OTC Hearing Aids vs Open-Ear Headphones vs Sound Amplifiers: Only One of the Three Is an FDA Medical Device
Three products sit side by side online and are regulated completely differently. We check the FDA's 2022 OTC hearing aid rule, the PSAP line, Apple's 2024 AirPods authorization, and what open-ear headphones legally may not claim.
Three things that look identical and are not
Open a shopping tab and search for something to help you hear better. Within the first screen you will see a $1,695 pair of “OTC hearing aids,” a $39 “rechargeable hearing amplifier for seniors,” and a $169.95 set of open-ear earbuds that a reviewer swears helped their mother at dinner. They share a shelf, a category page, and often a photograph. They are three entirely different things in the eyes of the law.
Exactly one of the three is a medical device. That single fact drives what the seller may say, what the hardware may do, and whether the thing in the box has any business addressing hearing loss at all. Sort the shelf into those three bins before you compare a single feature.
The category that is actually regulated
On August 17, 2022 the FDA issued a final rule establishing a new over-the-counter category of hearing aids, effective October 17, 2022. It did something unusual: it created a class of genuine medical devices you can buy without a prescription, a fitting appointment, or a medical exam.
The rule is narrow on purpose. OTC hearing aids are for adults 18 and over with perceived mild to moderate hearing impairment. Anything for more severe loss, or for anyone under 18, stays a prescription device. FDA also set hard engineering limits: output must not exceed 111 dB SPL at any frequency, rising to 117 dB SPL only where input-controlled compression is activated. Notably, FDA declined to finalize a separate gain limit, reasoning that capping gain would blunt the devices’ ability to amplify soft sounds without adding much safety. There is also a physical constraint — the device must not be designed to be inserted deeper than about 10 mm from the eardrum.
Labeling is part of the deal. Packaging has to help a buyer recognize whether their difficulty plausibly falls in the mild-to-moderate band, and it has to carry a list of red flag conditions that mean stop and see a physician.
Check OTC hearing aids on Amazon
”Sound amplifiers” are legally something else entirely
The same day it published the OTC rule, FDA finalized its guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. That guidance draws the second line on the shelf.
A personal sound amplification product — PSAP — is a consumer product intended to accentuate sounds in specific listening situations for people who are not hearing impaired. Birdwatching. A lecture from the back row. Hunting. The technology overlaps heavily with a hearing aid, which is precisely why FDA bothered to write the guidance: similar electronics, entirely different intended use, entirely different regulatory status. A PSAP is not a hearing aid and may not be marketed to compensate for impaired hearing.
Here is the uncomfortable part, and it is the single most useful thing to know when you are shopping. Marketplace listings routinely ignore this. It takes about ten seconds to find products whose own titles contain both the phrase “Personal Sound Amplification Product (PSAP)” and the words “for mild hearing loss.” Those two claims cannot both be true of the same regulatory category. When you see a listing straddling that line, you are not looking at a bargain hearing aid. You are looking at a product that has not met the OTC hearing aid requirements and is describing itself as though it had.
Where open-ear headphones sit
Nowhere near either of the above. Open-ear headphones — the ear-cuff, clip-on, and bone conduction designs that leave your ear canal open — are consumer audio. Not medical devices, not OTC hearing aids, not PSAPs marketed for hearing difficulty. They are not authorized to treat hearing loss and may not claim to.
That is not a knock on them. Leaving the canal open is genuinely valuable: you keep situational awareness on a run, you hear the doorbell, you can wear them for eight hours without the plugged-up feeling. Shokz has been building this category for years, and the current OpenDots 2 is a good illustration of how far the hardware has come — 6.4 g ± 0.2 g per side, two custom 11.8 mm drivers, Bluetooth 6.1, IP57, 10 hours on the buds and 40 with the case, launched 4 June 2026 at $169.95.
None of that makes them a hearing aid. Buy them because you want music and awareness at once. Do not buy them as a treatment.
