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

描述（由申请人提供）：根据美国人口普查局最近的人口估计，约有3900万美国人年龄超过65岁，占美国人口的13%。大约有1360万美国老年人患有严重的听力损失，足以使他们成为助听器的候选人。然而，只有大约20%的人可以从助听器中受益，实际上寻求他们。听力保健的可及性和可负担性的限制似乎是购买助听器的美国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提供模式是似乎限制助听器可及性和可负担性的关键因素。作为生产 设备本身的成本相当低，购买价格较高的理由是 通常基于在设备的选择、编程、装配和评估中提供的专业服务。该项目建议进行研究，提供有关购买价格和服务交付模式对助听器效果影响的新知识。拟定研究将通过一项II期双盲、安慰剂对照、随机临床试验（包含5个平行分支）获得这些知识。除了安慰剂 分支，其余四个分支代表服务提供模式（当前最佳做法和非处方模拟）和购买价格（低和典型）的因素组合。将进行非劣效性分析，以比较当前最佳做法模式与服务提供模式和购买价格的替代组合的结果。根据所获得的结果，这些发现可能对轻度至中度听力损失的老年人的听力保健的可及性和可负担性产生重大影响。

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.