The audiology community has given a guarded welcome to newly announced guidance from the UK Government that aims to make it easier for patients to manage their own hearing loss, while green-lighting businesses worldwide to sell certain over-the-counter (OTC) devices on the domestic market.

A January 16 policy paper reveals that the Government seeks to navigate a balance through the trail of existing regulations to “both protect patient safety while improving access to innovative technologies”.  And it says it plans to review these regulations. For now, the regulations in place serve as the framework for a series of purchase and download scenarios presented in the policy paper as situations whereby the market for devices, such as earphones with hearing test and hearing aid software functionalities, can be exploited by both seller and user to their mutual benefit.

Immediate reaction from two of the big players in hearing health in the UK – the Royal National Institute for Deaf People (RNID) charity, and the country’s biggest retail audiology chain, Specsavers – indicates a shared welcoming of the government spotlighting hearing loss and the boosting of mechanisms to encourage people to seek help for their hearing difficulties. But both stress the need for user safety to be paramount, and for face-to-face contact with audiology professionals to be part of efficient diagnosis and treatment.

 

Urgent review called for to confront “significant risks”

 

“We share the Government’s excitement about the potential benefits of over-the-counter hearing aids, including as a mechanism to encourage people to take action on their hearing loss,” said Harriet Oppenheimer, Chief Executive of RNID, qualifying the welcome, however, by stressing that “changes need to be introduced carefully and with the right regulatory safeguards in place.”

“There are some significant risks to consider in allowing all hearing aids to be made available without the user having first received a gold-standard hearing test, a referral to an audiologist to consider any underlying health conditions, or having their hearing aids fitted by a trained professional,” continued Oppenheimer.

“Furthermore, without these safety checks and balances in place, there is also a risk that many people may either delay seeking medical help for hearing loss, or even wrongly self-prescribe hearing aids which, if used incorrectly, could worsen hearing loss,” she added.

“In order to avoid such potential risks to people’s hearing health, we would recommend an urgent review of all the regulations covering hearing aid provision and for coherent changes to be made across the different elements,” said the RNID chief.

 

Follow the USA on OTC?

 

The Government’s paper acknowledges that it has looked at the USA’s creation in 2022 of a specific category of OTC hearing aids that can be sold without prescription in the US and without the intervention of a healthcare professional. “Since the introduction of the rule, a number of self-fitting, over-the-counter hearing aids have been developed and launched with the US Food and Drink Administration’s (FDA) approval,” reads the guidance paper.

The RNID is urging the UK Government to make a similar ruling. “One area the Government needs to urgently explore is the introduction of a new category of device for specifically regulated over-the-counter hearing aids. RNID would also welcome research to more fully understand the effectiveness of these products for people with hearing loss,” affirms Harriet Oppenheimer, which is already in direct conversation with the Department of Health and Social Care (DHSC).

Also in dialogue with the DHSC, and with other professional bodies in UK audiology, is Specsavers, whose director of audiology professional advancement, Gordon Harrison, called the new guidance “an exciting step forward in tackling hearing loss stigma”, and new technology, “game-changing”.

Should Government go further on changes to UK audiology services?

 

Throughout 2024, Specsavers has been leading a campaign to persuade Westminster and the UK’s devolved governments to allow high street providers to offer primary care NHS adult audiology services to all citizens. But this new Hearing aids in the UK – policy statement stops far short of any such pathway change. Although highlighting hearing aids and hearing care, it is a statement that leans more towards a DIY approach for the user, reflecting the emphasis in the Government’s Plan for Change on the benefits of technology and the economic and political benefits of boosting market conditions for technology players. In the words of Health and Social Care Secretary Wes Streeting, which the DHSC amplifies in its announcement of the new policy guidance: “This is part of the work this government is undertaking in partnership with leading technology companies, to harness the revolution in medical technology, bring our analogue healthcare into the digital age, and make life more convenient for patients.”

As a small part of its embracing technology, and launching its blueprint to unleash artificial intelligence across the UK, the Government is looking to over-the-counter hearing aid options to support shifts in health policy shaped by its new 10-Year Health Plan for England, the principal strands of which are: from hospital to the community, analogue to digital, and sickness to prevention.

Specsavers’ Gordon Harrison expresses concern, however, over OTC options alone meeting the needs of the population with hearing loss. “Face-to-face consultations with specialists remain essential for accurate diagnosis, whether it’s earwax buildup or more serious conditions, and for recommending the right hearing aid or treatment to protect long-term hearing health. With ongoing support from audiologists, people can finely tune digital hearing devices to help them adapt to different environments and changes in their hearing over time.”

“Patient safety is paramount. Specsavers remains in open dialogue with professional bodies, including the Department of Health and Social Care, to ensure this and, critically, that any new products that come to market are safe, backed by solid clinical evidence and deliver positive outcomes for people experiencing hearing loss,” Harrison affirms.

And Specsavers will, indicates Harrison, keep pressure on politicians to go further than it has with this policy statement focusing OTC devices. “As the Health Secretary has said today, hearing aids can help those with hearing loss live their lives to the full and he is right to focus on how to make access to hearing care more convenient for patients. We urge the Government to build on today’s announcement and further improve access to care by introducing self-referral to community audiology services across the country – enabling those needing NHS hearing care to see a professional audiologist on the high street without having to see their GP first.”

Sources: Gov.UK/DHSC/RNID/Specsavers