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经皮骨锚式助听器吸引系统:法国多中心研究的长期结果。

Transcutaneous Baha Attract system: Long-term outcomes of the French multicenter study.

作者信息

Nevoux Jérôme, Coudert Cyrille, Boulet Marc, Czajka Cécile, Tavernier Laurent, Daval Mary, Ayache Denis, Meller Renaud, Rossetto Stéphane, Papon Jean-François, Deveze Arnaud

机构信息

AP-HP, Hôpital Bicêtre, Service d'Oto-Rhino-Laryngologie, Le Kremlin-Bicêtre, France.

Faculté de Médecine, Université Paris-Saclay, Université Paris-Sud, Le Kremlin-Bicêtre, France.

出版信息

Clin Otolaryngol. 2018 Dec;43(6):1553-1559. doi: 10.1111/coa.13214. Epub 2018 Sep 14.

DOI:10.1111/coa.13214
PMID:30137669
Abstract

BACKGROUND

Bone conduction implants based on abutment-driven acoustic transmission result in good hearing outcomes; however, skin complications impact the quality of life (QOL) and possibly the viability of the device for many patients. The transcutaneous magnetic Baha Attract technology was developed with the goal of minimising skin complications.

OBJECTIVES

To analyse surgical, auditory and QOL outcomes for patients implanted with the Baha Attract.

DESIGN

Prospective multicentre cohort study.

SETTING

Four French tertiary referral centres.

PARTICIPANTS

Thirty-two patients implanted with the Baha Attract, including 25 with conductive and mixed hearing loss and 7 with single-sided deafness.

MAIN OUTCOME MEASURES

Postoperative follow-up involved the visual analysis of soft tissue adaptation and sound processor magnet strength measurement. The audiometric outcomes were evaluated in quiet and noise, and the QOL was assessed using three different questionnaires.

RESULTS

After 12 months of use, soft tissue was thinner, and mean magnet strength was significantly decreased (3.7-3.1, P < 0.05) relative to measures during surgery. The speech recognition threshold in quiet significantly improved compared to unaided situation (73-44 dB HL respectively, P < 0.001) as did functional gain in noise (+2.8). All QOL scores improved, and the APHAB questionnaire score correlated with the audiometric outcomes.

CONCLUSIONS

The Baha Attract technology results in significant hearing gain and improves QOL. Skin complications were not observed, although surgeons, audiologists and patients should be aware of soft tissue evolution during the first postoperative year. The reversibility of this implant is a major advantage that allows switching to another system if hearing degrades.

摘要

背景

基于基台驱动声传输的骨传导植入物可带来良好的听力效果;然而,皮肤并发症会影响许多患者的生活质量(QOL),甚至可能影响该装置的适用性。经皮磁体Baha Attract技术的研发旨在尽量减少皮肤并发症。

目的

分析植入Baha Attract的患者的手术、听觉及生活质量结果。

设计

前瞻性多中心队列研究。

地点

法国四家三级转诊中心。

参与者

32例植入Baha Attract的患者,其中25例为传导性和混合性听力损失,7例为单侧耳聋。

主要观察指标

术后随访包括软组织适应性的视觉分析和声音处理器磁体强度测量。在安静和嘈杂环境中评估听力结果,并使用三种不同的问卷评估生活质量。

结果

使用12个月后,软组织变薄,与手术期间的测量值相比,平均磁体强度显著降低(从3.7降至3.1,P<0.05)。与未使用辅助设备时相比,安静环境下的言语识别阈值显著改善(分别为73 dB HL和44 dB HL,P<0.001),嘈杂环境中的功能增益也有所改善(+2.8)。所有生活质量评分均有所提高,APHAB问卷评分与听力结果相关。

结论

Baha Attract技术可显著提高听力并改善生活质量。未观察到皮肤并发症,不过外科医生、听力学家和患者应了解术后第一年软组织的变化情况。这种植入物的可逆性是一个主要优势,若听力下降可更换为另一种系统。

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