title: Long-term outcome of round window Vibrant SoundBridge implantation in extensive ossicular chain defects.
abstract: OBJECTIVE
  To evaluate retrospectively the long-term safety and efficacy of the first 50 patients, all suffering from severe ossicular chain defects and with moderate to severe mixed hearing loss, who received the Vibrant SoundBridge with the floating mass transducer located on the round window membrane. To evaluate differences in outcome versus etiology and age of the patient population.
  
  
  METHODS
  Case series with planned data collection.
  
  
  METHODS
  Tertiary referral medical center.
  
  
  METHODS
  Patients eligible for implantation of the floating mass transducer on the round window membrane ranged in age from 2 months to 74 years with a moderate to severe conductive or mixed hearing loss from different etiologies. For each adult patient, preoperative versus postoperative bone and air conduction thresholds, air-bone gaps, and speech understanding scores were evaluated at 24-month follow-up. At 60-month follow-up, data were available from 33 patients. Preoperative and postoperative free-field auditory brainstem responses were studied in infants and children. Intraoperative and short- and long-term postoperative complications are presented.
  
  
  RESULTS
  There were significant improvements in speech perception and pure-tone audiometry in adults and auditory brainstem response thresholds in infants immediately after surgery and at follow-up examinations (12 to 71 months). No significant complications or device extrusions were observed in the present series.
  
  
  CONCLUSIONS
  Infants, children, and adults with moderate to severe conductive or mixed hearing loss obtained substantial benefit from implantation of the floating mass transducer on the round window membrane regardless of the etiology of hearing loss and previous surgery.
authors.affiliation: ENT Department, University of Verona, Verona, Italy.
authors.forename: Liliana
authors.initials: L
authors.lastname: Colletti
authors.forename: Marco
authors.initials: M
authors.lastname: Mandalà
authors.forename: Vittorio
authors.initials: V
authors.lastname: Colletti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001309:Auditory Threshold; D002648:Child; D002675:Child, Preschool; D003054:Cochlear Implants; D015331:Cohort Studies; D000013:Congenital Abnormalities / Q000601:surgery*; D004423:Ear / Q000002:abnormalities / Q000601:surgery; D005260:Female; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000209:etiology / Q000628:therapy*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis; D019933:Ossicular Replacement; D010033:Otitis Media / Q000150:complications / Q000601:surgery; D012189:Retrospective Studies; D012405:Round Window, Ear / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: active middle ear implant; bone conduction; chronic otitis media; conductive mixed hearing loss; congenital aural atresia; hearing aid; ossiculoplasty; radical or modified radical cavities; tympanosclerosis