Hearing rehabilitation with the closed skin bone-anchored implant Sophono Alpha1: Results of a prospective study in 15 children with ear atresia. Issue 3 (March 2015)

• Record Type: Journal Article
• Authors: Denoyelle, Françoise; Coudert, Cyrille; Thierry, Briac; Parodi, Marine; Mazzaschi, Olivia; Vicaut, Eric; Tessier, Natacha; Loundon, Natalie; Garabedian, Eréa-Noël
• Is Part Of: International journal of pediatric otorhinolaryngology. Volume 79:Issue 3(2015:Mar.)
• Page Start: 382
• Page End: 387
• Publication Date: 2015-03
• Subjects: Otolaryngology -- Periodicals; Pediatrics -- Periodicals; Otolaryngology -- Periodicals; Pediatrics -- Periodicals; Oto-rhino-laryngologie -- Périodiques; Pédiatrie -- Périodiques; 618.9209751
• DOI: 10.1016/j.ijporl.2014.12.032
• Languages: English
• ISSNs: 0165-5876

Abstract

<abstract abstract-type="author" id="abs0005"> <title id="sect0005">Abstract</title> <sec> <title id="sect0010">Objective</title> <p id="spar0005">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.</p> </sec> <sec> <title id="sect0015">Methods and materials</title> <p id="spar0010">Fifteen children included in a prospective clinical trial from September 2010 to November 2012. Tertiary care center. Main outcomes: 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.</p> </sec> <sec> <title id="sect0020">Results</title> <p id="spar0015">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 ± 9.31 dB, and a mean SRT of 71.73 ± 9.20 dB. Follow-up was 12–32 months. At M6, the mean aided ACPTA was 33.49 ± 4.89 dB, the mean aided SRT 38.27 ± 4.54 dB and the mean aided SRT in noise was statistically improved (−7.80 dB). Sophono Alpha1 demonstrated non-inferiority compared to BAHA® on a test-band. At M12, mean aided ACPTA was 2.94 dB higher (<italic>p</italic> < 0.001) but the mean SRT variation (+0.73 dB) was not significantly different (<italic>p</italic> = 0.35).</p> <p id="spar0020">At M12, all children used the implant 5 to 12 h 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.</p> </sec> <sec> <title id="sect0025">Conclusions</title> <p id="spar0025">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.</p> </sec> </abstract>