Samsung Electronics announced this week that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration (FDA). This approval means compatible Galaxy Buds models can now function as self-fitting over-the-counter (OTC) hearing aids. The new feature will roll out to Galaxy Buds 3 Pro and Galaxy Buds 4 Pro users in the fourth quarter of 2026, offering adults with perceived mild-to-moderate hearing loss a new, accessible solution.[news+2]
New Hearing Aid Feature Explained
The newly cleared functionality includes two main components: a "Hearing Test" and a "Hearing Aid" feature. The Hearing Test is a self-administered, five-minute assessment available within the Galaxy Buds settings. It analyzes each ear individually and generates an audiogram, which Samsung states is comparable to a professional audiologist's evaluation.The test then categorizes a user's hearing as normal or indicates one of four stages of hearing loss: mild, moderate, severe, or profound.This Hearing Test feature is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.[pcmag+4]
Based on these results, the Hearing Aid feature personalizes sound amplification for the user. It specifically amplifies sounds that users find hard to hear, such as high frequencies, whispers, and distant voices.The feature also includes advanced capabilities like noise elimination and beamforming. Noise elimination helps to suppress background noise, while beamforming focuses sounds in front of the user, improving clarity in noisy environments.Samsung developed this technology in collaboration with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC).The Galaxy Buds use NAL-NL2, a globally recognized clinical standard formula for fitting prescription hearing aids.[pcmag+7]
All hearing insights and test results will be available through the Samsung Health app, providing users with a comprehensive view of their hearing health.To use these new features, users will need a compatible Galaxy Buds 3 Pro or Galaxy Buds 4 Pro paired with a Galaxy device running One UI 8 or later.[pcmag+2]
FDA's Role and the OTC Market
This FDA clearance for Samsung's Galaxy Buds aligns with the agency's 2022 rule that established a new category for over-the-counter hearing aids.This landmark decision allows adults aged 18 and older with perceived mild to moderate hearing loss to purchase hearing aids directly from retailers. They do not need a prescription, medical exam, or professional fitting from an audiologist.The rule was designed to increase competition, reduce costs, and provide more convenient access to hearing assistance for millions of Americans.[news+4]
Globally, more than 1.5 billion people experience some degree of hearing loss, a figure projected to reach 2.5 billion by 2050.Despite this widespread need, many individuals who could benefit from hearing aids do not use them. High costs, social stigma, and limited access to professional care often create significant barriers.The FDA's OTC hearing aid category aims to address these challenges by making devices more affordable and readily available.[news+4]
Samsung's entry into this market adds a major consumer electronics brand to the growing list of companies offering OTC hearing solutions.Apple also introduced an FDA-cleared hearing health feature for its AirPods Pro in 2024, allowing them to function as clinical-grade hearing aids.This growing trend from consumer tech giants increases competitive pressure on traditional hearing aid manufacturers, potentially lowering the barrier to amplification for millions of people.[news+3]
Samsung's Commitment to Hearing Health
Samsung has been actively involved in advancing hearing support technologies for consumers for several years. In 2020, the company introduced a Personal Sound Amplification Product (PSAP) feature on its Galaxy Buds+.This PSAP feature was clinically validated in 2021 as effective support for daily communication for those with hearing loss, laying the groundwork for the current Hearing Aid feature.[news+4]
Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics, emphasized the importance of hearing health. "Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world," Pak said.He added that with the latest FDA clearance, Samsung is "expanding access to hearing support and making proactive care effortless by integrating Hearing Test and Hearing Aid functionality directly into the Galaxy Buds."[news+5]
The development of this new OTC solution involved robust clinical validation studies. These studies were conducted at reputable institutions, including Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.This ensures the technology is backed by scientific evidence. Clinicians should be aware that patients with perceived mild-to-moderate hearing loss may increasingly inquire about consumer-grade OTC alternatives like the Galaxy Buds.This move by Samsung marks a significant step towards integrating medical-grade hearing support into everyday consumer electronics, making hearing care more accessible to a wider population.[pcmag+2]
