South Korea’s MFDS registered both the Hearing Test and Hearing Aid as a single Software as a Medical Device package — a structurally different regulatory model from the FDA’s separate classifications, and the first time consumer earbuds have cleared major medical device authorities in two jurisdictions simultaneously.

Samsung Electronics announced November 3, 2026, that its Galaxy Buds4 Pro and Galaxy Buds3 Pro have received medical device authorization from South Korea’s Ministry of Food and Drug Safety (MFDS, 식약처) for both their built-in hearing assessment and hearing amplification features — completing the first simultaneous dual-jurisdiction medical clearance of consumer earbuds as hearing devices, and surfacing a significant structural difference between how South Korea and the United States regulate the same software.

That difference matters for how the technology works in practice. South Korea’s regulator registered both features — the five-minute in-ear hearing screen and the NAL-NL2-fitted hearing amplification — as a single, unified medical software package. The U.S. Food and Drug Administration, which cleared the same features on July 31, 2026, treated them as two separate regulatory objects: the Hearing Aid feature received Class II over-the-counter (OTC) hearing aid clearance, and the Hearing Test received a standalone Software as a Medical Device (SaMD) designation. The MFDS, by contrast, registered them together under a unified SaMD framework as one integrated clinical system.

The distinction is not bureaucratic bookkeeping. It reflects a clinical philosophy: the MFDS is treating diagnosis and therapeutic output as a single continuous workflow rather than two discrete products that happen to run on the same hardware.

The MFDS authorization covers what Samsung calls 청력 체크 (Hearing Check) and 청력 케어 (Hearing Care) in its Korean software — the Korean-market equivalents of the Hearing Test and Hearing Aid features cleared in the United States.

Hearing Check is a self-administered pure-tone air-conduction audiogram: the user sits quietly, earbuds inserted, as the software plays test tones at different frequencies to each ear separately. When a tone is heard, the user taps a button on their phone. The software logs the threshold — the quietest level at which each tone is audible — and from those measurements generates an audiogram: a graph of hearing sensitivity across frequencies.

The Korean version of this audiogram outputs results on a seven-tier severity scale, from normal through profound. That is clinically more granular than the U.S. version, which categorizes results as normal or one of four stages: mild, moderate, severe, or profound. Samsung has not publicly explained why the Korean implementation uses seven tiers rather than four or five. The added granularity may reflect MFDS classification standards, Samsung Medical Center clinical input, or both.

Hearing Care then uses that audiogram to configure the earbuds as amplification devices, applying the NAL-NL2 prescriptive fitting formula to personalize gain across frequencies to the user’s specific hearing profile.

The Korean rollout is expected in early 2027, following the Q4 2026 U.S. software update. Both require Samsung Galaxy Buds3 Pro or Buds4 Pro paired with a compatible Samsung device running One UI 8 or later. The features are limited to adults 18 and older with perceived mild-to-moderate hearing loss. Neither Samsung nor the MFDS describes either feature as a substitute for professional clinical evaluation.

How the FDA and MFDS Classified the Same Software Differently

Understanding the regulatory divergence requires a quick map of what each classification means.

In the United States, the FDA’s OTC hearing aid category — created by a 2022 final rule — permits adults with perceived mild-to-moderate hearing loss to purchase a hearing aid without a prescription, without visiting a clinic, and without a professional fitting. Samsung’s Hearing Aid Feature received clearance under this category via a Traditional 510(k) pathway (K261187, decision date July 31, 2026), using Apple’s AirPods Pro Hearing Aid Feature (DEN230081, authorized September 2024) as the predicate device. The FDA classified it under product code SCR: air-conduction hearing aid software. The Hearing Test received a separate SaMD registration.

South Korea’s MFDS, working under the Digital Medical Products Act (DMPA) that entered force in January 2025 and an updated SaMD framework published in MFDS Notice 2026-6 earlier this year, registered both features together as a unified SaMD package. Under the IMDRF-aligned definition that South Korea adopted, SaMD is software that performs medical functions without being embedded in a physical medical device. By treating the hearing screen and the hearing amplification as a single registered entity, the MFDS is saying: these two software functions constitute one clinical device, not two.

The practical implications are still unfolding. A unified SaMD designation may make it simpler for future regulatory updates — changes to the fitting algorithm or the diagnostic thresholds, for example — to be evaluated as modifications to a single approved system rather than amendments to two separately tracked products. It may also set a template for how South Korea’s healthcare system eventually integrates earbud-based hearing assessment into clinical workflows.

