Back in 2024, when the Galaxy Buds 3 Pro launched, Samsung introduced the ability for the earbuds to function as over-the-counter hearing aids. However, pending FDA approval, the feature never went live. Now, that hurdle has been cleared as the Galaxy Buds 3 Pro and the fairly recent Galaxy Buds 4 Pro have been approved by the FDA.
FDA Approves Hearing Aid Feature for Galaxy Buds 3 Pro and Galaxy Buds 4 Pro
Samsung has shared an official newsroom post confirming that the Food and Drug Administration (FDA) has allowed Galaxy Buds 3 Pro and Galaxy Buds 4 Pro to act as hearing aids for users in the USA. The feature will only work as over-the-counter (OTC) hearing aids for adults aged 18 and above.
Samsung has confirmed that the Hearing Aid feature is not a replacement for medical-grade hearing aids. It is only applicable for individuals who have perceived mild to moderate hearing loss, with no need for an audiologist's prescription or visit.
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Hearing Aid Feature in Galaxy Buds 3 Pro and Galaxy Buds 4 Pro: How Does It Work?
The feature is built around two components that work together. The first is a Hearing Test that users can self-administer directly from the Galaxy Buds settings menu. The test involves clinical-grade, pure-tone audiometry to test hearing sensitivity in each ear.
At the end of the test, the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro will generate a personal audiogram that categorises results into one of four levels - mild, moderate, severe, or profound. The Hearing Aid feature will then use the audiogram to personalise the audio output of the Galaxy Buds to the user's specific hearing profile.
Depending on the requirement, Hearing Aid can boost high-frequency sounds, heighten surrounding whispers, and/or clarify distant voices that would otherwise be difficult to hear. The feature also uses noise cancellation and beamforming to further clean up the listening experience for users who need it.
FDA's approval for Hearing Aid in Galaxy Buds 3 Pro and Galaxy Buds 4 Pro build on Samsung's broader Hearing Health initiative, which the brand introduced in June 2026 via a major Samsung Health app overhaul.
Hearing Aid uses the Galaxy Watch and smartphone together to monitor environmental noise levels and alert users when prolonged loud sound exposure could damage their hearing over time. The newly launched Galaxy Watch 9 and Galaxy Watch Ultra 2 already ship with this Hearing Health monitoring out of the box.
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Hearing Aid Feature in Galaxy Buds 3 Pro and Galaxy Buds 4 Pro: Rollout
Samsung has confirmed that Hearing Test and Hearing Aid features will roll out to the Galaxy Buds 4 Pro and Galaxy Buds 3 Pro via a software update in Q4 2026. The feature will be limited to the USA for now and will extend to approved markets later. There is no clarity on whether the feature will reach India.
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