OTC Hearing Aids Explained: What the FDA Rule Means for You

In 2022, the FDA permanently changed hearing aid rules. Adults can now buy certain hearing aids without a prescription. This guide explains exactly what changed, who it applies to, and what it means before you spend a dollar.

What Is the FDA OTC Hearing Aid Rule?

The OTC hearing aid rule is a federal regulation published by the U.S. Food and Drug Administration. It is formally titled: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.

It created a new regulatory category called over-the-counter (OTC) hearing aids. This category did not exist before 2022. Before the rule, all hearing aids were prescription devices. Buying one required a professional exam and a licensed dispenser.

The rule changes that for one specific group. Adults aged 18 and over with perceived mild to moderate hearing loss can now buy certain hearing aids without going through a professional.

This does not abolish prescription hearing aids. That category still exists for people who need it. The OTC rule simply adds a new path for a specific group of consumers.

When Did the Rule Take Effect?

The FDA published the final rule in the Federal Register on August 17, 2022. It took effect on October 17, 2022.

The rule had a long history before that date. The Over-the-Counter Hearing Aid Act of 2017 directed the FDA to create this category. The FDA published a proposed rule in 2021. After a public comment period and revisions, the FDA issued the final rule in 2022.

From October 17, 2022 onward, manufacturers could legally sell OTC hearing aids that meet the FDA's requirements. Retailers could sell them directly to consumers without requiring a professional exam.

What Exactly Changed for Consumers?

The practical changes for consumers are significant. Here is what the rule actually removed and what it added.

What was removed

• The requirement to see a licensed hearing professional before purchasing
• The requirement for a prescription or medical waiver for some adults
• The requirement for a professional fitting appointment
• In most states, the previous state-level restrictions tied to federal prescription requirements

What was added

• A legal OTC category with specific safety standards manufacturers must meet
• A required maximum output limit to protect hearing from further damage
• Mandatory labeling telling consumers exactly who the device is for
• A required 60-day money-back trial period for consumer protection
• Access through pharmacies, retail stores, and online channels

Who Does the OTC Rule Apply To?

The FDA OTC rule specifies its intended users. It applies to:

• Adults aged 18 years and older
• People who perceive themselves to have mild to moderate hearing difficulty
• People who want to manage their hearing without a prescription device

The rule does NOT apply to:

• Children under the age of 18
• Adults with severe or profound hearing loss
• People with sudden hearing loss (loss that comes on quickly and needs medical evaluation)
• People with drainage or pain in the ear (these symptoms need a doctor first)
• People whose hearing loss is related to a medical condition requiring treatment

What Must an OTC Hearing Aid Include by Law?

The FDA sets specific requirements for any device sold as an OTC hearing aid. Manufacturers must meet all of them. These are not suggestions. They are legal requirements.

Output limit

OTC hearing aids must not exceed a maximum output of 117 dB SPL. This limit prevents further hearing damage. Devices above this limit cannot be legally sold as OTC hearing aids in the United States.

Required labeling

The device label must clearly state that it is intended for adults with perceived mild to moderate hearing loss. It must state that people with severe or profound loss should see a professional. It must include age restrictions.

User instructions

OTC hearing aids must include written instructions. These cover how to insert and adjust the device safely. They must also include guidance on when to stop using the device and seek professional help.

60-day return period

Manufacturers must offer consumers a 60-day money-back trial period. This protection did not exist before the OTC rule. It gives buyers time to test the device in real listening situations before committing.

Self-fitting controls

OTC devices must let users control volume and fit the device without professional involvement. Many use a smartphone app to make these adjustments. The FDA requires that self-fitting controls be accessible directly to the user.

How Does OTC Compare to Prescription Hearing Aids?

Prescription hearing aids are not going away. The OTC category is an addition, not a replacement. The two categories serve different needs.

The right choice depends on your level of hearing difficulty. If an audiologist has confirmed severe or profound loss, OTC aids are not the right tool. For mild to moderate loss and a confident self-fitter, OTC aids offer real access and cost savings.

How Do OTC Hearing Aids Differ from Personal Amplifiers?

This is one of the most common points of confusion. They are legally and functionally different products.

Personal sound amplification products (PSAPs) are not medical devices. The FDA does not regulate them as hearing aids. They are consumer electronics. They are intended for people with normal hearing who want to amplify specific sounds in specific situations.

