Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- Abbreviated Profile of Hearing Aid Benefit (APHAB)
研究概览
简要总结
The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.
详细描述
The aim of the proposed project is to evaluate the effectiveness of emerging over-the-counter (OTC) service delivery models with the gold standard traditional prescription hearing aids fit by hearing care professionals (HCP) using audiology best practices. OTC service delivery models include OTC HA fit to individual users using best practices with in person HCP support (OTC-HPC), via remote consultation (OTC-R) and self-fit OTC HAs without any clinical support (OTC-SF). The study will use a prospective four-arm randomized controlled trial design with longitudinal repeated measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation
- •Aged 40 years or older
- •No previous HA experience greater than 3 months
- •Able to read and understand patient education materials
- •Willing to be randomized to one of the four groups, and
- •Owns a smartphone
排除标准
- •Hearing loss that is too severe for OTC HAs
- •Middle ear disorders or conductive pathology present
- •Asymmetrical hearing loss
- •Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the MOCA
- •Non-English speaking as it may impact the ability to complete our test battery
结局指标
主要结局
Abbreviated Profile of Hearing Aid Benefit (APHAB)
时间窗: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention
It is a 24-item self-reported measure of hearing disability and hearing aid benefit. It includes four subscales that address different listening challenges: ease of communication, reverberation, background noise, and aversiveness of sounds, with each subscales comprising six items. The ease of communication, reverberation, and background noise primarily measure challenges related to speech communication. The global score on the APHAB is the average of these three subscale scores. The hearing aid benefit is calculated by comparing the difficulty level reported without amplification (unaided) to the difficulty level with amplification (aided). Scores range from 1% to 99%, with higher scores indicating greater perceived hearing difficulty.
次要结局
- Satisfaction with Amplification in Daily Living (SADL)(T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention)
- Revised Hearing Handicap Inventory -Screening (RHHI-S)(T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention)
- Patient Global Impression of Change (PGI-C)(T1= 6 months post intervention, T2= 12 months post intervention)
- Connected Speech Test (CST)(T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention)
- Quick Speech in Noise (QuickSIN)(T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention)