Participants
Twenty-nine participants aged between 18 and 79 years joined the workshops (Table 1). 24.1% of participants had a self-reported hearing loss and 13.8% used sign language. Overall, eight relevant parties (i.e. groups who would be personally or professionally affected by the topic of this study) were represented amongst the workshop participants. Eleven participants selected the category ‘other’ to add detail about their specific role or a previous role that they held and that is relevant to the topic of this study (e.g. a role within a consumer representative group or a professional association).
Stakeholders’ views on regulation and innovation in the hearing health sector
The analysis of participants’ views covered three broad themes: (1) conceptualising regulation and innovation; (2) the need for ethical congruence between innovation, regulation and societal values; and (3) shifting roles and responsibilities (see Table 2).
The three identified themes converged around a central, organising understanding that saw effective regulation and innovation within the hearing health sector as dependent on a holistic approach that places humans at its centre and requires the dynamic involvement of a range of individuals and organisations. The three themes are discussed further below, supported by verbatim quotes from participants. Because several participants in this study were part of more than one stakeholder group (hypothetical example: a researcher in the field who also has hearing loss and has a family member with deafness), the specific roles of the participants are not provided with the quotes. Not providing the specific roles increases the anonymity of the participants. When comments were provided in a written form only (Padlet discussion boards), the researchers were also unable to identify the authors of the comments. These instances are noted as anonymous comment written during the Australian (or UK) workshop. Any clarification added to the quotes by the researchers is noted with brackets within the quote.
Theme 1: conceptualising innovation and regulation in hearing health care
1a. Innovation and regulation is about more than technology
Participants discussed a range of innovations during the workshops. These discussions highlighted the depth and breadth of innovation taking place in the hearing health sector. Discussions about technological innovations included hearing devices (e.g. hearing aids and cochlear implants) and other technologies (e.g. apps) to support remote monitoring and self-management of devices and rehabilitation. In light of the rapid pace of technological innovation in hearing health, there was considerable consensus amongst all participants that a ‘device-centric’ focus to innovation and regulation risked side-lining non-technological innovations of potential benefit to consumers. Innovation in service delivery reflected new models of care such as ‘direct-to-consumer’ (DTC; where hearing-related products and services are provided directly from the device manufacturer to the consumer without the involvement of a traditional hearing health care professional such as an audiologist) was discussed. Pharmacological therapies and other biotechnologies were also discussed in the context of hearing restoration and genetic testing for hearing loss. Participants highlighted the human aspects that are embedded within the hearing health sector, beyond the technology, and the importance of centring discussions about innovation and regulation within a holistic person-centred approach.
With the regulation for hearing, is there regulation on the whole person, I guess, if that makes sense? Their language development, as a person are they involved in their community and their family life? Are they able to socialise within their community? So taking the person as a whole, I don’t know how you can regulate one without considering the rest. (participant 1, Australia)
Australian participants suggested that an emphasis on technology over other interventions (e.g. aural rehabilitation and counselling) limited how innovation and regulation were conceptualised in the hearing sector.
The misunderstanding that a device alone is not enough. Another way to consider this, is a lack of value placed on the importance and nuances of hearing loss and communication behaviours. (anonymous comment written during the Australian workshop)
We need to be really cautious of that [push on device sales] becoming an even bigger problem with over-the-counter hearing aids and future technology. When people have hearing impairment, technology is not necessarily, or devices are not necessarily, the answer. (participant 11, Australia)
A UK participant also commented on the growing ‘digital divide’ that has developed: with millions of people in developed countries not being able to use digital technologies due to a lack of support and training. This emphasises the need for innovation and regulation to encompass hearing care beyond hearing technologies.
1b. Quality and risk: drivers of innovation and regulation
Participants from both countries suggested regulation and innovation shared the common goal of ensuring quality and minimising risk. They viewed quality and risk to be inversely related in the sense that high-quality hearing health care was presumed to minimise risk, which participants defined implicitly as potential for harm. Quality and risk therefore were lenses through which innovation and regulation were viewed, contextualised and understood by participants.
Participants viewed quality as a cross-cutting, multi-dimensional construct. Quality was discussed in the context of (1) the effectiveness, safety and suitability of interventions (including devices and other technologies, aural rehabilitation and pharmacological therapies); (2) the delivery of services (e.g. timeliness, patient-centredness); and (3) information sharing (e.g. accuracy and reach). Some participants were optimistic, describing technological innovation as ‘positive’ and ‘exciting’, with potential to improve patient outcomes through greater empowerment. Positive outcomes, however, were perceived as not only related to quality technology, but to ensuring the suitability of different technologies for different individuals.
For as long as I can remember, we have been trying to move away from the medical model in audiology more to patient-centred care and giving people the tools to be able to manage their hearing and their hearing health. So technology can only help with that. But we do need to be careful to not put pressure on people who are not able to [use technology] or have too many expectations that everybody is going to be able to manage that through the technology. (participant 12, UK)
Participants highlighted safety concerns in relation to innovation, which would need to be addressed to ensure quality. Self-fitting devices were suggested to pose risks including potential for further hearing damage arising from overamplification or risks of missed or delayed diagnoses if hearing was not evaluated by a trained hearing healthcare professional (e.g. audiologist, otolaryngologist). Participants further highlighted risks related to the efficacy and safety of devices purchased online from unregulated vendors.
…patients buy medical devices online for many reasons – they don’t get advice from the clinicians, go online, [devices] have fraudulent CE marks attached to them [CE marks aim to attest compliance to European standards; CE=Conformité Européenne]…it’s just a horrendous situation that we find ourselves in. (participant 9, UK)
Participants discussed how the promise of new treatments for hearing loss could also impact on the quality of outcomes and could pose a further risk if consumers opted to wait for new treatments not yet on the market or available to healthcare providers and consumers (e.g. cellular therapies to restore hearing loss). The majority viewed timeliness as a mark of quality. One participant commented in the chat ‘the best treatment [for hearing loss] is the treatment that is available now’. Other participants highlighted potential risks to wellbeing and cognitive health associated with delayed intervention for hearing loss. They stated that most consumers lacked awareness of these risks, attributing lack of awareness to the inconsistent quality and effectiveness of public health messaging about hearing loss. Lack of reliable, high-quality information was also viewed as perpetuating misconceptions about the availability and quality of publicly funded hearing healthcare services (such as the UK’s National Health Service; participant 1, UK).
I think we need to be mindful that actually there is a general lack of public awareness …. It’s [hearing loss] considered an invisible disability – doesn’t matter much, not life threatening, no-one will die of hearing loss. [Yet] we know it has a huge impact. It does matter. So it’s getting that across because you can bet everybody knows somebody that’s had a hearing loss (participant 11, UK)
1c. Perception of regulation is context dependent
Perception of regulation varied by country and by interested or affected group. In Australia, some participants expressed a degree of scepticism towards regulation, asking ‘who regulates the regulators?’ (anonymous comment written during the Australian workshop). Limitations to regulation—such as the retrospective application of regulation to innovation—were also highlighted. Some participants stressed the point that regulation is only ‘one tool in the toolbox’ (participant 13, Australia) for ensuring quality and minimising risk, noting also that successful regulation is contingent upon its implementation by human actors.
[Regulation] addresses the harm after it has occurred rather than before it occurs …. but it quite commonly comes back to the underlying human who is performing their everyday services or receiving services. (participant 13, Australia)
In the Australian context, some participants saw the need for greater professional regulation, since audiology and audiometry are currently self-regulated professions and privately funded hearing services can be offered without professional association membership.
Audiology is currently NOT a registered profession under AHPRA [the Australia Health Practitioner Regulation Agency]. Regulating and allowing for registration of our profession would provide a better framework for hearing care (hence removing commissions in hearing aid sales). (anonymous comment written during the Australian workshop)
I don’t feel there is near enough regulation on who can prescribe hearing aids & the accountability of hearing aid suppliers. (anonymous comment written during the Australian workshop)
While the UK professional regulation framework is different to Australia’s, its effectiveness was also questioned:
Regulation of practitioners remains variable with three different routes for Audiology professionals 2 being statutory and 1 voluntary, hence the workforce is arguably unregulated. (anonymous comment written during the UK workshop)
Overall, UK participants viewed current regulation positively, but considered further work essential for regulators to ensure quality and minimise risk. Participants considered regulation critical in ensuring safe practices around data capture, storage, sharing and use, particularly regarding personal data. Participants agreed that data should be used to facilitate and not hinder consumer benefit. It was suggested that fear was a key driver to the hearing sector’s response to data sharing and use.
