Briggs Robert, Van Hasselt Andrew, Luntz Michal, Goycoolea Marcos, Wigren Stina, Weber Peter, Smeds Henrik, Flynn Mark, Cowan Robert
*HEARing Cooperative Research Centre, Melbourne, Australia; †Chinese University of Hong Kong, Hong Kong, China; ‡Bnai Zion Hospital, Haifa, Israel; §Clínica Las Condes, Santiago, Chile; ∥Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden; and ¶Cochlear Americas, Denver, Colorado, U.S.A.
Otol Neurotol. 2015 Jun;36(5):834-41. doi: 10.1097/MAO.0000000000000712.
The aim of the investigation was to prospectively evaluate, in a multicenter setting, the clinical performance of a new magnetic bone conduction hearing implant system.
The test device was the Cochlear Baha Attract System (Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden). Instead of the skin-penetrating abutment of traditional bone conduction hearing implants, the test device uses an implantable and an external magnet to transmit sound from the sound processor (SP) through intact skin to the skull bone. Twenty-seven adult patients with a conductive or mild mixed hearing loss or single-sided sensorineural deafness were included in the clinical investigation across four investigational sites. The patients were followed for 9 months after implantation. The study evaluated efficacy in terms of hearing performance compared with unaided hearing and with hearing with the SP on a softband. Patient benefit, soft tissue status, device retention, and safety parameters were monitored continuously throughout the investigation.
Surgery and healing was uneventful. Statistically significant improvements in audibility and speech understanding in noise and quiet were recorded for the test device compared with preoperative unaided hearing. Speech recognition was similar or better than tests performed with the same SP on a softband. Good soft tissue outcomes were reported, without major pressure-related complications. At the end of the investigation, all patients continued to use and benefit from the device.
The test device provides good hearing performance in patients with a conductive hearing loss or single-sided sensorineural deafness, with good wearing comfort and minimal soft tissue complications.
本研究旨在多中心前瞻性评估一种新型磁骨传导听力植入系统的临床性能。
测试设备为科利耳巴哈吸引系统（科利耳骨锚式听力解决方案公司，瑞典莫恩利克）。该测试设备并非采用传统骨传导听力植入设备的经皮基台，而是使用植入式磁铁和外部磁铁，将声音从声音处理器（SP）透过完整皮肤传输至颅骨。27例患有传导性或轻度混合性听力损失或单侧感音神经性耳聋的成年患者参与了在四个研究地点开展的临床研究。患者在植入后随访9个月。该研究评估了与未佩戴辅助设备时的听力以及使用软带式声音处理器时的听力相比，该测试设备在听力性能方面的疗效。在整个研究过程中持续监测患者受益情况、软组织状况、设备固定情况及安全参数。
手术及愈合过程顺利。与术前未佩戴辅助设备时的听力相比，该测试设备在可听度以及噪声和安静环境下的言语理解方面均有统计学意义上的显著改善。言语识别能力与在软带式声音处理器上进行的测试结果相似或更佳。报告显示软组织愈合情况良好，未出现与压力相关的重大并发症。在研究结束时，所有患者均继续使用该设备并从中受益。
该测试设备为患有传导性听力损失或单侧感音神经性耳聋的患者提供了良好的听力性能，佩戴舒适度高，软组织并发症极少。
