Over-the-Counter Hearing Aids: How to Choose and Set One Up

You keep asking people to repeat themselves. Restaurants feel like a wall of noise. Your family says the TV is too loud. You suspect it’s your hearing, but booking an appointment, getting tested and paying for prescription hearing aids feels like a big leap.

Since October 2022, there has been another option. Adults can buy hearing aids off the shelf or online, set them up with a phone app, and adjust them at home. Some popular wireless earbuds can even work as hearing aids with the right software.

This guide explains who OTC hearing aids are for, how to choose one, how setup and fitting actually work, and when you should skip the store and see a professional.

This is general information, not medical advice. If you have any of the warning signs below, see a doctor first.

What OTC hearing aids are (and what they are not)

The FDA created the over-the-counter hearing aid category with a final rule published in August 2022, which took effect on October 17, 2022. Under the rule, adults can buy air-conduction hearing aids without a medical exam, prescription or fitting appointment.

The key points:

• Who they’re for: adults 18 and older with perceived mild to moderate hearing loss.
• Who they’re not for: anyone under 18, and people with severe or profound hearing loss. OTC devices have limited maximum output, so they can’t deliver enough sound for severe loss.
• They are medical devices. The FDA regulates them, and the box has required labeling, including warnings and the return policy.
• They are different from sound amplifiers. Personal sound amplification products (PSAPs) are meant for people without hearing loss who want to boost sound in certain situations, such as hunting or birdwatching. They are not a substitute for a hearing aid.

Prescription hearing aids are still available through licensed professionals for all ages and all levels of hearing loss.

Step 1: Check whether OTC is right for you

The FDA’s labeling lists signs that suggest mild to moderate hearing loss:

• Speech sounds muffled, or you have trouble hearing in noisy places
• You struggle to follow group conversations
• Phone calls are hard to hear
• Listening leaves you tired
• You turn up the TV or radio louder than others like

The FDA also says to see a hearing health professional if you can’t hear speech in a quiet room, or you don’t hear loud sounds like music, power tools or engines well. That points to more than mild to moderate loss.

Red flags: see a doctor first

The FDA lists these red flags. If any apply, see a doctor, preferably an ear, nose and throat specialist (ENT), before buying:

• Ear deformity, injury or a birth defect of the ear
• Blood, pus or fluid from the ear in the past 6 months
• Ear pain or discomfort
• Heavy earwax or a feeling that something is in your ear
• Severe dizziness or vertigo
• Sudden hearing change in the past 6 months, or hearing that gets worse then better
• Hearing that is worse in one ear
• Ringing or buzzing in only one ear

Key takeaway: OTC hearing aids are a good fit for adults with mild to moderate, gradual hearing loss in both ears. Sudden, one-sided or painful hearing problems need a doctor, not a device.

Step 2: Get a baseline hearing test

You don’t need a test to buy, but knowing your hearing levels makes setup much better. You have 3 options.

1. App-based test. Many OTC devices include a hearing check in their app, played through the hearing aids themselves. Apple’s Hearing Test runs on an iPhone or iPad with compatible AirPods Pro.
2. Bring an existing audiogram. If you’ve had a test from an audiologist, many apps let you enter or import the results.
3. Professional hearing test. An audiologist can test you and give you a copy of your records, and you can still buy OTC devices elsewhere.

For app-based tests, sit in the quietest room you have, use fresh batteries or a full charge, and make sure the ear tips seal well. A poor seal or background noise skews results.

Step 3: Choose the right type of device

OTC devices come in a few broad forms. Here’s how they compare.

What to check on the box

The FDA requires certain information on the outside of the package. Look for:

• “OTC” and “hearing aid” displayed clearly (if it doesn’t say hearing aid, it isn’t one)
• Whether you need a smartphone or a remote to use it
• Battery type and whether it’s rechargeable
• Whether the device is used or rebuilt
• The return policy, or a statement that there isn’t one

Be wary of packaging that says “FDA Registered” or “FDA Certified” or uses the FDA logo. The FDA notes those claims can be misleading.

Features worth paying for

• Self-fitting. Devices that adjust to your hearing test results, rather than offering only a few fixed presets.
• Noise and directional modes. Help in restaurants and groups.
• Rechargeable battery. Easier for people with dexterity issues.
• Bluetooth streaming. Calls and TV audio straight to your ears.
• A real trial window. The FDA does not require a warranty, but the box must state the return policy. Give yourself time to test in quiet rooms, noisy places and on the phone.

