Clinical Validation of the Lexie Lumen Over the Counter Hearing Aid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Abbreviated Profile of Hearing Aid Benefit (APHAB)
研究概览
简要总结
More than half a billion people globally have hearing loss. Most hearing loss is sensorineural, meaning that the hearing loss is irreversible and requires rehabilitation. The majority of people with hearing loss have mild to moderate degrees, for which the most effective treatment options are hearing aids. Over the past few years, there have been many developments in hearing technology and the service delivery models in which they are supplied. Traditional hearing care models include several visits to a qualified hearing professional who must both perform diagnostics and prescribe hearing aids, which in the past has been the only way to obtain hearing aids. However, newer developments include forms of self-fitting hearing aids that enable a user to perform threshold measurements to determine the degree of hearing loss and automatically program and fine-tune hearing aids. These devices are now becoming available as direct-to-consumer (DTC) or over-the-counter (OTC) hearing aids. Furthermore, alternative care models have been suggested to bolster access and uptake of assistive technology for hearing loss. Regulations on DTC and OTC hearing aids are starting to come into effect. In 2017, the FDA Reauthorization Act of 2016 directed the FDA to create a category for OTC hearing aids for adults with perceived mild-to-moderate hearing loss. In October 2021, the FDA formally proposed a rule to establish the OTC hearing aid category as part of this process. These changes in regulations would mean that soon, many of these self-fitting devices will become available. In response to these changes in service delivery models, the hearX group recently developed the Lexie Lumen hearing aids that can perform in-situ hearing threshold estimations and automatically prescribe hearing aid gain settings that closely approximate the gold-standard NAL-NL2 fitting prescription. This study aims to evaluate whether the performance of the novel Lexie self-test and self-fitting hearing aid is equivalent to the same hearing aid programmed professionally by an audiologist using a professionally obtained audiogram.
详细描述
Objective: To examine the difference in outcomes (satisfaction and objective benefit) of the Lexie self-test and self-fitting (Lexie- STF) hearing aid versus a Lexie hearing aid fitted professionally with a clinically obtained audiogram (Lexie-PTF) (n = 60).
Hypothesis: It is hypothesized that the Lexie-STF (experimental group) will be non-inferior to the Lexie-PFT (control group) in terms of perceived satisfaction, speech perception in noise and real-ear measurements.
Design: A randomized control trial (RCT) will be conducted cross-sectionally (45 days) to evaluate the efficacy of Lexie-STF compared to Lexie-PTF.
Setting: This study will involve clinical, audiometric testing as well as a user field-trial of the fitted hearing aids.
Participants: Eligible participants will include 60 adults (18 to 99 years) with a self-perceived level of hearing loss, free from symptoms of ear disease or excessive cerumen and who own a smartphone (Android or iOS). Participants will be recruited for each group and will randomly be assigned using a computer-generated randomization by an independent research assistant, after being stratified for sex and degree of hearing loss.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between the ages of 18 to 99 years, living in South Africa.
- •Good English proficiency (measured using an online English proficiency test as well as self-report of English speaking competence)
- •Must have a self-perceived hearing loss
- •Mild to severe sensorineural hearing loss (thresholds <= 80 dB HL across frequencies bilaterally)
- •Possession of a smartphone compatible with the Lexie app (iOS or Android)
- •Access to mobile data to operate the Lexie app.
- •Willingness and availability to participate in the study over a period of 45 days
排除标准
- •Normal hearing or profound hearing loss
- •Active outer or middle ear disease
- •Poor English proficiency
- •Diagnosed cognitive impairment
结局指标
主要结局
Abbreviated Profile of Hearing Aid Benefit (APHAB)
时间窗: Change from baseline assessment to final assessment after 30 day field trial use.
The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24 item self-assessment inventory in which patients report the amount of trouble they experience hearing and communicating in noise in different everyday listening environments. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).The final score is determined by subtracting the aided average from the unaided average, keeping in mind that the score indicates how frequently the individual experiences communication difficulty. Therefore a higher score indicates a poorer outcome. (Minimum score 1% to a maximum score of 99%).
次要结局
- International Outcome Inventory for Hearing Aids (IOI-HA)(Final assessment after 30 day field use)
- QuickSIN Speech in Noise Test(Baseline and benefit at the end of 30 day field use)
- Digits-in-noise Test (DIN)(Baseline unaided test and aided fitting final assessment after 30 day field use)
- Live Speech Mapping Using Real Ear Measurements (REM)(Final assessment after 30 day field use)
研究者
De Wet Swanepoel
Principal Investigator
hearX Group