Figure 1
Apple's Hearing Aid Feature in FDA records
| Device type | Software-only mobile medical application; 21 CFR 874.3335, Class II, product code SCR | De Novo summary, first page |
|---|---|---|
| Intended user | 18 or older with perceived mild to moderate hearing impairment | Indications for use |
| Fitting | Self-fitting, adjusted by the user without a hearing healthcare professional | Indications for use |
| How it is sold | Over the counter | Indications for use |
| Hardware named | Summary: AirPods Pro 2 with a compatible iOS product. Identifier records: AirPods Pro 2 or later firmware | Device description; openFDA identifier records |
| Audiogram | Required, with results at 250, 500, 1,000, 2,000, 4,000 and 8,000 Hz | Device description; clinical section |
| Maximum output | 105.93 dB SPL; limit 117 dB SPL with input-controlled compression | Table 1 |
| Distortion | Not above 1% at the listed test points; limit 5% | Table 1 |
| Self-generated noise | 28.20 dBA maximum; limit 32 dBA | Table 1 |
| Latency | 3.15 ms median; limit 15 ms | Table 1 |
| Frequency bandwidth | 100 to 10,000 Hz; rule asks for 250 Hz or below up to 5 kHz or greater | Table 1 |
| Authorized later changes | Gain limit, bandwidth and environment-specific programs, within set limits | Predetermined Change Control Plan |
How to read these numbers (1)
- Rows come from FDA's De Novo summary and openFDA records, read in October 2026. They describe the authorized feature and its bench file on the hardware the summary names, for a reader checking what the record says before buying.
- FDA,accessdata.fda.gov/…/DEN230081.pdf
- FDA, openFDA,api.fda.gov/device/udi.json
What FDA authorized under DEN230081
FDA classified Apple's Hearing Aid Feature as air-conduction hearing aid software: 21 CFR 874.3335, Class II, product code SCR. Apple's request reached the agency on December 4, 2023, and FDA granted it on September 12, 2024.
The indication has four parts. The product is a software-only mobile medical application, used with compatible wearable electronic products. The user is 18 years of age or older, with perceived mild to moderate hearing impairment. Fitting follows a self-fitting strategy that the user adjusts without a hearing healthcare professional. The sale is over the counter.
Setup configures amplification from an audiogram. Three fine-tuning sliders then adjust amplification, tone and balance, and those settings stay available when the AirPods Pro are away from the iOS device.
What sits outside the authorization
The grant concerns the hearing function. FDA's summary says AirPods Pro and iOS products host numerous other functions for non-medical, general wellness and general consumer purposes, and that the agency assessed those functions only for their possible impact on the reviewed one.
The labeling excerpt in the summary draws the user limits. It tells anyone younger than 18 not to use the feature. It tells a person to see a doctor, preferably an ear-nose-throat doctor, in listed situations, among them hearing that changed suddenly in the past 6 months, worse hearing in one ear, and ringing or buzzing in only one ear. Someone who can't hear speech even in a quiet room is pointed to a hearing healthcare professional. The same text says a hearing aid will not restore normal hearing.
Which AirPods Apple and FDA name
Apple's support page lists two models for the Hearing Aid feature: AirPods Pro 2 and AirPods Pro 3.
FDA files use different wording. The De Novo summary names one model: AirPods Pro 2, formerly AirPods Pro (2nd generation), which it says supported the grant. FDA's device identifier records, read through openFDA, use wider wording. Apple's firmware entries read "Hearing Aid Feature AirPods Pro 2 or later Firmware", once for version 1.X, published October 21, 2024, and once for version 2.X, branded Hearing Aid Feature 2.0 and published September 9, 2025. Companion entries cover iOS, macOS and watchOS. The firmware entry for Apple's hearing test reads "Hearing Test Feature AirPods Pro 2 Firmware", without "or later".
AirPods Pro 3 appears by name on Apple's support page and in none of these FDA files, where "or later" describes a range and lists no models. FDA's special controls leave the model list to labeling, which must state compatible hardware and software platforms by model or specification, and the summary says Apple publishes updated Instructions for Use on its website and in the Health App.
Do you need a hearing test first?
Yes, you need hearing test results, and you can get them without going to a clinic. FDA's summary states that audiogram input is required. Apple's support page gives two routes: take the Hearing Test with AirPods Pro 2 or AirPods Pro 3 on an iPhone or iPad, or use audiogram results from your hearing healthcare professional.
FDA's summary says setup starts when the user selects a saved audiogram from iOS HealthKit, and that users are told to choose one from a reliable source.
A compatible audiogram holds results at 250, 500, 1,000, 2,000, 4,000 and 8,000 Hz and meets other minimum quality requirements. If you use a clinic test, ask for all six frequencies on the report.
The Hearing Test Feature is a separate FDA device: Class II exempt under 21 CFR 874.1050, with its identifier record under product code EWO, audiometer. Our hearing test cost page has clinic figures, and free hearing tests lists no-cost routes.
