What "Over-the-Counter" Hearing Aids Are, and How Australia Differs

If you have read an American news article lately, you may have come across the phrase "over-the-counter hearing aids", often shortened to OTC hearing aids. It turns up in headlines fairly often, and it is easy to assume it describes a type of device. It is actually a regulatory label from a specific piece of United States law, and the Australian arrangements are written differently. This article is a plain-English explainer of what the phrase means and how the two systems are set up, written as general interest rather than as guidance for any individual.

Where the Term Comes From

The phrase came out of a rule-making process in the United States. The US Food and Drug Administration published a final rule on 17 August 2022 establishing a category of over-the-counter hearing aids, and that rule took effect on 17 October 2022. Before then, US federal regulation did not define a hearing aid class in this way. So when an article says "OTC hearing aids", it is pointing at a category that has existed in American law since 2022.

What the US Category Covers

According to the FDA, the category applies to devices intended for adults aged 18 and over with perceived mild to moderate hearing loss, and it allows those devices to be bought without the supervision, involvement or prescription of a licensed health care professional. The FDA also states that the category is not intended for severe or profound hearing loss. Those boundaries come from the FDA's own description of the category rather than being a matter of opinion, and they describe how the American rule defines its own category, not a general statement about hearing loss or its management.

The word "perceived" is the FDA's own wording. The American category is defined around what a person notices about their own hearing rather than around a clinical measurement, which is a description of how the rule is drafted.

What the Label Actually Describes

It helps to separate two things that often get mixed together. "Over-the-counter" describes a route to purchase and the rules that go with it. It does not describe a circuit design or a specific brand. Two devices could use broadly similar technology and still sit in different regulatory categories, simply because of the pathway their maker chose and the country they are sold in.

It is a separate thing again from personal sound amplification products, which the FDA describes as a different class of consumer electronics rather than hearing aids. Categories that sound similar in everyday speech can be quite distinct in the regulations. Mainstream consumer earbuds have entered the same conversation overseas, which is the subject of our separate look at using AirPods as hearing aids.

How Australia's Framework Is Set Up

In Australia, hearing aids are regulated by the Therapeutic Goods Administration as medical devices. The TGA explains that, unless exempt, therapeutic goods must be included in the Australian Register of Therapeutic Goods, usually called the ARTG, before they can be supplied in Australia. Entries in the ARTG are held by sponsors, the companies responsible for supplying a device here, and hearing aids are included in the register as therapeutic goods.

That is the structural difference in one sentence. The over-the-counter hearing aid category is a creation of United States law and describes the United States market. Australian arrangements sit under the therapeutic goods framework administered by the TGA, which has its own classifications and its own terminology. An American article describing OTC hearing aids is describing the American position, and it does not automatically describe the Australian one.

Why Shopping Across Borders Comes Up

Because so much of this conversation happens online, people sometimes come across devices advertised from overseas sellers. Two general points are useful background. The ACCC explains that consumer guarantees under the Australian Consumer Law generally apply to goods and services offered in Australia, that consumers are not covered where a business does not officially offer its products here, and that issues can be harder to resolve when a business is based overseas. The TGA, as noted above, sets out that therapeutic goods supplied in Australia are expected to be in the ARTG unless an exemption applies. Both are statements about how the systems work, not a comment on any particular product or retailer.

The Services Layer Sits Separately

Alongside the question of how a device is classified, Australia also has a funding and services layer. Eligible pensioner concession card and DVA card holders may access subsidised services under the Australian Government Hearing Services Program; eligibility criteria apply. Hearing Australia is one of the providers delivering services under it. That layer is handled separately from the device regulation described above, which is another reason the Australian picture does not line up neatly with a US regulatory label.

The Short Version

Over-the-counter hearing aids are a United States regulatory category, created by the FDA in 2022, covering devices for adults with perceived mild to moderate hearing loss that can be bought without professional involvement. In Australia, hearing aids are regulated by the TGA as medical devices under the therapeutic goods framework, with the ARTG at the centre of it. Neither description is a verdict on any product. They are two different sets of rules, written by two different regulators for two different markets. Knowing which system an article is describing makes the international news about hearing technology a good deal easier to follow.

If you'd like to chat about your hearing, the friendly team at CQ Audiology in Rockhampton is here to help. Call (07) 4848 6528 or book online.

This article is general information, not personal medical advice. For guidance about your hearing, speak with a qualified professional.

Sources: US Food and Drug Administration (final rule establishing over-the-counter hearing aids, published 17 August 2022 and effective 17 October 2022; OTC hearing aids consumer information; personal sound amplification products); Therapeutic Goods Administration (medical device regulation and the Australian Register of Therapeutic Goods); Australian Competition and Consumer Commission (consumer guarantees under the Australian Consumer Law); Hearing Australia and the Australian Government Hearing Services Program.