The FDA has cleared a second-generation pioezoelectric bone-conduction hearing implant from Cochlear , the company announced today.
The Osia 2 system is an active osseointegrated, steady-state implant (OSI) that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear. It is designed to treat hearing loss associated with chronic ear infections, otosclerosis and atresia/microtia. The FDA cleared it for use by adults and children 12 years and older with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness. The system delivers high power and gain and has a fitting range up to 55 dB sensorineural hearing level, according to the company.
Driven by a wireless digital link, a piezoelectric transducer expands and contracts to create vibrations that stimulate the inner ear while optimizing transfer of power and sound quality, according to Cochlear. Piezoelectricity has been used for years in many products like microphones, high-end speakers and medical equipment, but this is the first time it is being used in this type of hearing implant application, the company added. It can amplify high frequencies, the area of sound most important for speech understanding.
A new Osia Smart app lets the user adjust the sound processor from a compatible smartphone or Apple Watch. The Osia 2 sound processor is dust- and moisture-resistant, and comes with an optional waterproof accessory.
Cochlear said it sought clearance for Osia 2 based on the results of a one-year, multicenter clinical investigation on a first-generation device and sponsored research in clinics around the world. The clinical trial showed a significant improvement in patients’ ability to hear in both noise and quiet compared to unaided and aided preoperative testing, the company added. Patients also reported improvement in their overall health-related quality of life.
“We have been working to develop this technology for quite some time,” said Mats Dotevall, Cochlear Acoustics’ director of design and development, in a news release. “Rather than implanting a conventional electromagnetic transducer, we chose to work with piezoelectric material because of its unrivaled suitability for this type of implanted application.”
Findings from clinical trial will be presented this week at OSSEO 2019 International Congress in Miami Beach. A video demonstrating how the device works can be found here.
该公司今天宣布， FDA 已经清除了来自人工耳蜗的第二代 pioezoelectronic 骨传导听力植入物。
Osia2系统是一种主动的骨内整合，稳态植入（ OSI ），利用数字压电刺激绕过自然听觉系统的受损区域直接发送声音振动内耳。它的目的是治疗听力损失与慢性耳炎，耳硬化症和 atllica / microtia 。FDA 批准该药物用于成人和儿童12岁及以上的传导性听力损失，混合听力损失和单侧感觉神经性耳聋。据该公司介绍，该系统具有很高的功率和增益，适合55分贝的感音神经性听力。
在无线数字链路的驱动下，压电传感器扩展并收缩以产生振动，刺激内耳，同时优化能量和声音质量的传输，根据 Cochlear 。压电材料多年来一直用于麦克风、高端扬声器和医疗设备等多种产品，但这是首次用于这种类型的听力植入应用，该公司补充说。它能放大高频率，对语音理解最重要的声音区域。
一个新的 Osia 智能应用程序允许用户从兼容的智能手机或苹果手表（Apple Watch）调整声音处理器。奥西娅2声音处理器是防尘和防潮，并有一个可选的防水配件。
Cochlear 表示，根据对第一代设备进行为期一年的多中心临床调查的结果，该公司寻求获得 Osia2的许可，并赞助了世界各地诊所的研究。该公司补充说，临床试验显示，与未考虑和辅助的术前测试相比，患者在噪音和安静状态下的听力能力显著提高。病人也报告了改善他们的整体健康相关的生活质量。
“我们一直致力于开发这项技术已有相当长一段时间，” Cochlear Acousics 设计与开发总监 Mats Dotevall 在一份新闻稿中表示。“我们选择使用压电材料，而不是植入传统的电磁传感器，因为压电材料无可比拟地适合这种植入应用。”
临床试验结果将于本周在迈阿密海滩的 OSSEO 2019年国际大会上公布。这里可以找到一个演示设备工作原理的视频。