What FDA's bench table records
Table 1 of the summary sets the software, running on its required products, against the over-the-counter hearing aid rule at 21 CFR 800.30. Maximum output was 105.93 dB SPL against a 117 dB SPL limit for devices with input-controlled compression. Median latency was 3.15 ms against a 15 ms limit. Self-generated noise reached at most 28.20 dBA against a 32 dBA limit. Bandwidth ran from 100 to 10,000 Hz, where the rule asks for 250 Hz or below up to 5 kHz or greater.
These figures are electroacoustic bench measures from a review file. They describe output, noise and delay on the hardware the summary names, for the version reviewed in 2024.
Changes FDA authorized in advance
The submission contains a Predetermined Change Control Plan. It covers changes to the maximum allowable gain limit, expanded frequency bandwidth and environment-specific programs, each with acceptable limits, and it lets Apple implement them without an additional marketing submission first.
So the bench table is a dated picture. Apple's identifier records already show a 2.X version, published September 9, 2025; those records do not say what changed in it. The current Instructions for Use is the place that describes the version on your device.
What Apple hearing aids cost
The purchase is the earbuds. Apple listed AirPods Pro 3 at $249.00 in October 2026, on its buy page with no AppleCare coverage selected, and its support page lists that model for the Hearing Aid feature. That is one dated reading, for one model, so check Apple's page for the current amount. The FDA documents state no price for the feature.
Beyond the earbuds, the feature needs a compatible iOS product and hearing test results. Apple's Hearing Test runs on an iPhone or iPad with the AirPods, so a professional's audiogram is one option among two. The earbuds also carry the other consumer functions FDA set aside in its review, so the price buys more than the hearing function.
HSA and FSA: what the IRS wrote
IRS Publication 502 says you can include in medical expenses the cost of a hearing aid and batteries, repairs and maintenance needed to operate it. It also leaves out expenses merely beneficial to general health. A text search of Publication 502 and Publication 969 finds no mention of AirPods, so those two publications give the hearing aid rule and leave the earbud question open.
A health FSA pays qualified medical expenses specified in the plan, which makes your administrator the party to ask. Name the product and De Novo number DEN230081 in the request, and keep the written answer with your receipt. HSA distributions used for qualified medical expenses aren't taxed. Limits and carryover are on our FSA and HSA page.
Other software under the same FDA code
Product code SCR, air-conduction hearing aid software, held five records in openFDA's premarket data in October 2026: Apple's Hearing Aid Feature (DEN230081), Luxottica's Nuance Audio Hearing Aid Software (K243150), the Tuned Self-Fitting Mobile App (K251208), Meta's Hearing assist (K254044) and Samsung's Hearing Aid Feature (K261187). Each record is a regulatory file, so read each maker's labeling for its own hardware and limits. Our over-the-counter hearing aids and Medicare page covers how plans treat OTC devices.
Frequently asked questions
Is Apple coming out with a Hearing Aid?
Apple's FDA-authorized product is a software feature, granted on September 12, 2024, and its version 2.X firmware record is marked in commercial distribution. Its entry under FDA's hearing aid software code is the Hearing Aid Feature, which runs on AirPods. FDA records describe what exists and carry no forecast of future Apple products.
How much do Apple hearing aids cost?
Apple listed AirPods Pro 3 at $249.00 in October 2026, with no AppleCare coverage selected. Apple's support page lists AirPods Pro 2 and AirPods Pro 3 for the feature, while FDA files name AirPods Pro 2 "or later". You also need a compatible iOS product and hearing test results, which Apple's Hearing Test can supply on an iPhone or iPad.
Does Medicare cover hearing aids for seniors?
Medicare.gov says Medicare doesn't cover hearing aids or exams for fitting hearing aids, and that you pay all costs for non-covered services. Our Medicare hearing aid coverage page has the detail, including Medicare Advantage.
Sources
FDA details come from the DEN230081 database entry and review summary, and from openFDA device identifier and premarket records archived with their exact queries. IRS and Medicare.gov lines are quoted as served in October 2026. Apple's site terms bar automated reading, so the AirPods Pro 3 price and the support page lines on models and test routes were read by hand in a browser in October 2026; the price stays out of the table. Clinical study results in the FDA summary are left out because this page covers scope, requirements and cost.
- https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230081.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN230081
- https://api.fda.gov/device/udi.json?search=company_name:%22Apple%22+AND+product_codes.code:SCR&limit=100
- https://api.fda.gov/device/udi.json?search=company_name:%22Apple%22+AND+product_codes.code:EWO&limit=100
- https://api.fda.gov/device/510k.json?search=product_code:SCR&limit=100
- https://www.apple.com/shop/buy-airpods/airpods-pro-3
- https://support.apple.com/en-us/120992
- https://www.irs.gov/publications/p502
- https://www.irs.gov/publications/p969
- https://www.medicare.gov/coverage/hearing-aids
Cost and coverage research, not medical advice and not tax advice. FDA records describe a regulatory file; talk to a hearing care professional about your hearing and confirm account rules with your plan.