Division of Otolaryngology-Head and Neck Surgery, University of Utah, Salt Lake City, Utah, U.S.A.
Laryngoscope. 2013 Nov;123(11):2807-12. doi: 10.1002/lary.24091. Epub 2013 Jul 15.
OBJECTIVES/HYPOTHESIS: To determine the safety and efficacy of the SoundBite for patients over a 6 month period of use.
Prospective, multisite, nonrandomized patient enrollment with outcomes based on audiometric profile and self-reported assessment.
Patients with single-sided deafness were eligible for the study. Patients were fit with the standard SoundBite sound transducer and were asked to wear the device regularly for 6 months. At the end of the trial period, patients completed both a self-assessment and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaires.
Thirty-four subjects completed the study. Mean APHAB scores improved significantly for ease of communication (P < 0.001), background noise (P < 0.001), reverberation (P < 0.001), and global benefit (P < 0.001). Patients reported high rates of auditory benefit in a variety of listening situations and high rates of overall satisfaction with the device. One adverse event with a superficial mouth sore was reported and resolved after appropriate dental care. Twelve patients (35%) reported acoustic feedback. In six of these patients, the feedback resolved after device adjustment.
The SoundBite is a new hearing prosthesis that delivers bone conduction energy. It offers advantages over traditional osseointegrated devices that require surgical placement. Patient satisfaction with the device after 6 months of regular use is high. The SoundBite provided improvement in ease of communication, hearing in background noise, sound reverberation, and an overall global hearing benefit. Acoustic feedback is the most commonly reported problem with the SoundBite, and this is minimized with proper fitting.
目的/假设：确定 SoundBite 在 6 个月使用期间对患者的安全性和疗效。
前瞻性、多地点、非随机患者入组，根据听力图特征和自我评估得出结果。
符合单侧耳聋标准的患者有资格参加研究。患者配备标准的 SoundBite 声音换能器，并被要求在试验期间定期佩戴该设备 6 个月。在试验结束时，患者完成了自我评估和简短听力助听效果问卷（APHAB）。
34 名受试者完成了研究。沟通舒适度（P < 0.001）、背景噪声（P < 0.001）、混响（P < 0.001）和整体受益（P < 0.001）的 APHAB 评分均显著提高。患者报告在各种听力情况下均获得较高的听觉受益，并且对设备总体满意度较高。报告了 1 例口腔轻微疼痛的不良事件，经适当的牙科护理后得到解决。12 名患者（35%）报告存在声反馈。在这些患者中的 6 名，经设备调整后反馈得到解决。
SoundBite 是一种新的听力假体，可提供骨导能量。它比需要手术植入的传统骨整合设备具有优势。患者在经过 6 个月的常规使用后对设备的满意度较高。SoundBite 可改善沟通、背景噪声下的听力、声音混响和整体全球听力受益。声反馈是 SoundBite 最常见的报告问题，通过正确的适配可以最小化该问题。
