The short version
For most of the history of hearing aids in Australia, the path was fixed: notice a problem, see a GP or an audiologist, get an audiogram, get fitted, pay somewhere between one and twelve thousand dollars. In the space of about eighteen months, two consumer electronics products have carved a second path that skips every step of that.
Apple’s Hearing Aid feature has been on the Australian Register of Therapeutic Goods since 17 December 2024, entered by Apple Pty Ltd as a Class IIa medical device, and Apple switched it on for Australian users on 26 March 2025. It turns AirPods Pro 2 or Pro 3 — hardware most buyers acquired for music — into a self-fitted hearing aid for adults with perceived mild to moderate hearing loss.
Then, on 24 June 2026, EssilorLuxottica put Nuance Audio Glasses on sale in Australia: a TGA-registered spectacle air-conduction hearing aid, sold through OPSM, Laubman & Pank and EyeQ alongside ordinary eyewear, with or without prescription lenses.
Both are real medical devices under Australian law. Neither requires a hearing test, a referral, or a professional to fit. That is genuinely good news for a lot of people — and it creates a new way to get it wrong, because the thing these devices are worst at is telling you when you should not be using them.
What the TGA actually registered
Australia does not have a separate over-the-counter hearing aid category the way the United States created one in 2022. Here, hearing aids are simply medical devices: to be sold lawfully they must be included on the ARTG, and that applies whether a clinician fits them or you fit them yourself with a phone app. So “approved by the TGA” means something specific and fairly narrow. It means the sponsor has satisfied the regulator on safety, quality and performance for a stated intended purpose. It is not a verdict that the device is as good as the alternative.
| Apple — ARTG 473488 and 473487 | Entered by Apple Pty Ltd on 17 December 2024 as Class IIa: one entry for the hearing aid itself (“Hearing aid, in-the-ear”) and one for the fitting and programming software. Intended for people 18 and over with perceived mild to moderate hearing impairment, using a self-fitting strategy the user adjusts without a hearing professional. |
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| What runs it | AirPods Pro 2 or AirPods Pro 3 on current firmware, paired with an iPhone or iPad on iOS 18 / iPadOS 18 or later; the Hearing Aid function also works with a Mac on macOS Sequoia or later. Apple’s Australian availability page lists Hearing Test and Hearing Aid on both generations, and Hearing Protection on AirPods Pro 3 only. |
| EssilorLuxottica — ARTG 509390 | Held by Luxottica Retail Australia Pty Ltd and listed as a spectacle air-conduction hearing aid; the entry was added in August 2025 and the product went on sale in Australia on 24 June 2026. Directional microphones and noise reduction in the temples, open-ear speakers aimed at the ear, calibrated through a companion app on iOS 16+ or Android 12+. |
| What is not registered | Samsung’s Galaxy Buds have hearing-enhancement settings in the accessibility menu, and a University of Iowa clinical trial found they measurably improved speech perception for mild-to-moderate loss — but Samsung has not obtained a hearing aid authorisation for them in the United States, and we found no equivalent Australian registration. Reports in 2026 of a dedicated “Galaxy Buds Able” hearing product remain unconfirmed by Samsung. |
Does self-fitting actually work?
This is the part where the marketing and the evidence happen to agree, which is rare enough to be worth stating plainly.
The US Food and Drug Administration authorised Apple’s Hearing Aid feature on 12 September 2024 through its De Novo pathway, making it the first over-the-counter hearing aid software ever cleared. The clearance rested on a 118-participant clinical study in which self-fitted AirPods produced outcomes comparable to professionally fitted amplification, with no device-related adverse events. The TGA inclusion followed three months later.
That result is not an outlier. Randomised comparisons of dedicated over-the-counter self-fitting hearing aids against audiologist-fitted devices have repeatedly landed on non-inferiority for adults with mild-to-moderate loss, and a peer-reviewed evaluation found AirPods Pro with headphone accommodations performed similarly to a validated personal sound amplification product and clearly better than no help at all.
So the honest summary is: for the specific population these devices name — adults, self-perceived mild to moderate loss, no red flags — self-fitting works about as well as being fitted. The interesting question is not whether the technology is legitimate. It is whether you are in that population, and the device has no way of knowing.
