Cywka Katarzyna B, Skarżyński Henryk, Król Bartłomiej, Skarżyński Piotr H
Otorhinolaryngosurgery Clinic, World Hearing Center, Institute of Physiology and Pathology of Hearing, 02-042 Warsaw, Poland.
Institute of Sensory Organs, 05-830 Warsaw, Poland.
J Clin Med. 2021 Dec 16;10(24):5916. doi: 10.3390/jcm10245916.
the Bonebridge hearing implant is an active transcutaneous bone conduction implant suitable for various types of hearing loss. It was first launched in 2012 as the BCI 601, with a newer internal part (BCI 602) released in 2019. With the new size and shape, the BCI 602 can be used in patients previously excluded due to insufficient anatomical conditions, especially in patients with congenital defects of the outer and middle ear.
the purpose of this study is to evaluate the objective and subjective benefits of the new Bonebridge BCI 602 in children who have hearing impairment due to conductive or mixed hearing loss. Safety and effectiveness of the device was assessed.
the study group included 22 children aged 8-18 years (mean age 14.7 years) who had either conductive or mixed hearing loss. All patients were implanted unilaterally with the new Bonebridge BCI 602 implant. Pure tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed before and after implantation. Word recognition scores were evaluated using the Demenko and Pruszewicz Polish Monosyllabic Word Test, and speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. The subjective assessment of benefits was carried outusing the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire.
after implantation of the Bonebridge BCI 602 all patients showed a statistically significant improvement in hearing and speech understanding. The mean word recognition score (WRS) changed from 12.1% before implantation to 87.3% after 6 months. Mean speech reception threshold (SRT) before implantation was +4.79 dB SNR and improved to -1.29 dB SNR after 6 months. All patients showed stable postoperative results. The APHAB questionnaire showed that difficulties in hearing decreased after implantation, with a statistically significant improvement in global score. Pre-operative scores (M = 35.7) were significantly worse than post-operative scores at 6 months (M = 25.7).
the present study confirms that the Bonebridge BCI 602 is an innovative and effective solution, especially for patients with conductive and mixed hearing loss due to anatomical ear defects. The Bonebridge BCI 602 system provides valuable and stable audiological and surgical benefits. Subjective assessment also confirms the effectiveness of the BCI 602. The BCI 602 offers the same amplification as the BCI601, but with a smaller size. The smaller dimensions make it an effective treatment option for a wider group of patients, especially children with congenital defects of the outer and middle ear.
骨桥听力植入体是一种适用于各类听力损失的有源经皮骨传导植入体。它于2012年首次推出，型号为BCI 601，2019年发布了更新的内部部件（BCI 602）。BCI 602具有新的尺寸和形状，可用于因解剖条件不足而此前被排除在外的患者，尤其是患有外耳和中耳先天性缺陷的患者。
本研究旨在评估新型骨桥BCI 602对因传导性或混合性听力损失而有听力障碍的儿童的客观和主观益处。评估了该装置的安全性和有效性。
研究组包括22名年龄在8至18岁（平均年龄14.7岁）之间、患有传导性或混合性听力损失的儿童。所有患者均单侧植入新型骨桥BCI 602植入体。在植入前后进行了纯音听力测定、言语识别测试（安静和噪声环境下）以及自由场听力测定。使用德门科和普鲁谢维茨波兰单音节词测试评估单词识别分数，使用波兰句子矩阵测试评估噪声环境下的言语接受阈值。使用APHAB（助听器益处简表）问卷进行益处的主观评估。
植入骨桥BCI 602后，所有患者的听力和言语理解能力均有统计学意义上的显著改善。平均单词识别分数（WRS）从植入前的12.1%提高到6个月后的87.3%。植入前的平均言语接受阈值（SRT）为+4.79 dB SNR，6个月后改善至-1.29 dB SNR。所有患者术后结果稳定。APHAB问卷显示，植入后听力困难减少，总体得分有统计学意义上的显著改善。术前得分（M = 35.7）明显低于6个月后的术后得分（M = 25.7）。
本研究证实骨桥BCI 602是一种创新且有效的解决方案，尤其适用于因耳部解剖缺陷导致传导性和混合性听力损失的患者。骨桥BCI 602系统提供了有价值且稳定的听力学和手术益处。主观评估也证实了BCI 602的有效性。BCI 602提供与BCI601相同的放大功能，但尺寸更小。更小的尺寸使其成为更广泛患者群体的有效治疗选择，尤其是患有外耳和中耳先天性缺陷的儿童。
