Earphones with the capacity to be adapted into hearing aids – including Apple’s AirPods Pro 2 – have been given the all-clear to be sold ‘over-the-counter’ in the UK, under new guidance published by the Department of Health and Social Care this week.
Individuals will be able to take hearing tests at home to turn the audio devices into personalised hearing aids, with the government saying its approval is part of its work to “shift healthcare from analogue to digital” and move care “from hospital to the community”.
Announcing the decision on Thursday, Health Secretary Wes Streeting criticised what he called “pointless regulation” which “suffocates innovation”.
He said: “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.”
Apple’s AirPods Pro earbuds became the first product to be authorised as an “over-the-counter hearing aid software device” by the US Food and Drug Administration (FDA) in September, with users able to take a “clinical-grade hearing test” which generates a “personalised hearing profile” to be applied to the Apple device, turning it into a hearing aid for those with mild to moderate hearing loss.
“These features on AirPods Pro will make an impact on so many people by driving more awareness around hearing health and empowering individuals with new customisable tools to help them stay connected,” Sarah Herrlinger, Apple’s senior director of global accessibility policy and initiatives said in a statement at the time.
However, approval was not yet granted in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), which told Liam O’Dell in September that it was “unable to disclose ongoing application processes”.
Since then, the regulator’s Public Access Registration Database (PARD) lists an in-ear air-conduction hearing aid and a “self-testing tone audiometer” among Apple’s registered devices, though it’s not clear when these devices were registered.
A press release from Apple in December stated its hearing test was now available in the UK, but it cannot release the feature which turns AirPods Pro 2 earbuds into hearing aids “due to regulatory restrictions”.
But following the DHSC’s new guidance, a spokesperson for the tech company said it was now “[looking] forward to bringing the hearing aid feature on AirPods Pro 2 in the coming weeks”.
While DHSC has given its approval to over-the-counter hearing aids and earphones with hearing aid software, it stressed people will “still be encouraged to seek clinical advice through their GP” if they are experiencing problems with their hearing.
The green light was set out in a policy paper, in which the department addressed legislation placing restrictions on the dispensing of hearing aids.
Under the Health Professions Order of 2001, amended by the Health Professions (Hearing Aid Dispensers) Order in 2010, individuals can be convicted and fined if they provide someone with a hearing aid and are not a registered hearing aid dispenser.
Except the DHSC policy paper detailed scenarios and case studies in which it considers there to be no offence committed by a business, such as selling earphones in a shop or online store which then have the hearing aid functionality turned on by the owner at home.
Free and paid downloads of hearing aid software for earphones are also deemed not to be in breach by the government, though in every use case it stresses that only a court can make a binding determination on whether an offence has been committed.
In a statement, Harriet Oppenheimer, chief executive of the Royal National Institute for Deaf people (RNID), said the deaf charity shares “the government’s excitement about the potential benefits of over-the-counter hearing aids”, but added changes need to be made “carefully” and with the right regulatory safeguards.
“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.
“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 said.
Oppenheimer added the charity recommends a review of “all the regulations covering hearing aid provision” in order to avoid such possible risks.
The chief executive continued: “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.
“RNID is already in direct conversation with DHSC and stands ready to work in partnership with the Government to ensure the benefits of this exciting development are available to all.”
AirPods Pro 2 earbuds are available for £229.
Images: Apple.