The Clinical Fitting Chain — and Where Earbuds Fit in It

For a reader deciding whether to use these features, the most important technical context involves what the earbuds can and cannot do compared to a clinical hearing aid fitting.

A full clinical fitting involves three steps. First, an audiologist measures the patient’s hearing thresholds using calibrated equipment in a sound-treated booth — the audiogram. Second, the audiologist runs those thresholds through a prescription fitting formula, most commonly NAL-NL2, to generate gain targets: how much amplification the hearing aid should deliver at each frequency for soft, average, and loud sounds. Third, the audiologist uses a probe-tube microphone placed in the patient’s ear canal to measure what the hearing aid is actually delivering at the eardrum, compares that to the NAL-NL2 targets, and adjusts until the two match. That third step is called real-ear measurement (REM), and it is widely regarded as the gold standard in hearing aid fitting verification.

Galaxy Buds automate the first two steps. The Hearing Test generates the audiogram. The NAL-NL2 algorithm converts it to a gain prescription. But the third step — real-ear measurement — cannot be performed without a probe-tube microphone. Because individual ear canals vary in shape, volume, and acoustic reflectance, the gain delivered at the eardrum by any earbud can differ from the NAL-NL2 target, and without a probe measurement there is no way to confirm how close or how far the fit actually is for any given user.

Clinical literature is direct about the stakes: hearing specialist resources describe fitting a hearing aid without real-ear verification as “fitting hearing aids blindly.” A 2026 American Journal of Audiology study that evaluated the Hearing Aid Feature on Apple AirPods Pro 2 — the predicate device Samsung used for its own FDA clearance — found that actual amplification deviated from NAL-NL2 targets in some frequency ranges, with low frequencies over-amplified and mid-to-high frequencies under-amplified at moderate loss levels. Samsung’s own validation data, based on a 367-participant study comparing its Hearing Test results against clinical pure-tone audiometry, reported a median absolute difference of 3.75 dB — a figure that Samsung and clinical reviewers have characterized as comparable to professional evaluation accuracy.

None of this means the technology does not work. Research on OTC hearing aid self-fitting has shown it can be non-inferior to clinical fitting in some scenarios. Samsung’s clinical trial for the Hearing Aid feature itself enrolled 103 participants across multiple centers in a prospective study over approximately 30 days. The features are designed, tested, and authorized specifically for adults with mild-to-moderate hearing loss — not for severe or profound loss, and not as a replacement for professional evaluation when that evaluation is what the clinical situation requires.

The purpose of this disclosure is not to discourage use. It is to give the reader the accurate picture: these are medically authorized devices operating at the outer boundary of what earbud hardware can verify, and an audiologist visit remains the standard of care for anyone whose hearing loss falls outside the mild-to-moderate range, or who needs confirmation that their prescribed gain is what they are actually receiving.

NAL-NL2: The Algorithm Behind the Amplification

NAL-NL2 is not a marketing claim. It is a prescription fitting formula developed by Australia’s National Acoustic Laboratories (NAL) — the research division of Australian Hearing, a Commonwealth statutory body — and published in peer-reviewed audiology literature in 2011 by Dr. Harvey Dillon, Gitte Keidser, and colleagues. It is one of two internationally recognized clinical fitting standards used in audiology clinics worldwide.

The algorithm uses a neural network to combine audiogram threshold data with input signal levels, generating frequency-specific gain recommendations that aim to maximize speech intelligibility while keeping overall loudness at or below what a normal-hearing listener would experience. It accounts for gender (women typically receive approximately 2 dB less gain), experience level (new hearing aid users are started at reduced gain and expected to adapt over approximately two years for moderate-to-greater hearing loss), binaural versus monaural use, and tonal language — speakers of many East Asian languages, including several prominent in the Korean user population Samsung is targeting, receive slightly more low-frequency gain to preserve the acoustic cues their languages rely on.

That last adjustment is not a trivial detail for a product receiving its first approval in South Korea. Samsung Medical Center, one of the two institutions Samsung collaborated with to develop these features, is a Seoul-based academic medical center that has conducted clinical research on hearing in Korean populations. The specific clinical validation work that underpins the MFDS approval incorporated Korean patient data, and the MFDS application lists Samsung Medical Center alongside Australia’s National Acoustic Laboratories as development collaborators.

