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骨传导植入物——首次植入、手术及听力学方面

The bone conduction implant--first implantation, surgical and audiologic aspects.

作者信息

Eeg-Olofsson Måns, Håkansson Bo, Reinfeldt Sabine, Taghavi Hamidreza, Lund Henrik, Jansson Karl-Johan Fredén, Håkansson Emil, Stalfors Joacim

机构信息

*Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg; †Department of Signals and Systems, Chalmers University of Technology; and ‡Clinic of Oral and Maxillofacial Radiology, Department of Oral and Maxillofacial Radiology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

出版信息

Otol Neurotol. 2014 Apr;35(4):679-85. doi: 10.1097/MAO.0000000000000203.

DOI:10.1097/MAO.0000000000000203
PMID:24317216
Abstract

OBJECTIVE

To report on preoperative assessment, surgery, and audiologic outcome of the first patient implanted with the bone conduction implant (BCI).

BACKGROUND

The BCI is a bone conduction hearing device with an intact skin solution where the transducer is implanted close to the ear canal opening. By avoiding a percutaneous screw attachment to the skull, the BCI is anticipated to reduce complications associated with the Bone-Anchored Hearing Aid (BAHA) solution.

METHODS

The first patient to receive a BCI was a 42-year-old woman with a unilateral mixed hearing loss due to tympanosclerosis. Preoperative and postoperative cone beam computed tomography and a virtual planning tool for 3D reconstruction were used to optimize and control the position of the BCI in the mastoid. The transducer was placed in a 5-mm deep seating in the mastoid and secured with a titanium bar. Free field tone and speech audiometry were conducted to evaluate the audiologic outcome at baseline (1 month postoperatively) and 1 month after baseline.

RESULTS

The BCI was placed in the position according to the preoperative 3D planning. On average, the tone thresholds improved by 30 dB, speech reception thresholds by 25.5 dB and speech signal-to-noise ratio by 9.7 dB. The surgical procedure was considered simple and safe.

CONCLUSION

The BCI can be implanted by a safe and easy surgical procedure. 3D preoperative planning can be helpful to optimize the BCI position. The BCI is a realistic alternative to the BAHA.

摘要

目的

报告首例植入骨传导植入物(BCI)患者的术前评估、手术过程及听力结果。

背景

BCI是一种具有完整皮肤解决方案的骨传导听力装置,其换能器植入靠近耳道开口处。通过避免经皮颅骨螺钉固定,预计BCI可减少与骨锚式助听器(BAHA)解决方案相关的并发症。

方法

首例接受BCI植入的患者为一名42岁女性,因鼓室硬化症导致单侧混合性听力损失。术前和术后使用锥形束计算机断层扫描及三维重建虚拟规划工具,以优化和控制BCI在乳突中的位置。将换能器置于乳突内5毫米深的位置,并用钛棒固定。在基线(术后1个月)和基线后1个月进行自由声场纯音和言语听力测试,以评估听力结果。

结果

BCI按照术前三维规划放置。平均而言,纯音阈值提高了30分贝,言语接受阈值提高了25.5分贝,言语信噪比提高了9.7分贝。手术过程被认为简单且安全。

结论

BCI可通过安全简便的手术程序植入。术前三维规划有助于优化BCI位置。BCI是BAHA的一种切实可行的替代方案。

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Patients' Experiences of an Active Transcutaneous Implant: The Bone Conduction Implant.患者对有源经皮植入物的体验:骨传导植入物
Audiol Neurootol. 2025;30(4):335-346. doi: 10.1159/000544774. Epub 2025 Feb 18.
2
Retrosigmoidal placement of an active transcutaneous bone conduction implant: surgical and audiological perspectives in a multicentre study.经乳突后置入主动经皮骨导植入物:多中心研究中的手术和听力学观点。
Acta Otorhinolaryngol Ital. 2021 Feb;41(1):91-99. doi: 10.14639/0392-100X-N0609.
3
Three-Year Follow-Up with the Bone Conduction Implant.
骨导植入物的三年随访结果。
Audiol Neurootol. 2020;25(5):263-275. doi: 10.1159/000506588. Epub 2020 Apr 8.
4
Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices.鼻声压作为有源经皮骨传导装置植入的客观验证方法。
Med Devices (Auckl). 2019 May 28;12:193-202. doi: 10.2147/MDER.S197919. eCollection 2019.
5
Robustness and lifetime of the bone conduction implant - a pilot study.骨传导植入物的耐用性和使用寿命——一项初步研究。
Med Devices (Auckl). 2019 Feb 26;12:89-100. doi: 10.2147/MDER.S192860. eCollection 2019.
6
VEMP using a new low-frequency bone conduction transducer.使用新型低频骨传导换能器的前庭诱发肌源性电位
Med Devices (Auckl). 2018 Sep 6;11:301-312. doi: 10.2147/MDER.S171369. eCollection 2018.
7
Implantable hearing devices.可植入式听力设备
GMS Curr Top Otorhinolaryngol Head Neck Surg. 2017 Dec 18;16:Doc06. doi: 10.3205/cto000145. eCollection 2017.
8
Postoperative imaging of the internal auditory canal : Visualization of active auditory implants.内耳道术后影像学检查:有源听觉植入物的可视化
HNO. 2017 Aug;65(Suppl 2):81-86. doi: 10.1007/s00106-016-0296-6.
9
[Postoperative imaging of the internal auditory canal : Visualization of active auditory implants. German version].[内耳道术后影像学检查:有源听觉植入物的可视化。德文版]
HNO. 2017 Sep;65(9):735-740. doi: 10.1007/s00106-016-0295-7.
10
The bone conduction implant: Clinical results of the first six patients.骨传导植入物:前六名患者的临床结果。
Int J Audiol. 2015 Jun;54(6):408-16. doi: 10.3109/14992027.2014.996826. Epub 2015 Feb 23.