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

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 and materials 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. 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 ± 9.31 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 ( p < 0.001) but the mean SRT variation (+0.73 dB) was not significantly different ( p = 0.35). 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. 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. [ABSTRACT FROM AUTHOR]