Check Shokz OpenDots 2 on Amazon
Check the Shokz OpenDots 2 on Shokz.com
The three-way comparison
| OTC hearing aid | PSAP / “sound amplifier” | Open-ear headphone | |
|---|---|---|---|
| Regulated as | FDA-regulated medical device under the 2022 OTC rule; output capped at 111 dB SPL (117 with input-controlled compression) | Consumer product, not a hearing aid; covered by FDA guidance distinguishing it from hearing aids | Consumer audio product; no hearing-device regulation applies |
| May claim | To compensate for perceived mild to moderate hearing impairment, adults 18+ | To amplify sounds in specific situations for people who are not hearing impaired | Sound quality, fit, awareness, battery. Not hearing-loss treatment |
| Who it is for | Adults 18+ who have had a hearing test showing mild to moderate loss | People with normal hearing who want situational amplification | Anyone who wants audio without blocking the ear canal |
| Typical price | Roughly $600–$2,700; e.g. Sennheiser All-Day Clear ~$600, Lexie B2 Plus ~$999/pair, Jabra Enhance Select 300 ~$1,695/pair, Eargo 8 ~$2,699 | Roughly $20–$350 | Roughly $100–$200; Shokz OpenDots 2 $169.95 |
Apple blurred the line, legally
The most interesting development in this space is the one that makes the shelf harder, not easier, to read. On September 12, 2024 the FDA authorized Apple’s Hearing Aid Feature through the De Novo pathway — the first over-the-counter hearing aid software device the agency has ever cleared.
The precision matters. FDA did not approve AirPods as hearing aids. It authorized a software feature, intended for use with compatible AirPods Pro, that turns them into an OTC hearing aid once installed and customized to the user’s hearing. The scope tracks the OTC rule exactly: adults 18 years or older with perceived mild to moderate hearing impairment. Apple’s clinical study ran 118 participants with mild to moderate loss and observed no adverse effects, and the feature is supported on AirPods Pro 2 with current firmware and on AirPods Pro 3.
So consumer earbuds can legally become a regulated hearing aid — by running authorized software, within a defined severity band, for adults only. With the feature off, they are earbuds.
The same line runs through wrist wearables: the best smartwatches of 2026 and what their health sensors actually claim report ECG, SpO2 and sleep as wellness estimates rather than medical measurements, except where a specific feature has been cleared.
Check Apple AirPods Pro on Amazon
Bone conduction: the honest version
Bone conduction gets oversold here, so here is the careful statement. As a clinical principle it is real, and it genuinely helps certain conductive hearing losses by routing vibration past a blocked or damaged outer and middle ear to a working cochlea. Bone-anchored hearing devices built on that principle are FDA-cleared medical devices, typically involving a surgically implanted post and an audiologist programming the processor to your audiogram.
Consumer bone conduction headphones are not that. They couple through skin rather than bone, and carry no audiogram-matched gain, no medical output limits, and no authorization as hearing aids. The physics rhyme; the device class does not.
Jurisdiction: federal rules, state licenses
Jurisdiction note (US). Device regulation here is federal and uniform: FDA classifies hearing aids, sets the OTC category’s output and labeling requirements, and authorizes software like Apple’s. That federal layer deliberately overrode a patchwork of state rules — the statute behind the rule preempts state and local requirements specifically related to hearing products that would restrict or interfere with commercial activity involving OTC hearing aids where those requirements are not identical to the federal ones. In practice, a state cannot require a special license simply to sell OTC hearing aids. What states retain is licensure of hearing aid dispensers and audiologists generally, requirements attached to prescription devices and fitting, and consumer protections tied to licensing, which FDA indicated are not automatically preempted and may still apply to dispensers who are licensed. Net effect: the product rules are national, the people rules are still state-by-state.
What “mild to moderate” actually means, and how to find out
Severity is measured in decibels hearing level on an audiogram. On the widely used ASHA scale, mild is roughly 26–40 dB HL and moderate is roughly 41–55 dB HL; above that you are into moderately severe, severe, and profound, which are outside what any OTC device is designed to serve. Severe loss needs an audiologist and, usually, prescription hardware.