Where the line sits
Every one of these products is indicated for perceived mild to moderate hearing loss. That word is doing an enormous amount of work. It means the eligibility test is your own impression of your hearing, checked at most by a tone test run through earbuds in your kitchen.
Several things fall outside that boundary, and they are exactly the things that matter clinically:
- Severe or profound loss. Open-ear glasses in particular are constrained by physics — a speaker sitting near the ear rather than in it cannot deliver the gain a fitted receiver can without feedback. Reviewers of the Nuance glasses describe four preset audiogram profiles and note they are not powerful enough for severe cases.
- Asymmetric loss. Hearing that is noticeably worse in one ear is a finding, not a preference. It warrants investigation rather than amplification.
- Sudden loss, pain, discharge, or persistent one-sided tinnitus. These are reasons to see a doctor quickly, not to buy earbuds.
- Anything under 18. Both Apple’s indication and the general framing of self-fitting devices stop at adults.
Apple says so itself, in the fine print on its own Australian hearing health page: the Hearing Test “is not a substitute for seeking medical advice from a healthcare practitioner if you have any concerns about your hearing health”. Audiology Australia’s position is compatible rather than hostile — it supports the provision of hearing devices including self-fitting ones, while recommending an accredited audiologist be involved in diagnosing loss and in supporting adjustment. The TGA publishes its own consumer guidance on the challenges of buying and fitting a self-fitting device.
Read all three together and the message is consistent: these devices are a legitimate treatment for a mild problem, and a poor substitute for a diagnosis.
The scale of the problem they are aiming at
The best current Australian data landed a few weeks ago. On 2 July 2026, The Lancet Global Health published the Australian Eye and Ear Health Survey — more than 4,500 participants across 30 sites, described by the University of Sydney as the country’s largest survey of hearing and vision health. It found more than 3.5 million Australians aged 50 and over with some hearing impairment, and approximately 1.2 million with disabling hearing loss.
It also found the gap that gets least attention in consumer coverage: among Indigenous Australians aged 50–59, moderate-or-worse hearing impairment was almost three times as prevalent as among non-Indigenous Australians of the same age, and roughly twice as prevalent in the 60–69 bracket. Senior author Professor Bamini Gopinath’s framing was that many of the factors associated with hearing loss are preventable or treatable.
You will also see a figure of 5.86 million Australians with mild to moderate hearing loss attached to coverage of the Nuance launch. That number comes from EssilorLuxottica’s own launch material, not from the survey, and it is worth treating as a vendor market-sizing estimate rather than an epidemiological finding — particularly since it counts all ages and a milder threshold than the Lancet paper.
What it costs, and what it costs instead
The price argument is the whole reason this category exists. Prices below are recommended or advertised retail as at 9 August 2026 and move constantly, especially on the earbuds.
| AirPods Pro 3 | A$429 on Apple’s Australian store. Launched 10 September 2025. Trade coverage reports up to 10 hours in Transparency mode — the mode that matters if you are using them as a hearing aid — against Apple’s listed 8 hours of listening with noise cancellation. |
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| AirPods Pro 2 | A$399 recommended retail, routinely discounted to around A$299 at Australian retailers since the Pro 3 launch. Same Hearing Aid and Hearing Test features; no Hearing Protection listed for Australia. |
| Nuance Audio Glasses | Australian pricing is quoted inconsistently: one Australian hearing-device site lists A$1,690 for the frame through the Luxottica retail network, while other retail listings show about A$1,220, or from about A$1,425 with prescription lenses, with member discounts on top. Confirm at the counter before committing. |
| Conventional hearing aids, privately | An Australian retailer price guide updated for 2026 puts entry level at roughly A$1,500–$2,500 a pair, mid-range at A$2,500–$4,500, and premium from A$4,500 past A$7,000. These are seller-published ranges, and they normally bundle assessment, fitting and follow-up. |
| Conventional hearing aids, subsidised | Potentially nothing, if you are eligible for the Hearing Services Program — see below. |
The subsidy nobody mentions in the earbud coverage
Australia has run a national hearing subsidy for decades, and a large share of the people most likely to need help already qualify for it. Under the Hearing Services Program voucher scheme you are eligible if you are an Australian citizen or permanent resident aged 21 or over and you hold a Pensioner Concession Card (or are the spouse of a holder), hold a Department of Veterans’ Affairs Gold Card, hold a DVA White Card issued for hearing loss, are a dependant of someone in those categories, or are a serving member of the ADF. Vouchers run for five years, across a network the department describes as more than 300 providers at some 3,000 locations. Separate arrangements through Hearing Australia cover people under 26, eligible Aboriginal and Torres Strait Islander people, and those in remote areas or needing specialist services.
