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

描述(申请人提供)：根据美国人口普查局最近作出的人口估计，约有3900万美国人年龄在65岁以上，占美国人口的13%。在美国65岁以上的人中，约有35%，即约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%的人真的会去找助听器。听力保健的可及性和可负担性的局限性似乎是导致购买助听器的美国老年人比例较低的主要因素。助听器的购买价格和典型的服务提供模式似乎是限制助听器的可及性和可负担性的关键因素。就像制作 设备本身的成本相当低，购买价格较高的理由是 通常立足于在设备的选择、编程、安装和评估方面提供的专业服务。该项目建议进行研究，以提供关于购买价格和服务交付模式对助听器结果的影响的新知识。拟议的研究将通过二期双盲、安慰剂对照、随机临床试验获得这一知识，该临床试验有五个平行分支。除了安慰剂之外 除了分支机构，其余四个分支机构代表服务交付模式(当前最佳实践和场外模拟)和购买价格(低和典型)的因素组合。将进行非劣势分析，将当前最佳做法模式的结果与服务提供模式和采购价格的替代组合进行比较。根据所获得的结果，这些发现可能会对患有轻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相当大的影响。

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.