“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,” said Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics. “With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating the Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.”

Hearing loss is incredibly common, yet it remains one of the most overlooked health conditions worldwide. The World Health Organization (WHO) estimates that globally, more than 1.5 billion people experience some degree of hearing loss — a figure projected to reach 2.5 billion people by 2050. Despite this, many people who could benefit from hearing aids do not use them due to high cost, social stigma or limited access to professional care.

Samsung has been committed to advancing hearing support technologies for consumers since 2020. That year, the company introduced a Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+.

The PSAP feature was clinically validated in 2021 as effective support for daily communication for those with hearing loss, building the foundation for the Hearing Aid feature. To develop this new OTC solution, Samsung collaborated closely with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC). The resulting technology is backed by robust clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.

Samsung’s holistic hearing health experience centers around two major features integrated directly into Galaxy Buds without requiring a separate app.³ By navigating to the Galaxy Buds menu in Settings, users can complete a self-administered Hearing Test in just five minutes. Using clinical-grade, pure-tone audiometry, the software tests each ear individually to pinpoint the user’s specific hearing deficits. It then generates an audiogram with accuracy comparable to a professional audiologist’s evaluation. The results categorize the user’s hearing as normal or one of four stages of hearing loss: mild, moderate, severe or profound.

Based on those results, the Hearing Aid feature amplifies the sounds users have difficulty hearing — such as high frequencies, surrounding whispers and distant voices — personalized to each user’s hearing profile. Hearing Aid also supports additional advanced features typically found in premium hearing aids, such as noise elimination and beamforming, which help focus sounds in front of the user and suppress background noise.

Galaxy Buds use NAL-NL2, recognized globally as the clinical standard formula for fitting prescription hearing aid. This advanced approach ensures highly personalized, accurate results tailored to each individual’s hearing profile.

To give users a comprehensive view of their overall wellness, hearing-related insights — including noise exposure levels and Hearing Test results — are accessible directly within the Samsung Health app.

Availability
The Hearing Aid and Hearing Test features will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the U.S. and select approved markets in Q4 2026.

1. Available on Galaxy Buds3 Pro and Galaxy Buds4 Pro only. ︎
2. Availability may vary by market, model or paired device. The Hearing Aid feature is intended for users 18 years and older with perceived mild to moderate hearing loss and is not a substitute for professional diagnosis or treatment by a qualified clinician. ︎
3. Full support requires a compatible Galaxy device with One UI 8 or later. ︎

Samsung Electronics and Stanford University today jointly announced a research project with Stanford Medicine to initiate an innovative health solution based on Samsung’s obstructive sleep apnea (OSA) feature¹ which has received De Novo — the first of its kind authorization — by the United States Food and Drug Administration (FDA). In recognition of World Health Day, this project underscores the importance of sleep in overall health by taking further steps in proactive care, beginning with a pioneering study.

Led by professor Robson Capasso as principal investigator and professor Clete Kushida as co-principal investigator, the joint study is designed to explore potential ways to further enhance Samsung’s Sleep Apnea feature to better support sleep health through timely interventions. Looking ahead, efforts will focus on going beyond detection by leveraging AI technology for daily monitoring to sleep apnea management, empowering users with the best possible sleep tools to improve their health.

Samsung’s Sleep Apnea feature on the Galaxy Watch,² which detects signs of moderate to severe obstructive sleep apnea, previously received authorization by the US FDA following approval by Korea’s Ministry of Food and Drug Safety (MFDS). With its latest approval by Brazil’s National Health Surveillance Agency (ANVISA), the feature will become available to users in Brazil in late April, increasing availability to 29 markets globally. The Sleep Apnea feature will continue to be expanded to more countries around the world, allowing more people to proactively spot symptoms earlier, which help prevent further long-term OSA health-related complications.

“The ethical, equitable and evidence-based use of technology, after its validation through research is crucial in developing new approaches to detection and management of sleep apnea and other serious sleep-related health conditions,” said Robson Capasso, MD, FAASM, Chief of Sleep Surgery, Professor of Otolaryngology and Head and Neck Surgery, former Associate Dean of Research, Stanford University School of Medicine. “We are excited about this groundbreaking collaboration and proud to be initiating a study utilizing smartwatches, a friendly and commonly accepted wearable.”

“This collaboration with Stanford Medicine will combine our deep technological expertise with Stanford’s leading research capabilities to unlock new innovation in preventive care,” said Dr. Hon Pak, Senior Vice President and Head of the Digital Health Team, Mobile eXperience Business, Samsung Electronics. “Together, we aim to move beyond screening to also provide more meaningful daily support that helps people better understand and manage their sleep health.”

¹ The Sleep Apnea feature is an over-the-counter (OTC), software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. It is intended for on demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
² Availability may vary by market, carrier, model, or a paired smartphone. Available on Galaxy Watch4 series and later models. The watch requires the Wear OS 5.0 version or later and must be paired with a Samsung Galaxy smartphone with Android 12.0 or later.