Here is the part that matters for this article: the program subsidises devices from its own published device schedule, fitted by a contracted provider. That schedule lists hearing aid manufacturers — GN Hearing, Oticon, Bernafon and the like. Apple is not on it. Neither is Luxottica. A self-fitted consumer device bought at a retail counter sits entirely outside the subsidy, by design.
So the sequencing advice writes itself. If you hold a Pensioner Concession Card or a DVA card, check your entitlement before spending A$429 or A$1,690, because a fully subsidised, professionally fitted device may cost you less than the earbuds and will do more. The consumer devices are aimed squarely at the large group in the middle: people who are not eligible for the subsidy, would not yet spend three thousand dollars privately, and have therefore been doing nothing at all.
And doing nothing is the real comparator. The published research on untreated hearing loss is not about audio quality; it is about withdrawal from conversation. On that measure a A$299 pair of earbuds that someone will actually wear beats a A$4,000 device they never bought.
What these devices are still bad at
Three practical limits, none of which appear in the packaging.
Battery. A conventional hearing aid runs all waking day. Earbuds do not. Even the improved AirPods Pro 3 figure is around ten hours in the relevant mode, which is a working day only if you never forget the case. For someone with a genuine, constant need, that is a materially different product from a hearing aid, and the glasses — reported at roughly eight to ten hours — have the same constraint.
Social signalling, in both directions. Modern hearing aids are designed to be unnoticed. Earbuds are noticed, and in some settings — a meeting, a service, a conversation with someone who does not know — visible earbuds read as inattention rather than as assistance. The glasses solve this neatly and it is arguably their strongest argument, which is presumably why they are sold in optical stores rather than hearing clinics.
Nobody verifies the fit. A clinical fitting includes objective verification that the amplification actually delivered to your eardrum matches the prescription target. Self-fitting substitutes your own judgement for that measurement. The trial evidence says that substitution works acceptably for mild-to-moderate loss on average; it says nothing about whether it worked for you.
What to actually do about it
| Check your subsidy eligibility first | Pensioner Concession Card, DVA Gold Card, DVA White Card issued for hearing loss, dependants of those holders, ADF members. If you qualify, the government path is cheaper and clinically better than anything in this article. Under 26, Aboriginal or Torres Strait Islander, or remote — check the Hearing Australia arrangements. |
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| Get a real hearing test before you buy, if you can | An in-ear tone test on a phone is a screening tool, not an audiogram. A proper assessment also rules out the boring, fixable causes — wax being the most common — that no amount of amplification will help. |
| Treat asymmetry as a stop sign | Noticeably worse hearing in one ear, sudden loss, pain, discharge or one-sided tinnitus are reasons to see a doctor. Do not amplify past a symptom. |
| If you already own the hardware, try it tonight | If you have AirPods Pro 2 or Pro 3 and an iPhone on iOS 18 or later, the Hearing Test and Hearing Aid features cost nothing to try and are in Settings. This is the lowest-risk way to find out whether amplification helps you at all. |
| Consider the glasses if you already wear glasses | The Nuance proposition only makes sense for people who wear spectacles all day anyway. If that is you and earbuds are socially awkward in your work, it is a genuinely different answer — at conventional-hearing-aid money, without the conventional fitting. |
| Confirm the price and the return terms in store | Published Australian pricing for the glasses varies by hundreds of dollars across retailers and lens options. Ask what the return window is before you pay; a self-fitted device you cannot get on with is worth nothing. |
| Do not let it end there | If a consumer device helps, that is evidence you have hearing loss worth managing properly — not evidence the problem is solved. Treat it as the cheapest possible trial, then get assessed. |
The bottom line
The genuinely new thing in 2026 is not the technology inside these products. Directional microphones and frequency-shaped amplification are old ideas. What changed is the channel: a registered hearing aid is now something you can buy from an electronics retailer or an optometrist, on a whim, without ever speaking to a clinician, and the regulator has agreed that this is acceptable for a defined and modest degree of hearing loss.
