Samsung Electronics is elevating its wireless earbuds to a medical-device standard. With the Galaxy Buds now recognized as hearing aids in the United States, the company’s hearing-health rivalry with Apple is set to intensify.
Samsung announced on August 11 (local time) via its U.S. newsroom that the “Hearing Aid” feature for Galaxy Buds has received clearance from the U.S. Food and Drug Administration (FDA). This means compatible Galaxy Buds can be used as over-the-counter (OTC) hearing aids without a prescription or a visit to a doctor. The feature is intended for users aged 18 and older who perceive themselves as having mild to moderate hearing loss, such as difficulty following conversations in noisy environments.
Regarding the clearance, Hon Pak, Senior Vice President and Head of the Digital Health Team at Samsung’s MX Business, stated, “Hearing health is a cornerstone of overall well-being, profoundly influencing how we communicate, connect with loved ones, and engage with the world.” He added, “By integrating hearing test and hearing aid capabilities directly into Galaxy Buds, this FDA clearance allows us to broaden access to hearing care and make proactive management significantly easier.”
The feature will be available on the Galaxy Buds3 Pro and Galaxy Buds4 Pro and works in tandem with the built-in “Hearing Test” function. Users can take a pure-tone audiometry test in about five minutes directly from the Galaxy Buds settings menu, without installing a separate app. The test is registered as Software as a Medical Device (SaMD), providing medical-grade accuracy. It measures the hearing levels of each ear to generate an audiogram, classifying hearing status into four stages: normal, mild, moderate, and severe-to-profound loss.
Based on the test results, the hearing aid feature provides personalized amplification for high-frequency sounds, soft sounds, and distant voices that the user may struggle to hear. It also supports noise cancellation and beamforming to reduce ambient noise and focus on sounds coming from the front. Samsung applied the NAL-NL2 prescription formula used for fitting professional hearing aids and collaborated with the National Acoustic Laboratories (NAL) in Australia and Samsung Medical Center (SMC) during development. Clinical validation studies were conducted with Vanderbilt University Medical Center, San Jose State University, and the University of Memphis. Noise exposure levels and hearing test results can also be viewed in the Samsung Health app.
This is not Samsung’s first foray into hearing assistance technology. The company first introduced a Personal Sound Amplification Product (PSAP) feature on the Galaxy Buds+ in 2020, and a 2021 clinical trial validated its effectiveness in helping users with hearing loss in daily conversations. The new hearing aid feature was developed on the foundation of this accumulated technology and clinical data.
The hearing aid and hearing test features are scheduled to roll out via a software update in the U.S. and select authorized markets in the fourth quarter of this year. Full functionality requires a compatible Galaxy device supporting One UI 8 or later. Samsung added that the feature is not intended to replace diagnosis or treatment by a medical professional.
This FDA clearance marks a paradigm shift in the global wireless earbud market, expanding its focus from sound quality and noise control to hearing health management. Apple previously received the FDA’s first authorization for an OTC hearing aid software device for its AirPods Pro in September 2024. Apple currently supports hearing test and hearing aid features on the AirPods Pro 2 and AirPods Pro 3.
CategorySamsung Galaxy Buds3 Pro & 4 ProApple AirPods Pro 2 & Pro 3FDA Clearance DateAug. 11, 2026Sept. 12, 2024Consumer Price$249.99$249Hearing Test MethodBuilt-in, ~5 minutesApp-based pure-tone audiometryTarget Users18+, mild to moderate hearing loss18+, mild to moderate hearing lossU.S. LaunchQ4 2026 (planned)September 2024 (immediate)
Note: According to HearingTracker, the average price for a pair of prescription hearing aids ranges from $3,432 to $6,500, and can reach as high as $8,000.
With Samsung’s market entry, the wireless earbud competition between the two companies is expanding its battleground from artificial intelligence (AI) and audio technology into the healthcare sector. According to the World Health Organization (WHO), over 1.5 billion people globally experience some degree of hearing loss, a figure projected to rise to 2.5 billion by 2050. The OTC hearing aid market is growing rapidly due to aging populations and increasing interest in health management, drawing attention as an alternative that can break down the high price barrier of prescription hearing aids, which previously cost thousands of dollars. Given the vast smartphone and wearable ecosystems both companies possess, the integration of hearing health data with other healthcare services is likely to become a key differentiator going forward.