Samsung Electronics announced it has secured FDA clearance on August 11 for the new Galaxy Buds hearing aid feature, designed for adults with hearing difficulties.
The approval covers users aged 18 or older who report mild to moderate hearing loss. Samsung plans to launch the feature in the United States and selected markets during the fourth quarter of 2026, though Europe is notably not among the markets confirmed so far.
The clearance allows compatible Galaxy Buds to function as over-the-counter hearing aids without requiring a prescription. Samsung designed the feature specifically to help people who struggle with conversations, particularly within noisy environments, by adjusting sound based on each user’s individual hearing profile.
The feature will be supported on the Galaxy Buds3 Pro and Galaxy Buds4 Pro. These devices also offer a Hearing Test that users can complete through Samsung’s existing settings, and the company has registered the testing software as a Software as a Medical Device, as it provides medical-grade results.
How the features work
The Galaxy Buds Hearing Test uses pure tone audiometry to assess each ear separately, a process that takes about five minutes. After testing, the software produces an audiogram showing the user’s hearing ability across different frequencies and classifies their hearing as normal or as mild, moderate, severe or profound loss.
Samsung built the hearing system to amplify sounds that users may struggle to detect, including higher frequencies, distant voices, and quieter speech in surrounding environments. The system adjusts amplification according to the results of the user’s completed hearing assessment.
The feature also uses noise reduction and beamforming to improve speech clarity in difficult listening environments, focusing on sounds coming from the front while reducing competing background noise.
The South Korean tech giant uses the NAL-NL2 fitting formula, a standard that hearing professionals commonly use when programming prescription hearing aids for individual needs.
Samsung claims it worked with hearing researchers and medical institutions while developing and validating the technology, and it will integrate hearing information into Samsung Health so users can view Hearing Test results and noise-exposure data alongside their broader wellness information.
Consumer hearing aid access
Samsung began expanding hearing support on its earbuds several years before receiving its latest clearance, introducing personal sound amplification on the Galaxy Buds+ in 2020.
Clinical research later supported that technology’s ability to assist daily communication for people with hearing loss.
The new clearance follows broader changes in the U.S. hearing aid market, where federal rules now allow eligible adults to buy certain kinds of hearing aids without a prescription or a clinic visit. Competitor Apple received its own FDA clearance for hearing aid software on the AirPods Pro in September 2024.
Global hearing loss gives consumer hearing technologies a large potential audience. The World Health Organization estimates that more than 1.5 billion people, or nearly 20% of the world’s population, currently experience some degree of hearing loss, a figure that it projects could reach roughly 2.5 billion worldwide by 2050.
Samsung expects its hearing features to reach the Galaxy Buds3 Pro and Galaxy Buds4 Pro during the fourth quarter, with availability covering the U.S. and other markets where regulators approve the technology, placing Samsung deeper into the expanding market for accessible consumer hearing support.
What this means for Europe
Samsung’s hearing feature is not yet cleared for the EU, as it needs separate CE compliance, required for devices like toys, drones, and pressure equipment, before the feature can be switched on for European users.
To add the CE marking, manufacturers must identify relevant EU-wide product requirements, determine if they can assess the conformity of a product alone or with a notified body, gather evidence to prove compliance including a compilation of technical documentation, and sign a EU declaration of conformity.
The fourth-quarter 2026 timeline is Samsung’s own target, not a confirmed date for Europe. The UK, in fact, is explicitly excluded for now, too.
Apple’s own hearing aid rollout of the AirPods Pro offers a preview of how uneven that path can be. Whereas the California giant got FDA approval in September 2024, the feature reached the UK only that October, followed by France, Italy, Spain, Cyprus, Luxembourg, and Romania two months later, while other EU states waited well over a year.
One Belgian user’s exchange with the country’s medical device regulator, recounted on Apple’s own support forum, found that CE marking under EU regulation already permits sale across the EU, suggesting the delay reflected a rollout choice by manufacturers rather than a legal barrier.
The need in Europe is substantial and, by most measures, still underserved. A 2024 report from the European Federation of Hard of Hearing People found that only 22% of Europeans with disabling hearing loss use hearing aids, pointing to a large unmet need across the region.
Adoption also varies sharply country by country, and tracks closely with reimbursement policy. France’s adoption rate reached 55% in 2025 after the country expanded coverage under its “100% Santé” reform, while the UK’s adoption rate sits closer to 50%, per industry-run EuroTrak surveys.
Countries with little or no reimbursement tend to lag further behind, meaning the population most likely to benefit from a low-cost, prescription-free option is concentrated in markets where regulatory approval has been slowest to arrive
Europeans are not entirely without options in the meantime, and the gap left by U.S.-first launches from Samsung and Apple has become an opening for homegrown players. Belgium-based Jacoti builds its hearing software around the EU’s own regulatory framework, holding Medical Device Regulation certification that gives it a more direct route to European markets than devices cleared through the FDA’s OTC pathway.
Meanwhile, Berlin’s Mimi Hearing Technologies has raised roughly $25 million (€21.6 million) to turn smartphones into hearing test and amplification tools, and London-based Tympa has raised over $30 million (€25.9 million) for a smartphone-linked hearing assessment system aimed at clinics and community health providers, as per startup tracker MedicalStartups.
Smaller entrants are following the same path. French startup Xenylab and Dutch firm MindAffect were both selected to showcase diagnostic technology at October’s EUHA Congress in Hanover, Europe’s largest hearing care industry gathering.
For now, it is this cluster of European hearing-tech startups, along with traditional manufacturers like Switzerland’s Phonak and Denmark’s GN-owned Jabra, that are positioned to serve the region’s hearing care gap while Samsung and Apple work through an increasingly pressing market diversification.
Featured image: Babak Habibi via Unsplash+