We need to tackle fear of data ….. it’s making sure we are open, transparent, honest on who uses what data where and being really clear about that. Making sure we are clear about that. (participant 11, UK)
Concerns raised relating to data management practices included (1) direct industry interaction with consumers; (2) complexity of data capture, storage, sharing and use in a context spanning healthcare, medical devices, non-medical devices and other technologies; and (3) access to transparent information about how the data would be used. Technological innovations such as data logging—whereby a hearing device records and stores information relating to device use (e.g. types of acoustic situations a user encounters, frequency of device use, location of device)—were a specific concern. Participants suggested many consumers did not have a clear understanding of what data were being collected and how these data were being utilised. Some expressed worries that lack of clear communication and thus understanding could potentially lead to legal claims in the future (participant 5, UK). The sharing of personal and clinical data with device manufacturers, through the outsourcing of services traditionally delivered by healthcare professionals (e.g. device maintenance and repair), was also a source of unease. Others worried that consumers may be put off by the complex nature of data storage and ultimately decline to engage with technology and other interventions, potentially resulting in missed opportunities to improve care and support, and communication outcomes.
…patients should be able to sign up to what data is collected, what it’s used for. I think the difficulty is making it simple enough because it is very complex ….. it needs to be clear what you are signing up to. So often in an appointment you are given this “Oh sign this for our records” and a) you don’t read it, b) if you did read it, it’s not simple enough for a lot of people to understand. I am guilty of not signing up for apps and doing lots of things [because] I don’t like my data being used. I suspect there are a lot of people like me, and we may be missing out on something that may be tremendously valuable because we are put off by pages and pages of things you have to sign. (participant 13, UK)
Theme 2: the need for ethical congruence between innovation, regulation and societal values
The groups represented at the workshops appeared to share a number of common values. These values are a set of contextualising factors which participants used to define quality and risk in the context of innovation and regulation. Participants hoped that developments within hearing health care would be congruent with these values.
2a. A desire for consumer involvement at every stage of innovation and regulation
Participants in both countries expressed strong preferences for consumer and public involvement in regulation, innovation and the research underpinning innovation. Consumer engagement was described as critical to ensuring relevance and quality, while minimising risk. UK participants described recent initiatives to embed consumer involvement across regulation and research. One participant expressed their approval of these efforts, noting ‘that’s what’s been missing, within Deaf Community [research] in the past—users have not been involved in the design’ (participant 1, UK). An Australian participant similarly articulated the importance of consumer involvement in the following comment: ‘Innovation may not always reflect the difficulties or needs that people experience in real life’ (anonymous comment written during the Australian workshop). Participants emphasised that when designing new interventions, it would be essential to involve consumers at every stage of the product design lifecycle, including how information describing innovation is written and disseminated.
…go back to that patient after the procedure and say, we said we were going to do x, y or z, did x, y or z actually happen? So having more patient involvement in constructing clinical evaluations is something as a regulator we are putting forward. (participant 9, UK)
The other really strong point that is coming out is about ‘nothing about us without us’. So I think that is a really such a clear point, but actually we do it, we do it quite poorly at the moment. We need to really understand the perspectives of people who are – the deaf community, people with hearing loss, people with hearing impairment. We need to be open to all the different perspectives in this debate, and it is not an easy thing, [to] bring together all of those different perspectives, so we need to know that it is not just everyone agrees, and we all know where to go. It is an iterative process that is going to keep changing as the technology changes as well. (researcher JSM summarising the main insight expressed by the workshop participants in Australia)
To achieve meaningful consumer and public involvement in hearing health care, participants from both countries suggested that a paradigm shift away from a medical, expert-driven model of care as well as away from care models driven by a profit-oriented approach. Adopting a social model of disability (which centres on making societies, services and places more accessible for everyone instead of trying make people with disability ‘fit in’ within inaccessible environments [25]) was suggested to help achieve this shift as it requires meaningful involvement from individuals with disability.
