Samsung Electronics Co., Ltd. today announced that its Galaxy Buds Hearing Aid feature has received U.S. Food and Drug Administration (FDA) clearance. The feature enables compatible Galaxy Buds[1] to serve as an over-the-counter (OTC) hearing aid,[2] offering users 18 years and older a convenient solution for addressing perceived mild to moderate hearing loss — which may be indicated by difficulty following conversations in noisy environments — without a prescription or clinic visit. Users can assess their hearing with the Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) in the U.S. and provides medical-grade results.

“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.”

Samsung has been committed to advancing hearing support technologies for consumers since 2020 when Samsung introduced a Personal Sound Amplification Product (PSAP) feature on the 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.

Example of a Hearing Test result

Hearing Aid settings screen

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.

Compatible 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.

In its Best Wireless Earbuds of 2026 roundup, SoundGuys named the Galaxy Buds4 Pro its top recommendation for Samsung users, highlighting the earbuds’ impressive sound quality, Galaxy-exclusive features and overall value. Tom’s Guide also reviewed and praised the Galaxy Buds4 Pro for their Hi-Fi sound, Adaptive Active Noise Cancellation [1] (ANC), refined design and Galaxy AI-powered experiences, recognizing them as a standout choice for Samsung users seeking premium wireless audio.

Refined Design for Everyday Comfort

Reviewers also recognized the Galaxy Buds4 Pro’s comfortable fit and premium everyday wearability.

Whether worn during a morning commute, a long-haul flight or throughout the workday, the redesigned Galaxy Buds4 series was built to deliver comfort without compromising on performance.

The Galaxy Buds4 series introduces Samsung’s most refined earbud design yet, featuring a sleek metal finish, an ergonomic shape designed for all-day comfort and redesigned stems with intuitive pinch controls for easier music, call and feature management.

While Galaxy Buds4 Pro feature silicone ear tips that create a secure seal for immersive listening and enhanced Adaptive ANC, Galaxy Buds4 offer an open-type design that prioritizes lasting comfort and greater awareness of surrounding sounds, giving users the flexibility to choose the listening experience that best suits their lifestyle.

Both reviewers noted that the Galaxy Buds4 Pro combine a sleeker design with a polished feel.

Personalized Hi-Fi Sound That Adapts to You

Much of the recognition from both SoundGuys and Tom’s Guide centred on the Galaxy Buds4 Pro’s premium audio performance and adaptive listening experience.

Reviewers praised the earbuds’ immersive sound quality, powerful bass and exceptional clarity, experiences made possible by Samsung’s advanced two-way speaker system with a dedicated woofer and tweeter, dual amplifier architecture and support for 24-bit/96kHz Ultra High-Quality Audio. Whether listening to music during a workout, taking calls on the go, streaming a favourite show or enjoying a playlist while travelling, Galaxy Buds4 Pro are designed to deliver balanced, Hi-Fi sound across a wide range of listening environments.

Enhanced Adaptive ANC [2] and Adaptive EQ further personalize the experience by intelligently optimizing audio performance based on each user’s ear shape, fit and surroundings.

Reflecting their experience with the Galaxy Buds4 Pro:

• Tom’s Guide wrote, “If sound quality is what you’re after, then the Samsung Galaxy Buds4 Pro will be your MVP.”
• SoundGuys highlighted, “For Samsung phone owners, they’re an easy pick over any generation of Galaxy Buds before them,” recognizing their premium sound quality, Ultra High-Quality Audio, seamless device switching, deep One UI integration and effective noise reduction.

Premium Audio Across the Galaxy Buds4 Series

While Galaxy Buds4 Pro deliver Samsung’s most advanced audio experience, Galaxy Buds4 extend many of the same intelligent Galaxy experiences, including adaptive audio technologies and seamless Galaxy ecosystem connectivity, to users seeking a more accessible option.

Recognition from SoundGuys and Tom’s Guide reinforces Samsung’s commitment to wireless audio, with the Galaxy Buds4 series delivering immersive sound, intelligent features and everyday comfort designed for the way Canadians listen today.

[1] The earbuds automatically recognize the user’s voice, boosting the ambient sound to enhance conversation clarity when it begins and increasing Active Noise Cancellation (ANC) to block out background noise when the conversation ends.

[2] The earbuds automatically recognize the user’s voice, boosting the ambient sound to enhance conversation clarity when it begins and increasing Active Noise Cancellation (ANC) to block out background noise when the conversation ends.

