Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)
研究概览
简要总结
This document describes a clinical validation study for a double-blind repeated-measures comparative study of the Great Nordic (GN) self-fitting method to a validated audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover wear-time field trial will be conducted. The focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the GN Self-fitting Hearing Aid, and the safety and effectiveness of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 - 8000 Hz less than 60 decibels Hearing Level (dB HL) and from 2000 - 8000 Hz, at least one threshold greater than 20 dB HL)
- •Mix of male and female subjects (aiming for a representative balance)
- •Mix of prior hearing-aid use (aiming for 70-80% persons with no prior hearing aid use)
- •18-75 years old (aiming for primarily 50-70 years old, with avg. age ~65 years)
- •Apple iPhone (iOS 14 compatible or greater, as required for the SELF-FIT app)
- •Able to read and comprehend English
- •Patient willing to provide informed consent
排除标准
- •Hearing outside of limits noted above
- •Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)
结局指标
主要结局
Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)
时间窗: 10-14 days
The APHAB is a 24-item self-assessment of the amount of trouble the respondent has with communication in everyday situations. Sample question: "When I'm at the dinner table with several people, and I am trying to have a conversation with one person, understanding speech is difficult." For each of the 24 items, person asked to select one of the following percentages to indicate how frequently this occurs: Always (99%); Almost Always (87%); Generally (75%); Half-the-time (50%); Occasionally (25%); Seldom (12%); or Never (1%). Mean scale scores are expressed as a percentage or proportion representing the average frequency of difficulty experienced. An APHAB global score based on the 18 items from the three speech-communication subscales was used in the statistical analyses. APHAB scores were obtained unaided (Visit 1) and following use of the hearing aids for 10-14 days for each fit (Visits 2 \& 3; aided). The primary outcome is the mean difference in aided scores, Self-Fit minus Pro-Fit.
次要结局
- Quick Speech in Noise Test (QuickSIN)(Measurement after 10-14-day wear time for each fit.)