Over the counter hearing aids have been in the news lately with bi-partisan Over the Counter Hearing Aid act getting signed in to law. The new law directs the Food and Drug Administration (FDA) to regulate the sale of hearing devices that can be sold off the shelf without the assistance of an audiologist. The goal of the legislation is to make hearing aids more accessible as more than 50 million people in the US have hearing loss, yet 80% goes untreated.
WHAT IS AN OVER THE COUNTER HEARING AID?
First off, OTC hearing devices have been available for many years, they are known as Personal Sound Amplification Products or PSAPs. Perhaps you’ve seen ads on late night TV or offers for low priced “hearing devices” available online. These devices are currently not regulated nor can they be called a hearing aid. Prices are very low, ranging from $15 -$300 or more a piece. They are amplifiers that simply make all sounds louder, where a hearing aid can be programmed by a professional (like us) to meet the unique hearing loss of the patient. If you have a high frequency hearing loss (like the pitch of a woman or child’s voice) it makes no sense to make the lower frequencies louder too. It will only make it more difficult to hear what a person is trying to say, especially if other noise is present.
Who are OTC hearing aids meant for?
OTC hearing aids are intended for adults with perceived mild to moderate hearing loss only. FDA rules limit how much amplification they can deliver, and they are not designed for more severe hearing loss, for children, or for ears with underlying medical conditions. If you have not had a diagnostic hearing test, you don’t yet know which category you’re in — that’s the practical problem with buying based on how your hearing feels.
How are OTC hearing aids fit?
Most OTC devices are “self-fit,” meaning you configure them yourself through a smartphone app or choose from preset programs. There’s no measurement involved — the device applies a setting based on averages and your own responses to an in-app screening.
A hearing aid fit by an audiologist works differently. It’s programmed to your specific audiogram, then verified with real ear measurement (REM) — a probe microphone in your ear canal that shows whether the device is actually delivering the amplification your prescription calls for. Self-fit devices skip that verification step entirely, so there’s no way to know how far off target they are.
We can perform real ear measurement on OTC devices you already own. If yours aren’t hitting target, that’s worth knowing before you decide whether the problem is the device or the fitting.
If an OTC hearing aid stops working, what support is available?
Support varies widely, and there’s no regulation requiring it. Some OTC manufacturers offer a return window or limited warranty; others offer little beyond email support. If the device stops working or you’re having trouble getting it to sound right, you’re generally on your own.
Hearing aids purchased through an audiologist come with a manufacturer’s warranty that typically covers repair, and in many cases loss and damage replacement. They also come with in-office service — cleaning, tubing and filter changes, and software updates as your hearing changes.
That ongoing maintenance matters more than most people expect. Hearing aids sit in a warm, humid ear canal all day; earwax and moisture are the leading causes of failure. Regular cleaning is what keeps them working, and it’s the part of the process that ends when you buy a device online.
Hearing aids that do not have professional maintenance will frequently quite working after several months.How much do OTC hearing aids cost?
OTC hearing aids are generally less expensive than hearing aids purchased through an audiologist — typically a few hundred to around a thousand dollars per pair, compared to two thousand to several thousand for prescription hearing aids fit by a clinician. The gap reflects what’s not included: no diagnostic testing, no professional fitting or verification, more limited warranty coverage, and no ongoing in-office service.
Whether OTC or traditional hearing aids are right for you, an audiologist can help you make that decision. We strongly recommend a baseline hearing test even if you plan to buy OTC — it confirms your ears are healthy, rules out treatable causes like earwax or fluid, and tells you whether your hearing loss actually falls in the range OTC devices are built for.
WHAT IS DRIVING THE OTC LEGISLATION?
Many studies have shown that hearing aids fit without any follow up care are more likely to end up in the dresser drawer.
Why did OTC hearing aids become legal?
The FDA’s OTC category was created to expand access — hearing loss is common, hearing aids are expensive, and many people who could benefit from them never get them. That’s a real problem worth solving.
It’s also a large commercial opportunity. Hearing loss rises with age and noise exposure, and the tail end of the baby boom is now well into their fifties. Companies without the research and development investment the established hearing aid manufacturers have made are entering that market, and FDA regulation of the category lends their devices credibility they didn’t previously have.
Whether the change improves outcomes depends largely on follow-up care, and the evidence there is not encouraging. A British study — conducted in a system where hearing aids are provided at no cost — found that roughly 60% of patients given hearing aids without follow-up care stopped using them. Devices that don’t get adjusted tend to end up in a drawer.
That’s the part worth weighing. The barrier to hearing aid use has never been only cost; it’s also fit, verification, and having someone to call when they don’t sound right. OTC removes the cost barrier. It doesn’t remove the others.
The Myth of OTC Hearing Aids?
Excerpt from the opinion column article published in The Hill. “Here’s what the OTC bill does: It uses the power of government to re-brand existing devices that are already sold over the counter. That’s it. There’s no improved access to anything; the devices covered by this bill are already available at Wal-Mart. The Warren bill will simply empower the FDA to regulate them as medical devices, allowing some companies to use government regulation to their financial advantage. “You Get What you Pay For
It’s valuable advice we received from our parents.
Something that has more features and higher quality will generally cost more. A Cadillac Escalade and Chevy Spark are both cars made by General Motors. The Cadillac is considerably more in price because it has more space, a more powerful engine, a high end sound system, heated and cooled seats, etc. If you are six adults traveling through 8 inches of snow, you can’t get the job done with a Chevy Spark.
Hearing aids are the same way…not all devices will get the job done. That’s where an audiologist comes in. Without first knowing the degree of hearing loss, it is difficult to get the right level of performance.
Hearing Evaluation/Testing
The first step on your journey to better hearing is a comprehensive assessment of your ears and hearing.
Hearing Aid Repair
We work with all the major hearing aid brands and can service, repair, and re-tune your existing devices.
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Do you have ringing in the ears? Our trained specialists can help you with answers and solutions.