The Hearing Aid and Hearing Test features will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and select approved markets in Q4, 2026. Image: Samsung Electronics. Certain Samsung Galaxy Buds can be used as over-the-counter (OTC) hearing aids by adults with “perceived mild to moderate hearing loss” after its Hearing Aid feature received Food and Drug Administration (FDA) clearance....
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No immediate practice change is required; however, clinicians should anticipate patient inquiries about Samsung OTC hearing aids and be prepared to discuss their appropriate candidacy (mild-to-moderate perceived loss only) relative to professionally fitted devices.
Samsung's FDA clearance of a consumer-grade OTC hearing aid using the evidence-based NAL-NL2 fitting algorithm marks a significant expansion of the OTC hearing aid market and increases competitive pressure on traditional dispensing channels.
- 01FDA has cleared Samsung Galaxy Buds3 Pro and Buds4 Pro as OTC hearing aids for mild-to-moderate hearing loss in adults.
- 02The devices use the NAL-NL2 prescriptive fitting algorithm, widely accepted in professional audiology practice.
- 03Availability is planned for the US and select international markets in Q4 2026.
- 04Clearance is for adults with perceived mild-to-moderate hearing loss — not for severe or profound loss.
- 05This adds a major consumer electronics brand to the growing OTC hearing aid segment alongside Apple and others.
Samsung Galaxy Buds3 Pro and Buds4 Pro have received FDA clearance as OTC hearing aids for adults with perceived mild-to-moderate hearing loss.
press releasesupportedThe devices use the NAL-NL2 fitting algorithm for hearing aid amplification.
press releasesupportedThe hearing aid feature will be available in the US and select markets in Q4 2026.
press releaseunclear