title: Hearing rehabilitation with the closed skin bone-anchored implant Sophono Alpha1: results of a prospective study in 15 children with ear atresia.
abstract: OBJECTIVE
  To study gain and cutaneous tolerance of the Sophono Alpha1 implant, used for unilateral hearing rehabilitation in children with ear atresia, and to demonstrate non-inferiority compared to the referral closed skin device, BAHA® on a test-band.
  
  
  METHODS
  Fifteen children included in a prospective clinical trial from September 2010 to November 2012. Tertiary care center.
  
  
  RESULTS
  Pure tone and speech audiometry before surgery and at M6 and 12; Speech-in-noise tests with and without Alpha1 at M6. Quality of life questionnaire completed before surgery and at M6; children and parent's satisfaction assessed at M6. Cutaneous appearance assessed at M6, M12 and during the last clinical assessment.
  
  
  RESULTS
  Patients' ages ranged from 61 to 129 months. They had a pure conductive deafness with a mean air conduction pure-tone average (ACPTA) of 69.02±9.31dB, and a mean SRT of 71.73±9.20dB. Follow-up was 12-32 months. At M6, the mean aided ACPTA was 33.49±4.89dB, the mean aided SRT 38.27±4.54dB and the mean aided SRT in noise was statistically improved (-7.80dB). Sophono Alpha1 demonstrated non-inferiority compared to BAHA® on a test-band. At M12, mean aided ACPTA was 2.94dB higher (p<0.001) but the mean SRT variation (+0.73dB) was not significantly different (p=0.35). At M12, all children used the implant 5 to 12h daily (mean: 10) without cutaneous complications. Both children and parents reported being satisfied or very satisfied. The score for 7/10 questions in silence or noisy environment was statistically improved when wearing the device.
  
  
  CONCLUSIONS
  This prospective study demonstrate non inferiority, good cutaneous tolerance, satisfaction of children and parents and improvement of the quality of life with the Sophono Alpha1 compared to BAHA® on a test-band. In the light of this study and of the previously published series, the aided threshold is between that obtained with BAHA on a softband and percutaneous BAHA. The Sophono Alpha1 device needs to be part of the hearing solutions proposed for the hearing rehabilitation in children with ear atresia.
authors.affiliation: Otolaryngology-Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France. Electronic address: f.denoyelle@nck.aphp.fr.
authors.forename: Françoise
authors.initials: F
authors.lastname: Denoyelle
authors.affiliation: Otolaryngology-Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France; Audionova™ Audiometry Center, 75015 Paris, France.
authors.forename: Cyrille
authors.initials: C
authors.lastname: Coudert
authors.affiliation: Otolaryngology-Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France.
authors.forename: Briac
authors.initials: B
authors.lastname: Thierry
authors.affiliation: Otolaryngology-Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France.
authors.forename: Marine
authors.initials: M
authors.lastname: Parodi
authors.affiliation: Otolaryngology-Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France.
authors.forename: Olivia
authors.initials: O
authors.lastname: Mazzaschi
authors.affiliation: Unité de Recherche Clinique-Centre d'évaluation des dispositifs médicaux, APHP, Université Paris-Diderot Paris V, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.affiliation: Unité de Recherche Clinique-Centre d'évaluation des dispositifs médicaux, APHP, Université Paris-Diderot Paris V, Paris, France.
authors.forename: Natacha
authors.initials: N
authors.lastname: Tessier
authors.affiliation: Otolaryngology-Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France.
authors.forename: Natalie
authors.initials: N
authors.lastname: Loundon
authors.affiliation: Otolaryngology-Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France.
authors.forename: Eréa-Noël
authors.initials: EN
authors.lastname: Garabedian
mesh_terms: D000293:Adolescent; D001301:Audiometry, Pure-Tone; D001302:Audiometry, Speech; D002648:Child; D002675:Child, Preschool; D004431:Ear, External / Q000002:abnormalities*; D005260:Female; D006310:Hearing Aids; D006314:Hearing Loss, Conductive / Q000601:surgery*; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D011446:Prospective Studies; D013069:Speech Reception Threshold Test
keywords: Bone anchored hearing device; Children; Conductive hearing loss; Congenital aural atresia; Sophono Alpha1