Manchaiah Vinaya, Sharma Anu, Rodrigo Hansapani, Bailey Abram, De Sousa Karina C, Swanepoel De Wet
Department of Otolaryngology-Head and Neck Surgery, University of Colorado School of Medicine, Aurora, CO 80045, USA.
UCHealth Hearing and Balance, University of Colorado Hospital, Aurora, CO 80045, USA.
Audiol Res. 2023 Mar 1;13(2):185-195. doi: 10.3390/audiolres13020018.
Over-the-counter hearing aids have been available to consumers in the US since 17 October 2022 following a ruling by the Food and Drug Administration. However, their reception by hearing healthcare professionals (HHP) has been mixed, and concerns have been expressed by many HHPs. The aim of this study was to examine the concerns that HHPs have towards over-the-counter (OTC) hearing aids. The study used a retrospective survey design. The survey data of HHPs (n = 730) was obtained from Hearing Tracker. A 22-item structured questionnaire was administered using a Question Scout platform. Descriptive analyses examined reported areas of concern and a Fisher's exact test examined the relationship between demographics and responses. A cluster analysis with partitioning around medoids (PAM) was used to identify a sub-group of participants based on responses. Nearly half of HHPs who participated reported that they will support patients with OTC hearing aids purchased elsewhere, whereas a quarter reported that they will sell OTC hearing aids in their clinic or website. HHPs expressed over 70% agreement in 'concern' statements in 14 of the 17 items. Issues about safety, counseling, and audiological care were the key concerns expressed by HHPs about OTC hearing aids. Some demographics (i.e., profession, primary position) were associated with responses to some statements. Two groups were identified based on the responses to concern statements. The HHPs in the first cluster 'OTC averse' (51%) agreed on all the 17 concern statements, whereas the second cluster 'OTC apprehensive' (49%) had some items rated as disagree (i.e., consumers will give up on amplification) and neither agree nor disagree (i.e., do not provide good value, warranties and return periods will be worse), and remaining items were rated as agree. OTC hearing aids were initiated to improve affordability, accessibility, and hearing aid uptake and are currently a rapidly emerging category of hearing devices. Overall, the results of the current study indicate that HHPs have serious concerns about OTC hearing aids. HHP concerns cited in this study provide useful feedback to stakeholders (e.g., HHP professional agencies, FDA, industry, and insurance payers) involved in improving OTC hearing aid implementation.
自美国食品药品监督管理局做出一项裁决后，非处方助听器自2022年10月17日起可供消费者购买。然而，听力保健专业人员（HHP）对其的接受程度不一，许多HHP表达了担忧。本研究的目的是调查HHP对非处方（OTC）助听器的担忧。该研究采用回顾性调查设计。HHP（n = 730）的调查数据来自听力追踪器。使用问题侦察平台发放了一份包含22个条目的结构化问卷。描述性分析检查了报告的担忧领域，Fisher精确检验检查了人口统计学与回答之间的关系。使用围绕中心点划分法（PAM）的聚类分析根据回答来识别参与者的一个子群体。参与调查的HHP中近一半报告称他们会支持使用在其他地方购买的非处方助听器的患者，而四分之一报告称他们会在诊所或网站上销售非处方助听器。HHP在17项中的14项“担忧”陈述上表示超过70%的认同。安全、咨询和听力护理问题是HHP对非处方助听器表达的主要担忧。一些人口统计学特征（即职业、主要职位）与对某些陈述的回答相关。根据对担忧陈述的回答确定了两组。第一组“厌恶非处方助听器”的HHP（51%）对所有17项担忧陈述都表示认同，而第二组“对非处方助听器有所顾虑”的HHP（49%）对一些项目评为不认同（即消费者会放弃放大功能）以及既不认同也不反对（即性价比不高、保修和退货期限会更差），其余项目评为认同。非处方助听器的推出是为了提高可承受性、可及性以及助听器的使用量，目前是一类迅速兴起的听力设备。总体而言，当前研究的结果表明HHP对非处方助听器存在严重担忧。本研究中提到的HHP的担忧为参与改进非处方助听器实施的利益相关者（如HHP专业机构、美国食品药品监督管理局、行业和保险支付方）提供了有用的反馈。
