Over-the-counter hearing aids, four years in

In October 2022, a rule from the U.S. Food and Drug Administration took effect that created a new category: over-the-counter hearing aids. For the first time, adults could buy a hearing aid in a pharmacy, a big-box store or online, with no medical exam, no prescription and no professional fitting.

Four years on, the shelves are full and the choices can feel endless. This file is about the practical part: whether an over-the-counter device fits your hearing, and how to buy one without regret.

Why this sits at age 55 on the timeline

Hearing usually fades slowly, so slowly that people adjust without noticing. Treating it early helps with conversation, safety and staying connected to family. It belongs on a planning timeline well before 70, and this is a good age to get a baseline test.

What the FDA rule says

The FDA's over-the-counter category is for:

• Adults 18 and older.
• With perceived mild to moderate hearing loss.

There is no requirement to see a doctor or audiologist first. Children, and adults with more severe loss, still need prescription hearing aids.

Signs that you may be in the mild-to-moderate range

• You hear people talking but miss words, especially from women's and children's voices.
• Restaurants and family gatherings are tiring because of background noise.
• You turn up the TV and others say it is too loud.
• You ask people to repeat themselves more than you used to.
• You can hear well one-on-one in a quiet room.

When to see a doctor first

Skip the store and book an appointment if you have any of these, because they can point to a medical problem a device won't fix:

• Sudden hearing loss or a sudden change.
• Loss in one ear only, or much worse in one ear.
• Pain, fluid or drainage from the ear.
• Dizziness or balance problems.
• A feeling of blockage, which may be earwax.
• Loud, constant ringing in one ear.

Over the counter or prescription?

	Over the counter	Prescription
Who it's for	Adults with perceived mild to moderate loss	Any degree of loss, including severe, and children
Exam needed	No	Yes, with fitting by a hearing professional
Setup	You set it up, often with a phone app or preset programs	Programmed to your hearing test by a professional
Follow-up	Usually by phone, chat or app	In-person adjustments
Price	Generally lower	Generally higher, often bundled with services

Even if you buy over the counter, a hearing test is still worth having. Many audiologists and some pharmacies and retailers offer them, and a baseline helps you choose a device and notice changes later.

How to shop

When you compare devices, look for these things on the box or the website:

1. Self-fitting or preset. Self-fitting devices adjust to your hearing using a test in an app. Preset devices offer a few fixed settings to choose from. If you don't use a smartphone, a preset model with simple buttons may suit you better.
2. Return policy and trial period. This is the most important line. Your brain needs time to adjust to amplified sound. Make sure you can return the device if it doesn't work for you, and know how long you have.
3. Battery. Rechargeable or replaceable? Rechargeable saves fiddling with tiny batteries, which matters for stiff fingers.
4. Fit and comfort. In-the-ear and behind-the-ear styles feel different. Try to read about the sizes of ear tips included.
5. Support. Is there a phone number with a person on the other end?
6. Warranty. How long, and what does it cover?

Who pays

• Original Medicare (Part A and Part B) does not cover hearing aids or exams for fitting them. Medicare Part B may cover a diagnostic hearing exam if your doctor orders it.
• Medicare Advantage plans often include some hearing benefit. Call your plan and ask how it applies to over-the-counter devices.
• FSAs and HSAs. Hearing aids, including over-the-counter models, are generally eligible expenses. Check your plan.
• Taxes. Hearing aids and batteries count as medical expenses in IRS Publication 502, for those who itemize.
• VA. Veterans enrolled in VA health care may be able to get hearing aids through the VA.

The first month

Expect your own voice to sound strange, and expect ordinary noises like rustling paper and the refrigerator to seem loud. That fades as your brain adjusts. Wear the device every day, starting in quiet rooms and moving to busier places. Write down what bothers you so you can adjust settings or ask support. If, near the end of the trial, conversations are still a struggle, return it and see a hearing professional. That isn't failure. It's information.