临床试验结果评估:比较自配助听器和按最佳做法配制的助听器

Anusha Yellamsetty, Rebecca M. Lewis
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引用次数: 0

摘要

这项研究旨在确定助听器的自我验配算法是否能产生与专业验配助听器相媲美的效果。这项研究涉及多达 40 名 18 至 80 岁的受试者,比较了两种验配方法:一种是由经过专业培训的听力学家进行的最佳实践验配(BP-FIT),另一种是使用自我验配软件(SELF-FIT)进行的验配。受试者完成了两种验配,在现场使用任何一种验配前都进行了真耳测量和噪声中快速言语(QuickSIN)测量。受试者被随机分配从 SELF-FIT 或 BP-FIT 开始,在整个试验过程中,受试者对自己的情况一无所知。在每种条件下使用助听器 2 周后,受试者提供主观的获益报告(通过 APHAB 调查),并对助听器进行重新编程,以适应剩余的条件。该研究通过客观(REM)、行为(QuickSIN)和主观(APHAB)测量来评估疗效。总之,研究结果表明,SELF-FIT 助听器系统在多个领域的表现与 BP-FIT 类似。这包括通过 REM 评估自配助听器输出的客观测量,不同验配条件下的差异小于 5 dB SPL;通过 QuickSIN 评估背景噪声中的言语理解能力的行为评估,不同验配条件下的差异小于 2.7 dB SNR;以及用户通过 APHAB 报告的主观功效评估,不同验配条件下的差异小于 10%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of outcomes in a clinical trial: comparing self-fit hearing aids and hearing aids fit with best practices
The study aimed to determine whether a self-fitting algorithm for hearing aids could produce outcomes comparable to those achieved with professionally fitted hearing aids. Involving up to 40 subjects aged 18 to 80, the research compared two fittings: one conducted by a professionally trained audiologist Best Practice Fit (BP-FIT) and one using a self-fitting software (SELF-FIT). Subjects completed both fittings, with Real Ear Measures and Quick Speech In Noise (QuickSIN) measures taken before field use of either fitting. The subjects were randomly assigned to start with either SELF-FIT or BP-FIT, remaining unaware of their condition throughout the trial. After 2 weeks of hearing aid use in each condition, subjects provided subjective reports of perceived benefit (via the APHAB survey) and had their hearing aids reprogrammed for the remaining condition. The study assessed the efficacy through objective (REM), behavioral (QuickSIN), and subjective (APHAB) measures. In summary, the study findings reveal that the SELF-FIT hearing aid system performed similar to the BP-FIT across multiple domains. This includes objective measures of self-fitting hearing aid output assessed through REM, with a difference of <5 dB SPL between fitting conditions, behavioral evaluation of speech understanding in background noise via QuickSIN, with a difference of <2.7 dB SNR between fitting conditions, and subjective assessment of efficacy as reported by the user via APHAB, with a difference of <10% between fitting conditions.
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