title: The Vibrant Soundbridge in Children and Adolescents: Preliminary European Multicenter Results.
abstract: OBJECTIVE
  Evaluation of safety and efficacy of the Vibrant Soundbridge in the treatment of hearing loss in children and adolescents with primary focus on improvement in speech discrimination.
  
  
  METHODS
  Prospective, single-subject repeated-measures design in which each subject serves as his/her own control.
  
  
  METHODS
  Tertiary referral center.
  
  
  METHODS
  Nineteen patients aged 5 to 17 years.
  
  
  METHODS
  Implantation of an active middle ear implant.
  
  
  METHODS
  Improvement in word recognition scores, speech reception thresholds, and signal-to-noise ratios (SNRs) were evaluated, in addition to air and bone conduction. Oldenburger Kids Satztest/Oldenburger Satztest sentences and Göttinger/Freiburger monosyllables at 65-dB hearing level were tested in two age groups.
  
  
  RESULTS
  Significant speech discrimination improvement was seen in all patients after 6 months. In children 5 to 9 years old, mean monosyllable recognition improved from 28.9% (unaided) to 95.5% (Soundbridge-aided). Aided 50% sentence discrimination at 44.1 dB and SNR of -4.9 dB were measured. In patients 10 to 17 years old, mean word recognition improved from 18.5% to 89.0%, sentence reception threshold improved to 40.2 dB, and SNR to -3.6 dB. Comparison between age groups indicated a slight trend toward quicker adaptation by older subjects. However, after initial adjustment, a higher level of overall benefit was seen at 6 months in younger children.
  
  
  CONCLUSIONS
  Currently, the only middle ear implant approved for pediatric patients, the Vibrant Soundbridge, provides an option in cases of congenital aural atresia or disease-induced defects, when surgical intervention and reconstruction is indicated. The 6-month results in this comparatively large study population validated conclusions found in previous trials.
authors.affiliation: *Department of Otorhinolaryngology and Plastic Operations, University Hospital Schleswig-Holstein, Lübeck, Germany; †Ear, Nose and Throat Department, Landesklinikum St. Pölten, St. Pölten, Austria; ‡Department of Otorhinolaryngology, Head & Neck Surgery, Franz Tappeiner Hospital, Meran, Italy; §Department of Otolaryngology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; and ∥Clinic and Policlinic for Ear Nose and Throat Treatment, University Clinic Grosshadern, Munich, Germany.
authors.forename: Henning
authors.initials: H
authors.lastname: Frenzel
authors.forename: Georg
authors.initials: G
authors.lastname: Sprinzl
authors.forename: Christian
authors.initials: C
authors.lastname: Streitberger
authors.forename: Thomas
authors.initials: T
authors.lastname: Stark
authors.forename: Barbara
authors.initials: B
authors.lastname: Wollenberg
authors.forename: Astrid
authors.initials: A
authors.lastname: Wolf-Magele
authors.forename: Nadia
authors.initials: N
authors.lastname: Giarbini
authors.forename: Tobias
authors.initials: T
authors.lastname: Strenger
authors.forename: Joachim
authors.initials: J
authors.lastname: Müller
authors.forename: John-Martin
authors.initials: JM
authors.lastname: Hempel
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001299:Audiometry; D001844:Bone Conduction; D002648:Child; D002675:Child, Preschool; D019929:Cochlear Implantation; D005060:Europe; D005260:Female; D034381:Hearing Loss / Q000601:surgery*; D006314:Hearing Loss, Conductive / Q000601:surgery; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000601:surgery; D006320:Hearing Tests; D006801:Humans; D008297:Male; D009998:Ossicular Prosthesis; D011446:Prospective Studies; D059629:Signal-To-Noise Ratio; D013067:Speech Perception; D013069:Speech Reception Threshold Test; D016896:Treatment Outcome