Non-licensed retailers can now sell certain over-the-counter hearing aids and related software without a regulated practitioner

Plain-language summary · AI-assisted · not legal advice

The regulation has been updated to explicitly allow businesses and individuals who are not registered health practitioners to sell specific wearable hearing instruments without needing dispensing authority. To qualify for this exemption, the device must operate through air conduction, sit at least 10 mm from the eardrum, cap maximum output at 111 dB SPL (or 117 dB SPL with compression active), hold a federal Class II Medical Device Licence, and be designed for adults aged 18 and over with mild to moderate hearing loss — not custom-fitted to any specific person. The changes also extend the definition of 'wearable hearing instrument' to include software designed for hearing conditions that pairs with a wearable device, meaning app-based hearing tools are now captured by the same rules. Sellers of qualifying devices are explicitly told that built-in self-assessment and auto-adjustment features do not, on their own, constitute the restricted activity of 'fitting' a hearing instrument. Wholesale distributors of hearing instruments also get a clear exemption regardless of the device type. Businesses selling or distributing hearing-related products — including software-based tools — should review whether their products meet these specific technical and regulatory criteria to confirm they can operate without a registered practitioner on staff.

Who this affects: retailers selling hearing aids or hearing software · wholesale distributors of hearing instruments · app and software developers offering hearing-related products · regulated health practitioners advising on scope of practice · consumers purchasing over-the-counter hearing devices