Before You Buy Over-the-Counter Hearing Aids in 2026: Eargo and Lexie Are Winding Down. "FDA" on the Box Can Mean Very Little.

The U.S. Food and Drug Administration (FDA) created the over-the-counter (OTC) category for people 18 and older with perceived mild to moderate hearing loss. You can buy one without a prescription or an appointment.

That makes access easier. It also makes the return policy and the maker's staying power part of the purchase.

The FDA says OTC hearing aids are not for the treatment of severe or profound hearing loss. It says PSAPs are not medical devices like hearing aids and are not alternatives to them.

So if the package avoids the words OTC and hearing aid, don't assume a low-cost amplifier is the same product.

One OTC option is a phone brand's earbuds. The FDA authorized Apple's Hearing Aid Feature on September 12, 2024, for adults 18 and older with perceived mild to moderate hearing loss. It's a software feature on AirPods Pro 2 or later, and AirPods Pro 3 listed at $249 on Apple's page. It needs a compatible iPhone, iPad or Mac. See the headphones guide for what happens to earbud batteries.

Do not use a store shelf to solve a problem that may need medical care.

The FDA says to see a doctor, preferably an ear, nose and throat doctor, if any of these apply. Here's its list:

• Your ear has a birth defect or an unusual shape
• Your ear was injured or deformed in an accident
• You had blood, pus or fluid coming out of your ear in the past 6 months
• Your ear feels painful or uncomfortable
• You have a lot of ear wax, or you think something could be in your ear
• You feel really dizzy or have a feeling of spinning or swaying, called vertigo
• Your hearing changed suddenly in the past 6 months
• Your hearing changes: it gets worse then gets better again
• You have worse hearing in one ear
• You have ringing or buzzing in only one ear

That's the FDA's own list, from its page on OTC hearing aids. Read the page itself, not just this copy.

A device can make sound louder. It cannot remove wax, treat an infection, explain sudden loss, or rule out another condition.

Apple says its Hearing Test feature is not a substitute for seeking medical advice. And if a seller's quiz skips past this list, treat that as a warning about the seller.

Nothing here is medical advice. See a doctor or a licensed hearing professional about your own ears.

An OTC product may fit when you hear well in a quiet room but lose words in a restaurant, group talk, television program, or phone call. Listening may feel tiring. Other people may complain that the television is too loud.

It may be too little help when you cannot follow speech in a quiet room or cannot hear loud music, engines, or power tools. In that case, the device output may be too limited. A hearing test can show whether prescription fitting, medical treatment, or another device is more useful.

The FDA says OTC aids are limited in their maximum output and may not be adequate to treat more severe hearing losses. Its rule caps output at 111 decibels, or 117 with input-controlled compression.

The National Institute on Deafness and Other Communication Disorders says if you have trouble hearing in quiet settings or with loud sounds, consult a hearing health professional.

Here's the scale of the market. The institute says about 28.8 million US adults could benefit from hearing aids. Among adults 70 and older who could benefit, fewer than one in three has ever used them. Sellers are fighting for first-time buyers.

Many OTC aids are set up and adjusted through a phone app and the maker's cloud. When the company goes, the app can go with it.

Here's the live case. LXE Hearing owns Eargo, Lexie and Go Hearing. The brands' own notices say LXE and four related US companies each made an assignment for the benefit of creditors on July 15, 2026 and began winding down US operations.

The dates from those notices:

• September 15, 2026: last day for warranty and repair requests
• October 8, 2026: Lexie's notice says its app is removed and cloud connectivity ends
• October 22, 2026: Eargo's notice says app removal and end of support
• October 30, 2026: online manuals archive
• January 31, 2027, 5:00 p.m. Pacific: deadline for monetary claims

The two notices disagree on the app date, and Lexie's is dated September 2 while Eargo's is dated September 15. A proof of claim doesn't guarantee payment. Returns of non-defective devices more than 45 days after delivery fall outside the standard policy and go through the claims process.

The notices say the aids are expected to keep amplifying sound through on-device controls or saved local profiles. Trade coverage says no asset sale was announced.

Sony also left. Its CRE-E10, CRE-C10 and CRE-C20 are discontinued, per HearingTracker in April 2026. WS Audiology said existing customers keep warranty and service support.

