Over-the-Counter Hearing Aids

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.

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." It sounds promising, but questions immediately flood your mind. Are these real hearing aids, or just glorified amplifiers?

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.

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, or you've turned up the TV volume higher than others prefer.

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, 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.

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.

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, and in-person care.

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, and follow-up visits.

Major OTC Hearing Aid Brands and Features

The OTC hearing aid market has matured significantly since 2022. 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.

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 fitting and programming difference

Prescription hearing aids involve an audiologist who tests your hearing, programs the hearing aids using your individual results, and verifies the fit. 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.

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.

Frequently Asked Questions

How do I know if my hearing loss is mild to moderate versus severe?

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.

Can I buy just one OTC hearing aid if I only have hearing loss in one ear?

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.

What's the difference between OTC hearing aids and personal sound amplifiers (PSAPs)?

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.

Will insurance cover OTC hearing aids?

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.

Can I return OTC hearing aids if they don't work for me?

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.