Samsung licensed NAL-NL2 from NAL / the HEARing Cooperative Research Centre, the same commercialization pathway used by other companies that have implemented NAL-NL2 in OTC hearing products.

The Apple Precedent and the Competitive Landscape

Samsung’s hearing features would not exist in their current regulatory form without Apple’s.

Apple received FDA De Novo authorization for the AirPods Pro Hearing Aid Feature in September 2024 — approximately two years before Samsung’s FDA clearance. De Novo is the pathway for novel medical devices without a predicate; it effectively created the regulatory category that Samsung’s Traditional 510(k) application subsequently used. Samsung’s K261187 submission lists Apple’s DEN230081 as the predicate device, meaning Samsung’s regulatory path was substantially expedited by the trail Apple blazed.

That sequence matters for evaluating real-world performance: the peer-reviewed evidence base for earbud-based OTC hearing aids is currently built on Apple’s implementation, not Samsung’s. The 2026 American Journal of Audiology study, the independent evaluation by Australia’s NAL, and the HearingTracker review are all assessments of the AirPods Pro — the hardware Samsung used as its clinical comparator. Samsung’s own published validation data covers the Hearing Test accuracy (3.75 dB median absolute difference) and the 103-participant Hearing Aid feature study, but independent peer-reviewed evaluation of Samsung’s specific NAL-NL2 implementation is not yet publicly available as of this writing.

HearingTracker, which serves an audiologist readership, noted that the AirPods Pro 3 “could become surprisingly competitive with dedicated OTC hearing aids when appropriately configured.” The implication for Samsung’s products — which use the same clinical fitting standard — is that the technology category itself is becoming a credible entry point into hearing care, not merely a consumer electronics novelty.

The global OTC hearing aid market was valued at approximately $1.34 billion in 2026, growing at a compound annual rate of around 8.1 percent. Consumer electronics brands represent a small but rapidly legitimizing segment of that market, with regulatory clearances in multiple jurisdictions accelerating adoption.

Who Can Use This, and When

Device eligibility: Galaxy Buds4 Pro and Galaxy Buds3 Pro only. Not all Galaxy Buds models are supported. Requires a compatible Samsung Galaxy device running One UI 8 or later.

User eligibility: Adults 18 and older with perceived mild-to-moderate hearing loss. Not intended for children, not intended for severe or profound hearing loss.

US availability: Q4 2026, as a software update — no new hardware purchase required for existing compatible Buds owners.

Korean availability: Early 2027.

Cost: No additional cost. For users who already own compatible Galaxy Buds, the Hearing Test and Hearing Aid features arrive as a free firmware update — turning hardware already in their possession into a medically authorized hearing device.

What the features cannot do: Neither feature can diagnose conductive hearing loss (which requires bone-conduction testing). Neither can substitute for a full audiological evaluation if the user has ear pain, asymmetric hearing loss, or sudden-onset hearing loss — conditions that require clinical diagnosis. Samsung explicitly states the features are not a substitute for professional care.

For the estimated 28.8 million U.S. adults who could benefit from hearing aids but have not pursued them — a figure from the National Institute on Deafness and Other Communication Disorders — the Q4 2026 update means that a free, medically authorized hearing screen and OTC hearing aid feature will appear in the settings menu of earbuds millions already own. Whether that changes the statistic that only about 16 percent of U.S. adults aged 20–69 with hearing loss have ever used a hearing aid remains to be seen.

About the Regulatory Approval

What is the MFDS? South Korea’s Ministry of Food and Drug Safety (식약처) is the country’s national medical device regulator, roughly equivalent to the FDA’s device center in function. Under South Korea’s Digital Medical Products Act — which entered force in January 2025 — the MFDS regulates Software as a Medical Device under an IMDRF-aligned framework with safety grades from A (no injury risk) through C (potential for serious harm).

What does SaMD designation mean? A SaMD designation means the software itself, not the hardware it runs on, is the regulated medical device. The Galaxy Buds earbuds remain consumer electronics. The Samsung Hearing Check and Hearing Care software that runs across the earbuds and phone is what carries the medical authorization. The same architecture applies in the U.S.: the FDA’s K261187 clearance covers software running on “off-the-shelf Samsung Galaxy mobile devices and earbuds,” not the earbuds themselves.

