Policy paper

Hearing aids in the UK - policy statement

Published 16 January 2025

The 10 Year Health Plan for England is centred on 3 big shifts in healthcare: from hospital to the community, analogue to digital, and sickness to prevention. As part of the plan, we are looking at the potential of wearable technology (and similar home monitoring technology) to support these shifts.  

Under the existing regulations in the UK, 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. 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 government wants to make sure that our regulations both protect patient safety while improving access to innovative technologies. We will review these regulations to ensure that our regulatory landscape provides the right balance. This will accelerate patient access to products that best suit their needs by making the UK an attractive place to develop and supply safe and effective innovative technologies.

We are aware of the establishment of a specific category of over-the-counter hearing aids in the US in 2022. This product category allows for certain types of hearing aids to be sold without a prescription or oversight from 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.

There are lots of possible causes of hearing loss. It may be caused by something treatable or it may be permanent. For information on when you should seek clinical advice, see NHS guidance on hearing loss.

Case studies

Below are some example scenarios relating to the sale of hearing aids under existing regulations considering the Health Professions Order 2001 as amended by the Health Professions (Hearing Aid Dispensers) Order 2010.

Manufacturers must 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), see also Regulating medical devices in the UK.

This statement represents the views of the Department of Health and Social Care (DHSC); although only a court can determine whether an offence has been committed in the light of specific facts. If uncertain, you should refer to the legislation and/or the relevant regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA) or the Health and Care Professions Council (HCPC).

These case studies are intended as examples that are not prevented by the Health Professions Order 2001. While only a court can make a binding determination, DHSC considers that the following scenarios do not constitute an offence under article 39A of the Health Professions Order 2001, as amended.

Retail purchase scenario

A person walks into a shop. They’ve heard about some earphones which include functionality such as a hearing test and hearing aid which complies with the relevant medical device regulations. They ask the shop assistant about the earphones and the shop assistant points them out. They purchase the earphones. At home, they use the hearing test functionality, which indicates mild hearing loss. As a result, the person then uses the hearing aid functionality on the earphones.

DHSC considers that in this scenario the shop assistant did not assess or test the person’s hearing using the earphone functionality. The person purchased the earphones before carrying out the hearing test themselves.

Online purchase scenario

A person suffers from moderate hearing loss. They read an online article about earphones which include a clinical-grade hearing aid functionality which complies with the relevant medical device regulations. They purchase the earphones from an online store. Upon delivery of the earphones, they activate the hearing test functionality, which indicates hearing loss. They set up the hearing aid functionality and use it on their earphones.

As above, they purchased the earphones before carrying out the hearing test themselves.

Free download scenario

A person is using their wireless earphones when they receive a notification offering them a free download of a new hearing health software which complies with relevant medical device regulations. They download the software. Once downloaded they run a hearing test functionality, which indicates they have hearing loss. They start to use the hearing aid functionality on their earphones.

DHSC considers that in this example a sale has not taken place. This is because the new software was free at the point of download.

Paid download scenario

A person is on an online marketplace when they find a hearing app which offers both a hearing aid and hearing test. They purchase the app including both the hearing test and hearing aid functionality which comply with the relevant medical device regulations. They take the test using the functionality which indicates hearing loss. They subsequently activate the hearing aid functionality on their device.

DHSC considers that in this example a sale has not taken place after testing. This is because both of the following apply:

• the testing is self-administered
• the hearing test and hearing aid were bought at the same time at the point of download