Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, welcomes a new approach to promote access to innovative hearing technology.
Innovative hearing aids will be more readily available over the counter and online after an announcement from the UK Department of Health and Social Care.
Under current UK regulations, assessing or testing an individual’s hearing and prescribing hearing aids are protected functions, only to be carried out by specified professionals. The new approach acknowledges the potential of wearable technology and home monitoring devices and points to over-the-counter hearing aids in the US, which do not require a prescription or professional oversight.
The statement gives examples of scenarios where similar purchases, without professional oversight, would not be considered unlawful in the UK, while ensuring compliance with relevant legislation, including the Medical Devices Regulations 2002 and the EU Medical Device Regulations.
If adopted more widely across the MedTech sector, this approach could give a major boost to patient choice of devices.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.