We are not going to tell you which band you are in, and neither should any product page. Get tested. The most accessible option now is Apple’s Hearing Test, a self-administered pure-tone audiometry test that runs in about five minutes on compatible AirPods Pro and stores an audiogram in the Health app; it went through FDA review alongside the Hearing Aid feature, and a study published in the AAO-HNSF journal Otolaryngology–Head and Neck Surgery found it delivered clinically acceptable accuracy and reliability against conventional pure-tone audiometry, faster. Several OTC brands also offer free online hearing checks — treat those as screeners, not diagnostics. A full evaluation by a licensed audiologist remains the reference standard, and it is the only route that can rule out causes a gadget cannot see.
Two hard stops. First, sudden hearing loss is a medical emergency, not a shopping problem: it is treated as an ENT emergency, and treatment delayed much beyond 72 hours is associated with meaningfully worse recovery. Go to a doctor, today. Second, FDA’s red flag list exists for a reason — ear pain, blood or fluid from the ear, excessive wax or a suspected object, vertigo, a sudden change in hearing, hearing clearly worse in one ear, or ringing in only one ear all mean a clinician first, a purchase second.
Check Shokz OpenRun Pro 2 on Amazon
Check the Shokz OpenRun Pro 2 on Shokz.com
Summary
Three bins, one question each. Is it an FDA-regulated OTC hearing aid, cleared for adults 18+ with mild to moderate loss? Is it a PSAP, legally intended for people who are not hearing impaired? Or is it a headphone, which may not make hearing claims at all? Price sorts them almost as reliably as the law does, and the listings that straddle two bins are the ones to walk away from.
If your interest is the third bin — great audio without sealing your ears — start with our guide to ear-cuff and open-ear earphones, and browse the rest of our reviews at the English section. If your interest is the first bin, the next step is not a shopping cart. It is a hearing test.
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Frequently Asked Questions
- Q: Are open-ear or bone conduction headphones hearing aids?
- A: No. Open-ear and bone conduction headphones such as the Shokz range are consumer audio products, not medical devices. They are not authorized by the FDA as hearing aids and may not be marketed as treating or compensating for hearing loss. They can be genuinely useful for staying aware of your surroundings, but that is a different job from correcting a hearing impairment.
- Q: What is the difference between an OTC hearing aid and a PSAP?
- A: An OTC hearing aid is an FDA-regulated medical device intended to compensate for perceived mild to moderate hearing impairment in adults 18 and over. A PSAP, or personal sound amplification product, is a consumer product intended to amplify sounds for people who are not hearing impaired, such as for birdwatching or distant lectures. FDA guidance treats them as separate categories with different intended uses, and a PSAP may not be marketed to treat hearing loss.
- Q: Do AirPods Pro count as real hearing aids?
- A: The Hearing Aid feature does. On September 12, 2024 the FDA authorized Apple's Hearing Aid Feature as the first over-the-counter hearing aid software device, for adults 18 and over with perceived mild to moderate hearing loss. That authorization covers the software feature running on compatible AirPods Pro, not the earbuds as a general product. Used with the feature switched off, they are ordinary earbuds.
- Q: How do I know if my hearing loss is mild, moderate, or worse?
- A: Only a hearing test can tell you, and this article cannot. Clinically, severity is measured in decibels hearing level on an audiogram, with mild commonly defined as 26 to 40 dB HL and moderate as 41 to 55 dB HL under the widely used ASHA scale. Anything beyond that range is outside what OTC devices are designed for and belongs with an audiologist or ENT physician.
- Q: When should I see a doctor instead of buying a device?
- A: Immediately, if your hearing changed suddenly. Sudden sensorineural hearing loss is treated as an ear, nose and throat emergency, and delay past roughly 72 hours is associated with worse recovery. The FDA also requires OTC hearing aid labeling to list red flag conditions, including ear pain, fluid or blood from the ear, vertigo, hearing that is clearly worse in one ear, and ringing in only one ear. Any of those means see a clinician first.