Objective: The auditory deficits of single-sided deafness (SSD) can be treated with a novel intra-oral device, SoundBite, which delivers sound by applying vibratory signal to the teeth. The purpose of this study was to evaluate the efficacy and benefit of the bone conduction device for Chinese adults with SSD. Methods: Eighteen patients aged 19-66 yrs with acquired, permanent sensorineural SSD and no current treatment by any other devices for SSD, were recruited in a prospective controlled, nonrandomized, unblinded study. They were requested the continually daily wear of the new device over a 30-day free trial period. The intra-oral hearing device was placed around two maxillary teeth and was similar to a small partial denture or retainer. The audiological tests included pure tone air conduction thresholds, monosyllable word recognition score (WRS) in quiet and sentence reception thresholds in noise (via CMNmatrix test). The benefit was determined with the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire. Results: The monosyllable WRS and the 50% threshold of signal-to-noise ratio (SNR50) were significantly better in all aided conditions. The head shadow effect, assessed by the SNR50 via CMNmatrix test improved an average of 2.6 dB after 30 days' wearing compared with unaided condition (P<0.001). The APHAB scores improved (P<0.05) for all subjects for the Global and Ease of Communication, Reverberation, Background Noise subscales. The SSQ scores improved (P<0.05) for all subjects for Speech, Spatial and Qualities of Hearing subscales. Conclusion: The SoundBite is a good alternative to the well-established implantable bone conduction devices in patients with SSD. An improvement in listening ability in noise and quiet as well as a decrease of the head shadow effect is validated as the expected.目的: 分析SoundBite™/品音®牙骨传导听力系统(通过牙齿上配戴微型骨振器将声信号直接传至健侧耳蜗)对单侧感音神经性听力损失患者干预早期的听力改善情况,探讨该装置的应用前景。 方法: 招募单侧感音神经性听力损失成人患者18例,其中男10例,女8例,年龄19~66岁;纯音测听500、1 000、2 000、4 000 Hz四频率纯音平均听阈患耳≥70 dB HL,健耳平均听阈均≤30 dB HL。其中先天或自幼单耳失聪8例,突发性聋7例,梅尼埃病1例,听神经瘤术后1例,慢性中耳炎术后失聪1例。患者上颌后牙槽部位须至少一侧有连续两颗牙齿,以保证微型骨振器(称为口内机)的制作与日常佩戴。成效观测期限为配戴SoundBite™/品音®装置后的(30±7)d,未同时使用其他单侧聋干预装置。成效评估包括:应用TDH50P气导耳机测试患侧助听前后的纯音听阈;以“心爱飞扬”言语测听软件测试患耳在50、65 dB SPL声级下的单音节识别率;在声场中采用普通话版矩阵式语句(CMNmatrix)测试信噪不同方位下的信噪比识别阈(50% threshold of signal-to-noise ratio,SNR50),以反映患者头影效应、静噪效应及双耳加合效应;采用助听器效果缩略简表(Abbreviated Profile of Hearing Aid Benefit,APHAB)、言语-空间-听音质量(Speech,Spatial and Qualities of Hearing Scale,SSQ)问卷来评价患者使用牙骨装置后的助听效果、空间言语感知等方面的改善程度。 结果: 配戴SoundBite™/品音®装置30 d后,患侧助听听阈和单音节识别率均显著提高(P值均<0.001);声场中患侧扬声器播放语句而健侧播放稳态言语谱噪声时的SNR50下降幅度(反映头影效应)为(2.6±2.1)dB;而患者前方播放语句而患侧播放噪声时的SNR50(反映静噪效应)降幅则为(0.3±2.8)dB,差异无统计学意义(P值均>0.05);患者前方同时播放语句和噪声时的SNR50下降幅度(反映加合效应)为(1.0±2.2)dB。APHAB的四个亚项中EC(交流便利)、RV(混响环境)、BN(嘈杂背景)三个亚项及整体得分均有显著提升(P值均<0.01);更能反映单侧聋交流困境的SSQ问卷中,事关空间听觉、言语识别及听音质量的得分均有显著性的改善(P值均<0.05)。 结论: SoundBite™/品音®牙骨传导听力系统干预早期成效表明,其能显著提升单侧聋患侧的听力及言语识别能力,帮助患者克服在声场噪声环境下识别语句时的头影效应,改善空间听觉的主观感受和言语交流能力,是一种很有前景的非植入式骨导助听装置。.