Chris J. ; Parnes, Lorne S. ; Slattery, William H. ; Telian, Steven A. ; Vrabec, Jeffrey T. ; Rauch, Steven. / Audiology in the sudden hearing loss clinical trial. In: Otology and Neurotology. 2012 ; Vol. 33, No. 6. pp. 907-911.
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