Over-the-Counter Hearing Aids Versus Traditional Hearing Aids in Patients With Mild-to-Moderate Hearing Loss: Protocol for a Noninferiority Randomized Controlled Trial.

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-10-25 DOI:10.2196/59894
Ga-Young Kim, Mini Jo, Young Sang Cho, Il Joon Moon
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Abstract

Background: With the aging of society, the prevalence of hearing loss (HL) is increasing. Currently, approximately 5% of the global population has HL, and this number is projected to reach 7 million by 2050. Although hearing aids (HAs) are the primary treatment for HL, their use is limited by barriers such as high costs and social stigma. To address these limitations, over-the-counter (OTC) HAs have been introduced, but their effectiveness and drawbacks require further investigation.

Objective: This study aims to conduct a noninferiority randomized controlled trial comparing OTC HAs with traditional HAs to assess the clinical effectiveness of OTC HAs.

Methods: We designed a noninferiority randomized controlled trial comparing OTC HAs and traditional HAs in adults with mild-to-moderate HL. A total of 64 participants (32 per group) will be recruited. Randomization will be performed using block randomization (block sizes of 2 or 4) with an equal allocation ratio. The study will include 2 types of HAs: an OTC HA (Jabra Enhance Pro) and a traditional HA (LiNX Quattro LE561-DRW) by GN ReSound A/S. OTC HAs will be self-fitted using a smartphone app, while traditional HAs will be fitted by a licensed audiologist using the National Acoustics Laboratories-Non-Linear Prescription, second generation. Assessments, including functional gain, real-ear measurement, speech audiometry, and questionnaires, will be conducted at 6-month intervals over the course of 3 visits. Statistical analysis will compare the 2 outcomes, focusing on functional gain, to determine noninferiority.

Results: This study is scheduled to begin in August 2024 and has not yet recruited any participants. The study will be conducted over 2 years, from August 2024 to July 2026. Each participant will have 2 follow-up visits at 6-month intervals, making the total follow-up period 1 year.

Conclusions: Since 2022, the introduction of OTC HAs has revolutionized access to these devices. Researchers, clinicians, and the general public are keen to evaluate the clinical effectiveness of OTC HAs, as more individuals will likely use them for HL. This increased usage will provide valuable real-world data to understand the benefits and limitations of OTC HAs. Monitoring the outcomes and user feedback will provide insights into their effectiveness and impact on hearing rehabilitation.

International registered report identifier (irrid): PRR1-10.2196/59894.

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轻度至中度听力损失患者使用非处方助听器与传统助听器的对比:非劣效随机对照试验方案。
背景:随着社会老龄化的加剧,听力损失(HL)的发病率也在不断上升。目前,全球约有 5% 的人口患有听力损失,预计到 2050 年,这一数字将达到 700 万。虽然助听器(HAs)是治疗听力损失的主要方法,但其使用却受到高昂费用和社会偏见等障碍的限制。为了解决这些问题,人们开始使用非处方(OTC)助听器,但其有效性和缺点需要进一步调查:本研究旨在进行一项非劣效性随机对照试验,将非处方药 HA 与传统 HA 进行比较,以评估非处方药 HA 的临床有效性:我们设计了一项非劣效性随机对照试验,比较 OTC HA 和传统 HA 对轻度至中度 HL 成人的治疗效果。总共将招募 64 名参与者(每组 32 人)。随机分配将采用等分配比例的区组随机法(区组大小为 2 或 4)进行。研究将包括两种类型的助听器:一种是 OTC 助听器(Jabra Enhance Pro),另一种是 GN ReSound A/S 生产的传统助听器(LiNX Quattro LE561-DRW)。OTC 助听器将使用智能手机应用程序自行安装,而传统助听器将由持证听力学家使用美国国家声学实验室第二代非线性处方进行安装。评估包括功能增益、实耳测量、言语测听和问卷调查,将在 3 次就诊过程中每 6 个月进行一次。统计分析将比较两种结果,重点是功能增益,以确定非劣效性:该研究计划于 2024 年 8 月开始,目前尚未招募任何参与者。研究将从 2024 年 8 月至 2026 年 7 月进行,为期 2 年。每位参与者将每隔 6 个月进行 2 次随访,总随访期为 1 年:自 2022 年以来,非处方药 HAs 的推出彻底改变了人们对这些设备的使用。研究人员、临床医生和公众都热衷于评估非处方 HA 的临床效果,因为可能会有更多的人将其用于 HL。使用量的增加将为了解 OTC HAs 的优点和局限性提供宝贵的真实数据。监测结果和用户反馈将有助于深入了解它们对听力康复的有效性和影响:PRR1-10.2196/59894。
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CiteScore
2.40
自引率
5.90%
发文量
414
审稿时长
12 weeks
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