Samsung is one of the companies integrating Auracast into its ecosystem, notably its phones and earbuds. Now it has gone a step further and received approval for its Galaxy Buds to be used as a hearing aid in the United States.
The country’s Food and Drug Administration (FDA) has to give permission for companies to retail products as health devices, and they have given the green light to let Samsung sell compatible Galaxy Buds as over-the-counter (OTC) hearing aids, offering adults a convenient solution for addressing perceived mild to moderate hearing loss – such as difficulty following conversations in noisy environments – without a prescription or clinic visit.
Instead, users can self-diagnose their hearing with the Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.
The feature is available only on the Galaxy Buds3 Pro and Galaxy Buds4 Pro and may not be available in every country.
Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics, said: “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.
“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.”
The feature is due to roll out starting in Q4 of 2026 and requires a compatible Galaxy smartphone running One UI 8 or later.
A hearing journey
While over-the-counter hearing aids are rare in the UK, partly because the NHS is the country’s largest hearing aid dispenser, in other parts of the world they can be beneficial for those confident enough to self-diagnose their hearing health.
Samsung’s path to FDA approval for hearing aids began in 2020, when it introduced a Personal Sound Amplification Product (PSAP) feature on the Galaxy Buds+. Clinically validated a year later, this laid the foundation for the work that has followed since.
To develop the new OTC solution, Samsung collaborated with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC), and underwent clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
Samsung says its hearing health experience centres on two major features integrated directly into Galaxy Buds, without requiring a separate app.
Users 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 categorise the user’s hearing as normal or one of four stages of hearing loss: mild, moderate, severe or profound.
This then adjusts the settings in the Buds to match the wearer’s hearing profile, amplifying sounds users have difficulty hearing, such as high frequencies, surrounding whispers and distant voices. It also has noise elimination and beamforming, which help focus sounds in front of the user and suppress background noise.
Samsung says the Galaxy Buds use NAL-NL2 – recognised globally as the clinical standard formula for fitting prescription hearing aids.
Award for the Galaxy Buds4 Pro
Samsung has been celebrating the news that the Galaxy Buds4 Pro has received the EISA In-Ear Headphones 2026-2027 Award by the Expert Imaging and Sound Association (EISA) – the first time it has earned this recognition.
It was judged by a collective of expert editors from top technology publications across more than 25 countries, with the accolade providing an independent assessment of audio performance and innovation.
The delighted firm said that the award is significant because it validates the core engineering philosophy behind Galaxy Buds4 Pro: delivering sound as it was meant to be heard. This includes a new, wider woofer that increases the effective speaker area by nearly 20% over the previous generation, paired with a dedicated tweeter to deliver clean bass, rich treble, and 24-bit/96 kHz UHQ audio true to the original recording.
Ljubisa Miodragovic, President at EISA, said: “Employing a two-way speaker with individual amplifiers dedicated to the woofer and tweeter Samsung’s Galaxy Buds4 Pro yields clean, musical detail.
“Meanwhile, advanced Sensor Fusion technology combines a dedicated Voice Pickup Unit (VPU) with DNN-powered noise reduction to ensure exceptionally clear calls.”
The decision delighted Han-gil Moon, Master and Head of Audio Group, Mobile eXperience (MX) Business at Samsung Electronics, who said the company’s goal has always been to deliver Hi-Fi sound that faithfully reproduces the original recording.
“Receiving the EISA In-Ear Headphones Award validates our commitment to audio engineering excellence and affirms our promise of delivering premium sound quality and user experiences.
“Users can be confident that Galaxy Buds4 Pro are built to provide the best and most satisfying sound experience. We will continue to build on this foundation to offer even richer listening experiences in the future.”
For more, log on to: https://www.samsung.com/uk/audio-sound/galaxy-buds4-pro/buy/
They can be bought directly from https://amzn.to/4y4LFFM (affiliate link)
Aurahear in your inbox!
Leave a comment