Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial.
Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial.
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与听力学家合适的助听器相比，非处方自身助听器的有效性：一项随机临床试验。
DOI：
10.1001/jamaoto.2023.0376
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发表时间：
2023-06-01
影响因子：
7.8
通讯作者：
Swanepoel, De Wet
中科院分区：
文献类型：
--
作者：
De Sousa, Karina C.;Manchaiah, Vinaya;Moore, David R.;Graham, Marien A.;Swanepoel, De Wet
与根据听力学家最佳实践安装的助听器相比，自验配非处方（OTC）助听器能否提供类似的结果？在这项对64名听力损失成年人进行的随机临床试验中，在6周结束时，自装配OTC和听力学家装配的助听器条件之间的自我报告和噪声中的言语益处是等同的。这些研究结果表明，自装配OTC助听器可能是轻度至中度听力损失患者的有效干预选择，并产生与听力学家装配助听器相似的自我感知和临床结果。这项随机临床试验比较了具有远程支持的自装配非处方助听器与听力学家装配助听器在听力损失成人中使用最佳实践的有效性。听力损失是一种非常普遍的疾病，如果不加以治疗，会造成许多衰弱的后果。然而，只有不到20%的美国成年听力损失患者使用助听器。非处方（OTC）助听器于2022年10月上市，以改善获取和负担能力。然而，使用市场上现有器械的OTC助听器的临床有效性研究有限。比较具有远程支持的自验配OTC助听器与使用听力学家验配最佳实践验配的助听器的临床有效性。本随机临床有效性试验于2022年4月14日至8月29日进行。招募了68名自认为轻度至中度听力损失的成年人，并随机分配到自我装配组或听力学家装配组。在双侧助听器装配后，参与者首先完成了为期2周的带回家现场试验，没有任何支持。两组的微调仅在2周试验后可用。根据要求，为自装配组提供远程支持和调整，并由听力学家为听力学家装配组提供支持和调整。然后，在额外的4周带回家试验后，对参与者进行重新评估。向自装配组的参与者提供了市售自装配OTC助听器，预期他们将使用市售指导材料和随附的智能手机应用程序设置助听器。在听力学家验配组中，听力学家根据国家声学实验室非线性第2版算法，使用带有助听器使用说明的真耳验证，验配相同的助听器。主要的结果测量是自我报告的助听器益处，使用助听器益处的简要描述（APHAB）进行测量。次要指标包括国际助听器结果量表（IOI-HA）和噪声中的语音识别，使用简化的噪声中语音测试和噪声中数字测试进行测量。所有测量均在基线和助听器装配后2个时间间隔（2周和6周）完成。分析样本中包括64名参与者（33名男性[51.6%];平均[SD]年龄，63.6 [14.1]岁），每组随机分配相同数量的参与者（n = 32）。各组在年龄（效应量r =-0.2 [95%CI，-0.3至0.2]）或4频纯音平均值（效应量r = 0.2 [95%CI，-0.1至0.4]）方面没有显著差异。在为期2周的现场试验后，与听力学家组相比，自适应组在自我报告的APHAB（Cohen d =-0.5 [95%CI，-1.0至0]）和IOI-HA（效应量r = 0.3 [95%CI，0.0-0.5]）方面具有初始优势，但在噪声中的语音识别方面没有优势。在6周试验结束时，两组在任何结局指标上均无明显有意义的差异。在这项随机临床有效性试验中，具有远程支持的自验配OTC助听器在验配后6周的结果与使用听力学家最佳实践验配的助听器相当。这些研究结果表明，自适应OTC助听器可以为轻度至中度听力损失提供有效的干预。ClinicalTrials.gov标识符：NCT 05337748
Can self-fitting over-the-counter (OTC) hearing aids provide similar outcomes compared with hearing aids fitted according to audiologist best practices? In this randomized clinical trial of 64 adults with hearing loss, self-reported and speech-in-noise benefit was equivalent between the self-fitting OTC and audiologist-fitted hearing aid conditions at the end of 6 weeks. These findings suggest that a self-fitting OTC hearing aid may be an effective intervention option for individuals with mild to moderate hearing loss and produce self-perceived and clinical outcomes similar to those of an audiologist-fitted hearing aid. This randomized clinical trial compares the effectiveness of a self-fitting over-the-counter hearing aid with remote support with an audiologist-fitted hearing aid using best practice in adults with hearing loss. Hearing loss is a highly prevalent condition, with numerous debilitating consequences when left untreated. However, less than 20% of US adults with hearing loss use hearing aids. Over-the-counter (OTC) hearing aids became available in October 2022 to improve access and affordability. However, clinical effectiveness studies of available OTC hearing aids using the existing devices in the market are limited. To compare the clinical effectiveness of a self-fitting OTC hearing aid with remote support and a hearing aid fitted using audiologist-fitted best practices. This randomized clinical effectiveness trial was conducted between April 14 and August 29, 2022. Sixty-eight adults with self-perceived mild to moderate hearing loss were recruited and randomly assigned to either the self-fitting or the audiologist-fitted group. Following bilateral hearing aid fitting, participants first completed a 2-week, take-home field trial without any support. Access to fine-tuning for both groups was only available after the 2-week trial. Support and adjustment were provided remotely for the self-fitting group per request and by the audiologist for the audiologist-fitted group. Participants were then reassessed after an additional 4-week take-home trial. A commercially available self-fitting OTC hearing aid was provided to participants in the self-fitting group who were expected to set up the hearing aids using the commercially supplied instructional material and accompanying smartphone application. In the audiologist-fitted group, audiologists fitted the same hearing aid according to the National Acoustics Laboratories nonlinear version 2 algorithm for prescriptive gain target using real-ear verification with hearing aid use instruction. The primary outcome measure was self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. All measures were completed at baseline and at 2 intervals following hearing aid fitting (2 and 6 weeks). Sixty-four participants were included in the analytic sample (33 men [51.6%]; mean [SD] age, 63.6 [14.1] years), with equal numbers of participants (n = 32) randomized into each group. The groups did not differ significantly in age (effect size r = −0.2 [95% CI, −0.3 to 0.2]) or 4-frequency pure-tone average (effect size r = 0.2 [95% CI, −0.1 to 0.4]). After the 2-week field trial, the self-fitting group had an initial advantage compared with the audiologist-fitted group on the self-reported APHAB (Cohen d = −0.5 [95% CI, −1.0 to 0]) and IOI-HA (effect size r = 0.3 [95% CI, 0.0-0.5]) but not speech recognition in noise. At the end of the 6-week trial, no meaningful differences were evident between the groups on any outcome measures. In this randomized clinical effectiveness trial, self-fitting OTC hearing aids with remote support yielded outcomes at 6 weeks post fitting comparable to those of hearing aids fitted using audiologist best practices. These findings suggest that self-fitting OTC hearing aids may provide an effective intervention for mild to moderate hearing loss. ClinicalTrials.gov Identifier: NCT05337748
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影响因子：
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作者：
Humes, Larry E.;Kinney, Dana L.;Rogers, Sara E.
通讯作者：
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