The advertisements usually run late at night or real early in the morning because they're targeted at the senior crowd – those of us who have trouble sleeping. Or you see them in weekly coupon books and magazines. The commercials and ads push various hearing devices that enable "You to hear the TV without disturbing your partner for less!"
Well, maybe it's true but there's plenty of research to demonstrate that these ear amplifiers are not true hearing aids. And worse, yet, these low-ball, $19.95 plus shipping and handling personal sound amplification devices can actually be dangerous.
A study published by Michigan State University (MSU) in 2008 found low-cost amplifying devices not only do not meet the fitting requirements to help a person with hearing loss, but could actually potentially damage a person's hearing.
As reported in an article on Healthy Hearing, "Can You Put a Price on Good Hearing?": "The MSU research is important to consumers, Callaway said. Aside from being of extremely poor quality, very low-cost hearing aids - those under $100 - have the potential to damage your hearing because they send very loud sounds into the ear. The study's mid-range hearing aids ($100-500) were of higher quality and were not considered a safety hazard."
Regulation Hearing Aids Versus Personal Sound Amplification Products (PSAPs)
The strictest definition of a hearing aid covers a broad range of hearing "support" and conditions. Here's the definition, plain and simple.
Hearing aid means any wearable instrument or device for, offered for the purpose of, or, represented as aiding persons with or compensating for, impaired hearing.
So, a tiki shell necklace sold by a voodoo man who claims the necklace, when worn for eight full moons, will clear up that lost hearing qualifies as a hearing aid under this definition. After all, the salesperson "represented" the voodoo magic as a cure for hearing loss. Hey, what more do you need?
Ok so perhaps that is an extreme and silly example. And of course we all know a shell necklace is not a hearing aid; however, you may think you know what a hearing aid really is and does. But when it comes to PSAPs versus hearing aids, looks can often be deceiving. In all reality, many PSAPs look like an actual hearing aid and many consumers, persuaded by a cheap price, purchase them thinking they are getting a hearing aid for their hearing loss.
Consumer must look beyond appearance to know if a device is an actual hearing aid. Hearing aids are compact devices comprised of digital circuitry that can be adjusted to the wearer based on professionally administered hearing evaluations.
So, a true hearing aid:
- is programmed by the hearing professional (such as an audiologist or licensed hearing aid dispenser) in order to precisely amplify for a diagnosed hearing loss
- may or may not be manually adjusted by the consumer, depends on model chosen
- are intended to compensate for hearing loss and are labeled with this intention
- are regulated by the Food and Drug Administration (FDA)
Now, how is a hearing aid different from a personal sound amplification device or PSAP?
- PSAPs are intended to amplify environmental sounds for non-hearing impaired consumers
- Amplification is preset and is further controlled by the wearer by volume control changes
- They are not programmed based on a hearing loss
- They are low cost, which translates in to low quality sound quality
- The PSAP is not fit by a hearing professional
- A PSAP is NOT recognized as a medical instrument, which means (1) it doesn't have to meet the same FDA standards as hearing aids do and (2) it doesn't have to fulfill the promise on the box of "Easy, natural sound." (no labeling restrictions)
The Food and Drug Administration
The FDA requires hearing aid manufacturers to adhere to a strict set of regulations and standards in the design, development and use of their hearing aids. These stringent standards fall into the Category of Class I (General Controls) under FDA regs and these, in no uncertain terms, set the bar for even minimum quality standards for hearing aids.
The FDA defines a hearing aid as "any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing." This definition encompasses both air and bone conduction devices in a variety of styles.
PSAPs are regulated under something called the Radiation Control for Health and Safety Act of 1968 that simply states that PSAP makers must provide "Notification of defects or failure of compliance of manufacturers" and "repurchase, repair of replace the electronic product."
The FDA states: "PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers and listing of these products with FDA."
That's it. Basically unregulated devices are available to persons to purchase just as long as they do not claim to compensate for hearing loss on their labeling.
So what's the Big Deal?
Several big deals, actually, all involving your ability to hear and keeping what natural hearing you have left. So, that makes it pretty important.
The problem comes from the widespread use of PSAPs by a lot of people who don't need them. In addition, these devices can be cranked to max volume, no sweat. No hearing, either, but no sweat.
PSAPs, which are currently under study by the FDA, are growing in popularity and actually replacing the use of certified, quality hearing aids for a number of reasons:
- easily accessible (just watch TV for half an hour)
- much lower cost and,
- ease of use
However, the use of these listening devices creates some problems that users might not have even considered:
- the delayed diagnosis of a treatable hearing loss problem
- the inappropriate use of the o-t-c devices
- less-than ideal fit – in fact, PSAPs are usually a one-size fits all gizmo
- less-than ideal fits due to the poor quality of PSAPs can lead to negative opinions toward amplification devices in general and prevent persons with hearing loss from pursuing hearing aids when they actually truly need them
And while all of these are serious, potentially dangerous aspects of PSAP use, the worst is yet to come.
Hearing aids – even basic, plain vanilla hearing aids – come standard with sound limiters and filters that prevent further damage to the already-damaged hearing mechanism. These hearing aids are further tuned by your hearing professional to ensure that you get the boost you need at certain frequencies, but limits the loudness the device produces.
This protects the inner ear from further damage caused by exposure to loud noise over a long time period. Not so with PSAPs.
PSAP maximum volume comes preset and is determined by the wearer who, naturally, amps up the volume to a comfortable hearing level. Unfortunately, it may also be a dangerous hearing level due to existing hearing loss – the reason the consumer purchases the PSAP in the first place, in many cases.
To hear the TV better, to hear on the telephone (watch that feedback), or to hear the deer before it hears you – some people who purchase PSAPs don't even have hearing loss. The just want to hear better in certain situations. Unfortunately, PSAPs don't come with limiters or filters so the danger of further hearing loss is always a possibility.
And though the FDA is in the process of defining regulations for PSAPs, in the end it's your responsibility to get pro-active when it comes to hearing health. What does that mean?
If you're considering the purchase of a PSAP, you already suspect hearing loss, right? So, have a hearing evaluation and consider purchasing actual, legit hearing aids and enjoy the sounds that surround you. (If you truly are looking at a PSAP for recreational use and do not have hearing loss, great - wear with caution.)
Your hearing aid – even the entry-level variety – will deliver a healthier and more natural listening experience – one worth the investment. In fact, you'll wonder why you waited this long. Treating hearing loss with hearing aids has been shown time and time again in studies to improve overall quality of life. When it comes to your quality of life, is it worth going cheap?
See a hearing professional today and take the first step toward a better quality of listening, a better quality of life. And stay clear of any device that let's YOU decide what's loud enough. Chances are, it's too loud.
Think "healthy" hearing, your ears will thank you.
