Select Samsung Galaxy Buds will double as hearing aids following FDA approval

Samsung has announced that two of its earbuds will now double as hearing aids. The news comes after the feature was approved by the FDA.

Earbuds with a clinical-grade hearing aid function aren't new, as Apple's AirPods Pro 2 and AirPods Pro 3 have support for the feature. This allows users to buy them as an over-the-counter (OTC) hearing aid. Now, Samsung is joining the list with two pairs of earbuds — the Galaxy Buds 3 Pro (available on Amazon for $134.49) and Galaxy Buds 4 Pro ($249.99 on Amazon).

According to Samsung, it worked in partnership with the National Acoustic Laboratories (NAL) and the Samsung Medical Center (SMC) to develop the OTC solution. When the feature rolls out, users (18 and older) will be able to diagnose their hearing with the built-in Galaxy Buds Hearing Test feature. Samsung says this feature, which as been registered as a Software as a Medical Device (SaMD), provides medical-grade results.

After the test, it categorizes a user's hearing into either normal hearing or mild, moderate, severe or profound hearing loss. Users can proceed to set up their compatible earbuds as hearing aids using the Galaxy Buds menu in the Settings app on your compatible Galaxy smartphone (running One UI 8 or newer).

It is not stated if users of a non-Galaxy smartphone will be able to use the Galaxy Buds app for the hearing test and to set up their earbuds as hearing aids. Although Samsung does mention that users will be able to view hearing-related insights such as noise exposure levels and hearing tests results in the Samsung Health app which is available for Android and iPhones. 

Once setup is complete, the Galaxy Buds will amplify the sounds a user has difficulty hearing. These adjustments are personalized to each user and to each ear. As seen in the image above, users will be able to adjust the volume for the earbuds (together or separately), reduce background noise, and choose what sound direction they prefer.

The feature is expected to begin rolling out in the US and select approved markets in the fourth quarter of 2026.