Xi X, Zhao A R, Pang X H, Zhang L H, Wang Q, Wang Y, Su Y Y, Yuan L D, Zhao Q, Shi Quan
Department of Otolaryngology Head and Neck Surgery, Chinese PLA General Hospital, Beijing 100853, China.
School of Medical Technology and information Engineering, Zhejiang Chinese Medical University, Hangzhou 310053, China.
Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2021 May 7;56(5):478-486. doi: 10.3760/cma.j.cn115330-20200602-00465.
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. 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. The monosyllable WRS and the 50% threshold of signal-to-noise ratio (SNR) were significantly better in all aided conditions. The head shadow effect, assessed by the SNR via CMNmatrix test improved an average of 2.6 dB after 30 days' wearing compared with unaided condition (<0.001). The APHAB scores improved (<0.05) for all subjects for the Global and Ease of Communication, Reverberation, Background Noise subscales. The SSQ scores improved (<0.05) for all subjects for Speech, Spatial and Qualities of Hearing subscales. 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.
单侧耳聋（SSD）的听觉缺陷可用一种新型口腔内装置SoundBite进行治疗，该装置通过向牙齿施加振动信号来传递声音。本研究的目的是评估这种骨传导装置对中国成年SSD患者的疗效和益处。在一项前瞻性对照、非随机、非盲研究中，招募了18名年龄在19 - 66岁之间、患有后天性永久性感音神经性SSD且目前未使用任何其他SSD装置进行治疗的患者。要求他们在为期30天的免费试用期内持续每天佩戴新装置。口腔内听力装置放置在上颌的两颗牙齿周围，类似于一个小型局部义齿或固定器。听力测试包括纯音气导阈值、安静环境下单音节词识别得分（WRS）以及噪声环境下的句子接受阈值（通过CMNmatrix测试）。益处通过助听器益处简表（APHAB）和言语、空间及听力质量量表（SSQ）问卷来确定。在所有助听条件下，单音节WRS和50%信噪比（SNR）阈值均显著更好。通过CMNmatrix测试的SNR评估的头影效应，与未佩戴装置的情况相比，佩戴30天后平均改善了2.6 dB（<0.001）。所有受试者在整体、交流便利性、混响、背景噪声子量表上的APHAB得分均有所改善（<0.05）。所有受试者在言语、空间及听力质量子量表上的SSQ得分均有所改善（<0.05）。对于SSD患者，SoundBite是成熟的可植入骨传导装置的良好替代方案。在噪声和安静环境下听力能力的改善以及头影效应的降低得到了验证，符合预期。
