Camino Ear Nose and Throat, San Jose, California, USA.
Otol Neurotol. 2011 Oct;32(8):1262-9. doi: 10.1097/MAO.0b013e31822a1cac.
To determine the long-term safety and benefit of a new intraoral bone conduction device (SoundBite Hearing System by Sonitus Medical) for single-sided deafness (SSD).
A multi-center, controlled, nonrandomized, prospective unblinded study of SSD patients wearing the device over a 6-month period.
Ambulatory care centers typical of those where SSD patients are diagnosed and treated.
Adults (N = 22) with acquired, permanent SSD and no current use of any other SSD device.
Continual daily wear of the new device for 6 months.
Comprehensive medical, audiologic, and dental measures; aided thresholds; Abbreviated Profile of Hearing Aid Benefit scores, and an SSD questionnaire.
There were no related adverse events or changes in the medical or audiologic findings at the end of the trial compared with the beginning. There were no significant changes in the mean aided thresholds (p > 0.01) or the mean dental measures (p > 0.05) at 3 or 6 months compared with pretrial measures. The mean Abbreviated Profile of Hearing Aid Benefit benefit scores showed improvement (p < 0.01) for the Background Noise, Reverberation, and Ease of Communication subscales and the Global scale at 3 and 6 months. The results of the SSD questionnaire indicated that the vast majority (>90%) of the subjects reported satisfaction and improvement in a variety of areas after wearing the device long term.
The SoundBite system is safe and continues to provide substantial benefit for SSD patients with continual daily use over a 6-month period.
确定新型口腔骨导装置（Sonitus Medical 的 SoundBite Hearing System）治疗单侧耳聋（SSD）的长期安全性和益处。
对佩戴该设备的 SSD 患者进行为期 6 个月的多中心、对照、非随机、前瞻性非盲研究。
类似于 SSD 患者接受诊断和治疗的常规门诊护理中心。
患有获得性、永久性 SSD 且目前未使用任何其他 SSD 设备的成年人（N=22）。
持续日常佩戴新设备 6 个月。
全面的医疗、听力和牙科措施；助听听阈；听力辅助获益简明评估量表评分和 SSD 问卷。
与试验开始时相比，试验结束时无相关不良事件或医疗或听力发现的变化。与术前测量值相比，3 个月和 6 个月时平均助听听阈（p>0.01）或平均牙科措施（p>0.05）均无显著变化。听力辅助获益简明评估量表的平均评分显示，在 3 个月和 6 个月时，背景噪声、混响和交流容易度子量表以及总体评分均有所改善（p<0.01）。SSD 问卷的结果表明，绝大多数（>90%）受试者在长期佩戴该设备后报告在各种领域的满意度和改善。
SoundBite 系统在持续日常使用 6 个月的情况下对 SSD 患者是安全的，并继续提供实质性益处。