How is the Korean model different from the U.S. model? In the United States, the Hearing Aid feature is a Class II OTC hearing aid (product code SCR), and the Hearing Test is a separately registered SaMD. They are distinct regulatory objects. In South Korea, both are registered together under a single unified SaMD package — one integrated clinical software system rather than two separate authorizations.

What about Samsung Health integration? Both the Hearing Test results and noise exposure level tracking are accessible within the Samsung Health app, connecting hearing data to the broader Samsung health ecosystem that also includes Galaxy Watch sleep tracking, blood oxygen monitoring, and activity data.

The Significance

Samsung’s simultaneous clearances in the United States and South Korea — the company’s home market — are the first time consumer earbuds have achieved major medical device authorization in both jurisdictions for hearing assessment and amplification. The process took approximately six years from Samsung’s first hearing-related feature (the PSAP on Galaxy Buds+ in 2020) to full dual-jurisdiction medical clearance.

For Dr. Hon Pak, MD, Samsung’s Senior Vice President and Head of Digital Health, and a past president of the American Telemedicine Association, the FDA clearance was straightforward in its purpose: “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 MFDS approval closes the loop on Samsung’s domestic regulatory strategy. It also gives South Korean audiologists, healthcare providers, and health insurers a clinically authorized, software-registered hearing tool on a device that hundreds of thousands of Korean Galaxy Buds owners already carry.

The two authorizations are built on the same clinical science. How two different regulatory systems chose to classify that science — as one integrated device or as two separate functions — reflects something real about how each country’s medical device framework approaches the increasingly blurred boundary between consumer electronics and healthcare delivery.

Disclosure: Samsung Electronics is a publicly traded company (KRX: 005930 / OTC: SSNLF). TechTimes covers Samsung products and corporate news as part of its standard technology news coverage.

Frequently Asked Questions

What Galaxy Buds models support the new hearing features?

Only the Galaxy Buds4 Pro and Galaxy Buds3 Pro are eligible. Not all Galaxy Buds models are supported. The features also require a compatible Samsung Galaxy smartphone or tablet running One UI 8 or later software. Existing owners of supported Galaxy Buds will receive the update at no additional cost.

When will the Samsung Galaxy Buds hearing aid feature be available in the US and South Korea?

The U.S. software update is scheduled for Q4 2026 — no new hardware purchase is required for existing compatible Buds owners. The Korean rollout, following the MFDS approval, is expected in early 2027.

How is Samsung Galaxy Buds hearing aid different from Apple AirPods hearing aid?

Both use the NAL-NL2 prescriptive fitting algorithm and have received FDA clearance as OTC hearing aids. The key regulatory difference is in pathway: Apple received FDA De Novo authorization in September 2024 as the first device of its type, while Samsung received Traditional 510(k) clearance in July 2026, using Apple’s authorization as the predicate. Samsung has also received South Korea’s MFDS authorization — no equivalent Korean clearance is currently reported for AirPods. The peer-reviewed evidence base currently covers Apple’s implementation; independent evaluation of Samsung’s specific hardware is not yet publicly available.

What is NAL-NL2 and why does it matter for hearing aids?

NAL-NL2 is a prescriptive fitting formula developed by Australia’s National Acoustic Laboratories and published in peer-reviewed literature in 2011. It uses a neural network to generate frequency-specific amplification targets based on a user’s audiogram, aiming to maximize speech intelligibility while keeping overall loudness at or below what a normal-hearing listener experiences. It is one of two internationally recognized clinical fitting standards used in audiology clinics worldwide. Its presence in an OTC device means the amplification prescription is based on the same algorithm audiologists use for $4,600 prescription hearing aids — though without the real-ear measurement step that clinicians use to verify actual gain delivered at the eardrum.

What is MFDS approval and what does it mean for Samsung’s hearing features?

The Ministry of Food and Drug Safety (MFDS, 식약처) is South Korea’s national medical device regulator. Its approval means that Samsung’s Hearing Check and Hearing Care software has been classified as a Software as a Medical Device (SaMD) under South Korea’s Digital Medical Products Act framework. Unlike the FDA, which classified Samsung’s features as two separate regulatory objects (an OTC hearing aid and a standalone SaMD), the MFDS registered both features together as a single unified SaMD package — treating the diagnostic tool and the therapeutic output as one integrated clinical system.