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（由申请人提供）：根据美国人口普查局的最新人口估计，约有3900万美国人年龄在65岁以上，占美国65岁以上年龄段的美国约135％，约1360万美国老年人，有大量的听力损失，足以使他们成为听力的候选人。但是，只有大约20％可以从助听器中受益的人实际上会寻找它们。听力医疗保健的可及性和负担能力的局限性似乎是购买助听器的老年人比例低的主要因素。助听器的购买价格和典型的服务交付模型代表了似乎限制助听器的可访问性和负担能力的关键因素。作为生产 设备本身的成本相当低，更高购买价格的理由是 通常基于对设备的选择，编程，拟合和评估中提供的专业服务。该项目建议进行研究，以提供有关购买价格和服务销售模型对听力aid结果的影响的新知识。拟议的研究将通过II期双盲，安慰剂对照的随机临床试验获得这些知识，并具有五个平行分支。除了安慰剂 分支机构，其余四个分支代表服务交付模型（当前最佳实践和非处方模拟）和购买价格（低和典型）的阶乘组合。将进行非效率分析，以将当前最佳实践模型的结果与服务销售模型和购买价格的替代组合进行比较。根据获得的结果，这些发现可能会对听力损失轻度至中度的老年人的听力医疗保健的可及性和负担能力产生重大影响。 公共卫生相关性：大约有1360万年长的美国人有轻度至中度的听力损失，但只有五分之一的人最终购买了助听器。迫切需要提高这些人的可及性和可负担性。重点 拟议的项目的评估是对高质量助听器提供的收益，以及服务销售模型和购买价格对观察到的收益的影响。