Over the summer, a law was passed in the US – the ‘Food and Drug Administration Reauthorization Act of 2017’ – which included the Over the Counter Hearing Aid Act, the aim of which is to provide greater public accessibility and affordability of hearing aids.
The Act is designed to enable adults with perceived mild-to-moderate hearing loss to access over-the-counter hearing aids without first being seen by a hearing care professional. It follows on from the abolition of the “physician waiver” system which formerly required consumers to either seek a medical evaluation or to sign a waiver before obtaining a hearing aid. The US Food and Drug Administration (FDA) is also now required to create and regulate a special category of OTC hearing aids to ensure they meet appropriate safety and consumer standards, although these standards are up for considerable debate.
This development in the US has inevitably prompted the UK’s hearing industry to consider its implications and the potential for similar proposals in Europe. However, in the UK, universal free-at-the-point-of-delivery provision by the NHS makes hearing care freely accessible. This, combined with a regulated but diverse retail market, means that consumer access to hearing services and solutions is comparatively high compared to the rest of the world.
Whilst we know that intervention improves quality of life and that therefore improved distribution of hearing solutions give societal and financial advantages, the BIHIMA members do not anticipate the same demand from consumers or believe that outcomes can be improved with an over-the-counter solution that excludes the hearing professional. Hearing instruments are a complex and mature specialist technology, providing consumers with professional guidance on their use must be the gold standard for consumer satisfaction and safety.
“We know that technology will continue to provide choices and options for consumers who will guide the future,” said the BIHIMA chairman Paul Surridge, “but our organisation will continue to value a quality standard approach so that all devices are safely regulated and CE-marked to ensure the highest standards of performance.”