What This Article Covers
This comprehensive guide explains the FDA-regulated category of over-the-counter hearing aids—what they are, who they're designed for, how much they cost, and how they differ from prescription devices. You'll learn about specific brands, understand regulations, and discover when professional care is essential.
You're at your local pharmacy picking up a prescription when you notice a display near the front counter. "Over-the-Counter Hearing Aids—FDA Approved," the sign declares. The sleek devices sit in clear packaging, priced at $799 for a pair. You pause. You've known your hearing isn't what it used to be—your family jokes about how loud you keep the TV, and restaurant conversations have become exhausting. But you've been putting off that audiology appointment for months, partly because of the hassle and partly because you've heard hearing aids can cost thousands of dollars.
Now here they are, available without an appointment, at a fraction of what you expected to pay. You pick up the box, studying the features listed on the back. "Self-fitting technology." "Bluetooth connectivity." "Rechargeable batteries." It sounds promising, but questions immediately flood your mind. Are these real hearing aids, or just glorified amplifiers? Will they actually work for your hearing loss? What's the catch?
You're not alone in these questions. Since October 2022, when the FDA finalized regulations allowing certain hearing aids to be sold directly to consumers, millions of Americans have encountered these devices. The change represents a fundamental shift in how hearing care can be accessed—but with this new accessibility comes the need for clear information about what OTC hearing aids can and cannot do.
What Are OTC Hearing Aids?
Over-the-counter hearing aids are FDA-regulated medical devices designed to help adults aged 18 and older who have perceived mild to moderate hearing loss. The key word is "perceived"—you don't need a formal diagnosis or hearing test to purchase them, though getting your hearing tested is still highly recommended.
The regulatory framework
The FDA Reauthorization Act of 2017 directed the FDA to create this new category of hearing aids, and the final rule took effect in October 2022. This wasn't just a matter of allowing hearing aids to be sold in stores—it established specific safety and effectiveness standards that all OTC devices must meet.
These regulations specify maximum output levels to protect users from overly loud sounds, require clear labeling to help consumers understand who should and shouldn't use the devices, and mandate that OTC hearing aids include user controls for adjusting volume and frequency response.
How they differ from what came before
Before October 2022, what many people called "hearing aids" available online or in stores were actually personal sound amplification products (PSAPs). These devices were not regulated as medical devices and could not legally claim to treat hearing loss. The distinction matters significantly. OTC hearing aids must meet specific FDA standards for safety, effectiveness, and labeling. PSAPs remain on the market but cannot be marketed for hearing loss.
OTC Doesn't Mean "One Size Fits All"
While you can purchase OTC hearing aids without a prescription, this doesn't mean they're appropriate for everyone. These devices are specifically designed and regulated for mild to moderate hearing loss in adults. If you have severe or profound hearing loss, sudden hearing loss, significant hearing differences between ears, or certain medical conditions affecting your ears, OTC devices likely won't provide adequate help and professional evaluation is essential.
Who Should (and Shouldn't) Use OTC Hearing Aids
Understanding whether OTC hearing aids are appropriate for you starts with honestly assessing your hearing loss and overall ear health. The FDA's regulations are clear about who these devices are designed to help—but recognizing when you fall outside those boundaries is equally important.
Ideal candidates for OTC hearing aids
OTC hearing aids work best for adults who have mild to moderate hearing loss that's relatively consistent across both ears. In practical terms, this often means you notice you're asking people to repeat themselves more often, you find it challenging to follow conversations in noisy environments like restaurants, you've turned up the TV volume higher than others prefer, or you're missing softer sounds like birds chirping or distant voices.
When OTC hearing aids are not appropriate
Several situations clearly indicate you should see a hearing professional rather than trying OTC devices. If you're under 18 years old, OTC hearing aids cannot legally be sold to you. If you have severe or profound hearing loss where you struggle to hear even loud sounds or have difficulty understanding speech even in quiet environments, OTC devices won't provide sufficient amplification.
Certain medical conditions require professional evaluation before using any hearing aids. These red flags include sudden hearing loss, significant hearing difference between your ears, ear pain, fluid drainage, dizziness, or excessive earwax. Any of these symptoms could indicate underlying medical conditions that need treatment—not just amplification.
Consider a Hearing Test First
While you don't legally need a hearing test to purchase OTC hearing aids, getting one provides valuable information. Many audiologists offer hearing evaluations that can help you determine your degree of hearing loss, identify any medical issues that need attention, and make informed decisions about whether OTC or prescription hearing aids make more sense for your situation.
Cost and Value Comparison
Price represents one of the most compelling reasons people consider OTC hearing aids. Understanding what you're paying for—and what you're not getting—helps you make realistic decisions about value rather than just focusing on the initial sticker price.
OTC hearing aid pricing
OTC hearing aids typically range from about $200 to $2,000 per pair, with most quality devices from established manufacturers falling between $700 and $1,500. This represents a significant discount compared to traditional prescription hearing aids, which typically cost $2,000 to $7,000 or more per pair when you include the professional services bundled with the devices.
Within the OTC market, you'll find distinct price tiers. Budget options ($200-$500) often offer basic amplification. Mid-range devices ($700-$1,200) usually include smartphone app connectivity and rechargeable batteries. Premium OTC options ($1,500-$2,000) may include advanced features like Bluetooth streaming, superior noise reduction, or professional pre-programming.
