Humes Larry E, Dhar Sumitrajit, Meskan Mary, Pitman Anna, Singh Jasleen
Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.
Department of Speech, Language and Hearing Sciences, Indiana University, Bloomington.
J Speech Lang Hear Res. 2025 Apr 8;68(4):2080-2103. doi: 10.1044/2024_JSLHR-24-00423. Epub 2025 Mar 20.
This is a randomized multisite noninferiority comparative-effectiveness clinical trial with three parallel branches comparing a best-practices audiologist-fit method to two experimental self-fit (person-fit) methods. Outcomes were measured at 6 weeks and 6 months post-fit.
Participants: Five hundred eighty-four participants met the following inclusion criteria and enrolled: (a) age between 50 and 79 years; (b) never used or tried hearing aids previously; (c) can speak, read, and understand English well; (d) willing to purchase the study hearing aids for $650/pair; (e) no diagnosis of a memory or cognitive impairment; (f) 25-item Hearing Handicap Inventory for the Elderly (HHIE) score > 4; (g) Montreal Cognitive Assessment score ≥ 23; and (h) not excluded due to specific audiometric criteria. The audiometric exclusion criteria, based on air-conduction pure-tone thresholds, were as follows: (a) thresholds at all frequencies (250-8000 Hz) < 20 dB HL, for both ears (no hearing loss); (b) pure-tone average for 500, 1000, 2000, and 4000 Hz (PTA4) in the better ear > 50 dB HL (greater than moderate hearing loss); and (c) interaural difference > 20 dB at three or more frequencies or ≥ 40 dB at 500 or 1000 Hz. Interventions: Three groups received the same hearing aids fitted either by an audiologist using best practices (Group AB) or by themselves using one of two efficacious self-fit methods (Groups CD and EF). Objectives: The effectiveness of each of the self-fit methods, CD and EF, was hypothesized to be noninferior to the professional-fit method, AB. Outcomes: The primary outcome measure was the global score from the Profile of Hearing Aid Benefit (PHAB), and the secondary outcome measure was the benefit score (unaided - aided) for the 25-item HHIE. Randomization: Participants were stratified into one of three hearing loss categories based on better-ear PTA4: normal (≤ 20 dB HL), mild (20.1-35 dB HL), or moderate (35.1-50 dB HL). The random assignment of sequential enrollees within each hearing loss category to the three treatment groups made use of a site-specific pregenerated randomization list produced from a random-numbers table. Blinding: It was not possible to blind the participants as to the fitting method used, but the research personnel assessing the outcomes were blinded to the treatment group.
Numbers randomized: The 584 enrollees were randomized to one of the three treatment groups: AB ( = 190), CD ( = 193), and EF ( = 201).
Trial status: The trial began on November 1, 2020, and 6-month outcomes were obtained from the last participant on March 29, 2024. Numbers analyzed: At the 6-week measurement interval, outcome measures were completed for 182 AB, 172 CD, and 178 EF participants, representing 91.1% of the 584 individuals who enrolled. At the 6-month interval, completed outcomes were available for 166 AB, 148 CD, and 151 participants, representing 79.6% of the 584 original enrollees. Outcome: Bootstrapped ( = 1,000) means and 95% confidence intervals (CIs) at 6 weeks were 16.4 (95% CI [14.3, 18.7]), 16.8 (95% CI [14.9, 18.6]), and 15.2 (95% CI [13.5, 17.1]) for the AB, CD, and EF treatment groups on the primary outcome measure (PHAB global). At 6 months, primary outcome scores were 15.5 (95% CI [13.4, 17.8]), 16.3 (95% CI [14.4, 18.2]), and 15.3 (95% CI [13.5, 17.3]) for the AB, CD, and EF treatment groups, respectively. At both measurement intervals, there were no significant effects of treatment group ( > .05) for the primary or secondary outcome measures. Harms: No significant adverse events or side effects were observed.
At both the 6-week and 6-month postfit intervals, each of the two self-fit methods (CD, EF) yielded outcomes (primary and secondary) that were noninferior to the professional-fit best-practices (AB) fitting method. In addition, on average, clinically meaningful benefit was provided regardless of the fitting method.
这是一项随机多中心非劣效性比较有效性临床试验，有三个平行分支，将最佳实践听力学家适配方法与两种实验性自我适配（个人适配）方法进行比较。在适配后6周和6个月测量结果。
参与者：584名参与者符合以下纳入标准并入选：（a）年龄在50至79岁之间；（b）以前从未使用或尝试过助听器；（c）能流利地说、读和理解英语；（d）愿意以每对650美元的价格购买研究用助听器；（e）无记忆或认知障碍诊断；（f）老年听力障碍问卷（HHIE）25项得分>4；（g）蒙特利尔认知评估得分≥23；以及（h）未因特定听力测定标准而被排除。基于气导纯音阈值的听力测定排除标准如下：（a）双耳所有频率（250 - 8000 Hz）阈值<20 dB HL（无听力损失）；（b）较好耳500、1000、2000和4000 Hz的纯音平均听阈（PTA4）>50 dB HL（大于中度听力损失）；以及（c）三个或更多频率的耳间差异>20 dB或500或1000 Hz处≥40 dB。干预措施：三组接受相同的助听器，分别由听力学家采用最佳实践方法适配（AB组）或由他们自己采用两种有效自我适配方法之一适配（CD组和EF组）。目标：假设CD组和EF组这两种自我适配方法的有效性不劣于专业适配方法AB组。结果：主要结果测量指标是助听器受益概况（PHAB）的总体得分，次要结果测量指标是25项HHIE的受益得分（未佩戴助听器 - 佩戴助听器）。随机分组：参与者根据较好耳的PTA4分为三个听力损失类别之一：正常（≤20 dB HL）、轻度（20.1 - 35 dB HL）或中度（35.1 - 50 dB HL）。每个听力损失类别内连续入选者随机分配到三个治疗组，使用从随机数字表生成的特定地点预先生成的随机分组列表。盲法：不可能让参与者对所使用的适配方法不知情，但评估结果的研究人员对治疗组不知情。
随机分组人数：584名入选者被随机分配到三个治疗组之一：AB组（n = 190）、CD组（n = 193）和EF组（n = 201）。
试验状态：试验于2020年11月1日开始，2024年3月29日从最后一名参与者获得6个月的结果。分析人数：在6周测量间隔时，182名AB组、172名CD组和178名EF组参与者完成了结果测量，占584名入选者的91.1%。在6个月间隔时，166名AB组、148名CD组和151名参与者有完整结果，占584名原始入选者的79.6%。结果：6周时，AB组、CD组和EF组治疗组主要结果测量指标（PHAB总体）的自抽样（n = 1000）均值和95%置信区间（CI）分别为16.4（95% CI [14.3, 18.7]）、16.8（95% CI [14.9, 18.6]）和15.2（95% CI [13.5, 17.1]）。在6个月时，AB组、CD组和EF组治疗组的主要结果得分分别为15.5（95% CI [13.4, 17.8]）、16.3（95% CI [14.4, 18.2]）和15.3（95% CI [13.5, 17.3]）。在两个测量间隔，治疗组对主要或次要结果测量指标均无显著影响（p > 0.05）。不良事件：未观察到显著的不良事件或副作用。
在适配后6周和6个月间隔时，两种自我适配方法（CD组、EF组）的每种方法产生的结果（主要和次要）均不劣于专业适配的最佳实践（AB组）适配方法。此外，无论适配方法如何，平均而言都提供了具有临床意义的益处。
