Humes Larry E, Rogers Sara E, Quigley Tera M, Main Anna K, Kinney Dana L, Herring Christine
Department of Speech and Hearing Sciences, Indiana University, Bloomington.
Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111.
The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models.
The design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (AB), (b) consumer decides OTC model (CD), and (c) placebo devices (P). Outcome measures were obtained after a typical 6-week trial period with follow-up 4-week AB-based trial for those initially assigned to CD and P groups.
Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic.
Participants were adults, ages 55-79 years, with mild-to-moderate hearing loss. There were 188 eligible participants: 163 enrolled as a volunteer sample, and 154 completed the intervention.
INTERVENTION(S): All participants received the same high-end digital mini-behind-the-ear hearing aids fitted bilaterally. AB and P groups received best-practice services from audiologists; differing mainly in use of appropriate (AB) or placebo (P) hearing aid settings. CD participants self-selected their own pre-programmed hearing aids via an OTC model.
Primary outcome measure was a 66-item self-report, Profile of Hearing Aid Benefit (Cox & Gilmore, 1990). Secondary outcome measure was the Connected Speech Test (Cox, Alexander, & Gilmore, 1987) benefit. Additional measures of hearing-aid benefit, satisfaction, and usage were also obtained.
Per-protocol analyses were performed. AB service-delivery model was found to be efficacious for most of the outcome measures, with moderate or large effect sizes (Cohen's d). CD service-delivery model was efficacious, with similar effect sizes. However, CD group had a significantly (p < .05) lower satisfaction and percentage (CD: 55%; AB: 81%; P: 36%) likely to purchase hearing aids after the trial.
Hearing aids are efficacious in older adults for both AB and CD service-delivery models. CD model of OTC service delivery yielded only slightly poorer outcomes than the AB model. Efficacious OTC models may increase accessibility and affordability of hearing aids for millions of older adults. Purchase price had no effect on outcomes, but a high percentage of those who rejected hearing aids paid the typical price (85%).
Clinicaltrials.gov: NCT01788432; https://clinicaltrials.gov/ct2/show/NCT01788423.
本研究的目的是使用听力学最佳实践来确定助听器对老年人的疗效，评估一种非处方（OTC）替代干预措施的疗效，并研究购买价格对两种服务提供模式结果的影响。
本研究的设计是一项单中心、前瞻性、双盲安慰剂对照随机试验，有三个平行分支：（a）听力学最佳实践（AB），（b）消费者自行决定的OTC模式（CD），以及（c）安慰剂设备（P）。在为期6周的典型试验期后获得结果测量值，对于最初分配到CD和P组的参与者，随后进行为期4周基于AB的试验随访。
通过报纸和社区传单招募来自普通社区的老年人，在大学研究诊所参与研究。
参与者为年龄在55 - 79岁之间、患有轻度至中度听力损失的成年人。共有188名符合条件的参与者：163名作为志愿者样本入组，154名完成了干预。
所有参与者均双侧佩戴相同的高端数字迷你耳背式助听器。AB组和P组接受听力学家的最佳实践服务；主要区别在于使用适当的（AB）或安慰剂（P）助听器设置。CD组参与者通过OTC模式自行选择预先编程的助听器。
主要结果测量指标是一份66项的自我报告，即《助听器益处概况》（考克斯和吉尔摩，1990年）。次要结果测量指标是《连贯言语测试》（考克斯、亚历山大和吉尔摩，1987年）的益处。还获得了关于助听器益处、满意度和使用情况的其他测量指标。
进行了符合方案分析。发现AB服务提供模式对大多数结果测量指标有效，效应大小为中等或较大（科恩d值）。CD服务提供模式也有效，效应大小相似。然而，CD组的满意度显著较低（p <.05），并且在试验后购买助听器的可能性百分比也较低（CD：55%；AB：81%；P：36%）。
对于AB和CD服务提供模式，助听器对老年人均有效。OTC服务提供的CD模式产生的结果仅比AB模式略差。有效的OTC模式可能会提高数百万老年人获得助听器的可及性和可承受性。购买价格对结果没有影响，但拒绝使用助听器的人中有很大比例支付了典型价格（85%）。
Clinicaltrials.gov：NCT01788432；https://clinicaltrials.gov/ct2/show/NCT01788423 。
