Tens of thousands of people in the UK with mild to moderate hearing loss could benefit from new Department of Health and Social Care (DHSC) guidance that will allow businesses to sell devices, such as earphones with hearing aid and testing functionality, direct to consumers ‘over the counter’ (OTC).
The new guidance was part of the Labour government’s ‘Plan for Change’ initiative, which has focused on positioning the UK as a global leader in technology and encouraging innovation to improve lives. The Prime Minister recently outlined a blueprint to integrate artificial intelligence (AI) across various sectors, including healthcare.
The government said one in three adults in the UK were deaf, or experienced hearing loss or tinnitus, a figure that increased to more than 50% of over 55-year-olds, with just over half (53%) of them wearing hearing aids.
‘Currently, there is uncertainty about whether patients are able to buy hearing aids directly, including as part of testing their hearing at home,’ a DHSC statement said. ‘The guidance will put an end to this confusion, speeding up patient access to the devices, while making the UK an attractive place to manufacture innovative and wearable medical technology.’
Health and Social Care Secretary, Wes Streeting, said: ‘Britain can be a powerhouse for medical technology, but only if we rip out pointless regulation that suffocates innovation.
‘This is part of the work this government is undertaking in partnership with leading technology companies, to harness the revolution in medical technology, bringing our analogue healthcare into the digital age.’
Existing regulations
There is a protected function for assessing or testing an individual’s hearing, or for prescribing a hearing aid with a view to the sale of a hearing aid to, or for the use of, that individual under the Health Professions Order 2001, as amended by the Health Professions (Hearing Aid Dispensers) Order 2010.
This does not include the sale of a hearing aid where prescription or professional assessment and testing is not involved, or the provision of hearing aids without a sale.
The new DHSC guidance focuses on the testing element of a hearing aid dispense, and puts the onus on the purchaser to conduct the hearing assessment themselves using the device or accompanying app.
Retailers that sell devices with sound amplification and self-testing functionality will not be committing an offence under article 39A of the Health Professions Order 2001, in the view of the DHSC, because the user is performing the test themselves. Device manufacturers must still comply with all relevant legislation.
This includes, but is not limited to, ensuring compliance with the Medical Devices Regulations 2002 (for Great Britain) or the EU Medical Device Regulations (for Northern Ireland, with continued time-limited acceptance in Great Britain). The public will still be encouraged to seek clinical advice through their GP if they are having problems with their hearing.
Devices such as Apple’s AirPods Pro 2, which have had hearing aid functionality through a software update since last autumn, will now have the functionality unlocked in the UK through a soon to be released patch. Other earphone manufacturers, such as Sennheiser, which is owned by audiology firm Sonova Holding AG, are expected to quickly follow suit.
The new guidance could also expedite the availability of products such as Nuance Audio’s Hearing Glasses, but approval is likely to be scrutinised heavily by regulators as the device does not form a seal from background noise in the same way in-ear earphones do, which affects the hearing assessment process.
Industry reactions
News of amended guidance was welcomed with a degree of caution by the British Academy of Audiology (BAA). Its president, Claire Burton, said: ‘The BAA supports innovation in audiology and hearing care.
While we encourage anyone with hearing concerns to consult a qualified audiologist, we recognise that OTC hearing products can help raise awareness of hearing loss and promote earlier intervention.’
‘Given the limited evidence base for OTC products, the BAA calls for high-quality studies to assess their suitability and effectiveness. Anyone with concerns should seek advice from a qualified audiology professional. BAA are in conversation with the DHSC representatives about this development, and will issue our position statement in due course,’ said Gordon Harrison, director of professional advancement, audiology, at Specsavers Hearcare, and part of BAA’s Service Quality Committee.
‘Face-to-face consultations with specialists remain essential for accurate diagnosis, whether it’s earwax buildup or more serious issues, 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 changes in their hearing over time,’ added Harrison.