A cheap price means little if the maker is gone before your trial ends.

Techlicious noted that many OTC devices rely on the app for setup and operation.

So before you buy, ask what happens when the app is removed. Ask who owns the warranty. And ask what settings stay on the device.

If you own an Eargo, Lexie or Go Hearing aid, read your own notice and the claims deadline.

Three different phrases get used as if they were one.

Registered is a directory entry. It isn't a seal.

Registered. A maker lists its establishment and product with the FDA. Federal regulation says registration does not in any way denote approval. Any representation that creates an impression of official approval because of registration is misleading and counts as misbranding.

Cleared. The FDA reviewed a premarket submission, called a 510(k). Self-fitting OTC aids are Class II and need one.

Exempt. Plain OTC hearing aids, product code QUF, are Class I and exempt from the 510(k). That means no clearance number doesn't prove a problem.

Here's what FDA's databases show:

The latest clearance in that list is the Jabra Enhance Select 550, K254108, dated June 25, 2026. openFDA says its data are unvalidated, and the list is by one product code, so it's not complete for every device.

Then the marketing. Nevada Attorney General Aaron Ford warned on May 30, 2025, as reported by KOLO-TV, that some OTC devices display FDA registration certificates that look official and can falsely suggest approval. He said many products are sound amplifiers.

His advice: get a screening from a hearing specialist, check the seller with the Better Business Bureau, be skeptical of reviews and be wary of deals that seem too good to be true.

Here's what the FDA says must appear on an OTC hearing aid's outside packaging:

• That it is an OTC hearing aid, for adults 18 and older
• Whether it is used or rebuilt
• The type and number of batteries, and whether they're included
• Whether a mobile phone or remote control is needed
• The maker's return policy, or a statement that there is none

One reading of the FDA page listed the return policy under the outside label and another didn't. Check the live FDA page.

So ask for the K-number, the De Novo number or the Class I listing. Apple's feature was authorized through a De Novo review, in a study of 118 subjects. A seller who says the device is approved by the FDA and gives no number hasn't answered.

Prices run from about $399 to about $2,000 a pair. They're list prices from the makers' own pages on October 20, 2026, unless marked.

The last two rows come from HearingTracker, a secondary source. HearingTracker lists Sennheiser at about $1,000 with a 45-day trial. That conflicts with Sennheiser's own page.

The Jabra M3 sale price equals the M2's regular price. The page showed a countdown timer. That's the pattern, not proof of anything wrong.

Financing deserves a look. Jabra lists rates from 0.00 to 34.99 percent APR. Its example is 36 monthly payments of $38.19 at 21.99 percent APR per $1,000 borrowed. On $1,195 that's about $448 of interest. Our arithmetic.

What do people actually pay? HearingTracker's survey of 2025 purchases found:

That survey is a trade site's, and professional fitting is bundled into the prescription prices. It's not a like-for-like comparison.

AARP wrote in October 2021 that prescription aids cost between $2,000 and $6,000 a pair.

HearingTracker warns about a brand called Lunova. It says the devices appear to be white-labelled and resold by sellers who won't honor refunds. That's its characterization, not a regulator's finding.

We found no sourced figures for battery life, battery cost, replacement of a lost aid or how long a device lasts.

The FDA doesn't require a warranty. It tells buyers to understand the return and warranty terms before purchase.

The National Institute on Deafness and Other Communication Disorders says most makers offer a trial of roughly 30 to 60 days. Ask which fees are nonrefundable.

Here's how terms compare:

HearingTracker says the trial clock starts as soon as you receive the package and returns usually end with it.

The FDA's own buying guide lists questions to ask:

• Is there a trial or adjustment period?
• Are any fees nonrefundable if you return the aids after it?
• What is covered during the warranty?
• Can the warranty be extended?

Put the return deadline on your calendar the day the package arrives. Keep the box, parts, receipt and serial number until the trial is over.

Federal rules also limit state action. A state can't add OTC requirements that differ from the federal rules, and sale to anyone under 18 is prohibited.

The first hour is not the test. New sounds can feel sharp or strange, and your brain needs time to adjust. Wear the aids regularly and test them in the rooms that matter.

