The UK Government has given the green light for over-the-counter (OTC) hearing aids and devices to be sold in the UK but the British Academy of Audiology (BAA) has called for studies to assess their suitability and effectiveness.
BAA called for “high-quality studies to assess their suitability and effectiveness, given the limited evidence base for OTC products”.
The Government said patient safety would be paramount, and it “will ensure that all manufacturers comply with the relevant legislation”. People will also still be encouraged to seek clinical advice through their GP if they are having problems with their hearing, the Government said.
On 16 January 2025, the UK Government issued a media release starting it had published fresh guidance, “giving businesses around the world the green light to sell certain pioneering hearing aids here in the UK”.
It said the Department of Health and Social Care had given the green light for companies to sell innovative devices, like earphones with hearing aid functionality.
“Tens of thousands of people with hearing loss will have access to groundbreaking new hearing aid devices, thanks to Government action,” it said.
“This includes earphones with both hearing test and hearing aid software functionalities. Such revolutionary products allow someone to take a hearing test at home using their earphones and an app on their phone. If the test indicates mild to moderate hearing loss, the person can then switch on the hearing aid function on the same earphones.
“This will make it easier and more convenient for patients to manage their own health. Combatting hearing loss can also reduce associated risks like social isolation.”
Health and Social Care Secretary Mr Wes Streeting said: “Britain can be a powerhouse for medical technology, but only if we rip out pointless regulation that suffocates innovation.
“Groundbreaking new hearing aid devices have the potential to help tens of thousands of people with hearing loss, helping them to live their life to the full. The action we’re taking will give businesses the green-light to start selling these products to patients across the UK.
“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.”
British Academy of Audiology in discussions with health department
Audiologist Ms Claire Benton, president of the British Academy of Audiology said: “The British Academy of Audiology (BAA) supports innovation in audiology and hearing care.
“While we encourage anyone with hearing concerns to consult a qualified audiologist, we recognise that over-the-counter (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.”
She said BAA was in conversation with Department of Health and Social Care representatives about the development, and would issue a position statement in due course.
The Government statement said one in three adults in the UK were deaf or experienced hearing loss or tinnitus – which rises to more than 50% of over-55s.
“Of these, approximately 53% use 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,” the Government statement said.
“Today’s 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.”
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