An OTC hearing aid is a medical device. It is regulated by the FDA. It is designed specifically to compensate for mild to moderate hearing loss. It must meet output limits, carry required labeling, and include a 60-day return period.

A personal amplifier has none of those legal requirements. It can still be useful. But it is a different product serving a different purpose.

What Does This Rule Mean for You Practically?

The OTC rule has real-world effects for anyone considering a hearing device for the first time.

Cost can be lower

Prescription hearing aids have historically cost thousands of dollars. That price often includes professional services bundled into the device cost. OTC aids separate the device from the service. Entry-level OTC models start at much lower price points. Check the live product page for current pricing on any specific device.

Access is easier

You can buy an OTC hearing aid at a pharmacy, a big-box retailer, or online. No appointment needed. No waiting for a referral.

You control the fitting

Most OTC aids use a smartphone app. You answer questions about your hearing. The app adjusts the device settings for you. Some apps let you fine-tune the frequencies you hear best or least well.

The 60-day period protects you

You are legally entitled to a 60-day return window. Use it. Try the device in the situations that matter to you: at home, at work, in noisy places, on the phone. If it does not help, return it within the window.

Professional help is still available

Buying OTC does not mean giving up professional support. You can still see an audiologist. Many offer OTC fitting support as a separate service. If your OTC device is not working after adjustment, a professional evaluation is worth the step.

Where Can You Buy OTC Hearing Aids?

Since October 2022, OTC hearing aids are available through a wide range of channels.

• Pharmacies: Major pharmacy chains stock OTC hearing aid brands in-store and online
• Big-box retailers: Electronics and general merchandise retailers carry multiple models
• Online direct: Many OTC brands sell through their own websites with app-based self-fitting
• Audiologist clinics: Some clinics now offer OTC brands alongside prescription devices
• Hearing care chains: National chains often carry OTC options at lower price tiers

When buying online, confirm the return policy matches the FDA's 60-day requirement. Some third-party sellers may not honor manufacturer policies. Buy direct from the brand or a verified authorized retailer where possible.

How Bellman Amplifiers Relate to OTC Hearing Aids

Bellman makes personal sound amplification products. They are not OTC hearing aids. They are not FDA-regulated medical devices.

This is an important distinction. Bellman amplifiers are consumer electronics. They are designed to make sounds louder in specific situations. They are not intended to diagnose, treat, or compensate for hearing loss.

That said, they fill a real gap. Some people with age-related hearing changes find everyday conversations harder to follow. A personal amplifier can help in those situations. It is a simpler, lower-cost tool than a medical hearing aid for situations where amplification is all that is needed.

What Bellman amplifiers do that OTC aids may not

• Some Bellman models have a built-in Telecoil for hearing loop systems in public venues
• Simple controls with no app or smartphone required on some models
• Can be used with headphones, earbuds, or a neck loop for T-coil hearing aids
• Work independently of internet connectivity or Bluetooth pairing

The Bellman Mino Personal Amplifier has a built-in Telecoil. It picks up magnetic signals from hearing loop systems in churches, theaters, and airports. The Bellman Maxi Classic Personal Amplifier also has a built-in Telecoil and runs on AA batteries for extended use.

The Mino and Maxi Classic are personal sound amplification products. They are not hearing aids and are not intended to treat, correct, or diagnose any medical condition.

Before You Buy: Key Questions to Ask

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Written by

The Bellman Team

The Bellman editorial team produces content grounded in verified primary sources and decades of experience designing listening and alerting solutions for people who are deaf or hard of hearing. Our work draws on primary reading of FDA regulatory documents, the Federal Register, NIDCD resources, and HLAA materials. We do not present secondary interpretations as fact where primary sources are available.

Sources used in this article:

• U.S. Food & Drug Administration - Over-the-Counter Hearing Aids: What You Should Know - fda.gov/medical-devices/hearing-aids/over-counter-hearing-aids
• Federal Register - Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (August 17, 2022) - federalregister.gov - OTC Hearing Aid Final Rule 2022
• National Institute on Deafness and Other Communication Disorders (NIDCD) - Hearing Aids - nidcd.nih.gov/health/hearing-aids
• Hearing Loss Association of America (HLAA) - OTC Hearing Aids - hearingloss.org/hearing-help/technology/ota

This article is for informational purposes only and does not constitute medical advice. Consult a licensed audiologist for guidance on your specific hearing needs.