2b. A desire for innovation and regulation to tackle perceptions of stigma
Innovation and regulation in hearing care were viewed as opportunities to address perceived stigma associated with hearing loss which often compounds the stigma of ageing. The stigmas of hearing loss and ageing, together with the conception that hearing loss is part of the normal ageing process, were viewed as significant barriers to hearing care. That is, individuals may delay hearing care or access incomplete communication support because of the negative perception they or their family have about hearing loss, hearing device, sign language or ageing.
Hearing aids get such a bad rap. I fitted hearing aids to a 90 something year old – she was so worried they would make her look old. (anonymous comment written during the UK workshop)
Perceived stigmas can lead to denying, hiding or normalising increased hearing difficulties instead of exploring potential communication support options [26]. The availability of new and more streamlined forms of technologies and services such as self-management apps, access to direct-to-consumers or over-the-counter (OTC) hearing aids and the use of mainstream consumer technologies (i.e. Apple Airpods or other hearables) to manage hearing loss were innovations that participants considered could reduce stigma by promoting access to care outside of traditional clinical settings.
I almost feel that making HA available from manufacturers like Apple (airpods) makes them more socially acceptable. (anonymous comment written during the UK workshop)
By considering interventions beyond traditional hearing technologies and situating hearing health innovation and regulation within a social model of disability, participants proposed that digital innovations for managing hearing loss, deafness and hearing care could be less stigmatised. The value of education in this respect was further highlighted, some viewing education as a way to foster ‘…more awareness around hearing loss, take it out of the darkness, more conversations about it to remove the stigma’ (anonymous comment written during the UK workshop). A similar point was made in relation to the need for normalising discussions around sign languages, to broaden communication opportunities:
I grew up as a hearing aid user for nearly all my whole life, so from 15 months of age, and at no point was I exposed to Auslan. I discovered Auslan as an adult and went “Wow, this is brilliant”. If we could look at regulation that would ensure that every child who was hard of hearing had the option to consider Auslan as one of the benefits or one of the tools that they can use in their life and that culture that comes with that as well, and that acceptance of being somebody who is hard of hearing and not fixing it but actually gaining from having a language like Auslan. (participant 16, Australia)
2c. A desire for holistic, inclusive, accessible and ethical hearing healthcare
Participants suggested that innovation and regulation in hearing health care provided an opportunity to promote equity, diversity and inclusivity. They recognised that culture plays a central role in ensuring equitable and inclusive hearing health care and that hearing care professionals have a responsibility to actively identify and address sources of bias when striving for quality and minimising risk.
I was involved in one group talking about Aboriginal and Torres Strait Islander people with hearing loss and it was interesting in that group they said, “No, I don’t want to be talking about that topic. That’s a topic for the indigenous community”. I thought that was very interesting that because it’s okay for hearing people to talk about deaf people, but it’s not okay for non-indigenous people to talk about indigenous people. So it is something to keep in the back of our mind as we move forward in discussions to make sure that deaf people are recognised as people too… (participant 1, Australia)
Regulating the language used to communicate hearing health information was suggested to promote inclusive and ethical care:
One thing that can be kind of easily regulated is just the kind of the way, the language that is used in this space to talk about people and their lives and their hearing loss. It is obviously an issue that is very hurtful in the way that [hearing loss] is represented. (participant 3, Australia)
The cost of innovation was identified by some participants as a barrier to consumers accessing the latest hearing technologies. Cost barriers were therefore suggested to restrict access to innovation and limit inclusivity. Participants also discussed worries associated with the sustainability of publicly funded innovative services and interventions, in particular when these services are provided for free by hearing device manufacturers (e.g. aural rehabilitation apps). They described an ethical dilemma in so far as they are eager to offer these innovative services, but need to balance this against a risk for future harm to patients should funding be cut or currently freely available services be associated with a cost in the longer term.
