Knoetze Megan, Manchaiah Vinaya, Swanepoel De Wet
*Department of Speech-Language Pathology and Audiology, University of Pretoria, Pretoria, South Africa.
J Am Acad Audiol. 2025 Jan 1;36(1):23-36. doi: 10.3766/jaaa.240037. Epub 2025 Feb 3.
Over-the-counter (OTC) hearing aids can potentially improve access to hearing-health care and enable individuals with mild-to-moderate hearing loss to self-manage their condition. This study compared the usability and performance of a range of self-fitting over-the-counter (OTC-SF) hearing aids. This cross-sectional study evaluated six OTC-SF hearing aids. Forty-three adults with self-perceived mild-to-moderate hearing difficulties participated in this study. Participants were randomly assigned to two of six OTC-SF hearing aids and used the manufacturer-provided instructions and smartphone applications. These hearing aids included HP Hearing PRO, Jabra Enhance Plus, Lexie B2 Powered by Bose, Lexie Lumen, Soundwave Sontro, and Sony CRE-C10. Usability was assessed based on the fitting time, hearing aid skills and knowledge (HASK), self-reported ease of the SF process, and Post-Study System Usability Questionnaire (PSSUQ) results. Performance was evaluated using the judgment of sound quality (JSQ) test and speech-in-noise benefit using the digits-in-noise and quick speech-in-noise tests. Fitting time ranged from 14.4 to 27.1 min, with Lexie Lumen requiring the longest time (27.1 min; standard deviation [SD], 5.9 min) and HP Hearing PRO requiring the shortest time (14.4 min; SD = 1.9 min). The HASK scores varied, with Soundwave Sontro achieving the highest score (8.9/10) and HP Hearing PRO achieving the lowest score (6.8/10). Self-reported ease of SF and PSSUQ scores did not differ significantly between the OTC-SF hearing aids. Overall sound quality and clarity ratings significantly differed, with Lexie B2 receiving the highest rating (8.1/10 and 7.5/10) and HP Hearing PRO receiving the lowest rating (6.3/10 and 5.1/10). Speech-in-noise benefit did not differ significantly between devices. A thematic analysis identified seven themes of the participants' SF experiences and six themes of the researcher's field notes. Participants generally considered OTC-SF hearing aids user-friendly, although issues with Bluetooth connectivity, handling and insertion, and sound quality were noted by the researcher as common challenges. Usability and performance of OTC-SF hearing aids were similar across devices in terms of usability and speech-in-noise benefits. However, the devices exhibited variations in fitting time, HASK, and sound quality, including the overall impression and clarity. These findings can support the decisions of consumers and recommendations of health-care professionals. Further research of the long-term usability and selection processes of OTC-SF hearing aids is necessary.
非处方（OTC）助听器有可能改善听力保健服务的可及性，并使轻度至中度听力损失的个体能够自我管理其病情。本研究比较了一系列自适配非处方（OTC-SF）助听器的易用性和性能。这项横断面研究评估了六种OTC-SF助听器。43名自我感觉有轻度至中度听力困难的成年人参与了本研究。参与者被随机分配到六种OTC-SF助听器中的两种，并使用制造商提供的说明书和智能手机应用程序。这些助听器包括HP Hearing PRO、Jabra Enhance Plus、由Bose提供动力的Lexie B2、Lexie Lumen、Soundwave Sontro和索尼CRE-C10。基于适配时间、助听器技能和知识（HASK）、自我报告的自适配过程的难易程度以及研究后系统易用性问卷（PSSUQ）的结果来评估易用性。使用音质判断（JSQ）测试以及数字噪声和快速噪声中的语音测试来评估语音噪声受益情况。适配时间从14.4分钟到27.1分钟不等，Lexie Lumen所需时间最长（27.1分钟；标准差[SD]，5.9分钟），HP Hearing PRO所需时间最短（14.4分钟；SD = 1.9分钟）。HASK得分各不相同，Soundwave Sontro得分最高（8.9/10），HP Hearing PRO得分最低（6.8/10）。在OTC-SF助听器之间，自我报告的自适配难易程度和PSSUQ得分没有显著差异。总体音质和清晰度评分有显著差异，Lexie B2获得最高评分（8.1/10和7.5/10），HP Hearing PRO获得最低评分（6.3/10和5.1/10）。各设备之间的语音噪声受益情况没有显著差异。一项主题分析确定了参与者自适配体验中的七个主题和研究人员现场记录中的六个主题。参与者普遍认为OTC-SF助听器对用户友好，不过研究人员指出蓝牙连接、操作和佩戴以及音质方面的问题是常见挑战。在易用性和语音噪声受益方面，OTC-SF助听器在不同设备间的易用性和性能相似。然而，这些设备在适配时间、HASK和音质方面存在差异，包括总体印象和清晰度。这些发现可以为消费者的决策和医疗保健专业人员的建议提供支持。有必要对OTC-SF助听器的长期易用性和选择过程进行进一步研究。
