Willenborg Kerstin, Avallone Emilio, Maier Hannes, Lenarz Thomas, Busch Susan
Department of Otorhinolaryngology, Medical University Hannover, Hannover, Germany.
Cluster of Excellence Hearing4all, Medical University Hannover, Hannover, Germany.
Audiol Neurootol. 2022;27(1):83-92. doi: 10.1159/000515489. Epub 2021 Apr 26.
The Cochlear™ Osia® System (Osia) is an active transcutaneous bone conduction implant system intended for patients with conductive and mixed hearing loss but can also be used in cases of single-sided deafness (SSD) for the contralateral routing of signal (CROS). The Osia implant is placed subcutaneously under the intact skin behind the ear with the piezoelectric actuator connected to an osseointegrated BI300 implant - a titanium screw used for a 2-stage Baha surgery - on the mastoid. The external processor is magnetically attached to the subcutaneous implant receiver coil. As the Osia has recently been CE certified and is new on the market, with limited patient outcome data for SSD available, the objective of this study was the evaluation of surgical procedure, audiological results, and patient satisfaction for the Osia in SSD patients.
In a prospective, monocentric clinical observation study, 6 patients (18 years of age or older) with SSD and bone conduction thresholds pure tone average 0.5, 1, 2, and 4 kHz ≤25 dB HL on the contralateral side were implanted with an Osia. Analysis of clinical outcome data with respect to surgical technique, adverse events, audiological measurement, and subjective benefit for SSD patients was conducted. Audiological measurements performed included hearing thresholds, sound field thresholds, word recognition scores (WRS; in %) in quiet, and speech recognition thresholds in noise (in dB SNR). All tests were performed unaided and aided with the Osia. The subjective benefit with the Osia was determined by using 2 questionnaires; the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Bern Benefit in Single-Sided Deafness (BBSSD).
Preliminary results indicate a straightforward surgical procedure with a low rate of complications and an improvement in speech perception in quiet, listening performance in everyday situations and patient satisfaction. However, in one of 6 subjects, a revision surgery had to be performed.
Provided that SSD patients are open for CROS hearing, they can benefit from the Osia by reduced head shadow effects and better speech recognition. Special caution should be given to the skin at the site of implantation to avoid complications.
科利耳™奥西阿®系统（Osia）是一种有源经皮骨传导植入系统，适用于传导性和混合性听力损失患者，也可用于单侧耳聋（SSD）患者的对侧信号路由（CROS）。Osia植入体通过皮下放置在耳后完整皮肤下方，压电驱动器连接到乳突上的骨整合BI300植入体（一种用于两阶段巴哈手术的钛螺钉）。外部处理器通过磁力附着在皮下植入体的接收线圈上。由于Osia最近已获得CE认证且刚进入市场，SSD患者的患者结局数据有限，本研究的目的是评估Osia在SSD患者中的手术过程、听力学结果和患者满意度。
在一项前瞻性、单中心临床观察研究中，对6例年龄在18岁及以上、SSD且对侧0.5、1、2和4kHz纯音平均骨导阈值≤25dB HL的患者植入了Osia。对SSD患者的手术技术、不良事件、听力学测量和主观获益方面的临床结局数据进行了分析。进行的听力学测量包括听力阈值、声场阈值、安静环境下的单词识别分数（WRS；百分比）以及噪声环境下的言语识别阈值（dB SNR）。所有测试均在未佩戴辅助设备和佩戴Osia辅助设备的情况下进行。使用两份问卷确定使用Osia后的主观获益；助听器获益简表（APHAB）和单侧耳聋的伯尔尼获益（BBSSD）。
初步结果表明手术过程简单，并发症发生率低，安静环境下的言语感知、日常聆听表现和患者满意度均有所改善。然而，6名受试者中有1人需要进行翻修手术。
如果SSD患者愿意接受CROS听力，他们可以通过减少头部阴影效应和更好的言语识别从Osia中获益。应特别注意植入部位的皮肤，以避免并发症。
