Samsung Electronics announced that its Galaxy Buds Hearing Aid Feature has received US Food and Drug Administration (FDA) clearance, allowing compatible Galaxy Buds to serve as over-the-counter hearing aids for adults with perceived mild-to-moderate hearing loss. Following Apple’s 2024 FDA authorization for the AirPods Pro Hearing Aid, the feature will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States.

Samsung Electronics announced that its Galaxy Buds Hearing Aid Feature has received US Food and Drug Administration (FDA) clearance, allowing compatible Galaxy Buds to serve as over-the-counter hearing aids for adults with perceived mild-to-moderate hearing loss. Following Apple’s 2024 FDA authorization for the AirPods Pro Hearing Aid, the feature will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States and select approved markets in Q4 2026, with full support requiring a compatible Galaxy device running One UI 8 or later.
 


The announcement is significant because it confirms a wider category shift. After Apple received FDA authorization in September 2024 for the first over-the-counter hearing aid software intended for compatible AirPods Pro, Samsung is now bringing a comparable regulated hearing layer to Galaxy Buds. Consumer earbuds are no longer being used only for music playback, calls, active noise cancellation, or voice assistants. In this new regulatory context, they can become wearable platforms for self-fitting hearing aid software.

The FDA product classification for hearing aid software defines the device as intended to be used with a compatible wearable hardware platform to compensate for impaired hearing, while allowing customization to the user’s hearing needs. The FDA classification also states that the physical hardware platform is separate from the regulated medical device, and specifically gives the example of software running across “smart earbuds” and a smartphone.

Samsung’s Hearing Aid Feature follows that architecture. According to the publicly available 510(k) summary for K261187, the Samsung Hearing Aid Feature is an over-the-counter, software-only mobile medical application operating on off-the-shelf Samsung Galaxy mobile devices and earbuds. The mobile device provides the user interface, onboarding, self-fitting workflow, configuration, safety information, and instructions. The earbuds provide audio processing, amplification, and output through the earbud hardware.

The FDA record lists the Samsung device under product code SCR, air-conduction hearing aid software, with a July 31, 2026 decision date and a Traditional 510(k) pathway. The submission identifies Apple’s Hearing Aid Feature, DEN230081, as the predicate device, meaning Samsung’s clearance is directly connected to the regulatory path opened by Apple’s AirPods Pro hearing aid software authorization in 2024.

 



Samsung also says its hearing-health experience enables two features integrated directly into Galaxy Buds: Hearing Test and Hearing Aid. Users navigate to the Galaxy Buds menu in Settings and complete a self-administered Hearing Test in about five minutes. Samsung describes the test as clinical-grade pure-tone audiometry, testing each ear individually to identify hearing deficits and generate an audiogram. The results categorize hearing as normal or as one of four hearing-loss stages: mild, moderate, severe, or profound.

The Hearing Aid Feature then uses the results to personalize amplification for sounds the user has difficulty hearing, including high frequencies, surrounding whispers, and distant voices. Samsung says the feature also supports noise elimination and beamforming to help focus sounds in front of the user while suppressing background noise. The company also states that Galaxy Buds use NAL-NL2, the fitting procedure from Australia’s National Acoustic Laboratories widely used in prescription hearing-aid fitting.

The 510(k) summary provides additional technical context. It describes the Samsung Hearing Aid Feature as using audiogram-derived hearing thresholds to fit amplification through NAL-NL2, with additional user controls for volume tuning and beamforming. The same summary lists wide dynamic range compression, feedback cancellation, beamforming, and noise suppression among the technological characteristics evaluated for the device. 

 



The acoustic performance data also shows why this is now being treated as hearing aid software rather than only hearable enhancement. The Samsung submission lists maximum OSPL90 of 111.9dB SPL with activated input-controlled compression, full-on gain of 31.5dB, frequency response bandwidth from 100Hz to 9030Hz, total harmonic distortion of 1% or less for applicable test frequencies, equivalent input noise of 24.9dB, and latency of 2.7ms. The same table compares those values with the Apple predicate device and states that the acoustic characteristics comply with 21 CFR 800.30, the OTC hearing aid controls.

Samsung also points to a longer development path. The company first introduced a Personal Sound Amplification Product feature on Galaxy Buds+ in 2020, with clinical validation published in 2021 as support for daily communication for people with hearing loss. For the new OTC hearing aid solution, Samsung says it worked with the National Acoustic Laboratories and Samsung Medical Center, with validation studies conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.

The FDA clinical summary reports that the Samsung Hearing Aid Feature was validated in a prospective, multicenter study conducted over approximately 30 days with 103 participants in the mild-to-moderate hearing-loss range. The study compared a self-fit group using the Samsung Hearing Aid Feature with a clinician-fit group using the NAL-NL2 fitting procedure and found the self-fit group achieved non-inferior perceived benefit compared with the clinician-fit group. Supplemental validation of the Samsung Hearing Test Feature compared audiogram thresholds against clinical pure-tone audiometry in 367 participants and reported a median absolute difference of 3.75dB. 

 



A comparison with Apple’s Hearing Aid Feature application intended for the AirPods Pro (2 and 3), the self-fitting strategy through an iOS device, allowing users to refine volume, tone, and balance after setup is very similar. Intended for perceived mild-to-moderate hearing loss, the setup based on the AirPods Hearing Test also generates an audiogram from a hearing healthcare professional. The Hearing Aid settings are stored on the earbuds, allowing the feature to keep working with the most recent settings even when the paired iPhone or iPad is not nearby. The user can adjust amplification level, balance, tone, ambient noise reduction, Own Voice Amplification, and Conversation Boost, while Media Assist applies hearing-test-based adjustments to music, video, calls, and FaceTime calls. 

Samsung’s move follows its own 2026 Galaxy Buds4 platform update. Earlier this year, Samsung introduced the Galaxy Buds4 Pro and Galaxy Buds4, with the Pro model using a canal-fit design, a two-way speaker configuration, three microphones in each earbud, enhanced ANC/EQ, DNN processing for Adaptive Noise Control, Voice Detect, and Siren Detect, Bluetooth LE Audio, Auracast, and deeper AI integration. Those features help explain why premium earbuds are becoming suitable platforms for increasingly advanced audio processing. 

Galaxy Buds3 Pro and Galaxy Buds4 Pro remain consumer earbuds. The cleared medical device is the Hearing Aid Feature operating across compatible Samsung mobile and earbud platforms. That separation makes it possible for consumer audio hardware to support regulated hearing functions through software, fitting algorithms, audiogram workflows, signal processing, user controls, and clinical validation. 

This architecture implies that microphone placement, beamforming, feedback management, compression behavior, occlusion, ear-tip fit, low latency, user-guided fitting, and app-based onboarding all become part of a hearing-health system. At the same time, the earbud features must remain understandable and manageable for users who are self-fitting without a hearing healthcare professional.

 



As with Apple’s, Samsung’s FDA clearance does not make Galaxy Buds a substitute for professional diagnosis or treatment; the company states that the feature is intended for users 18 years and older with perceived mild-to-moderate hearing loss and is not a substitute for care by a qualified clinician. But it does place another major consumer electronics manufacturer inside a regulated category that Apple helped define only two years earlier. The difference in Samsung’s case is the fact that both his smartphones and earbuds already come with Bluetooth LE Audio and Auracast support, which should represent a significant argument for anyone who requires hearing assistance.

Wireless earbuds are becoming software-defined hearing platforms where consumer audio, medical-device regulation, signal processing, and mobile health ecosystems are overlapping. Samsung’s clearance confirms that this will become a competitive category that will influence how the next generation of hearables is designed.

www.samsung.com