What's included versus what costs extra
Understanding what comes with your purchase helps you compare true costs. Most OTC hearing aids include the devices themselves, a charging case or batteries, different ear tips, a cleaning tool, and app access. What's usually not included: professional support, extended warranties, loss and damage insurance, and in-person care at hearing clinics.
Comparing to prescription hearing aids
Prescription hearing aids cost substantially more upfront but include services that add significant value. When an audiologist quotes you $4,000 for prescription hearing aids, you're typically paying for the devices plus a comprehensive hearing evaluation, professional fitting using real-ear measurement, initial programming, follow-up visits for fine-tuning, ongoing maintenance, and professional troubleshooting.
Major OTC Hearing Aid Brands and Features
The OTC hearing aid market has matured significantly since 2022, with established hearing aid manufacturers, consumer electronics companies, and new entrants all offering options. Understanding what distinguishes the major players helps you evaluate which features matter for your lifestyle.
Jabra Enhance Select
Jabra partnered with GN (maker of ReSound) to create its OTC line. The models consistently receive high marks for sound quality and battery life. All models feature Bluetooth connectivity for both app control and audio streaming.
Lexie powered by Bose
Lexie focuses on user-friendly self-fitting technology. The Lexie B2 Plus represents their flagship OTC model, featuring Bose-engineered sound processing. Lexie distinguishes itself by offering remote support from hearing professionals seven days a week at no extra charge.
Sony CRE series
Sony partnered with WS Audiology (maker of Widex/Signia) to create two models. The CRE-C10 and CRE-C20 are completely-in-canal devices prioritizing discretion. The CRE-E10 is a receiver-in-ear model with Bluetooth audio streaming capability for iOS users.
Eargo
Eargo emphasizes virtually invisible design with unique "Flexi" ear tips. They offer multiple models ranging from budget-friendly to premium options, all rechargeable with lifetime professional support via phone and video.
OTC Versus Prescription: Understanding the Differences
The existence of two distinct categories of hearing aids—OTC and prescription—reflects fundamentally different approaches to hearing care.
The fitting and programming difference
Prescription hearing aids involve an audiologist who tests your hearing, creates a detailed audiogram, programs the hearing aids using your individual results, verifies the fit using real-ear measurement, and adjusts the devices based on feedback. OTC hearing aids rely on self-fitting—you use the included instructions and smartphone app to adjust the devices yourself.
Ongoing support and services
Prescription hearing aids include ongoing professional care—you can return to your audiologist anytime for adjustments. OTC hearing aids offer variable support depending on the manufacturer. You're largely responsible for managing your own adjustments and solving problems independently.
Getting Started With OTC Hearing Aids
Successfully using OTC hearing aids requires more than just purchasing devices and putting them in your ears. A strategic approach to selection, fitting, and adjustment significantly impacts your satisfaction.
Before you buy
Assess whether OTC hearing aids are appropriate using the criteria discussed earlier. Research thoroughly, read reviews, and pay attention to common complaints. Compare return policies carefully.
Initial setup and fitting
When your OTC hearing aids arrive, follow the instructions carefully. Download the app and complete the initial setup. Begin wearing the hearing aids for short periods in quiet situations, gradually increasing wearing time.
Making adjustments
Use the adjustment capabilities methodically. Make one adjustment at a time and wear the devices for at least several hours before making additional changes. Keep notes on what situations are challenging.
Set Realistic Expectations
Even the best hearing aids don't restore hearing to normal. They amplify sound to make it accessible, but your brain still needs to work to process and understand speech. Success requires patience, consistent use, and realistic expectations. Most people need 3-4 weeks of regular use before they can fairly assess success.
Frequently Asked Questions
The only reliable way is a hearing test. Generally, mild to moderate hearing loss means you struggle with soft sounds and noisy situations but can hear speech in quiet environments. Severe hearing loss means you have difficulty hearing even in quiet rooms and rely heavily on visual cues. If unsure, get a professional evaluation.
This isn't typically recommended. Significant hearing differences between ears often indicate an underlying medical condition that should be evaluated by a professional. Single-sided hearing loss requires specialized solutions OTC devices aren't designed to provide.
OTC hearing aids are FDA-regulated medical devices intended to treat hearing loss. PSAPs are not regulated as medical devices and cannot legally claim to treat hearing loss. Look specifically for products labeled as "OTC hearing aids" to ensure you're getting a legitimate medical device.
Coverage varies. Original Medicare does not cover hearing aids. Some Medicare Advantage plans and private insurers may offer coverage, but you must check your specific plan. HSAs and FSAs can typically be used for OTC hearing aids.
Return policies vary by manufacturer and retailer. Most reputable companies offer trial periods (30-100 days). Verify the specific policy before purchasing and keep all packaging.
The Bottom Line
Over-the-counter hearing aids represent a genuine advancement in accessibility. For adults with mild to moderate hearing loss who are tech-comfortable, quality OTC devices can provide meaningful benefit at lower costs. However, they aren't a universal solution. If you have complex hearing needs or medical concerns, prescription hearing aids with professional care remain the better choice.
The smartest approach combines OTC accessibility with informed decision-making. Get a hearing test to confirm you're a candidate, research thoroughly, and give yourself adequate time to adjust. The goal is improved hearing and quality of life through whatever combination of technology and support works best for you.