自配非处方助听器干预与临床配装助听器干预的验证:使用相同设备的受试者交叉设计。

IF 3 2区 医学 Q1 AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY
Trends in Hearing Pub Date : 2025-01-01 Epub Date: 2025-03-25 DOI:10.1177/23312165251328055
Lucas S Baltzell, Kosta Kokkinakis, Amy Li, Anusha Yellamsetty, Katherine Teece, Peggy B Nelson
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引用次数: 0

摘要

2022年10月,美国食品和药物管理局(fda)最终确定了建立自配非处方药(OTC)助听器类别的法规,旨在减少自认为有轻度至中度听力损失的个人采用助听器的障碍。从那时起,一些自适应的OTC助听器进入了市场,少数已发表的研究表明,自适应的OTC干预措施比传统的临床医生干预措施更有效。考虑到各种各样的自配方法,以及证明有效性的少量研究,本研究的目的是评估市售自配OTC助听器干预与临床医生安装干预的有效性。与先前的研究一致,我们发现自我拟合干预在自我报告的获益和客观噪音语音结果方面并不亚于临床拟合干预。我们发现自拟结果与临床拟合结果相比有统计学上的显著改善,尽管在临床拟合干预中偏离最佳听力学实践可能会影响我们的结果。除了介绍我们的研究结果,我们还讨论了评估自拟合干预措施的非劣效性的现状,并提出了一些新的观点。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Validation of a Self-Fitting Over-the-Counter Hearing Aid Intervention Compared with a Clinician-Fitted Hearing Aid Intervention: A Within-Subjects Crossover Design Using the Same Device.

Validation of a Self-Fitting Over-the-Counter Hearing Aid Intervention Compared with a Clinician-Fitted Hearing Aid Intervention: A Within-Subjects Crossover Design Using the Same Device.

Validation of a Self-Fitting Over-the-Counter Hearing Aid Intervention Compared with a Clinician-Fitted Hearing Aid Intervention: A Within-Subjects Crossover Design Using the Same Device.

Validation of a Self-Fitting Over-the-Counter Hearing Aid Intervention Compared with a Clinician-Fitted Hearing Aid Intervention: A Within-Subjects Crossover Design Using the Same Device.

In October of 2022, the US Food and Drug Administration finalized regulations establishing the category of self-fitting over-the-counter (OTC) hearing aids, intended to reduce barriers to hearing aid adoption for individuals with self-perceived mild to moderate hearing loss. Since then a number of self-fitting OTC hearing aids have entered the market, and a small number of published studies have demonstrated the effectiveness of a self-fitted OTC intervention against a traditional clinician-fitted intervention. Given the variety of self-fitting approaches available, and the small number of studies demonstrating effectiveness, the goal of the present study was to evaluate the effectiveness of a commercially available self-fitting OTC hearing aid intervention against a clinician-fitted intervention. Consistent with previous studies, we found that the self-fitted intervention was not inferior to the clinician-fitted intervention for self-reported benefit and objective speech-in-noise outcomes. We found statistically significant improvements in self-fitted outcomes compared to clinician-fitted outcomes, though deviations from best audiological practices in our clinician-fitted intervention may have influenced our results. In addition to presenting our results, we discuss the state of evaluating the noninferiority of self-fitted interventions and offer some new perspectives.

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来源期刊
Trends in Hearing
Trends in Hearing AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGYOTORH-OTORHINOLARYNGOLOGY
CiteScore
4.50
自引率
11.10%
发文量
44
审稿时长
12 weeks
期刊介绍: Trends in Hearing is an open access journal completely dedicated to publishing original research and reviews focusing on human hearing, hearing loss, hearing aids, auditory implants, and aural rehabilitation. Under its former name, Trends in Amplification, the journal established itself as a forum for concise explorations of all areas of translational hearing research by leaders in the field. Trends in Hearing has now expanded its focus to include original research articles, with the goal of becoming the premier venue for research related to human hearing and hearing loss.
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