Apple’s AirPods Pro 2 just got FDA approval to double-up as hearing aids

The Apple AirPods Pro (2nd generation) serial number on the right earbud.

Lil
Katz
/
Android
Authority

TL;DR

Apple’s
AirPods
Pro
2
will
soon
function
as
over-the-counter
(OTC)
hearing
aids
for
adults,
following
FDA
approval.
The
update
will
amplify
sound
for
those
with
mild
to
moderate
hearing
loss
and
create
a
custom
sound
profile
through
the
Apple
Health
app.
This
marks
a
major
step
in
integrating
health
features
into
consumer
tech,
likely
inspiring
similar
innovations
from
competitors
like
Samsung.

Apple
is
all
set
to
introduce
hearing
aid
capabilities
to
the
AirPods
Pro
2
after
receiving
an

official
nod
for
the
software
from
the
Food
and
Drug
Administration
(FDA).
The
public
health
and
safety
body
has
recognized
the
Pro
AirPods
as
the
first
“over-the-counter
(OTC)
hearing
aid
software
device.”

When
the
update
comes
to
the
AirPods
Pro
2,
as
Apple
announced
during
the

iPhone
16
launch
event,
the
earbuds
will
amplify
sounds
for
individuals
with
perceived
mild
to
moderate
hearing
impairment.
To
be
clear,
the
FDA
has
approved
the
use
of

AirPods
Pro
2
as
hearing
aids
only
for
adults
18
years
or
older.
So
minors
and
children
with
hearing
issues
may
need
a
different
solution.

Apple’s
move
to
develop
the
hearing
aid
functionality
for
AirPods
marks
a
significant
milestone
for
the

true
wireless
ecosystem.
We’ll
likely
see
more
brands
inculcate
healthcare
solutions
in
earbuds
going
forward.
Samsung
also
offers
an
Ambient
Sound
feature
on
the
Pro
Galaxy
Buds,
which
lets
users
control
the
tone
range
of
individual
earbuds.
It’s
not
the
same
as
what
Apple
is
doing
with
its
planned
software
update
to
the
AirPods
Pro
2,
but
it
could
be
a
precursor
to
a
full-fledged
hearing
aid
mode
from
Samsung.

Currently,
the
AirPods
Pro
2
are
the
only
wireless
earbuds
the
FDA
has
certified
as
OTC
hearing
aids.
They
fall
under
a
regulation
that
allows
customers
to
purchase
hearing
aids
directly
from
stores
or
online
retailers
without
the
need
for
a
medical
exam,
prescription,
or
seeing
an
audiologist.

Apple
hasn’t
started
rolling
out
the
hearing
aid
software
to
the
AirPods
Pro
just
yet,
but
an
automatic
update
shouldn’t
be
far
off
now
that
the
FDA
has
given
its
approval.
Once
the
update
arrives,
users
will
be
able
to
take
a
clinically
validated
hearing
test
through
the
Apple
Health
app
to
identify
if
they
have
hearing
loss.
If
the
test
detects
a
hearing
impairment,
the
AirPods
will
create
a
custom
sound
profile
to
optimize
the
user’s
listening
experience.