One of the things that ……I think is really important is that currently a number of these systems that are available through the manufacturers are free. And we’re all capitalising on those. From that we can do some quite nice cost-benefit exercises as to why it would really be useful for us to introduce these things. But I think there is a massive risk here that this is not going to be free forever because these things are very costly to keep updated in terms of applications. (participant 5, UK)
As public services grapple with the challenges of increasing workloads and decreasing budgets, there was a concern amongst healthcare professionals that cost could hinder innovation with organisations prioritising the delivery of essential services. In such situations, participants worried about the ethical implications if innovations fail to reach all intended beneficiaries. Participants endorsed an ethical approach to innovation and regulation, which respects and supports autonomous decisions and promotes nonmaleficence, beneficence and justice [27].
2d. A desire for fair and trustworthy business practices
Hearing care in the UK and Australia are delivered by a range of publicly funded and for-profit organisations and individuals. It was clear from participants that discussions about innovation and regulation in the hearing health sector must consider business-related aspects and market factors. In particular, participants discussed the importance of having transparent systems to promote fairness and trust within hearing health care. Participants discussed concepts of ‘endorsement’, ‘warranties’, ‘professional standards’ and ‘national registries’ to report on efficacy and safety events, as ways to promote transparency and trust in the quality of products, services and information.
People are constantly seeking information/products from places they trust, that could be big brands, patient organisations or the NHS. In order for people to feel like they are getting the best product/service, they may look for some kind of endorsement from these sources. (anonymous comment written during the UK workshop)
Participants discussed how potential conflicts of interest could impact on the quality of services. To promote trust in the sector, transparency about sales targets and financial remuneration (e.g. benefits, commissions) received by a provider as a result of a ‘sale’ (Australian participant) was considered important, if not essential.
There were also concerns related to several hearing device brands clustering within a small number of ‘parent companies’:
Are the Big 5 [five largest hearing device firms] doing the best/right thing […] with consumer brands? – This doesn’t create more competition in the market, it siloes it. (anonymous comment written during the Australian workshop)
Similarly, participants raised efficacy and safety risks that could come with consumers making purchases through non-regulated avenues, stating that ‘…the role of regulator in [addressing the problem of] counterfeit devices also needs to be communicated’ (UK participant). Participants worried that current innovation and regulation may contribute to the growth of opportunistic businesses that may not be able to offer quality care. This was more salient with the Australian compared to the UK participants.
With OTC and a lower cost of entry this is likely to get worse as potential “cowboys” enter the market for a quick buck. (anonymous comment written during the Australian workshop)
Moreover, being unable to confirm the quality of devices purchased online impacts the extent of services hearing care professionals can provide:
Can that money be better spent getting a brand new [device] where it comes with a three-year warranty, and we have to make sure that you’re satisfied with it. If they’re paying for a fitting fee, it is a fit. I can’t guarantee whether it will be amazing. We will do the verification, but you won’t get a warranty with it because we don’t know where you have purchased it from. (participant 15, Australia)
A number of participants also discussed the importance of having effective regulation to limit inadequate advertising practices in order to create trust in hearing care. Inadequate advertising practices were discussed in relation to device manufacturers, clinical services and social media using targeted marketing. These practices were raised as a particular concern for Australian participants. For example:
There is often a significant gap between advertised claims and fulfilment in use. […] This needs clear and VISIBLE policing to ensure only quality products and prudent advertising claims (anonymous comment written during the Australian workshop)
The industry is nowhere near regulated enough at the moment and not enough basic benchmarks. Too much advertising that claims that once you have a hearing device or two all will be just dandy. This pretty much false advertising (anonymous comment written during the Australian workshop)
I’m connected with a deafness information page on [social media provider], so these are the ads that get pushed to my feed on [tech company] News. It is quite frustrating because it happens all the time. There is just no way that I can see how to stop that type of directed targeted marketing. I wonder how many other people feel pressured by [this] constant stream of promotion. (participant 1, Australia)
Theme 3: shifting roles and responsibilities
Participants conceptualised the hearing health sector as a network of organisations (e.g. consumer groups, private and public clinics, technology developers and manufacturers, research and education organisations, regulatory bodies) and individuals (e.g. consumers, clinicians, engineers, managers, researchers) having different knowledge, roles and interests. Workshop discussions suggested that these roles, interests and knowledge were in a state of flux that was fuelled, in part, by innovation and regulation.
