Hearing Aids and Earbuds: Where the Line Now Is

Until recently there were two things: hearing aids, which required an appointment, a prescription and a substantial cost, and headphones, which were for music.

That gap has been filled, and the change is recent enough that most people have not registered it.

This article describes device categories and what regulators have authorised. It is not health advice. Hearing changes have causes worth investigating, and that is a conversation with a doctor or an audiologist rather than with an article or a shop.

What changed

In 2022 the FDA established a category of hearing aids that do not require medical exams and can be sold over the counter at retailers and pharmacies.

Then the category widened again. The FDA authorised the first over-the-counter hearing aid software device, the Hearing Aid Feature, intended for use with compatible versions of Apple AirPods Pro. Once installed and customised, it enables the earbuds to serve as an OTC hearing aid, amplifying sounds for adults 18 or older with perceived mild to moderate hearing impairment.

It uses a self-fitting approach — users adjust it themselves without a hearing professional, with settings based on a hearing check taken on an iPhone or iPad. It was evaluated in a clinical study with 118 participants at multiple US sites, and was reviewed under the De Novo pathway used for novel low-to-moderate-risk devices.

The regulator described it as advancing the availability, accessibility and acceptability of hearing support.

What this means practically

Three tiers now exist:

Ordinary earbuds and headphones. Music and calls. Some have a "transparency" or "ambient" mode that passes outside sound through, which is not a hearing device but is genuinely useful in conversation.

Over-the-counter hearing devices. No appointment, no prescription. This now includes both purpose-built devices and, on compatible hardware, a software feature on earbuds you may already own. Over-the-counter hearing aids range from roughly $99 to $3,000, and AirPods Pro 2 retail around $249.

Prescription hearing aids, fitted by an audiologist.

Where the over-the-counter category stops

This is the important boundary and it is stated plainly by the regulator.

Over-the-counter hearing aids are intended for adults with perceived mild to moderate hearing loss. Where a condition needs specialised care, that is what it needs.

See a professional rather than buying a device if:

• Hearing changed suddenly, or in one ear only
• There is pain, discharge, ringing or dizziness
• There is a history of ear problems or ear surgery
• It is for someone under 18
• An over-the-counter device did not help

Sudden or one-sided changes in particular are the ones where the advice is unambiguous: that is a same-week appointment, not a purchase.

Why the earbud route matters beyond price

Two reasons that come up repeatedly and are not about the money.

Stigma. A great many people who would benefit from hearing support do not use it, and appearance is a large part of why. Earbuds that everyone wears remove that entirely.

Trying before committing. Someone unsure whether they need anything can find out with hardware they may already have, rather than by booking an appointment they are reluctant to book.

And a caution worth stating: the self-fitting model means people manage this themselves, without a professional involved. That is the point of the category and it is also its limitation. A device that helps is not the same as knowing why hearing changed.

If you are considering it

Try what you already have. If you own compatible earbuds, the feature is a software update and a five-minute check. It costs nothing to find out.

Consider the practical fit. Battery life measured in hours matters if the intention is to wear them all day — a purpose-built device runs far longer.

Comfort over hours is different from comfort over a podcast.

Check the return policy. OTC devices should be returnable; some retailers set short windows.

Do not assume louder is better. These devices shape sound rather than simply amplifying it, and the setup matters more than the volume.

For a family member

Do not buy one as a surprise. Hearing is a sensitive subject and a device arriving unannounced generally lands as a comment rather than a gift.

A hearing check on a phone is a low-pressure way to raise it, if it is their idea to run it.

If they are already resistant to hearing aids, the earbud route sometimes gets past the objection, because the objection was frequently never about the device working.

See helping a parent with technology.

The summary

A category exists now that did not a few years ago, it requires no appointment, it may already be on hardware you own, and it is authorised for adults with mild to moderate difficulty.

And it has a defined edge. Sudden change, one-sided change, pain or dizziness are not what this category is for — those are for a doctor, promptly.

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