Otolaryngology Department, Sheffield Teaching Hospitals, Sheffield, UK.
ENT Department, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.
Eur Arch Otorhinolaryngol. 2020 Nov;277(11):2995-3002. doi: 10.1007/s00405-020-06022-7. Epub 2020 May 13.
Bone conduction hearing devices are widely used and indicated in cases of conductive, mixed or single-sided deafness where the conventional hearing aids are not indicated or tolerated. This prospective study aims to investigate the surgical and hearing outcomes of a novel active piezoelectric transcutaneous bone conduction device (t-BCD).
Prospective data were collected from the first 10 patients who underwent implantation with the t-BCD Osia (Cochlear, Australia) (between Dec 2018 and March 2019) in a tertiary referral centre. The main outcome measures include: surgical outcome, free field speech testing with speech recognition thresholds, audiological gain and patient-reported outcomes including the 'Glasgow Benefit Inventory' (GBI) and the 'Client Oriented Scale of Improvement (COSI).
The mean length of surgery was 70.6 min (range 50-87, SD = 9.5). Mean skin thickness measured was 5.6 mm (range 4-8, SD = 1.1). There were two post-operative wound infections which settled conservatively. One required revision surgery to thin skin. The average gain in hearing with the implant was + 39.4 dB. Pre-implantation mean unaided SRT was 38.1 dB (SD = 7.8) and the post-implantation mean-aided SRT was 22.7 dB (SD = 4.6) (p = 0.000078). There was improvement in COSI domains. The mean Glasgow disability score dropped from 52% pre-implantation to 20% post-implantation (p = 0.001).
This new active t-BCHD provides excellent audiological gain and improvement in speech recognition. Patient-reported outcomes have also been very positive. The surgery was straightforward with no major surgical complications reported. Further studies will be required to examine long-term outcomes in larger number of patients.
骨导听力设备在传导性、混合性或单侧聋的情况下被广泛应用和推荐，在这些情况下，传统助听器不适用或不能耐受。本前瞻性研究旨在探讨一种新型主动式压电经皮骨导装置（t-BCD）的手术和听力结果。
在一家三级转诊中心，对 2018 年 12 月至 2019 年 3 月期间接受 t-BCD Osia（科利耳，澳大利亚）植入的前 10 例患者进行前瞻性数据收集。主要观察指标包括：手术结果、自由声场言语测试的言语识别阈值、听力增益和患者报告的结果，包括“格拉斯哥受益量表”（GBI）和“患者导向的改善量表”（COSI）。
手术平均时间为 70.6 分钟（范围 50-87，SD=9.5）。平均皮肤厚度为 5.6 毫米（范围 4-8，SD=1.1）。有两例术后伤口感染，经保守治疗痊愈。一例需要进行皮肤变薄的修正手术。植入后听力平均增益为+39.4dB。植入前未助听的平均 SRT 为 38.1dB（SD=7.8），植入后的平均助听 SRT 为 22.7dB（SD=4.6）（p=0.000078）。COSI 各领域均有改善。植入前平均格拉斯哥残疾评分（GDS）为 52%，植入后为 20%（p=0.001）。
这种新型主动式 t-BCHD 提供了出色的听力增益和言语识别改善。患者报告的结果也非常积极。手术简单，没有报告重大手术并发症。需要进一步的研究来检查更大数量患者的长期结果。
