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±9.31dB, 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.

[Epidemiology and anatomy of head and neck cancers]. / Épidémiologie et anatomie des cancers ORL.

Oral cavity and pharyngeal cancers account for 75% of head and neck cancers and are the fourth most spread cancer in men. Their incidence has decreased since 1980 in men (incidence from 2011 gives 13,930 for lip, oral cavity, pharyngeal and laryngeal carcinomas) but has increased in women, linked to the more recent smoking or alcohol intoxication in women. In addition to the smoking or alcohol consumption risk factors, the EBV role in nasopharyngeal carcinomas, HPV in the oropharyngeal carcinomas and professional exposures in paranasal sinuses cancers are recognized. Head and neck cancers are the fifth most common cancer in men mortality in France. Extended anatomical sites reflect the diagnostic's complexity specific to some locations (sinuses, nasopharynx), possible therapies and prognosis depending on the affected site.

New closed skin bone-anchored implant: preliminary results in 6 children with ear atresia.

OBJECTIVE: To report preliminary results of a new closed-skin, transcutaneous bone conduction device (BCD) in 6 children with high-grade ear atresia. SETTINGS: Tertiary care center; prospective study; we evaluated the gain with masking of the contralateral ear and the benefit of hearing rehabilitation with the transcutaneous BCD in noise: speech-in-noise tests, conducted in real life condition (with contralateral ear unmasked and fitted with a hearing device if done before implantation), with and without BCD, with determination of the speech reception threshold (SRT). Children and parent's satisfaction was assessed. RESULTS: Patients' ages ranged from 6 to 9 years. All had high-grade ear atresia with a preoperative mean pure-tone average (PTA) loss of 71.46 +/- 6.59 dB on air conduction and 14 +/- 4.98 dB on bone conduction. At M6, all children used the implant 5 to 12 hours daily (mean, 10) without pain or cutaneous complications. At M6, the mean air conduction PTA with transcutaneous BCD was 28.45 +/- 1.68 dB, the mean gain 43 +/- 6.96 dB, and the mean SRT gain 33.33 +/- 10.75 dB. Using speech-in-noise tests in real-life conditions, the mean SRT was statistically improved with the transcutaneous BCD (-8 +/- 2.83 dB, p = 0.0313). Both children and parents reported being satisfied or very satisfied. CONCLUSION: These preliminary results show satisfactory functional gain, cutaneous tolerance, and patients' satisfaction with the new transcutaneous BCD.