26 February 2025

Audiology sector: initial guidance on the use of OTC hearing aids in the UK

As sector bodies we fully support evidence-based and safe care for all ear and hearing care patients in the UK.

In January 2025 the Department of Health and Social Care (DHSC) published a policy statement on hearing aids in the UK. It is important to note that the DHSC makes clear that its statement should be read in conjunction with existing regulations -  Health Professions Order 2001 as amended by the Health Professions (Hearing Aid Dispensers) Order 2010 and Regulating medical devices in the UK. We support these important caveats, as these regulations are designed to protect individuals from harm.

At the heart of these regulations, is a simple premise; we must all put people with ear and hearing needs first. To ensure this happens, all ear and hearing care interventions in the UK should comply with these regulations and evidence-based clinical guidelines, including NICE Hearing loss in adults: assessment and management (NG98).

In practical terms this means

• ensuring the public has access to good information, so individuals can make informed choices
• suppliers are transparent about how their devices work and whether they are set up in a way to comply with NG98 and other applicable clinical guidelines, disclosing to users when this is not the case
• claims about clinical effectiveness and other scientific references meet ASA standards
• where products and services claim to provide diagnostic accuracy, placement of such products is supported by appropriate insurance, including medical malpractice insurance, so people have a right to redress if things go wrong.

We will publish more detailed guidance soon. If you have any questions in the meantime, please contact the audiology sector bodies listed below.