Diagnosis (general) · Diagnosis and imaging
Meta gets FDA clearance for hearing-aid software
The FDA cleared Meta's 'Hearing assist' software as air-conduction hearing aid software on 13 July 2026. The FDA's summary says it runs on compatible smart glasses with an iPhone app, but doesn't name the glasses model. The FDA's summary reports a 142-person study at three US sites where people who set it up themselves did as well as those fitted by a professional. Rating: In clinical trials. We haven't confirmed which glasses model it runs on or that it's on sale.
How far away is this?
There's a US regulator record of clearance, and the FDA's summary reports a 142-person study that met its goals, but the full results aren't published and we haven't confirmed which glasses model it runs on or that it's on sale, so it's In clinical trials.
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Where is it approved?
| Region | Regulator | Status | Notes |
|---|---|---|---|
| United States | FDA | Cleared | FDA 510(k) clearance, 13 July 2026. FDA 510(k) K254044[1] |
| European Union | CE mark / EMA | Unknown | Register not searched yet. |
| United Kingdom | MHRA | Unknown | Register not searched yet. |
| Australia | TGA | Unknown | Register not searched yet. |
Cleared in the US only, as far as we've checked. "Register not searched yet" means we haven't searched that regulator's register; it doesn't mean the product is or isn't available. Approval in one country isn't approval in another.
What is it?
Hearing aid software turns a device's microphones and speakers into a hearing aid, making voices louder and clearer. 'Cleared' through the FDA's 510(k) route means the FDA found it substantially equivalent to a device already on the market. The FDA cleared it as an over-the-counter, self-fitted hearing aid for adults 18 and over with perceived mild to moderate hearing loss, comparing it with Apple's Hearing Aid Feature, which runs on earbuds.
What's the evidence?
FDA 510(k) K254044: 'Hearing assist' from Meta Platform Technologies, classed as Air-Conduction Hearing Aid Software, received 17 December 2025 and found substantially equivalent on 13 July 2026.[1]
Evidence stage: In clinical trials · #c1
The FDA record links a clinical study, NCT07115979, whose registry details are hidden because the device wasn't cleared when it was registered.[1]
Evidence stage: In clinical trials · #c2
What does it mean for me?
If you're an adult in the US with mild to moderate hearing difficulty, over-the-counter hearing aids, including software on earbuds or glasses, are an option. A hearing test from an audiologist is still the best way to know what you need, and sudden hearing loss needs urgent medical care.
What could I ask my doctor?
- Is my hearing loss the kind a consumer hearing device can help with?
These are general starting points, not a recommendation to choose any particular test or treatment.
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Change history
- : First published.
General information only, not medical advice. Talk to your doctor about your situation. AI-assisted source check. Not clinically reviewed.
References
- FDA 510(k) database: K254044 (Hearing assist). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254044
- FDA 510(k) summary: K254044 (Hearing assist). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254044.pdf
Publisher shown as the website hosting each source. Dates are given where the source label includes them.