title: Serial audiometry in a clinical trial of AIED treatment.
abstract: OBJECTIVE
  We analyzed pure-tone and speech audiometric results from a prospective trial of anti-inflammatory treatment of subjects with active autoimmune inner ear disease (AIED). We sought to characterize the pattern and size of the treatment effect as reflected in clinical audiometry and to identify audiometric predictors of response to steroid treatment of AIED.
  
  
  METHODS
  Adult participants demonstrated clinically established criteria for AIED (n = 116). Eligibility required audiometric evidence of active AIED as indicated by idiopathic sensorineural hearing loss with threshold elevations within 3 months of enrollment.
  
  
  METHODS
  We evaluated audiometric changes after 4 weeks of treatment with pharmacologic doses (60 mg/day) of prednisone. We examined the relationship between audiometric pure-tone thresholds at baseline and changes in word intelligibility score (WIS) using parametric and nonparametric analyses. Magnitudes of change were assessed using independent or paired t-tests. Separate analyses were performed on subgroups that did or did not show improved WIS score with steroid treatment.
  
  
  RESULTS
  Overall mean pure-tone averages improved from baseline to closeout of prednisone treatment in better hearing ears from 52.4 to 48.3 dB (p < .0001). Mean WIS improved in the better ear from 71.4% to 78.1% (p < .0001). Of pure-tone measures, only the six-tone average showed significant correlation with both the absolute improvements in WIS and with the percentage change in WIS after treatment. Individual frequencies at baseline showed no significant relationship with changes in WIS score after treatment. In 69 (59.5%) of 116 subjects, WIS improved (range, 2-80%) in the better ear. In these subjects, the baseline pure-tone thresholds and pure-tone averages correlated significantly and positively with improvement in WIS.
  
  
  CONCLUSIONS
  Steroid treatment in AIED-mediated hearing loss produce variable but significant hearing gains. Neither a focal, cochleotopic region of greatest vulnerability to AIED nor frequency-specific amenability to treatment were evident. We did observe that analysis of predictors and the degree of treatment effect vary with different approaches to measuring change in the WIS. Depending on the approach adopted, the size of the treatment effect may be greatest across intermediate hearing levels at baseline. These observations offer an audiometric database that may enable greater precision in judging clinically meaningful parameters for future studies of AIED treatment and other interventions for sensorineural hearing loss.
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, The Johns Hopkins University, Baltimore, MD, USA. jnipark@jhmi.edu
authors.forename: John K
authors.initials: JK
authors.lastname: Niparko
authors.forename: Nae-Yuh
authors.initials: NY
authors.lastname: Wang
authors.forename: Steven D
authors.initials: SD
authors.lastname: Rauch
authors.forename: Gregory B
authors.initials: GB
authors.lastname: Russell
authors.forename: Mark A
authors.initials: MA
authors.lastname: Espeland
authors.forename: June J
authors.initials: JJ
authors.lastname: Pierce
authors.forename: Stephen
authors.initials: S
authors.lastname: Bowditch
authors.forename: Ann
authors.initials: A
authors.lastname: Masuda
authors.forename: A Julianna
authors.initials: AJ
authors.lastname: Gulya
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Gantz
authors.forename: Gordon B
authors.initials: GB
authors.lastname: Hughes
authors.forename: Patrick E
authors.initials: PE
authors.lastname: Brookhouser
authors.forename: Maureen T
authors.initials: MT
authors.lastname: Hannley
authors.forename: Steven A
authors.initials: SA
authors.lastname: Telian
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Harris
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001301:Audiometry, Pure-Tone / Q000379:methods*; D001302:Audiometry, Speech / Q000379:methods*; D001309:Auditory Threshold; D001327:Autoimmune Diseases / Q000188:drug therapy*; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D007759:Labyrinth Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use*; D013067:Speech Perception; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D011241:Prednisone