AirPods as hearing aids: the clinical evidence behind the FDA's first OTC software

In September 2024 the FDA authorized Apple's Hearing Aid Feature, the first over-the-counter hearing aid software device, allowing compatible AirPods Pro to amplify sound for adults 18 and older with perceived mild to moderate hearing loss [s1]. Two separate features are bundled into the same earbuds — a self-administered hearing test and an amplification mode — and the independent evidence on each is now arriving. It is broadly supportive, with a clear boundary: this is a tool for mild-to-moderate loss, and it does not amplify like a fitted hearing aid.

What the FDA cleared, and on what

The authorization came through the De Novo pathway, which the agency uses for novel low-to-moderate-risk devices [s1]. The clearance rests on a clinical study of 118 subjects with perceived mild to moderate hearing loss across multiple US sites [s1]. The result that matters for a self-fitting product: "subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device," with comparable measured amplification in the ear canal and comparable speech understanding in noise, and no device-related adverse events [s1].

That is a real finding, and it echoes the wider over-the-counter hearing aid evidence, where a self-fitted device has matched an audiologist fitting in the head-to-head trials that exist. The population is the load-bearing detail. None of this speaks to severe or profound loss, which the feature is not intended for and which needs a fitted, more powerful aid.

The hearing test

The other half is the built-in audiometry — a threshold test the user takes at home to configure the amplification. An independent validation compared Apple's Hearing Test Feature against reference pure-tone audiometry performed by an audiologist in a sound booth [s2]. Across 400 threshold comparisons in 25 adults, 86.5% of the app's thresholds fell within 10 dB of the audiometric standard [s2]. Test-retest reliability was good — 84.1% of thresholds within 5 dB and 96.6% within 10 dB on repeat — and the app was faster, at a median of 5.5 minutes against 10.0 minutes for formal audiometry [s2].

Within 10 dB is clinically reasonable for a screening-grade self-test done outside a booth, and it supports the feature's intended job of setting up amplification. It is not a substitute for diagnostic audiometry, which resolves smaller differences and can distinguish types of hearing loss the app cannot.

Where the amplification falls short

The most useful caveat comes from bench measurement. Researchers compared the electroacoustic output of the AirPods Pro second and third generations against a traditional receiver-in-the-canal hearing aid across several hearing-loss configurations [s3]. On a standard coupler, the AirPods produced output comparable to the hearing aid, within about 7 dB [s3]. But on real-ear measurement — output in an actual ear canal, the meaningful test — both AirPods models delivered consistently less than the hearing aid fitted to established prescriptive targets, with the largest shortfalls, up to 14 dB, at higher frequencies and for moderate hearing loss [s3]. Maximum output was consistently highest for the hearing aid [s3].

The implication is specific. For milder losses, especially in quiet or one-to-one settings, the AirPods can deliver adequate amplification. For moderate loss, or where high-frequency gain matters for understanding consonants, they are likely to under-amplify relative to a properly fitted aid — precisely the range where the gap between "audible" and "intelligible" is decided.

The larger point

The value of this category is access. AirPods cost a fraction of prescription hearing aids and require no clinic visit, and untreated hearing loss is not a trivial condition — it is one of the modifiable factors in cognitive decline, and a large trial has tested whether treating it slows that decline in higher-risk older adults. A device that gets amplification to people who would otherwise go without has a real public-health case.

The honest framing keeps two facts in view at once. Apple's self-fitting approach cleared the FDA on a genuine study and holds up in independent testing of the hearing test; and the amplification is a mild-to-moderate tool that measurably trails a fitted aid where the loss is greater. It is also, pointedly, an amplifier — not a reason to keep pushing the volume on the same earbuds into the range that causes hearing loss in the first place.