Wu Yu-Hsiang, Stangl Elizabeth, Branscome Kjersten, Oleson Jacob, Ricketts Todd
Department of Communication Sciences and Disorders, University of Iowa, Iowa City.
Department of Hearing and Speech Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.
JAMA Otolaryngol Head Neck Surg. 2025 May 15. doi: 10.1001/jamaoto.2025.1008.
IMPORTANCE: The poor affordability of hearing aids (HAs) limits their adoption. To justify higher costs, HAs fitted by audiologists (AUD service model) and high-end HAs should deliver better outcomes than over-the-counter (OTC) service models and low-end HAs. OBJECTIVE: To determine the effect of HA service models (AUD, OTC, and a hybrid OTC+ model) and technology levels (high end and low end) on patient outcomes. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted at the University of Iowa and Vanderbilt University Medical Center in research laboratories from February 2019 to December 2023 and included adults older than 55 years with mild to moderate hearing loss and no previous HA experience who were randomly assigned to 1 of 6 parallel groups, representing factorial combinations of 3 service models and 2 technology levels. The data were analyzed between January 2024 and March 2024. INTERVENTIONS: The trial included 3 service models: AUD, in which audiologists fitted prescription HAs following best practices; OTC+, in which audiologists provided limited services for OTC HAs; and OTC, in which participants independently used OTC HAs. OTC HAs were simulated using prescription HAs. Two models of prescription HAs were used throughout the trial: a high-end HA with advanced features and a low-end HA. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the Glasgow Hearing Aid Benefit Profile (GHABP), which was administered using ecological momentary assessment (EMA). EMA-GHABP was conducted preintervention and throughout the seventh week postintervention. RESULTS: A total of 245 participants completed the study (121 women [49.4%]; mean [SD] age, 67.7 [8.1] years). After controlling for preintervention scores, the postintervention EMA-GHABP global score (ranging from 1 to 5) for AUD was significantly higher (indicating better outcomes) than for OTC+ and OTC by 0.33 points (95% CI, 0.14-0.52) and 0.32 points (95% CI, 0.13-0.51), respectively. The difference between OTC+ and OTC was not significant (0.02 points, 95% CI, -0.21 to 0.18). Nevertheless, EMA-GHABP global scores for OTC+ and OTC were close to 4 points, indicating positive outcomes. The effect of technology level and interaction between service model and technology level were not significant. CONCLUSIONS AND RELEVANCE: The trial results suggest that while OTC+ and OTC were effective, they did not achieve the same outcomes as AUD. As high-end and low-end HAs yielded similar outcomes, support for the higher cost of high-end HAs was not identified for individuals with mild to moderate hearing loss. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03579563.
重要性:助听器价格高昂,限制了其普及。为证明更高的成本合理,听力学家配备的助听器(听力学家服务模式)和高端助听器应比非处方(OTC)服务模式和低端助听器产生更好的效果。 目的:确定助听器服务模式(听力学家服务模式、非处方模式和混合非处方+模式)和技术水平(高端和低端)对患者治疗效果的影响。 设计、地点和参与者:这项随机临床试验于2019年2月至2023年12月在爱荷华大学和范德比尔特大学医学中心的研究实验室进行,纳入了55岁以上、患有轻度至中度听力损失且此前未使用过助听器的成年人,他们被随机分配到6个平行组中的1个,这6个组代表3种服务模式和2种技术水平的析因组合。数据于2024年1月至2024年3月进行分析。 干预措施:试验包括3种服务模式:听力学家服务模式,即听力学家按照最佳实践配备处方助听器;非处方+模式,即听力学家为非处方助听器提供有限服务;非处方模式,即参与者独立使用非处方助听器。非处方助听器使用处方助听器进行模拟。在整个试验过程中使用了两种处方助听器型号:具有先进功能的高端助听器和低端助听器。 主要结局和指标:主要结局指标是格拉斯哥助听器效益概况(GHABP),采用生态瞬时评估(EMA)进行评估。EMA-GHABP在干预前和干预后第七周全程进行。 结果:共有245名参与者完成了研究(121名女性[49.4%];平均[标准差]年龄为67.7[8.1]岁)。在控制干预前分数后,听力学家服务模式组干预后EMA-GHABP全球评分(范围为1至5)显著高于非处方+模式组和非处方模式组,分别高出0.33分(95%CI,0.14 - 0.52)和0.32分(95%CI,0.13 - 0.51)。非处方+模式组和非处方模式组之间的差异不显著(0.02分,95%CI,-0.21至0.18)。然而,非处方+模式组和非处方模式组的EMA-GHABP全球评分接近4分,表明治疗效果良好。技术水平的影响以及服务模式与技术水平之间的交互作用不显著。 结论和意义:试验结果表明,虽然非处方+模式和非处方模式有效,但它们未达到听力学家服务模式的治疗效果。由于高端和低端助听器产生的效果相似,未发现对于轻度至中度听力损失患者,高端助听器更高成本的合理性依据。 试验注册:ClinicalTrials.gov标识符:NCT03579563。
JAMA Otolaryngol Head Neck Surg. 2025-5-15
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