直接面向消费者的设备与助听器的比较:三种听力损失的放大精度。

IF 1.4 4区 医学 Q3 AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY American Journal of Audiology Pub Date : 2023-12-05 DOI:10.1044/2023_AJA-22-00170
Sterling W Sheffield, Molly Jacobs, Charles Ellis, Amber Gerasimchik
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引用次数: 0

摘要

目的:美国食品和药物管理局于 2022 年 8 月 17 日最终确定了非处方助听器(OTC-HA)的相关规定。人们对非处方药助听器和处方药助听器的性能比较知之甚少。本研究比较了处方助听器和直接面向消费者的设备(DTCDs,包括个人扩音产品 [PSAPs] 和非处方药助听器)的放大精度:方法:对 11 种设备进行编程,使其达到声学人体模型中针对三种听力损失程度的规定目标。设备包括高端和低端助听器、PSAPS 和非处方药助听器。对每种设备都进行了测试,并使用 HA 分析仪测量了在 10 个频率和低、中、高级输入的每种组合下与目标的偏差。使用多层次泊松模型对准确性进行比较,该模型具有特定设备截距,可控制输入电平、频率和设备类型:对于轻中度听力损失,高端和低端助听器与目标的偏差没有统计学差异,但 PSAP(5.50 dB,SE = 0.92 dB)和 OTC 助听器(8.83 dB,SE = 1.10 dB)的偏差较大。对于平面中度听力损失,与高端助听器相比,在所有输入水平和频率下,所有设备类型的平均差异都较大(低频助听器:3.82 dB,SE = 1.10 dB;PSAP:9.24 dB,SE = 1.10 dB):9.24 dB,SE = 1.22 dB;OTC-HA:8.61 dB,SE = 1.19 dB)。对于轻度倾斜至重度听力损失,与高端助听器相比,OTC-助听器(9.72 dB,SE = 1.20 dB)和 PSAP(7.34 dB,SE = 1.07 dB)在最高和最低频率上具有更大的差异和显著的变异性。一半(三台)的 PSAP 和 OTC-HAs 达到了大多数目标,误差在 ±5 dB 范围内:结论:DTCD 无法达到重度听力损失的规定目标,但可以达到轻度听力损失的规定目标。这项研究对目前的听力设备进行了检查。还需要进行更多的研究,以确定达到规定的目标是否会给 DTCD 设备的结果和性能带来任何好处。
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Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss.

Purpose: The U.S. Food and Drug Administration finalized regulations for over-the-counter hearing aids (OTC-HAs) on August 17, 2022. Little is known about the comparative performance of OTC-HAs and prescription HAs. This study compared amplification accuracy of prescription HAs and direct-to-consumer devices (DTCDs, including personal sound amplification products [PSAPs] and OTC-HAs).

Method: Eleven devices were programmed to meet prescriptive targets in an acoustic manikin for three degrees of hearing loss. Devices consisted of high- and low-end HAs, PSAPS, and OTC-HAs. Each was tested, and deviations from target measured with an HA analyzer at every combination of 10 frequencies and low-, average-, and high-level inputs. Accuracy was compared using a multilevel Poisson model with device-specific intercepts controlling for input level, frequency, and device type.

Results: For mild-moderate hearing loss, deviations from targets were not statistically different between high- and low-end HAs, but PSAPs (5.50 dB, SE = 0.92 dB) and OTC-HAs (8.83 dB, SE = 1.10 dB) had larger differentials. For flat moderate hearing loss, compared to high-end HAs, average differentials were larger for all device types at all input levels and frequencies (Low HA: 3.82 dB, SE = 1.10 dB; PSAP: 9.24 dB, SE = 1.22 dB; OTC-HA: 8.61 dB, SE = 1.19 dB). For mild sloping to severe hearing loss, compared to high-end HAs, OTC-HAs (9.72 dB, SE = 1.20 dB) and PSAPs (7.34 dB, SE = 1.07 dB) had larger differentials and significant variability at the highest and lowest frequencies. Half (three) of the PSAPs and OTC-HAs met most targets within ±5 dB.

Conclusions: DTCDs were unable to meet prescriptive targets for severe types of hearing loss but could meet them for mild hearing loss. This study provides an examination of current hearing devices. More research is needed to determine whether meeting prescriptive targets provides any benefit in the outcomes and performance with DTCD devices.

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来源期刊
American Journal of Audiology
American Journal of Audiology AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY-OTORHINOLARYNGOLOGY
CiteScore
3.00
自引率
16.70%
发文量
163
审稿时长
>12 weeks
期刊介绍: Mission: AJA publishes peer-reviewed research and other scholarly articles pertaining to clinical audiology methods and issues, and serves as an outlet for discussion of related professional and educational issues and ideas. The journal is an international outlet for research on clinical research pertaining to screening, diagnosis, management and outcomes of hearing and balance disorders as well as the etiologies and characteristics of these disorders. The clinical orientation of the journal allows for the publication of reports on audiology as implemented nationally and internationally, including novel clinical procedures, approaches, and cases. AJA seeks to advance evidence-based practice by disseminating the results of new studies as well as providing a forum for critical reviews and meta-analyses of previously published work. Scope: The broad field of clinical audiology, including audiologic/aural rehabilitation; balance and balance disorders; cultural and linguistic diversity; detection, diagnosis, prevention, habilitation, rehabilitation, and monitoring of hearing loss; hearing aids, cochlear implants, and hearing-assistive technology; hearing disorders; lifespan perspectives on auditory function; speech perception; and tinnitus.
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