Samsung Galaxy Buds 4 Pro and 3 Pro get approved as over-the-counter hearing aids

Published Nov 4, 2026, 11:17 PM EST Jade Bryan is a Feature Author at Android Police with over a decade of tech reviews and news reporting experience, stretching back to the Symbian era and the early days of Android. He covers the breadth of the mobile industry, specializing in operating system deep-dives, app testing, and hardware analysis. In his spare time, you can find him tinkering with his Android devices and wearables, seeking ways tech can improve daily life. He also enjoys playing MMORPGs, traveling, or feeding stray cats and dogs. Sign in to your Android Police account Samsung Galaxy Buds 4 Pro and Buds 3 Pro can now double as over-the-counter hearing aids. South Korea's Ministry of Food and Drug Safety has approved the hearing aid feature set. This follows the US FDA approval in August 2026, which cleared the feature as a medical device for use in the region. The green light from the South Korean regulatory agency means the company can release the hearing aid features to more countries. How Galaxy Buds diagnose hearing loss The hearing aid feature comes in two modules: Hearing Test and Hearing Aid, as detailed in the press release (via SamMobile). Hearing Test is registered as a software-based medical tool, while the Galaxy Buds serve as the hardware equivalent of the OTC hearing aid. Samsung says the hearing aid feature in the Galaxy Buds is designed for users 18 and older with mild to moderate hearing loss. It adds that the Galaxy Buds use NAL-NL2, a similar fitting technology used in standalone hearing aids. Credit: Samsung US Wearers can run a hearing check themselves using the Galaxy Buds app on their Samsung Galaxy phone. Samsung adds that the test uses clinical-grade audiometry, can last 5 minutes per session, and covers both ears. The result appears as an audiogram showing each ear's hearing capacity, comparable to audiologist results. The test will categorize whether users have normal hearing or hearing loss into four levels: mild, moderate, severe, or profound. Users can also access the detailed hearing test results and their profile from the Samsung Health app. Galaxy Buds amplify sound based on hearing profile Once the user's hearing profile is diagnosed, the Galaxy Buds 4 Pro or 3 Pro serve as hearing aids, boosting sound output on both sides or individually, depending on the level of hearing loss. For example, they can amplify voices in conversations or vocals in a track, making them more audible for the wearer. The hearing aid also supports advanced features such as noise reduction to enhance speech in conversation and help prevent hearing loss, along with beamforming to channel sound effectively to the ears. US users will get the new Galaxy hearing aid features first The Hearing Test and Hearing Aid will arrive for US users in Q4 2026, with arrivals in more countries, including South Korea, in early 2027. Samsung follows Apple after the iPhone maker launched its own hearing aid feature in the AirPods Pro 2 and Pro 3. Like the Galaxy Buds version, the AirPods hearing aid includes a built-in hearing test for diagnosis and personalized sound amplification. Beyond the new hearing aid features, Samsung recently received approval for advanced sleep apnea detection in its Galaxy Watches. The AI-based tool will offer deeper insights and categorize sleep and breathing disorders.