Earbuds as hearing aids: what the FDA's over-the-counter rules require, and which software it has cleared

Some earbuds can now double as hearing aids, through software the Food and Drug Administration has reviewed. Apple's Hearing Aid Feature for AirPods Pro was the first over-the-counter hearing aid software the FDA authorized, in September 2024. Samsung's Hearing Aid Feature, which the summary Samsung filed with the FDA describes as running on Galaxy earbuds such as the Galaxy Buds3 Pro, was cleared on July 31, 2026. This guide explains what the FDA's rules require of an over-the-counter (OTC) hearing aid, which records the FDA's database holds for this kind of software, and what is on record about the Apple and Samsung features, based on FDA and Apple pages read on November 11, 2026.

What counts as an over-the-counter hearing aid

The FDA's OTC category took effect on October 17, 2022. Under 21 CFR 800.30, an OTC hearing aid is an air-conduction device that needs no implant or surgery and is intended for people 18 or older to compensate for perceived mild to moderate hearing impairment. The user controls it and tailors it to their hearing through tools, tests or software, and it can be sold in stores, by mail or online with no prescription, supervision or other involvement from a licensed professional. Selling one to or for anyone younger than 18 is prohibited. A hearing aid that falls outside the definition or misses the requirements is a prescription hearing aid.

What the rule requires of the device

The FDA's page for consumers adds two points: its OTC rules do not oblige makers to offer a warranty, and claims on a package such as “FDA Registered” or “FDA Certified” may be misleading.

Software that turns earbuds into hearing aids

The FDA reviewed Apple's feature through the De Novo pathway, which it describes as being for some novel low- to moderate-risk devices with no legally marketed predecessor, and granted it on September 12, 2024. The FDA called it a software-only mobile medical application for compatible AirPods Pro that uses a self-fitting strategy, which users can adjust without help from a hearing professional. In the clinical study the FDA cited, 118 people with perceived mild to moderate hearing loss took part at several US sites. Those who set up the feature themselves reported perceived benefit similar to those fitted by a professional, and no adverse events related to the device were seen. The De Novo record files it under regulation 874.3335, product code SCR, “air-conduction hearing aid software”.

Later products under the same code were cleared through the FDA's 510(k) process as substantially equivalent. Samsung's record shows its submission was received on April 10, 2026 and decided on July 31, 2026. A search of the FDA's openFDA data for code SCR returned these five records:

The records name the software, not every product it runs on, and openFDA warns that its data should be treated as unvalidated.

Where the Apple and Samsung features stand

Apple's support page says the Hearing Aid feature needs AirPods Pro 2 or AirPods Pro 3 with the latest firmware and an iPhone or iPad on the latest software, and is intended for people 18 or older with perceived mild to moderate hearing loss. It can be set up from a Hearing Test taken with the AirPods on an iPhone or iPad, or from audiogram results from a hearing professional; depending on the results, Apple may suggest its Media Assist feature instead. Apple says the settings are stored on the AirPods, so the feature carries on with the latest settings when the paired device is out of reach. The page links to a list of the countries and regions where the feature is available.

Samsung's 510(k) summary, linked from the FDA's record, describes its Hearing Aid Feature as a pair of medical software applications: one on Samsung Galaxy earbuds, such as the Galaxy Buds3 Pro, and one on a Samsung Galaxy phone, such as the Galaxy S23. The phone app handles setup and self-fitting, and the earbuds process and amplify sound. Users create a hearing profile with Samsung's Hearing Test Feature, the software fits amplification with the NAL-NL2 formula from the National Acoustic Laboratories, and users can then adjust it. In the clinical study the summary reports, 103 participants with mild to moderate hearing loss took part. Those who fitted the feature themselves reported perceived benefit similar to that of participants fitted by an audiologist, and no device-related adverse events were reported. The FDA records do not say when Samsung will release the feature, and they do not list every compatible model.

What the FDA says about the limits

The FDA says OTC hearing aids are meant only for perceived mild to moderate loss, not for severe or profound loss, because their maximum output is limited, and it advises anyone who suspects a more severe loss to consult a licensed hearing health care professional. People younger than 18 need a prescription hearing aid, and the FDA says they should see a doctor, preferably an ear, nose and throat specialist. It asks users to report injuries, malfunctions or other problems with OTC hearing aids through its MedWatch form or by calling 1-800-FDA-1088.

For the volume side of hearing health, our guide to headphone volume limits covers the World Health Organization's safe listening figures.