Can Galaxy Buds Work as Hearing Aids? Samsung’s FDA Clearance—and How It Compares With AirPods Pro

Samsung is preparing to turn selected Galaxy Buds into something more
than wireless earphones.

On 31 July 2026, the US Food and Drug Administration cleared
Samsung’s Hearing Aid Feature for use with the Galaxy Buds3 Pro and
Galaxy Buds4 Pro. The software is intended to help adults with perceived
mild-to-moderate hearing loss configure the earbuds as self-fitting
over-the-counter hearing aids.

The feature has been FDA-cleared, not FDA-approved.
That distinction matters: Samsung used the FDA’s 510(k) process to show
that its product is substantially equivalent to a legally marketed
device with the same general purpose. The named predicate was Apple’s
Hearing Aid Feature for AirPods Pro. The
FDA lists Samsung’s submission as K261187, with a decision date of 31
July 2026.

Samsung says the feature will begin reaching the United States and
selected approved markets in the fourth quarter of 2026. It was
therefore cleared but not yet publicly available at the time of
writing.

Which Galaxy Buds support Samsung’s hearing-aid feature?

The clearance applies to Samsung’s hearing-aid software, not to every
pair of Galaxy Buds.

Users will need Galaxy Buds3 Pro or Buds4 Pro, plus a compatible
Samsung Galaxy phone running One UI 8 or later. The feature is intended
only for people aged 18 or older who perceive that they have
mild-to-moderate hearing loss. It is not intended for children or for
people with severe or profound hearing loss.

According to the FDA
decision summary, the system allows users to perform a hearing test,
generate an audiogram—a chart of the quietest sounds they can hear at
different frequencies—and configure the earbuds without assistance from
a hearing professional.

Samsung says its test takes about five minutes. The resulting profile
is used to adjust amplification according to the widely used NAL-NL2
prescription formula. Users can then fine-tune volume and other
settings.

The software also uses beamforming and noise-reduction technology to
focus on sound arriving from particular directions and improve speech
audibility in some environments. These features cannot restore normal
hearing, and their effectiveness will vary with a person’s hearing
pattern and surroundings.

What did Samsung’s studies
find?

The FDA filing describes several forms of testing, including a
prospective multicentre study involving 103 adults.

Participants used either Samsung’s self-fitting process or settings
programmed using a clinician-generated audiogram. After roughly 30 days,
researchers assessed perceived benefit using the Abbreviated Profile of
Hearing Aid Benefit, or APHAB, a questionnaire commonly used in
hearing-aid research.

The self-fitted system met the study’s predefined noninferiority
test. The reported difference between the fitting methods was minus 1.01
points, while the upper bound of the 95% confidence interval was
5.81—below the study’s noninferiority margin of 9.9 points. The filing
reports a p-value of 0.0046.

Speech-in-noise testing using QuickSIN did not show a meaningful
difference between the two fitting approaches, and the filing reports no
study-related or device-related adverse events.

That result supports the claim that users could configure the Samsung
feature themselves with performance comparable to the study’s
clinician-derived fitting method. It does not
demonstrate that Galaxy Buds outperform prescription hearing aids,
AirPods Pro or any other competing product.

Samsung separately validated its in-app hearing test in 367
participants. Compared with clinical pure-tone audiometry, the test
produced a median absolute threshold difference of 3.75 decibels.

Human-factors testing examined whether adults could understand the
instructions and complete the process safely. Thirty-one participants
took the test, of whom 15 met the feature’s criteria and proceeded
through setup and use. The FDA summary reports no harmful use errors,
although this was a relatively small assessment.

How does it compare with
AirPods Pro?

Apple reached this regulatory milestone first. Its Hearing Aid
Feature received FDA authorization in 2024 and became the predicate
device for Samsung’s 510(k) submission.

Apple’s system works with compatible AirPods Pro models and is
configured through an iPhone or iPad. Once hearing-aid settings are
stored on the AirPods, Apple says they can continue operating without
the setup device nearby. Apple provides its
compatibility and setup requirements here.

Samsung’s version follows a similar consumer-access model but is
built around the Galaxy ecosystem. It requires supported Galaxy Buds and
a compatible Galaxy phone running One UI 8 or later.

This creates a clearer choice for people already committed to one
mobile platform:

• Apple’s feature integrates with AirPods Pro and Apple devices.
• Samsung’s feature integrates with selected Galaxy Buds and
  compatible Galaxy phones.
• Both are aimed at adults with perceived mild-to-moderate hearing
  loss.
• Neither is designed for children or people with severe or profound
  hearing loss.

The FDA’s substantial-equivalence finding means the products have
comparable regulatory purposes and technological characteristics. It
should not be read as evidence that their sound quality, comfort,
battery life or real-world hearing performance is identical.

FutureTechDose previously explained how
AirPods Pro can function as over-the-counter hearing aids and what that
classification means.

Why this development matters

The significance extends beyond two brands of earbuds.

Over-the-counter hearing-aid rules were designed to reduce some of
the cost and access barriers faced by adults with mild-to-moderate
hearing difficulties. Bringing regulated hearing software to familiar
consumer earbuds could make amplification less intimidating and easier
to try.

Samsung’s clearance also introduces meaningful competition. Android
users have long been able to connect conventional hearing aids through
technologies such as ASHA and Bluetooth LE Audio, but Samsung is now
preparing a self-fitting hearing-aid feature built directly into its own
earbuds and phone software.

That could encourage further improvements in testing,
personalisation, battery life and speech enhancement across both major
mobile ecosystems.

It does not make professional hearing care obsolete. Consumer earbuds
have physical and acoustic limitations, and a self-administered test
cannot investigate every cause of hearing difficulty. People outside the
intended mild-to-moderate range may need different equipment and
clinical support.

Reporting note

Samsung announced the clearance on 11 August 2026 and said
availability would begin in the United States and selected approved
markets during the fourth quarter of 2026. The feature was not yet live
at the time of writing. Availability may depend on the country, device,
software version and local regulatory authorization. No Australian
approval or release date has been verified for this article.

The clinical evidence assessed Samsung’s self-fitting method against
a clinician-derived fitting approach. It was not a head-to-head trial
comparing Galaxy Buds with AirPods Pro or prescription hearing aids.

Sources and further reading

1. FDA
   510(k) database record for Samsung Hearing Aid Feature, K261187
2. FDA
   510(k) decision summary and performance evidence
3. Samsung
   announcement and planned availability
4. Apple Hearing Aid
   Feature compatibility and setup
5. FDA
   guidance on over-the-counter hearing aids
6. Google
   guidance on connecting hearing devices to Android

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