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新型 Osia 主动经皮压电骨传导植入物在英国的首次应用经验。

First United Kingdom experience of the novel Osia active transcutaneous piezoelectric bone conduction implant.

机构信息

Otolaryngology Department, Sheffield Teaching Hospitals, Sheffield, UK.

ENT Department, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.

出版信息

Eur Arch Otorhinolaryngol. 2020 Nov;277(11):2995-3002. doi: 10.1007/s00405-020-06022-7. Epub 2020 May 13.

Abstract

PURPOSE

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).

METHODS

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).

RESULTS

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).

CONCLUSIONS

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.

摘要

目的

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。

方法

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)。

结果

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)。

结论

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。

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