Efficacy of a Low-Cost Hearing Aid and Comparison of Service-Delivery Models

低成本助听器的功效和服务提供模式的比较

• 批准号: 8283191
• 负责人: LARRY E HUMES
• 金额: $ 38.03万
• 依托单位: TRUSTEES OF INDIANA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8283191
• 关键词: Address; Adult; Age-Years; American; Area; Censuses; Color; Communication; Complex; Counseling; Devices; Dimensions; Double-Blind Method; Ear; Elderly; Evaluation; Experimental Models; Healthcare; Hearing; Hearing Aids; Individual; Knowledge; Modeling; Noise; Outcome; Output; Persons; Phase; Phase II Clinical Trials; Placebo Control; Placebos; Play; Population; Price; Production; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Role; Sensorineural Hearing Loss; Services; Speech; Surveys; Technology; Testing; base; consumer product; cost; design; hearing impairment; improved; instrument; programs; research study; satisfaction; simulation; standard of care

DESCRIPTION (provided by applicant): According to recent population estimates made by the U.S. Census Bureau, about 39 million Americans are over 65 years of age, representing 13% of the U.S. Approximately 35% of those over age 65 in the U.S., or about 13.6 million older Americans, have a significant hearing loss that is sufficient to make them hearing-aid candidates. Yet, only about 20% of those who could benefit from hearing aids actually seek them out. Limitations in the accessibility and affordability of hearing health care seem to be primary factors underlying the low percentage of older Americans who purchase hearing aids. The purchase price of the hearing aids and the typical service- delivery model represent key factors that appear to limit the accessibility and affordability of hearing aids. As the production costs of the devices themselves are fairly low, the justification for the higher purchase prices is often grounded in the professional services provided in the selection, programming, fitting and evaluation of the devices. This project proposes to conduct research that would provide new knowledge about the impact of purchase price and service-delivery model on hearing-aid outcomes. The proposed study will acquire this knowledge through a Phase-II double-blinded, placebo-controlled, randomized clinical trial with five parallel branches. In addition to a placebo branch, the remaining four branches represent factorial combinations of service-delivery model (current best practices and over-the-counter simulation) and purchase price (low and typical). Non-inferiority analyses will be performed to compare the outcomes of the current best-practices model to alternative combinations of service-delivery model and purchase price. Based on the results obtained, the findings could have considerable impact on the accessibility and affordability of hearing health care for older adults with mild-to-moderate hearing loss. PUBLIC HEALTH RELEVANCE: About 13.6 million older Americans have mild-to-moderate hearing loss, but only one in five end up purchasing hearing aids. There is a critical need to improve the accessibility and affordability of hearing health care for these individuals. The focus of the proposed project is on the evaluation of the benefits provided by a high-quality hearing aid, as well as the impact of service-delivery model and purchase price on the observed benefits.

描述（申请人提供）：根据美国人口普查局最近的人口估计，大约有 3900 万美国人年龄在 65 岁以上，占美国人口的 13%。美国 65 岁以上人口中大约有 35%，即大约 1360 万老年人，听力损失严重，足以成为助听器候选人。然而，在那些可以从助听器中受益的人中，只有大约 20% 真正去寻求助听器。听力保健的可及性和可负担性的限制似乎是美国老年人购买助听器比例较低的主要原因。助听器的购买价格和典型的服务提供模式是限制助听器的可及性和可负担性的关键因素。由于生产 设备本身的成本相当低，购买价格较高的理由是 通常以在设备选择、编程、安装和评估方面提供的专业服务为基础。该项目建议进行研究，提供有关购买价格和服务提供模式对助听器结果影响的新知识。拟议的研究将通过一项具有五个平行分支的二期双盲、安慰剂对照、随机临床试验来获得这些知识。除了安慰剂之外 分支，其余四个分支代表服务交付模型（当前最佳实践和场外模拟）和购买价格（低且典型）的因子组合。将进行非劣效性分析，以将当前最佳实践模型的结果与服务交付模型和购买价格的替代组合进行比较。根据获得的结果，研究结果可能会对轻度至中度听力损失的老年人听力保健的可及性和可负担性产生相当大的影响。 公共健康相关性：大约 1360 万美国老年人患有轻度至中度听力损失，但只有五分之一最终购买了助听器。迫切需要提高这些人听力保健的可及性和可负担性。焦点 拟议项目的重点是评估高质量助听器带来的好处，以及服务提供模式和购买价格对观察到的好处的影响。