Use the same short conversation in:

• A quiet room
• A kitchen with running water
• A car
• A restaurant
• A phone call

Check whether speech is clearer without turning every sound harsh. Test comfort after several hours. Test feedback when hugging someone, battery life, charging and Bluetooth. Test whether you can clean and insert the device with your hands.

If the device only makes noise louder, the fitting may be wrong or the product may not match your hearing loss. Use support while the return window is still open.

If something goes wrong, the FDA says to report injuries, malfunctions or other adverse events through MedWatch online or at 1-800-FDA-1088. It lists examples such as ear canal irritation, battery-related burns, pieces lodged in the ear canal and sudden worsening of hearing loss.

A self-fitting model uses a phone, software or a hearing test to adjust sound. The FDA classes these separately, as Class II under product code QUH.

It can be useful, but only if your phone is compatible and you can finish the setup.

Ask these before you buy:

• Does the app still work if the phone changes?
• Are both ears adjusted separately?
• Do settings stay in the aids without the phone?
• Can another person help without taking over your account?
• What happens to the settings when the app is removed?

A clever app isn't useful if support ends after the return date. The Eargo and Lexie notices are the proof.

Original Medicare doesn't cover hearing aids or exams to fit them.

Part B covers diagnostic hearing and balance exams. You pay 20 percent of the Medicare-approved amount after the Part B deductible. The 2026 deductible is $283.

Medicare Advantage is different. KFF reported on June 5, 2026 that 95 percent of enrollees in individual Medicare Advantage plans are in plans offering hearing exams, hearing aids or both. Dollar limits vary. KFF's last detail, from 2021 plan files, found an average annual limit of $960 and one set per year as the most common frequency limit. That's old data.

Medicaid covers hearing aids for eligible people up to age 21, per the National Institute on Deafness and Other Communication Disorders.

Medicare Open Enrollment runs October 15 to December 7, 2026. Check a plan's hearing allowance, approved brands and network before you buy a pair yourself.

Compare the complete cost in a table before you buy. Include:

• The pair of devices and the charger
• Batteries, wax guards, domes and cleaning parts
• App or service fees
• Professional help
• A warranty extension
• Financing interest
• Replacement if one aid is lost

A low shelf price becomes a poor buy when basic parts and help are separate.

These are purchase rules. They don't say whether a hearing product is medically right for anyone.

We read the FDA and the National Institute on Deafness and Other Communication Disorders. We read Medicare.gov, KFF and the makers' own pages. We checked them on October 20, 2026. Where we state a medical fact, it's the FDA's or another named source's statement, with the page linked. The FDA's own pages carry older update dates. HearingTracker is a trade site and is treated as secondary.

Nothing here is medical, legal or financial advice. See a doctor or a licensed hearing professional about your own hearing.

The pages we used:

• The FDA on OTC hearing aids
• The FDA on other hearing devices and products
• The FDA on how to get hearing aids
• The FDA on Apple's Hearing Aid Feature
• 21 CFR 800.30 on OTC hearing aids
• 21 CFR 807.39 on registration
• FDA classification for product code QUF
• FDA classification for product code QUH
• NIDCD quick statistics about hearing
• NIDCD on hearing aids
• Medicare.gov on hearing aids
• Medicare.gov on hearing and balance exams
• KFF on Medicare Advantage in 2026
• Jabra Enhance
• Sennheiser All-Day Clear
• Apple's AirPods Pro hearing health page
• Eargo's wind-down notice
• Lexie's wind-down notice
• The Hearing Review on LXE Hearing's wind-down
• HearingTracker on OTC hearing aid prices
• HearingTracker's survey on hearing aid costs

What we couldn't confirm:

• Battery life, battery cost and device lifespan
• Apple's return terms and AppleCare price for AirPods Pro 3
• The FDA's warning-letter and recall database for OTC aids. One search found no 2025 or 2026 letter, which isn't proof there are none.
• Consumer Reports' findings, which are paywalled
• Whether a state law restricts OTC sales beyond the federal rule
• Pending Medicare coverage bills
• The Nevada attorney general's own release. We read a news report of it.

This guide is part of our series on what people research before they buy.