OTC Hearing Aids Explained: What Changed in 2022 and Who They're Right For

Why the Rule Was Created

Hearing aids have long been one of the most underused tools in medicine. NIDCD reports that only one in four adults who could benefit from hearing aids has ever used them, and among adults 70 and older who could benefit, fewer than one in three has. ^{[5] [6]} When the FDA finalized its over-the-counter rule, it named high cost, stigma, and perceived value as major barriers. ^[2]

That gap matters because hearing aids genuinely help. A 2017 Cochrane review of randomized trials found that hearing aids for mild to moderate hearing loss produced large improvements in hearing-related quality of life and listening ability. ^[9] Untreated hearing loss is also linked to social isolation and higher dementia risk, which we cover in our article on hearing loss and dementia.

What the FDA Rule Actually Changed

The FDA issued its final rule on August 17, 2022, and it took effect on October 17, 2022. ^[2] It created a new category of over-the-counter (OTC) hearing aids with these key features: ^{[3] [1]}

• Who they're for: adults 18 and older with perceived mild to moderate hearing loss. You don't need a hearing test to buy one, though one is still a good idea.
• Where to buy: directly in stores or online, without seeing an ENT doctor or audiologist and without a prescription or professional fitting.
• Safety limits: maximum output is capped (111 dB SPL in most settings) to reduce the risk of further hearing damage, the part inserted in the ear must stay a set distance from the eardrum, and the user must be able to adjust the volume.
• Labeling: the outside of the package must warn against use in people under 18, list the "red flag" symptoms that call for a doctor's visit, describe what mild to moderate hearing loss feels like, note that professional services are available, and state the manufacturer's return policy.

One common misunderstanding: the rule requires the box to tell you what the return policy is, but it doesn't require manufacturers to offer returns. ^[2] Check the return window before you buy, since adjusting to any hearing aid takes time.

OTC vs. Prescription Hearing Aids

Both categories are FDA-regulated medical devices. The differences are mainly about who they're designed for and how they're fitted: ^{[4] [3]}

• Degree of hearing loss. OTC aids are only for perceived mild to moderate loss. Prescription aids are for any degree, including severe and profound loss.
• Age. OTC aids are for adults 18 and older. Prescription aids can be fitted for children.
• Fitting. With OTC aids, you set them up yourself, often with a smartphone app. Prescription aids are programmed by a hearing professional based on your audiogram, with follow-up adjustments.
• Cost. One 2023 review estimated the average price of a pair of traditional hearing aids at around $4,600, compared with about $1,600 for OTC aids, with wide variation in both. ^[10] NIDCD notes that hearing aids are usually not covered by health insurance, and Medicare does not cover them for adults. ^[6]

Do Self-Fitted Hearing Aids Work?

The evidence so far is reassuring for people with mild to moderate loss. In a 2017 randomized, placebo-controlled trial of 154 adults aged 55 to 79, an over-the-counter style model, where participants chose and fitted their own devices, produced benefits similar to the audiologist best-practice model, and both beat placebo devices. More participants in the audiologist group said they'd keep their hearing aids afterward (81 percent vs. 55 percent), which hints at the value of professional support. ^[7]

A 2023 randomized trial in JAMA Otolaryngology compared a self-fitting OTC hearing aid with an audiologist-fitted one in 64 adults. After six weeks, there were no meaningful differences between the groups on any outcome measured. The self-fit group did have remote support available. ^[8] These studies are small, and they tested specific devices, so results won't apply equally to every product on the shelf.

Red Flags: When to See a Doctor First

The FDA advises seeing a doctor, preferably an ear, nose, and throat specialist, before using an OTC hearing aid if you have any of the following: ^{[3] [5]}

• A visible ear deformity or injury
• Fluid, pus, or blood coming from the ear in the past six months
• Ear pain or discomfort
• A history of excessive earwax, or suspicion something is in the ear canal
• Severe dizziness or vertigo, especially with hearing loss
• Sudden hearing loss, or hearing that worsened quickly, in the past six months
• Hearing that fluctuates
• Hearing loss in only one ear, or much worse in one ear
• Ringing or buzzing in only one ear

These matter because they can point to conditions that need medical treatment rather than amplification. Sudden hearing loss is an emergency (see our guide on sudden hearing loss), and one-sided loss can occasionally signal a benign nerve tumor, covered in our article on acoustic neuroma.

Is an OTC Hearing Aid Right for You?

The FDA describes typical signs of mild to moderate hearing loss as trouble following speech in noisy places or groups, difficulty on the phone, and turning up the TV louder than others prefer. ^[3] If that sounds familiar, none of the red flags apply, and you're comfortable with technology, an OTC device can be a reasonable, more affordable starting point, especially for the gradual, two-sided pattern typical of age-related hearing loss.

Even so, a baseline hearing test is worth getting. It confirms that your loss really is in the mild to moderate range, rules out problems that need treatment, and gives you numbers to compare against later. If an OTC aid doesn't help enough after a fair trial, a prescription fitting is the next step, not giving up.

A Daily Wellness Habit Alongside Your Hearing Plan

Whether you start with a hearing test, an OTC hearing aid or a prescription fitting, a daily routine can sit comfortably alongside your plan. Audifort is a morning liquid designed to support healthy hearing, and it is a simple, pill-free step. The 90-day money-back guarantee makes it a risk-free way to try.

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