Earbuds as hearing aids: what the AirPods Pro feature does

In September 2024, the FDA authorized the first over-the-counter hearing aid software: Apple’s Hearing Aid Feature for compatible AirPods Pro. It is for adults 18 and older with perceived mild to moderate hearing loss. Apple’s support pages list AirPods Pro 2 and AirPods Pro 3 as supporting the Hearing Test and Hearing Aid features, set up from an iPhone or iPad.

Setup, per Apple’s guide, goes roughly like this: connect the AirPods, open Settings, tap the AirPods name, open Hearing Assistance, then follow the prompts to take a Hearing Test or use an existing audiogram. Afterward you can adjust amplification, balance and tone. Feature availability varies by country, and you’ll need current software and firmware.

This is a real option if you already use an iPhone and your loss is mild to moderate. It’s less ideal if you want to wear devices 12 or more hours a day, use an Android phone, or find in-ear tips uncomfortable. For a broader comparison of earbuds, see our guide on how to choose wireless earbuds.

Step 4: Set up and fine-tune

Getting value from OTC hearing aids takes a few weeks, not a few minutes.

1. Fit the tips first. Try every dome or tip size in the box. The right size seals without discomfort. Too loose causes whistling (feedback); too tight is sore.
2. Run the in-app test or enter your audiogram, in a quiet room.
3. Start in a quiet setting. Wear them at home for a few hours a day in the first week. Your brain needs time to get used to sounds you haven’t heard clearly in a while, like footsteps and the fridge hum.
4. Increase wear time gradually until you’re wearing them most of the day.
5. Adjust one thing at a time. If voices sound tinny, lower treble a little. If your own voice sounds boomy, try a different tip or a vented dome.
6. Save programs for TV, restaurants and outdoors if your app allows it.
7. Keep notes on what works and what doesn’t, so you can decide before the return window closes.

The FDA notes that adjusting to hearing aids takes time and practice. If you aren’t benefiting after a fair trial, consider seeing a professional.

If you’re helping a parent with setup, our guide to setting up a phone for a senior covers larger text, simpler home screens and remote help, which make app-based hearing aids much easier to live with.

When to see an audiologist instead

OTC isn’t always the right path. Book a professional evaluation if:

• You have any of the FDA red flags listed above
• You can’t follow speech in a quiet room
• Your OTC devices haven’t helped after several weeks of real use
• You want a professional fitting with real-ear measurement, which checks what sound actually reaches your eardrum
• You have tinnitus that bothers you, balance problems or hearing loss that is changing

Many audiologists also sell and fit OTC devices, which can be a middle ground.

Costs and coverage

OTC hearing aid prices vary widely by style and features, and earbud-based options sit at a different price point from dedicated devices. Prescription hearing aids often bundle the devices with testing, fitting and follow-up visits.

Coverage is patchy:

• Original Medicare doesn’t cover hearing aids or fitting exams, according to Medicare.gov. It does cover diagnostic hearing exams ordered by a doctor to see whether you need medical treatment.
• Medicare Advantage plans may offer hearing benefits. Check your plan’s details.
• HSA and FSA funds: IRS Publication 502 lists hearing aids, batteries, repairs and maintenance as medical expenses, so they’re generally eligible. Check with your plan administrator.

Conclusion

OTC hearing aids have made it much easier to act on hearing loss early. Rule out the red flags, get a baseline test, pick a device that fits your ears and daily routine, and give yourself a few weeks to adjust. If it isn’t working, an audiologist is the next step, not a failure. For related home health tools, see our guides on home blood pressure monitors and fall detection devices, plus our look at telehealth and remote patient monitoring.

Sources

• FDA: OTC Hearing Aids - What You Should Know - eligibility, red flags, labeling and return policy rules
• FDA: FDA Authorizes First Over-the-Counter Hearing Aid Software - September 2024 authorization for AirPods Pro
• NIDCD: Over-the-Counter Hearing Aids - category overview and who it serves
• Apple Support: Use hearing health features with AirPods Pro 2 or AirPods Pro 3 - supported models and setup steps
• Medicare.gov: Hearing aids - Original Medicare coverage rules