Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results from a prospective clinical investigation

Abstract

Background: Bone-conduction hearing implants are standard of care devices.

Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing implant: Cochlear Osia™ system.

Material and methods: This device uses a transcutaneous connection between an external sound-processor and an osseointegrated implant that generates vibrations using a piezoelectricity-based internal bone-conduction system. Nine patients with conductive-hearing loss were implanted. Surgical efficacy, hearing performance and quality-of-life were evaluated. Hearing performance in quiet and in noise was compared with unaided hearing and hearing with the Baha 5 Power^® Sound Processor on a softband.

Results: Surgery and healing were uneventful. Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the Osia™ compared to preoperative unaided hearing and aided hearing with the Baha 5 Power^® Sound Processor on a softband. The active vibration system provided improvement at low and high frequencies. At 6 months postoperatively, all patients continue to use the device.

Conclusions and significance: The Osia™ is safe and effective, improving speech-recognition in quiet and in noise, at low and high frequencies, thus delivering better quality-of-hearing than passive devices.

Chinese abstract

背景：骨传导听力植入物是标准的护理设备。

目的：评价一种新型的主动磁性骨传导听力植入物：耳蜗Osia™ 系统。

材料和方法：该装置使用外部声音处理器和骨整合植入物之间的经皮连接, 通过压电性内部骨传导系统产生振动。9例传导性听力损失患者接受植入。评价手术疗效、听力及生活质量。将安静和噪声中的听力性能与在软带上使用Baha 5 Power®声音处理器的听力以及独立听力进行比较。

结果：手术和术后恢复顺利。与术前在软带上使用Baha 5 Power®声音处理器的独立听力和辅助听力相比, Osia™在噪声和安静中的听力、语音理解、语音识别以及声音质量方面都有显著的统计改进。主动振动系统在低频和高频时都有改进。术后6个月, 所有患者继续使用该装置。

结论与意义：Osia™ 是安全和有效的, 可以提高在安静和噪声中以及在低频和高频时的语音识别, 从而提供比被动设备更好的听觉质量。

Keywords:

• Active bone-conduction hearing-implant
• hearing improvement in high frequencies
• quality-of-hearing
• Bone anchored hearing aid
• Baha

Disclosure statement

Cochlear Corporation provided the devices free of charge for the patients. All members of the team did the surgical and audiological procedures free of charge to the patients and did not receive any compensation (direct or indirect) from Cochlear Corporation.