3a. Shifting the responsibility to consumers
In particular, innovation was perceived as a driver for a loss of professional accountability, with greater responsibility for care being handed from clinicians to consumers, without the underpinning clinical knowledge. This was perceived as a risk that was not yet addressed through existing regulation.
With the introduction of new technologies (e.g., OTC, remote fitting/adjustment) there is a blurring of what the individual is responsible for doing and what is the role of the hearing healthcare professional. Individuals may also lack knowledge/understanding of all the options available to them and in what circumstances they should/could be used. (anonymous comment written during the UK workshop)
A shift in roles and responsibilities was perceived as inadvertently complicating access to hearing products and services. In Australia, decision-makers for one of the main hearing care funding schemes seemed to have altered the expected support role audiologists and audiometrists would take with their clients:
the NDIS [Australian National Disability Insurance Scheme] will not communicate with providers [,] which creates a system that is difficult to navigate for participants and providers who are trying to help them. (anonymous comment written during the Australian workshop)
3b. Shifting the responsibility to product manufacturers
Participants also discussed the gradual shift from clinician-led hearing services towards a more direct-to-consumer service model offered by, or in collaboration with, product manufacturers. This discussion highlighted a lack of clarity and transparency about the regulation already in place to manage accountability and the potential risks related to consumer data shared between organisations.
Our patients are used to sharing their information with their clinicians, and that’s sort of part of the deal. Patients know it is going to happen but obviously now we are moving into the world where manufacturers have a much more direct relationship with patients and we are having to share patient information in a limited way directly with manufacturers so for example patients can get equipment delivered by courier direct from manufacturers using the apps and remote care services. (participant 6, UK)
The possibility of clinicians losing part of their professional responsibilities was raised as a potential de-skilling of the workforce or an underutilisation of the full range of skills audiologists are trained to use. Solutions such as the unbundling of services (i.e. charging for items or services separately rather than as part of a device-rehabilitation service package that combines the purchase of devices) were suggested in Australia as key ‘…for flexibility and to make clear the value (and cost) of [health care professional] services’. In the UK, greater regulation of purchases made directly from manufacturers was suggested, together with clear information about responsibilities within hearing care services. As a UK participant asked: what is the role or most appropriate role for clinicians in this environment of rapid technological change?
3c. Navigating the dominance of hearing health manufacturers
Throughout both the UK and the Australian workshops, participants raised concerns related to the perceived current dominance of hearing device manufacturers and the influence of corporate entities/organisations on hearing health care decisions. Participants suggested that the ‘…lack of regulation in the Audiology health care sector allows big brands to dominate health care creating an even greater device-centric system.’ While many agreed that ensuring access to quality and appropriate technologies is a core component of hearing services, there was a perceived imbalance of power across organisations and individuals, accompanied by a perceived lack of options and transparency for consumers. Participants highlighted that hearing device companies may also own hearing services clinics under a different name, sometimes unbeknownst to clients.
I agree with the comment about the big providers having their own chain of hearing clinics, so go to [specific clinic name], for example, there is a particular brand that they only use, nothing else, consumers and most Australians don’t understand that. They don’t see that. (participant 10, Australia)
For cochlear implants, we now only have three manufacturers which is not ideal for healthy competition. (participant 6, UK)
Overall, participants in this study described their wish for a whole person approach to quality hearing health care. They reflected on the dynamic interplay between innovation and regulation and how this interplay influences the roles and responsibilities within the field, which impacts on their perception of quality care. They further discussed the importance for ethical values to guide all phases of innovation and regulation.
Current initiatives
As participants discussed issues related to the three themes of this article, they also referred to recent positive initiatives in each country. For example, during the UK workshop, participants shared several web links including advice for buying medical devices online [28], recent initiatives to engage patients and the public in health product regulation [29], and a charity that aims to unite the UK’s health and care data [30]. In Australia, a participant compared the workshop discussion to the work led by the Hearing Health Sector Committee (now the Hearing Health Sector Alliance), which led to a Hearing Health Roadmap [31] and governmental funding for subsequent initiatives. While more work is clearly needed to better align valued regulation and services with new and coming hearing health innovation, several encouraging initiatives are underway.
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