Preliminary evaluation of a light-based contact hearing device for the hearing impaired.
Preliminary evaluation of a light-based contact hearing device for the hearing impaired.
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DOI：
10.1097/mao.0b013e31827de4b1
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发表时间：
2013-07
期刊：
影响因子：
--
通讯作者：
Puria S
中科院分区：
文献类型：
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作者：
Fay JP;Perkins R;Levy SC;Nilsson M;Puria S
评估广谱、光基接触式助听器（CHD）用于听力障碍听者的安全性、稳定性和性能。可行性研究。单站点研究和开发设施。13例对称性轻至重度感音神经性听力障碍患者双侧放置冠心病。一个定制的光激活鼓室接触驱动器（TCA）由医生放置在每只耳朵中，在那里它与耳膜和耳道内侧壁的一部分接触了四个月。每个CHD都经过校准和编程，以提供适当的广谱放大。通过常规耳科检查确定安全性。通过辅助听力阈值、句子接收阈值（RTS）和助听器益处简写谱（APHAB）测量来表征系统性能以及通过CHD放大的益处。tca在受试者的耳朵上平均停留了122天，没有引起炎症或感染的迹象，也没有发生与设备相关的严重不良事件。在0.25-10 kHz范围内测量的平均最大输出90-110 dB SPL，反馈前的平均最大增益40 dB，以及到10 kHz的功能增益显示了扩展带宽的广谱输出和增益。RTS结果显示显著的辅助改善高达2.8 dB， APHAB结果在11/12（92%）受试者中显示临床显著的辅助益处。这项为期4个月的初步研究表明，CHD的安全性、稳定性和性能表明，它可能是一种提供广谱放大的可行方法，适用于治疗轻度至重度听力障碍的听者。
To assess the safety, stability, and performance of the broad spectrum, light based Contact Hearing Device (CHD) on listeners with hearing impairment. Feasibility study. Single-Site Research and Development Facility. Thirteen subjects with symmetric mild to severe sensorineural hearing impairment had the CHD placed bilaterally. A custom-molded light activated Tympanic Contact Actuator (TCA) was placed into each ear by a physician, where it stayed in contact with the umbo and a portion of the medial wall of the ear canal for four months. Each CHD was calibrated and programmed to provide appropriate broad-spectrum amplification. Safety was determined through routine otologic examinations. Aided and pre-TCA-insertion unaided audiometric thresholds, Reception Threshold for Sentences (RTS), and Abbreviated Profile of Hearing Aid Benefit (APHAB) measurements were made to characterize system performance as well as the benefits of amplification via the CHD. The TCAs remained on subjects’ ears for an average total of 122 days, without causing signs of inflammation or infection, and there were no serious device-related adverse events. Measured average maximum output of 90–110 dB SPL in the 0.25–10 kHz range, average maximum gain before feedback of 40 dB, and functional gain through 10 kHz show extended bandwidth broad spectrum output and gain. RTS results showed significant aided improvements of up to 2.8 dB, and APHAB results showed clinically significant aided benefits in 11/12 (92%) subjects. The safety, stability, and performance demonstrated in this initial 4-month study suggest that the CHD may offer a feasible way of providing broad-spectrum amplification appropriate to treat listeners with mild to severe hearing impairment.