Are AirPods Pro hearing aids?

For two decades, "are these AirPods hearing aids?" was a rhetorical question for audiologists. As of fall 2024, it is a literal one. Apple's Hearing Aid feature, authorized by the FDA on September 12, 2024 under the De Novo pathway, is the first over-the-counter hearing aid software the agency has cleared. It runs on consumer earbuds — AirPods Pro 2 and AirPods Pro 3 — and turns them into a regulated medical device for adults 18 and over with perceived mild-to-moderate hearing loss.

That is a real shift, and it is worth understanding precisely what was approved and what was not.

What the FDA actually authorized

The FDA's September 2024 marketing authorization covers Apple's Hearing Aid Feature — software, not hardware. The approval went through the agency's De Novo premarket review pathway, which is reserved for low-to-moderate-risk devices that are novel enough that there is no prior legally marketed equivalent. Apple submitted its De Novo application in late 2023; the authorization arrived roughly nine months later.

What the software does:

• Runs a pure-tone Hearing Test in a quiet room. The app plays tones at several frequencies through the AirPods, the wearer taps when they can hear each one, and the result is an audiogram-like profile for each ear.
• Generates a personalized amplification curve from that profile and loads it into the AirPods.
• Lets the user accept an audiogram from a clinician in lieu of running the in-app test — useful for people who already have one.
• Provides ongoing fine-tuning controls for amplification level, left/right balance, tone, and Apple's "Conversation Boost" focused-listening mode.

The clinical evidence Apple submitted was a multi-site U.S. study of 118 adults with perceived mild-to-moderate hearing loss. Participants who self-fit AirPods Pro using the HAF software achieved similar self-reported benefit to participants who had the same devices fit by a hearing professional, with comparable measures of amplification and speech understanding. The FDA reported no device-related adverse events in the study.

This pattern — self-fit OTC hearing aid outcomes that match audiologist-fit outcomes for mild-to-moderate loss — is now consistent across the wider peer-reviewed literature, including a 2024 JAMA Otolaryngology study of dedicated OTC hearing aids (De Sousa et al.).

Who AirPods Pro hearing aid mode is appropriate for

The FDA indication for the Hearing Aid Feature is narrow and specific. It applies to:

• Adults 18 years and older.
• People with perceived mild-to-moderate hearing loss.
• Users with a compatible iPhone or iPad running iOS 18 or iPadOS 18 (or later).
• AirPods Pro 2 (firmware 7B19 or later) or AirPods Pro 3 hardware.

This is the same target population as the FDA's broader OTC hearing aid Final Rule, which took effect October 17, 2022. Apple's authorization is a software implementation of that regulated category, not a separate one.

Where AirPods Pro fall short of a dedicated hearing aid

The fairest way to describe AirPods Pro in hearing aid mode in 2026 is as a real, regulated OTC hearing aid with the trade-offs of consumer earbuds. The honest limits are:

Battery life

AirPods Pro deliver roughly 6 hours of listening time on a single charge, with the case providing additional charges across the day. Dedicated hearing aids, by contrast, are designed for 16–30 hours of continuous use between charges. For someone who needs hearing support from breakfast until bedtime, AirPods will require swap-and-charge breaks that dedicated devices do not.

Form factor and occlusion

AirPods Pro use silicone ear tips that seal the ear canal. That seal is what enables active noise control and effective amplification, but it can produce a sense of plugged-up "occlusion" that takes adjustment. Dedicated hearing aids in receiver-in-canal (RIC) or behind-the-ear (BTE) form factors are generally vented to reduce that effect.

Severity ceiling

The FDA indication caps AirPods Pro hearing aid mode at perceived mild-to-moderate loss. Adults with severe or profound loss, asymmetric loss, or atypical audiograms still need a prescription-fit device.

Not a substitute for clinical evaluation

An in-app Hearing Test estimates pure-tone thresholds; it does not diagnose hearing loss. It cannot distinguish sensorineural loss (the kind hearing aids help) from conductive loss caused by earwax impaction, fluid, infection, or middle-ear conditions — conditions a clinician must rule out. Sudden hearing loss, one-sided hearing loss, ear pain, drainage, persistent tinnitus, dizziness, or hearing loss after a head injury are all reasons to see an audiologist or ENT first.

Ecosystem dependence

The Hearing Aid Feature requires an iPhone or iPad. Android users, or adults uncomfortable with Apple's setup flow, cannot access it.

How AirPods Pro stack up against dedicated OTC hearing aids

On the dimensions we use in our methodology, AirPods Pro 2 in hearing aid mode have a distinctive profile:

• Speech clarity (real environments). Apple's active noise control and Conversation Boost focus on speech in front of the wearer. Independent reports describe the experience as competitive with mid-tier OTC self-fitting devices for restaurant-style noise, with the trade-off that adaptive behaviour is less varied than premium prescription devices.
• Ease of use. For adults already using iPhones, this is AirPods' strongest area. The Hearing Test runs inside Settings on the same device, results carry over to the AirPods automatically, and there is no separate app to learn.
• Personalization. The HAF supports left/right asymmetry, tone control, and an amplification slider. It does not offer the granular per-band tuning some dedicated self-fitting OTC devices include.
• Consumer protection. AirPods Pro carry Apple's standard return policy and one-year warranty rather than a hearing-aid-specific 45-day risk-free trial.

How to turn the feature on

Per Apple's support documentation, on a compatible iPhone or iPad:

1. Update to iOS 18 / iPadOS 18 or later.
2. Pair AirPods Pro 2 (firmware 7B19+) or AirPods Pro 3.
3. Open Settings → AirPods name → Hearing Health.
4. Run the Hearing Test in a quiet room, or import an existing audiogram from a hearing professional.
5. Enable Hearing Aid and fine-tune amplification, balance, tone, and Conversation Boost.

The Hearing Protection feature, which limits exposure to loud sounds, is separate but can be enabled in the same menu.

If you want the earbud look, but built as a hearing aid

The most common follow-up question from readers of this article is some version of: “I like the discreet earbud form factor of AirPods, but I need more daily wear time than 6 hours.” That gap — earbud-style look, hearing-aid-grade battery and processing — is exactly what the OTC market has begun to fill since the 2022 FDA Final Rule.

The bottom line

AirPods Pro are hearing aids, in the precise regulatory sense, for adults 18+ with perceived mild-to-moderate hearing loss when running Apple's FDA-authorized Hearing Aid Feature on a compatible iPhone or iPad. They are a meaningful new entry point into hearing care — especially for adults who would never have walked into an audiology clinic at the price point dedicated devices used to require. They are not a universal replacement for prescription hearing aids, and they are not a substitute for a clinical evaluation when symptoms warrant one. Treat them as exactly what the FDA approved them as: a regulated, software-based OTC hearing aid with the strengths and limits of consumer earbuds.