TY - JOUR
T1 - Changes in US hearing aid regulations
T2 - possible benefits and risks to Australia
AU - Willink, Amber
AU - Reed, Nicholas S.
AU - Boisvert, Isabelle
AU - McMahon, Catherine M.
AU - Lin, Frank R.
N1 - Copyright the Author(s) 2021. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2021/12/2
Y1 - 2021/12/2
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85121923438&partnerID=8YFLogxK
U2 - 10.17061/phrp3152132
DO - 10.17061/phrp3152132
M3 - Article
C2 - 34873617
AN - SCOPUS:85121923438
SN - 2204-2091
VL - 31
SP - 1
EP - 5
JO - Public Health Research and Practice
JF - Public Health Research and Practice
IS - 5
M1 - e3152132
ER -