将直销设备与助听器进行比较:三种类型的听力损失的放大精度
Sterling W Sheffield1, Molly Jacobs2, Charles Ellis1
1Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville.
American journal of audiology
|December 5, 2023
概括
非处方助听器 (OTC-HA) 和个人声音放大产品 (PSAP) 与处方助听器相比,与规定的目标有更大的偏差,特别是在更严重的听力损失方面. 虽然一些设备达到轻度损失的目标,但准确性差异很大.
科学领域:
- 听力学 听力学是指听力学.
- 医疗器械 医疗器械
- 监管科学 监管科学
背景情况:
- 美国食品和药物管理局 (FDA) 在2022年8月制定了无处方助听器 (OTC-HA) 的规定.
- 在OTC-HA和传统的处方助听器 (HA) 之间进行性能比较的数据有限.
- 包括个人音响放大产品 (PSAP) 和OTC-HA在内的直供消费者设备 (DTCD) 越来越多.
研究的目的:
- 为了比较处方助听器 (HA) 与直接向消费者提供的设备 (DTCD) 的放大精度.
- 评估的DTCD包括个人声放大产品 (PSAP) 和非处方助听器 (OTC-HA).
- 评估不同听力损失严重程度和输入级别的设备性能.
主要方法:
- 十一种设备 (高端HA,低端HA,PSAP,OTC-HA) 被编程为满足规定的目标.
- 测试是使用模拟轻度,中度和重度听力损失的声学玩偶进行的.
- 使用HA分析器测量了10个频率和三个输入级别的放大精度,并使用多层Poisson模型进行分析.
主要成果:
- 对于轻度至中度的听力损失,PSAP和OTC-HA与处方HA相比,与目标有更大的偏差.
- 在平坦中度听力损失中,所有DTCD在所有条件下都比高端HA显示出更大的平均偏差.
- 对于轻度倾斜至严重的听力损失,OTC-HA和PSAP的偏差和变异性明显更大,只有一半达到±5dB内的大多数目标.
结论:
- 直接销售给消费者 (DTCD) 的设备在严重听力损失方面难以达到规定的目标,但在轻度听力损失方面更成功.
- 该研究强调了当前助听器,特别是OTC-HA和PSAP的性能变化.
- 需要进行进一步的研究,以确定是否满足规范性目标与改善DTCD用户的现实世界结果相关.
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