When the American regulator authorised Apple's hearing-aid software in September 2024, the coverage framed it as a competitive win. The authorisation did the opposite of what a moat does, in terms the document itself sets out.
Apple did not get a product approved. It got a category created — and four companies have since walked through it by pointing at Apple's device.
What the authorisation actually did
The FDA's letter for DEN230081 opens with the administrative header that matters more than the headline:
"Trade/Device Name: Hearing Aid Feature (HAF) / Regulation Number: 21 CFR 874.3335 / Regulation Name: Air-conduction hearing aid software / Regulatory Class: Class II / Product Code: SCR"
A regulation number and a product code were issued, not merely cited. The operative sentence spells out the consequence:
"This order, therefore, classifies the Hearing Aid Feature (HAF), and substantially equivalent devices of this generic type, into Class II under the generic name air-conduction hearing aid software."
That clause is the whole story. A De Novo request is the route a manufacturer takes when there is nothing on the market like its device, and the statutory result is a new generic classification that anyone else may then use as a predicate. Apple absorbed a 283-day review, and by statute the classification it produced was available to everyone else the moment it existed.
⚠️ One detail makes the portability concrete: the word "AirPods" appears zero times in the authorisation. Against controls in the same document — "Hearing Aid Feature" nine times, "De Novo" eight, "Apple" twice — that zero is real. What the FDA authorised was "a software-only mobile medical application intended to be used with compatible wearable electronic products". The regulatory object was never the earbud, which is why the class turned out to fit a pair of eyeglasses.
Everyone who has walked through, from the register itself
The FDA's public device interface returns every device cleared under a given product code. A query for product_code:SCR returns five results, the entire class at the time of writing:
| Decided | Applicant | Device name | Route |
|---|---|---|---|
| 12 Sep 2024 | Apple | Hearing Aid Feature | De Novo — creates the class |
| 31 Jan 2025 | Luxottica | Nuance Audio Hearing Aid Software | substantially equivalent |
| 26 Sep 2025 | Tuned Ltd | Tuned Self-Fitting Mobile App | substantially equivalent |
| 13 Jul 2026 | Meta | Hearing assist | substantially equivalent |
| 31 Jul 2026 | Samsung | Hearing Aid Feature | substantially equivalent |
Samsung's device carries the same name as Apple's. Meta's is a pair of smart glasses.
Each of the four names Apple in its own filing. Meta's lists "Predicate Device Information — Device Name: Apple Hearing Aid Feature (HAF) · 510(k) Number: DEN230081 · Manufacturer: Apple Inc." Samsung's reads "Predicate Device: Hearing Aid Feature (DEN230081)". Tuned's cites "Apple Hearing Aid Feature (HAF) granted under DEN230081."
Luxottica's filing contains the sentence that makes the arrangement vivid:
"Insertion gain using an International Speech Test Signal (ISTS) was measured at 65 dB SPL from 250Hz to 5000Hz for both the Nuance Audio Glasses and the Apple AirPods Pro 2 devices (side-by-side testing) using a head and torso simulator (HATS)."
An Italian eyewear group cleared a pair of spectacles as a hearing aid by measuring them on a mannequin next to a pair of AirPods.
The timings
Apple received 2023-12-04, decided 2024-09-12 → 283 days
Luxottica received 2024-09-30, decided 2025-01-31 → 123 days
Tuned received 2025-04-18, decided 2025-09-26 → 161 days
Meta received 2025-12-17, decided 2026-07-13 → 208 days
Samsung received 2026-04-10, decided 2026-07-31 → 112 days
mean follower review = 604 / 4 = 151 days
Apple ÷ mean follower = 283 / 151 = 1.87×Apple's review took nearly twice the average of those that followed. Samsung's took 112 days — 40% of Apple's. And Luxottica filed on 30 September 2024, eighteen days after the door opened.
What this does not mean
None of this means Apple was outplayed, and an argument to that effect would be wrong on the law. Apple chose the De Novo route knowing the statutory consequence, which is that the resulting classification is public and reusable. That is a feature of the Food, Drug and Cosmetic Act, not an oversight and not a defeat.
Neither did the followers copy Apple's engineering. "Substantially equivalent" is a term of art about regulatory comparison, not about source code. Samsung's indications for use read very nearly as a paraphrase of Apple's — over-the-counter, software-only, 18 or older, perceived mild to moderate impairment, self-fitted without a professional — because that is what the pathway requires them to demonstrate.
Nor has any of it necessarily shipped to you. Clearance is permission rather than release, and we did not check whether Samsung's or Meta's features are available in any particular market.
And the outcome is not a bad one. The point of the 2017 legislation that created over-the-counter hearing aids was to get amplification to people who will never see an audiologist. A class four more manufacturers can build in serves that far better than a single proprietary approval would have.
What to do with it
Stop reading "FDA-authorised" on a consumer device as a moat. Sometimes it is the opposite — a De Novo authorisation is, by design, an invitation.
If you want to check any of this yourself, the audit key is the product code. Query the FDA's device interface for product_code:SCR and you get the current membership of the class, which was five when we ran it. That query stays valid as the class grows, which is the useful thing about it.
If you are choosing between a hearing-aid feature on earbuds, glasses or a phone, the regulatory status is now identical for all of them. They fall under the same regulation and product code, with the same 18-and-over indication for mild to moderate loss. The differences that remain are engineering and fit, not approval.
Where this comes from, and what will date it
The authorisation text is the FDA's own decision letter for DEN230081, a ten-page document of 253,230 bytes. The class membership is the FDA's device interface queried on product_code:SCR, which returned five results. The predicate quotations are from each applicant's own summary — Meta's K254044, Samsung's K261187, Tuned's K251208 and Luxottica's K243150. Every review interval above is arithmetic on the received and decided dates in those records.
⚠️ One number we deliberately left out. A clinical study size widely quoted in coverage of the Apple authorisation does not appear in the decision letter we read, and we did not retrieve the separate decision summary that would confirm it. We have not repeated it.
This dates in a specific and checkable way: another clearance under SCR. Re-run the query rather than trusting the table above, which was current on 10 September 2026. The finding itself, that a De Novo creates a reusable class, does not date; it is a matter of statute.