When developing the new Galaxy Buds4 Pro, Samsung focused heavily on completely reimagining how an earbud captures and transmits the human voice. Their first objective was to develop a brand-new Sensor Fusion technology — ensuring a user’s speech can cut through the noise with absolute clarity.

What is Sensor Fusion and How Is it Important for Call Quality?

When it comes to taking calls, an earbud’s microphone is much farther from your mouth than a phone’s, making your voice highly susceptible to being drowned out by ambient noise. For traditional earbuds relying on a single sensor, this physical limitation often means compromised call quality, especially when ambient noise is louder than the user’s voice.

To overcome this, Samsung engineered an environment-aware sensor fusion system for Buds4 Pro. Instead of relying on one input, Samsung’s technology intelligently combines multiple sensors to recognize and adapt to the surrounding environment.

Buds4 Pro is equipped with three microphones — two external microphones directly capture a user’s voice, while a third internal microphone detects speech transmitted within the body. A Voice Pickup Unit (VPU) sensor based on bone conduction also detects the head’s physical vibrations when a user speaks.

• A cutaway of Galaxy Buds4 Pro — three microphones and a VPU sensor work in harmony to precisely reconstruct voice data.

The voice data then activates a noise reduction algorithm that allows Buds4 Pro to precisely isolate and comprehensively reconstruct the user’s voice from surrounding noise with pinpoint accuracy, ensuring clear communication even in the most chaotic environments.

How Sophisticated Is the Buds4 Pro’s Noise Reduction Algorithm?

An AI-based system called a Deep Neural Network (DNN) — modeled loosely on the structure of the human brain — serves as the core noise reduction technology within Buds4 Pro’s sensor fusion architecture. Typically, software this powerful requires massive computing power that simply cannot fit inside a tiny earbud. However, Samsung meticulously optimized its algorithm for on-device processing, slashing the processing load to roughly 10% of the original computational requirements and shrinking the model size to just 30%, successfully bringing powerful AI voice processing to a compact earbud form factor.

But blocking noise isn’t enough to guarantee true call clarity — the earbuds must also make sure your voice sounds natural. To do that, Buds4 Pro analyzes past, present and predictive sound data to instantly adapt to rapidly changing environments. Samsung also upgraded its algorithm to capture 16 times more vocal detail than previous models. Because of this massive boost in precision, every part of your speech — from high-pitched tones to sharp consonants and subtle word endings — remains crisp and easy to understand, no matter how loud your environment gets.

Buds4 Pro even accounts for natural body movements that can cause the earbuds to shift, causing ‘fit leakages’ that allow unwanted background noise to seep in. To counter this, Buds4 Pro continuously analyzes signals from the inner and outer microphones to estimate leakage in real time, dynamically adjusting the audio to keep the call crystal clear.

Furthermore, Buds4 Pro’s superior DNN-powered voice clarity is truly maximized when paired with a Galaxy smartphone, harnessing a Super Wideband[1] (SWB) connection of up to 16 kHz to deliver exceptionally rich and natural voice quality.

• Voice data output before Buds4 Pro’s noise reduction algorithm is applied.

• Voice data output after Buds4 Pro’s noise reduction algorithm is applied.

How was Buds4 Pro’s Call Quality Tested for the Real World?

To ensure Buds4 Pro delivers exceptional call quality in the real world, Samsung brought the real world into the lab using massive wind generators to recreate acoustic scenarios based on actual location recordings.

In addition to lab testing, Samsung conducted extensive field tests in the noisiest everyday environments including bustling cafes, loud department stores and echoing train stations. They even tested call quality while walking outdoors late at night and riding in cars with the windows rolled down — all to perfect the earbuds’ performance in truly authentic, real-world scenarios.

Ultimately, Galaxy Buds4 Pro proves relentless engineering and technological innovation can shatter the physical limitations of true wireless earbuds. By merging an intricate sensor fusion technology with highly optimized algorithms — and validating it through exhaustive real-world testing — Galaxy Buds4 Pro offers an unprecedented level of call clarity, helping you find your voice, anywhere.

[1] Super wideband (SWB) call is available on Galaxy S26 series, S25 series, Z Fold7, Z Flip7, Z Fold6, Z Flip6, A56, Tab S11 series and Tab S10 series with One UI 6.1.1 or above. Additional devices may be supported in the future. Super wideband call is available regardless of the call app. SWB may not be supported depending on the mobile network between devices.