The 2022 FDA OTC Hearing Aid Rule — What Changed, and Why It Matters

The Short Version

In August 2022, the U.S. Food and Drug Administration (FDA) finalized a new rule. Hearing aids for mild and moderate hearing loss can now be sold over the counter. No doctor visit. No audiologist. No prescription. Adults 18 and up can walk into a store or shop online and buy one.

The rule went into effect on October 17, 2022. Big-name brands like Sony, Jabra, and Bose were on shelves within weeks. Prices for entry-level pairs dropped from $4,000 or more (the old prescription path) to as low as $99. Best Buy, Walmart, Costco, and CVS now stock them.

That is the big shift. Now let's break down what the rule actually says — and what it does not.

Why the Rule Came About

The U.S. has a hearing loss problem. About 30 million adults — one in eight — has some hearing loss. Of that group, only about one in five wears a hearing aid. The other four cite price, hassle, and stigma as the top reasons they go without.

Congress passed a law in 2017 (the Over-the-Counter Hearing Aid Act). It told the FDA to write rules that would create a new class of hearing aid — one for mild to moderate loss, sold direct to the public.

The FDA took five years. Pushback came from hearing aid makers and audiologists, who worried about safety, fit, and over-the-counter sound quality. Pushback also came from price-conscious adults, who pointed out that the old system had failed them. The final rule, signed in August 2022, tried to land in the middle.

What the Rule Actually Says

The rule sets up a new kind of medical device: an OTC hearing aid. To be sold OTC, a device must meet these terms:

• It is for adults 18 and up. Kids still need a clinic.
• It is for “perceived mild to moderate” loss only. The FDA does not let OTC aids be marketed for severe loss.
• It must follow rules on output volume so it cannot harm hearing.
• It must follow rules on insertion depth to avoid ear canal damage.
• It must come with clear labels — the label has to spell out warning signs that mean see a doctor.
• The user must be able to set it up and adjust it without a hearing pro.

Sales can happen anywhere — online, at big-box stores, at drug stores. No state restricts it.

What the Rule Does Not Cover

This is where the rule still has limits. The OTC class does not include:

• Hearing aids for severe or profound loss. Those still need a clinic.
• Hearing aids for kids under 18.
• Cochlear implants and bone-anchored devices.
• Personal sound amplifiers (PSAPs). These are not hearing aids and do not have to meet the new safety rules. They are sold for hunting, bird watching, and listening from the back of a room.

PSAPs are the trap to watch for. They look like hearing aids and cost $30 to $200. Many are sold online with vague claims. They are not held to the FDA hearing aid bar. If you want help with hearing loss, look for a device the FDA has classed as an OTC hearing aid — not a PSAP.

What Changed for Buyers

Before the rule, the path to a hearing aid looked like this:

1. Make an appointment with an audiologist.
2. Pay $100 to $250 for the hearing test.
3. Get a quote — often $4,000 to $7,000 for a pair.
4. Pay the bill (most plans did not cover it).
5. Come back for two or three fitting visits.
6. Wait weeks for the aids to ship and be tuned.

After the rule, the path can look like this:

1. Get a free hearing test at Costco, Sam's Club, or Walmart (or skip this step).
2. Go to BestBuy.com, Amazon, or the brand's site.
3. Buy a pair for $99 to $2,500.
4. Set them up with a phone app at home.
5. Use them.

The savings are real. A pair of Lexie B2s runs about $999. A Jabra Enhance Select 300 pair is around $1,795. The MDHearing Neo can be found under $300 a pair on sale. Compare any of those to a $5,000 prescription pair, and the gap is hard to ignore.

What Stays the Same

Some parts of the old path still apply, even with the new rule:

• A hearing test is still a smart move. You do not need one to buy OTC, but it tells you which loss bucket you are in. See our guide on how to read an audiogram for what those numbers mean.
• A return window matters more than ever. With no fitting clinic to swap a bad fit, the right to return is your safety net. Most OTC brands offer 45 to 100 days. Use that window.
• Some loss types still need a clinic. The FDA spells out warning signs on every OTC box. They are: sudden loss, loss in one ear only, pain, drainage, ringing, fluid, or a child with loss.

Who the Rule Is For

The rule fits best for these readers:

• Adults 55 and up with mild to moderate loss who have put off a clinic visit.
• Adult children buying for a parent who refuses to go to the doctor.
• Cost-conscious adults who priced a clinic pair and walked away.
• Tech-comfort users who want to set up and tune the aid themselves.
• People in rural areas where the nearest audiologist is hours away.

The rule fits less well for:

• Anyone with severe or profound loss.
• Anyone who wants a hearing pro to fit and tune the aid in person.
• Anyone with the warning signs above.
• Kids under 18.

How OTC Brands Stack Up

The first wave of OTC aids included a few clear winners. Each fits a different buyer.

Best for first-time users — Jabra Enhance Select 300. Comes with three video calls with a hearing pro. The fit is rechargeable and discreet. Strong app. Price: about $1,795 a pair.

Best for sound quality — Lexie B2 powered by Bose.Built on Bose's hearing tech (Bose has since exited the direct-to-consumer space and licensed the tech to Lexie). Tunes itself to your hearing in 10 minutes. Price: about $999 a pair.

Best for tech-comfort users — Sony CRE-10. Custom fit by mail using a 3D scan from your phone. Tiny. Sits inside the ear canal. Price: about $1,000 a pair.

Best for price — MDHearing Neo.Around $300 a pair on sale, often less. Made in the U.S. Comes with a full year's warranty.

For a side-by-side of all four, see our best OTC hearing aid guide.

How to Shop Smart

A few tips that will save you money and trouble.

Get a free audiogram first.Costco and Sam's Club both test for free. You will know which loss bucket you are in before you spend a dime. The OTC apps will use the chart to set the aid for your ears.

Read the return window. Look for at least 45 days. Some brands give 100. Use the full window to test the aid in real life — at home, at restaurants, at church.

Pick a model that matches your loss.Mild loss can use any OTC aid. Moderate loss needs more power — look for “up to 55 dB loss” support on the spec sheet.

Skip the PSAPs.If a $50 product on Amazon claims it can fix hearing loss, check the box. If it says “personal sound amplifier” or has no FDA hearing aid label, it is not held to the new rule.

Try the app before you buy.Each brand's app is part of the product. Some are great. Some are not. Free demo videos online can show you what to expect.

What Comes Next

The FDA may add more device classes in the next few years. There are talks of a “moderately severe” OTC class, and of clearer rules for direct-to-consumer prescription aids. The rule book is still young, and brands are still testing what they can sell.

For now, the 2022 rule is a real opening. If you have put off help for hearing loss because of cost or hassle, this is the door that finally opened.

Quick Recap

• The FDA OTC hearing aid rule went live in October 2022.
• It lets adults 18 and up buy hearing aids without a doctor or audiologist.
• It covers mild and moderate loss only.
• It opens up new low-cost paths — pairs as cheap as $99 to $2,500.
• It does not cover severe loss, kids, or special device types.
• It does not include PSAPs, which are not real hearing aids.
• A free hearing test, a long return window, and a model that fits your loss are the three things to look for.

Common Questions