Samsung’s FDA-cleared Hearing Aid and Hearing Test features for Galaxy Buds are still slated for the US in the fourth quarter of 2026. As of November 6, Samsung’s US release lists Q4 2026 and gives no specific date. You’ll need a Galaxy Buds4 Pro or Buds3 Pro, plus a Galaxy phone running One UI 9 or later.
The news hook comes from Korea. Samsung said on November 4 that Korea’s Ministry of Food and Drug Safety (MFDS) has approved both features as digital medical device software. Korean owners get them through a software update from early 2027. That timeline applies to Korea only and doesn’t change Samsung’s US window, which has about eight weeks left.
Which Galaxy Buds get the hearing aid feature
Samsung limits the features to two models, and they need a recent Galaxy phone too:
- Eligible earbuds: Galaxy Buds4 Pro and Galaxy Buds3 Pro
- Phone requirement: full support needs a compatible Galaxy device on One UI 9 or later
- Not eligible: Galaxy Buds4, Buds3, Buds FE and Buds Core
- Also left out: anyone pairing with a non-Galaxy phone, or a Galaxy phone that can’t run One UI 9
If you’re unsure about your phone, check our list of Galaxy phones expected to get One UI 9. Because Samsung says the feature is for the two Pro models only, the new Galaxy Buds On aren’t on the list either. That keeps the feature on Samsung’s premium earbuds, while Apple’s AirPods Pro 3 are the main rival offering a hearing-aid feature.
How the Hearing Test and Hearing Aid work
The Hearing Test runs from the Galaxy Buds menu in your phone’s Settings. It checks each ear with pure-tone air-conduction audiometry and builds an audiogram from the results. Samsung sorts those results into 7 grades, ranging from normal to profound. Follow-up guidance comes with the result.
The Hearing Aid feature then boosts the sounds you struggle to hear, based on your audiogram. It uses the NAL-NL2 fitting formula from Australia’s National Acoustic Laboratories. Noise exposure and test results also show up in the Samsung Health app.
Samsung’s scope is specific. The feature is an over-the-counter hearing aid for adults 18 and older with perceived mild to moderate hearing loss. It works without a prescription or a clinic visit. Samsung ran its US validation studies at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
This builds on earlier work. Samsung added a sound-amplification feature to the Galaxy Buds+ in 2020, and it was clinically validated in 2021. When Samsung announced FDA clearance on August 11, Hon Pak spoke for the company. He is Senior Vice President and Head of the Digital Health Team for Samsung’s Mobile eXperience Business.
With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.
Samsung’s own US window runs to the end of December. Buds4 Pro and Buds3 Pro owners can check now whether their Galaxy phone is on One UI 9, or on the list expected to get it.
Source: Samsung US Newsroom, Samsung Newsroom Korea
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