Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Prosper Hospital, Recklinghausen, Germany.
Otol Neurotol. 2013 Jul;34(5):927-34. doi: 10.1097/MAO.0b013e31828682e5.
Patients with air-bone-gaps that cannot be corrected successfully by tympanoplasty or with mixed hearing loss may be treated with bone conducting hearing aids. Their disadvantages are the obvious external fixation components or the biological and psychosocial problems of open implants. We have developed a new partially implantable Bone Conduction Hearing Device (BCHD) without a percutaneous abutment and have been using them clinically for over 6 years. The principle of these BCHD is a magnetic coupling and acoustic transmission between implanted and external magnets. The goal of this study was to evaluate its clinical and audiologic results in patients with unilateral or bilateral congenital aural atresia.
Magnets are implanted into shallow bone beds in a 1-step procedure. The skin above the magnets is slightly thinned. The external device fixed with counter magnets in a base plate.
Twenty-one patients who have been implanted due to congenital atresia showed up for this follow-up study. The follow-up period was 19.3 ± 12.2 months, with a range of 0.2 to 46.6 months. The average age of the patients at the time of implantation was 12.4 years with a wide range from 6.0 to 50.0 years.
The average hearing gain was 31 ± 8 dB, and the suprathreshold word recognition tests increased by 57% ± 23%. Strength of the magnetic force that the patients had chosen themselves measured 0.9 ± 0.4 N with a range from 0.3 to 1.8 N. Skin thickness over the implants measured sonographically was 3.9 ± 0.8 mm (range, 2.5-5.6 mm).
This new bone conducting hearing device only needs one operation, has a very low risk for complication, and a hearing gain similar to other bone conducting hearing aids. We have found high comfort and safety of this system and conclude that it could be a valuable alternative to other conventional or percutaneous bone conducting hearing solutions.
无法通过鼓室成形术或混合性听力损失成功矫正气骨导间隙的患者可以使用骨导助听器进行治疗。其缺点是明显的外部固定组件或开放式植入物的生物和社会心理问题。我们开发了一种新的部分可植入骨导听力设备（BCHD），没有经皮的衔接器，并已在临床上使用了超过 6 年。这些 BCHD 的原理是植入和外部磁铁之间的磁耦合和声音传输。本研究的目的是评估其在单侧或双侧先天性听骨闭锁患者中的临床和听力结果。
磁铁在一步手术中植入浅层骨床中。磁铁上方的皮肤稍薄。外部设备通过在底座上的对磁铁固定。
由于先天性闭锁而接受植入的 21 名患者参加了这项随访研究。随访期为 19.3 ± 12.2 个月，范围为 0.2 至 46.6 个月。植入时患者的平均年龄为 12.4 岁，范围为 6.0 至 50.0 岁。
平均听力增益为 31 ± 8 dB，阈上单词识别测试增加了 57% ± 23%。患者自行选择的磁力强度为 0.9 ± 0.4 N，范围为 0.3 至 1.8 N。超声测量植入物上方的皮肤厚度为 3.9 ± 0.8 mm（范围，2.5-5.6 mm）。
这种新型骨导听力设备只需进行一次手术，并发症风险非常低，听力增益与其他骨导助听器相似。我们发现该系统具有很高的舒适度和安全性，并得出结论，它可能是其他传统或经皮骨导听力解决方案的有价值的替代方案。