That is a good change on balance. The barrier to hearing help in Australia has never mainly been technical — it has been cost, waiting, and the fact that admitting to hearing loss feels like admitting to age. A A$429 pair of earbuds that a sixty-year-old already owns dissolves all three.
But the same properties that make the channel work — no gatekeeper, no test, no fitting — mean the device cannot tell you that your loss is asymmetric, or profound, or caused by something that needs treating. It will just amplify. If you are in the group these products were designed for, buy one and enjoy dinner conversations again. If you are not sure whether you are in that group, that uncertainty is the reason to book the appointment, not the reason to skip it.
Sources
Facts, figures and dates above are drawn from these primary and reputable sources, captured 9 August 2026:
- TGA — ARTG 473488, Apple Pty Ltd, hearing aid, in-the-ear and ARTG 473487, hearing aid fitting/programming application software: the sponsor, device types and register entries underpinning Apple’s Australian hearing aid claim.
- Information Age (ACS) — AirPods hearing aid feature enabled in Australia (26 March 2025): the TGA approval on 17 December 2024, the March 2025 switch-on for Australia, and the price comparison against conventional aids costing thousands.
- Hearing Practitioner Australia — TGA approves AirPods Pro 2 as hearing aids: the Class IIa classification on 17 December 2024, the 18-and-over perceived mild-to-moderate indication, and the self-fitting strategy adjusted without a hearing professional.
- Apple Australia — AirPods Pro hearing health and feature availability: the 18-and-over indication, iOS 18 / iPadOS 18 and macOS Sequoia requirements, Hearing Protection listed for AirPods Pro 3 only, and the “not a substitute for seeking medical advice” wording.
- Apple Australia — Buy AirPods Pro 3: the A$429 Australian price and the 8-hour listening figure with active noise cancellation.
- Hearing Practitioner Australia — AirPods Pro 3 launch: the 10 September 2025 launch, the up-to-10-hours Transparency mode figure and the 67 per cent improvement over AirPods Pro 2.
- US FDA — FDA authorizes first over-the-counter hearing aid software (12 September 2024): the De Novo authorisation, the mild-to-moderate adult indication and the clinical study underpinning it.
- PubMed — Apple AirPods Pro as a hearing assistive device in patients with mild to moderate hearing loss: peer-reviewed comparison against a validated personal sound amplification product and the unaided condition.
- Medianet — TGA-approved Nuance Audio Glasses (EssilorLuxottica launch release) (24 June 2026): the Australian on-sale date, ARTG number 509390 held by Luxottica Retail Australia, the directional microphone and open-ear speaker design, iOS 16+/Android 12+ app requirement, and the 5.86 million mild-to-moderate figure.
- SMBtech — EssilorLuxottica launches TGA-registered hearing glasses in Australia: the August 2025 ARTG listing, the spectacle air-conduction hearing aid classification, and distribution via OPSM, Laubman & Pank and EyeQ.
- EarPros Australia — Nuance Audio glasses: the A$1,690 frame price through the Luxottica retail network, the roughly 8–10 hour battery figure, the four preset audiogram profiles, and the note that they are not powerful enough for severe loss.
- University of Sydney — Australia’s largest survey of hearing and vision health (10 July 2026) and the paper in The Lancet Global Health (published 2 July 2026): more than 4,500 participants across 30 sites, more than 3.5 million Australians aged 50+ with hearing impairment, about 1.2 million with disabling hearing loss, the Indigenous prevalence ratios by age band, and Professor Gopinath’s comment.
- Audiology Australia — Self-fitting hearing devices: the position supporting provision of hearing devices while recommending an Accredited Audiologist be involved in diagnosis and device adjustment.
- Department of Health, Disability and Ageing — Hearing Services Program eligibility and the fully subsidised device schedule: the voucher criteria, the Community Service Obligations arrangements through Hearing Australia, and the list of manufacturers whose devices are fully subsidised.
- Hearing Matters — How much do hearing aids cost in Australia (2026 guide): the entry, mid-range and premium per-pair price bands quoted above, published by a hearing services retailer.
- Hearing Review — Samsung earbuds show promise as a hearing enhancement device: the University of Iowa trial finding significantly improved speech perception in mild-to-moderate loss, and the absence of a hearing aid authorisation for Galaxy Buds.