Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Centre for Disability Research and Policy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
BMC Med. 2024 Sep 27;22(1):417. doi: 10.1186/s12916-024-03627-1.
The hearing health sector is an example of a health sector that is experiencing a period of rapid innovation driven by digital technologies. These innovations will impact the types of interventions and services available to support the communication of deaf and hard-of-hearing individuals. This study explored the perceptions of informed participants on the topic of innovation and regulation within hearing healthcare in Australia and the United Kingdom (UK).
Participants (N = 29, Australia [n = 16], UK [n = 13]) were purposively sampled and joined one of two online workshops. Participants included adults with hearing loss and family members, hearing health professionals, academics/researchers, representatives of hearing device manufacturers, regulators and policymakers. Workshop data were analysed using reflexive thematic analysis.
Participants conceptualised the hearing health sector as a network of organisations and individuals with different roles, knowledge and interests, in a state of flux driven by innovation and regulation. Innovation and regulation were perceived as mechanisms to ensure quality and mitigate risk within a holistic approach to care. Innovations encompassed technological as well as non-technological innovations of potential benefit to consumers. Participants agreed it was essential for innovation and regulation to be congruent with societal values. Critical to ethical congruence was the involvement of consumers throughout both innovation and regulation stages, and the use of innovation and regulation to tackle stigma and reduce health disparities. Participants expressed the desire for accessible and inclusive innovation in the context of fair, transparent and trustworthy commercial practices.
This study explored how stakeholders within the hearing health sector understand and make sense of innovation and the role of regulation. Overall, and despite reservations relating to health care professionals' changing roles and responsibilities, innovation and regulation were conceptualised as beneficial when situated in the context of holistic, whole-person, models of care. The results of this study will inform considerations to support the development and implementation of innovations and regulation within the hearing sector and across other health sectors influenced by technological advances.
听力健康领域是一个受益于数字技术创新驱动的健康领域范例。这些创新将影响到可用于支持聋人和重听人士交流的干预措施和服务类型。本研究探讨了澳大利亚和英国（英国）听力保健领域内创新和监管议题的知情参与者的看法。
参与者（N=29，澳大利亚[n=16]，英国[n=13]）采用目的性抽样，参加了两个在线研讨会中的一个。参与者包括听力损失者及其家属、听力保健专业人员、学者/研究人员、听力设备制造商代表、监管机构和政策制定者。使用反思性主题分析对工作坊数据进行分析。
参与者将听力保健部门概念化为一个由具有不同角色、知识和利益的组织和个人组成的网络，在创新和监管驱动的不断变化的状态中。创新和监管被视为在整体护理方法中确保质量和降低风险的机制。创新包括对消费者具有潜在益处的技术和非技术创新。参与者一致认为，创新和监管必须与社会价值观保持一致。道德一致性的关键是在创新和监管的各个阶段让消费者参与进来，并利用创新和监管来解决污名化问题，减少健康差距。参与者表示希望在公平、透明和值得信赖的商业实践背景下实现可及和包容的创新。
本研究探讨了听力保健部门内的利益相关者如何理解和理解创新以及监管的作用。总的来说，尽管与医疗保健专业人员不断变化的角色和责任有关，但当创新和监管置于整体、全人护理模式的背景下时，它们被认为是有益的。本研究的结果将为支持听力保健领域和受技术进步影响的其他保健领域内创新和监管的制定和实施提供信息。
