Over-the-counter or prescription hearing aids: what to know before choosing

If conversations take more effort than they used to, you have more choices than you did a few years ago, and you can take your time understanding them. Hearing aids are now sold over the counter, in stores and online, alongside prescription hearing aids fitted by a licensed professional.

This article isn't a product review, and it isn't an argument against buying an over-the-counter device. It's a plain explanation of who the FDA designed over-the-counter hearing aids for, the signs the FDA says should prompt a visit to a doctor or hearing professional, and what's worth checking before you spend money.

The FDA's category of over-the-counter, or OTC, hearing aids took effect on October 17, 2022. OTC hearing aids can be sold in stores and online without the need for a medical exam, a prescription, or a fitting adjustment by an audiologist.

Prescription hearing aids remain available. The practical difference is who does the assessing: with an OTC device, the buyer decides whether their hearing fits the category; with a prescription device, a licensed professional tests hearing and fits the device.

The federal rule is specific. An OTC hearing aid is intended for adults 18 or older with perceived mild to moderate hearing loss. It is not intended for severe or profound hearing loss, and selling one to or for anyone younger than 18 is prohibited.

The word "perceived" matters. It means the buyer judges their own hearing; no exam is required to buy. The FDA gives a practical sign that hearing loss may be beyond what OTC devices are designed for: if you can't hear speech in a quiet room, or don't hear loud sounds well, see a doctor or hearing professional first.

The FDA lists specific situations where a person should see a doctor or hearing professional rather than start with an OTC device:

• An ear with a birth defect, an unusual shape, an injury, or a deformity
• Blood, pus, or fluid coming from the ear in the past six months
• Pain or discomfort in the ear
• A lot of earwax, or something in the ear
• Severe dizziness or vertigo
• Hearing that changed suddenly in the past six months, or that comes and goes
• Worse hearing in one ear, or ringing or buzzing in only one ear

If you're an adult child or care team member, start with what the person has noticed and what help they would like. Some want help reading the package or checking the return policy; others want someone with them at an appointment. Their preferences should lead.

Because the OTC category rests on perceived hearing loss, it relies on the person being able to notice and describe how they hear. Some OTC devices, which the FDA calls self-fitting, are also set up using hearing tests, software, and smartphone apps. If describing hearing or working through an app setup is hard for the person you're helping, that's a reason to talk with a hearing professional before choosing, not a judgment about them.

Choosing a hearing test from an audiologist doesn't mean you have to buy a device there. The FDA notes that you can have your hearing tested by an audiologist and take your records elsewhere to buy, including if you decide an OTC device is the right fit.

If prescription hearing aids turn out to be the better fit, a prescription fitting at HearQuest starts with a hearing evaluation, followed by counseling, fitting, programming, and follow-up adjustments as you get used to the devices.

According to Medicare, Original Medicare doesn't cover hearing aids or exams for fitting hearing aids. Some Medicare Advantage plans include hearing benefits, and the details vary by plan, so the plan itself is the place to confirm what's covered before you buy anything.

The FDA requires the outside package to state the manufacturer's return policy, but its rules don't require a warranty. Before buying, ask two questions: what is the return policy, and is a warranty offered? Leave enough time in the return window to try the device where it matters to you, such as at the dinner table, in the car, or at a family gathering, not only in a quiet room.

The FDA also cautions that claims like "FDA Registered" or "FDA Certified," or use of the FDA logo, may be misleading. Read the return policy on its own terms rather than relying on a badge.

HearQuest offers hearing evaluations at home and in senior living communities, and fits Starkey and Signia prescription hearing aids at home, with follow-up. You can ask about a hearing test while you're still weighing your options.

For more on what in-home hearing-aid care includes, from the first evaluation through follow-up adjustments, see the hearing aids and ongoing care service page.