Changes in US hearing aid regulations: possible benefits and risks to Australia.

Objective: Hearing aids are costly for many Australians with hearing loss who are not eligible for public funding, and are not widely used. The purpose of this article is to describe a recent policy shift from the United States (US) that might improve access to hearing devices and services in Australia. Type of program or service: In 2017, the US legislated the Over-the-Counter Hearing Aid Act of 2017, directing the Food and Drug Administration (FDA) to develop regulations for over-the-counter sale of hearing aids for mild to moderate hearing loss.
Findings: Changes in the development of hearing devices and changes to service delivery were well underway in the US prior to anticipated release of new FDA regulations, with new technology entrants in the 'hearables' market. For Australians with hearing loss not eligible for public funding, the current hearing health system is expensive and device-centred. If Australia follows suit with regulatory changes for a class of over-the-counter hearing aids, consumers are likely to benefit from access to safe and affordable devices. Additional policies to support access to hearing services are also likely to be needed.
Lessons Learnt: The hearing health system in Australia will undergo tremendous change in the coming years because of the introduction of over-the-counter hearing aids in the US. For Australians to benefit, changes to regulations of devices, as well as hearing services and device provision, will be required.
Competing Interests: IB has received funding from the Cochlear–Macquarie Partnership Scheme, and has been paid expenses to attend an Audiology Australia conference as a guest speaker (2018–19). AW has received grant funding from the Johns Hopkins Cochlear Center for Hearing and Public Health. FL has received consultancy fees from Cochlear Ltd, Amplifon and Boehringer Ingleheim. NR has received funding from NIH/NIA, one-time consultancy fees from Helen of Troy and is an advisory board member to audiometry company Shoebox and Neosensory.