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首页> 外文期刊>Otology and neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology >Efficacy and Safety of an In-the-Mouth Bone Conduction Device for Single-Sided Deafness
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Efficacy and Safety of an In-the-Mouth Bone Conduction Device for Single-Sided Deafness

机译：口腔内传导装置的功效和安全性单面耳聋

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摘要

Objective: To determine the efficacy, benefit, and safety of a new in-the-mouth bone conduction device (SoundBite Hearing System) for single-sided deafness (SSD). Study Design: A multicenter, controlled, nonrandomized prospective unblinded study of SSD patients wearing the device. Settings: Ambulatory care centers typical of those where SSD patients are diagnosed and treated. Patients: Adults (ages >18 and <80 yr) with acquired, permanent SSD (N = 28) and no current use of any SSD device. Intervention: Continual daily wear of the new device over a 30-day trial period. Main Outcome Measures: The Hearing in Noise Test (HINT), the Abbreviated Profile of Hearing Aid Benefit (APHAB), comprehensive pretrial and posttrial medical, audiologic, and dental examinations and an SSD questionnaire.Results: The Hearing in Noise Test scores improved an average of-2.5 dB after 30 days, compared with wearing no device (p < 0.001). The Abbreviated Profile of Hearing Aid Benefit scores improved (p < 0.05) for all subjects for the Global and Background Noise subscales and for all but 1 subject for the Reverberation and Ease of Communication subscales. There were no medical, audiologic, or dental complications. Conclusion: The SoundBite system is safe and effective and provides substantial benefit for SSD patients with continual daily use over a 30-day period.
机译：目的：确定新的口腔内传导装置（Soundbite听力系统）对单面耳聋（SSD）的疗效和安全性。研究设计：一项多中心，受控的，非随机的前瞻性无盲研究，对佩戴该设备的SSD患者。设置：诊断和治疗SSD患者的室外护理中心。患者：成人（年龄> 18岁和<80岁），具有永久性SSD（n = 28），并且目前没有使用任何SSD设备。干预：在30天的试用期内，新设备的日常磨损不断。主要结果措施：噪声测试的听力（提示），助听器福利的缩写概况（APHAB），全面的审前和审前医学，听力学和牙科检查以及SSD问卷：噪声测试的听力改进30天后平均为2.5 dB，而没有佩戴设备（p <0.001）。全球和背景噪声子量表的所有受试者以及除1个受试者的所有受试者的助听器益处得分的缩写（p <0.05），以进行回响和易于通信子量表。没有医学，听力或牙齿并发症。结论：Soundbite系统是安全有效的，并为30天内的日常使用的SSD患者提供了可观的好处。

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