软体助听器技术临床研究报告

Clinical trial results of SilFlex shell technology

目的 比较新型软体助听器与传统硬壳助听器的优缺点。方法30个调查对象 ,每人同时选配电子线路相同的一对传统的丙烯酸硬壳助听器和软体助听器。通过真耳测试比较:①是否与目标曲线适配;②在发生反馈啸叫前可获得的最大增益;③声学密封情况。通过助听器效果调查问卷(Abbreviated profile of hearing aid benefit, APHAB)问卷调查评估期间测试者两种助听器每天的使用情况、对助听器特性、配戴助听器的感觉、音质以及舒适度、留置率和反馈啸叫等。结果 真耳测试的结果显示在适配目标曲线方面软体和硬壳之间的真耳介入增益(REIG)差别无显著性意义。在发生反馈啸叫前软体助听器能产生比硬壳助听器更高的真耳最大增益REMG(p<0.05)。问卷调查结果显示在交流的难易、回响、背景噪音和厌恶方面两者的差异均无统计学意义。助听器特性的研究结果显示软体助听器在外观、留置率、反馈啸叫、验配和舒适度方面比硬壳助听器的得分更高,其差别有显著性意义(p<0.05)。直觉评价结果显示软体助听器明显优于硬体助听器。30个被调查者中有23个(76.7%)最终选择了软体助听器。统计学结果显示有极显著性意义。结论 两种类型助听器在真耳测试时满足目标曲线的指标无显著性差异。

Objective A clinical assessment of the potential benefits of SilFlex shell construction was recently conducted.Methods 30 hearing impaired listeners with gradually-sloping mild to moderate sensorineural hearing losses were recruited forparticipation. Subjects had an average age of 66 years and were roughly divided equally between males and females and betweenexperienced and inexperienced hearing aid users. Each subject was fit with two pairs of unvented completely-in-the-canal (CIC)hearing instruments, one pair made with traditional hard acrylic shells, the other with SilFlex shells. All instruments wereelectronically identical in terms of circuit design and were matched in terms of gain and frequency response in each ear, using theFig6 fitting method (Killion & Fikret-Pasa, 1993). During the initial fitting a variety of real ear measures were taken, Real earmeasures were made in order to assess ① goodness of fit to the prescribed Fig6 targets, ② maximum available gain before feedbackand ③acoustic seal. During the initial fitting subjects also completed the unaided portion of the Abbreviated Profile of Hearing AidBenefit (APHAB; Cox & Alexander, 1995).Once the fitting and real ear measures were completed.During an 'at-home' evaluation halfof the subjects wore the hard shell instruments first, the other half worn the SilFlex shell instruments. After a period of three tofour weeks subjects switched to the other type of shell for a similar evaluation period. During these evaluation periods, subjects kepta journal of daily Hearing Aid Use, in which they recorded the number of hours per day the devices were worn. Subjects also recordedtheir daily 'Hearing Aid Awareness', a rating scale ranging from 1 (not aware of the aids in the ear) to 10 (very much aware of thepresence of the aids when worn). At the end of the evaluation period, subjects were asked to provide their impressions of soundquality using 10-point rating scales described by Gabrielsson et al. (1988). Sound qualities included Softness, Brightness, Clarity,Fullness, Nearness, Loudness, Spaciousness and Total Impression. Ratings were based on impressions gained in the lab while listeningto 75 dB SPL speech (from the Speech Intelligibility Rating Test (Cox & McDaniel, 1989)) and to classical music (levels ranging from45-75 dB SPL). Subjects were also asked to complete a modified version of the MarkeTrak-IV hearing aid satisfaction survey(Kochkin, 1996). Portions of the survey dealing with listening situations and hearing aid features were presented in their original form. Finally, subjects were asked to rate the value of both types of shells choose which pair of instruments they wished to take homeat no charge. Results Statistical analysis revealed no significant differences between hard and soft shells in terms of REIG. REMGresults indicated that soft shells provided higher maximum gain before feedback than hard shells(p<.05) . REOR results showedthat at low frequencies soft shells provided slightly more attenuation of loud sounds than hard shells. At high frequencies the reversewas true (p<.05) at 2000 Hz, 3000 Hz and 4000 Hz. APHAB scores for each of four subscales: Ease of Communication (EC),Reverberation (RV), Background Noise (BN) and Aversiveness (AV) indicated both types of aids provided significant benefit (aidedscores compared to unaided scores) Statistical analysis (Wilcoxin Signed Ranks) indicated significant differences (p<0.05) between aidtypes for hearing aid features, with the soft shell devices having significantly higher satisfaction ratings and the soft shell valueratings to be significantly higher than those of hard shells. Twenty three of 30 subjects (76.7%) chose to keep the soft shell hearingaids, a statistically significant result.Conclusion SilFlex shell devices may have advantages over conventional hard, acrylic shells.These advantages may not be obvious during the initial fitting of the devices, but will likely become apparent to the user as the aidsare worn in the real world. The results from this study sugg