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临床试验/NCT03652909
NCT03652909已完成不适用

Personal Sound Amplification Smartphone Application Feasibility Study

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Sentence Perception in Noise Initial Fit v Unamplified

研究概览

简要总结

Find a personal sound amplification device that can help people hear better.

详细描述

Personal sound amplification devices (PSADs) have recently become available to the public. PSADs serve a potentially important role in providing audibility of sounds for adults who find themselves having difficulty hearing and understanding speech in some daily living situations, but may not be candidates for traditional, high-amplification hearing aids. Despite hearing loss being a very common problem, few adults who could benefit from some level of amplification actually access the technology. Only approximately 1 in 7 adults (14%) over the age of 50 with a hearing loss using amplification. High cost is the most commonly cited reason for not wanting to try amplification, and indeed, hearing aids range from $1000 to $5000 each (i.e., per ear). PSADs range from $50-$600 each, and may provide a reasonable option for people who are not ready, or are unwilling, to wear a hearing aid. This project aims to examine the feasibility of a PSAD to provide audible and clear sound signal to adult listeners. The significance of this project is its potential to develop an option for individuals to take advantage of amplification and access sound to improve quality of life, who may not otherwise do so without this technology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults who report difficulty hearing in some daily listening situations.
  • Primarily English-speaking
  • Able to follow instructions and perform study procedures.

排除标准

  • Non-English speaking
  • Unable to perform research procedures and/or follow necessary instructions

结局指标

主要结局

Sentence Perception in Noise Initial Fit v Unamplified

时间窗: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

The prescription gain (initial fit) Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.

Sentence Perception in Noise Fine-tuned v Unamplified

时间窗: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

The fine-tuned Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.

次要结局

  • Sentences Easy to Understand(The patient will wear the Personal Sound Amplification Device for approximately 30 minutes)
  • Words Clear(The patient will wear the personal sound amplification device on average for 30 minutes.)
  • Sounds Are Distorted(The patient will wear the Personal Sound Amplification Device for approximately 30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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