fda over the counter hearing aids


Here is the Real Story Behind Over the Counter (OTC) Hearing Aids

OTC (Over The Counter) hearing devices are back in the spotlight. Hearing healthcare professionals, manufacturers, and lawmakers are taking a hard look at what this means for the economy, and where these products currently stand in the marketplace.

Hearing devices known as PSAP’s (Personal Sound Amplified Products) have been around for many years and are nothing new. Currently they can legally be bought online or through mail order. Sadly, while there will always be people looking for the next “something for nothing” gadget that promises to fix their hearing problem, they inevitably end up losing their hard-earned cash while becoming disilussioned about amplification products and hearing professionals in general.

The most common mantras we hear from those who need hearing aids goes something like this:

It seems to me that hearing aids are so expensive! With all the new technology available to us today, why can’t we make something less costly for people who aren’t made of money? Besides, there is only about $48 worth of circuits and plastic in those things anyway – and I should know because I worked for company ABCXYZ for 6 months …“

“The cost of hearing aids is so high. It’s important for U.S. lawmakers to bring down these costs through new legislation, so that competition will drive prices down, thereby making hearing aids more affordable for everyone.”

The FDA and some lawmakers appear to make a valid point about making hearing help available to as many Americans as possible. They claim that the high cost of hearing devices make them inaccessible to those who need them most. However, many healthcare professionals, including myself, disagree.

These well meaning individuals are either ignorant of the facts, or present a biased argument because of political or monetary gain. Their biases prevent them from correctly evaluating the situation and coming up with the right solution to the problem.


Hearing aids are already priced at an affordable rate. Ironically it is the same rate that PSAP’s or OTC devices will be priced at when they hit the market (About $368-$650 each).  But why do more people not know about this?Simply because it’s not showcased at the Audiologist or Hearing Aid dispenser’s office, and for good reason!

The professionals know better than anyone else that these devices don’t work well enough. No matter which way you see it, an OTC device simply does not work as well as other (more expensive) hearing aids in a noisy environment. An OTC or PSAP will never ever be able to compete with a hearing system that processes complex speech in noise simultaneously while improving the SNR (Signal-to-Noise Ratio).


Let’s consider why using two hearing aids is far superior to using one. The human eye provides us with clues as to why this is true. With two eyes we can perceive depth because we have another perspective. But when using only one eye everything appears to be flat or subjects in view may look larger. This can be very deceiving because it impairs our ability to judge depth or distance correctly. There is no doubt that a person can see much better with two eyes rather than one.

The concept is the same with hearing aids. When wearing one hearing aid, (even with a directional microphone), it becomes difficult to locate the source of sound or speech. This principle applies to all hearing aid devices.

Firstly, with only a single point of reference your brain cannot compare signals effectively. For example, a sound created on your left side (while wearing a hearing aid in your right ear), will be perceived to originate from your right side. Without a second point of reference, you will automatically look toward the direction of the louder sound source. In other words, you will look in the wrong direction. The implication of this problem is that you could walk across a street, hear the sound of a car horn, then look in the wrong direction. The outcome could be fatal.

Secondly, wearing only one hearing device does not improve the signal-to-noise ratio for a person with binaural hearing loss, especially noise induced hearing loss. This is because background noise is predominantly low pitched. Therefore a person with this type of hearing loss (who has better hearing ability for low frequencies compared to their inability to hear high frequency portions of speech), will struggle to hear the speech cues. High frequency portions of speech are vital in isolating speech when we listen in a noisy environment.


Amplification alone does not solve the problem of being able to isolate speech above other sounds around us (i.e. it does not improve the signal-to-noise ratio). Many people who chant the mantra of “low cost hearing aids” purchase one hearing aid instead of two. Those suffering with mild to moderate hearing loss sometimes conduct a self-diagnosis, and opt to amplify sound in the ear they strugle with the most.

They are often reluctant to purchase a second hearing aid because it then moves them into a price point of more advanced hearing aids. But even if they do decide to purchase a second hearing aid, they fall into the trap of using two hearing aids that are designed to work INDEPENDANTLY OF EACH OTHER rather than being SYNCHRONISED. Because each individual unit has no way of interacting with the other unit, this can agravate the persons hearing problems even more. Every hearing professional knows that If the signal-to-noise ratio is not improved, audability in a noisy environment is not improved.

It is important to note that there is currently no technology that exists in over-the-counter hearing devices that enables them to isolate and redirect speech. Unlike advanced hearing aids.They are designed to work as independent devices and can therefore not interact with a second hearing device.


If we already have low cost products available at the dispensing offices of hearing instrument specialists and Audiologists, then why is there a push to introduce an over-the-counter device?

Many of my colleagues will say that “these are patients that will never come into your office in the first place. While this may be true in some cases, I contend that it is no reason for us to sit by idly and let them be taken advantage of by someone that wants to make millions in product sales, or who wants to make a name for themselves in the political arena!

Our ethics teach us to not engage in this kind of behavior. As a Board Certificant Holder I must adhere to what is in our Ethical Code of Conduct under the section:

Responsibilities To The Patient/Client

The Certificant, as a practitioner in the hearing health care profession, shall hold paramount the welfare of the patient/client. The Certificant shall respect the inherent dignity and rights of all individuals. The Certificant shall adhere to the core values of the profession and shall act in the best interest of the patient/client over the interest of the Certificant. The Certificant shall not engage in conflicts of interest that interfere with professional judgment.

I guess that the folks that are pushing this issue are not being held to a level of any standard, or ethics that compels them to do the right thing. It is my opinion that the driver of this bill to endorse OTC devices is surrounded by money or political gain, and not in the best interest of the consumer/patient/client.

Those of us professionals who see patients daily, and help them through their struggles to maintain their level of communication with their family, loved ones and the general public, know that being able to hear and understand is most important to them. Through counseling and low cost devices we find creative solutions to help them maintain their dignity and ability to communicate effectively.

Helen Keller, once said that losing one’s hearing is worse than one’s sight, because losing one’s sight cuts you off from “things” but losing your ability to hear cuts you off from “people”.

The proponents of OTC hearing aids, seek only to sell a product of sub-standard quality to an eager community desperate to engage with the people around them. It just does not seem right to me to take advantage of a person in a desperate situation in order to make a profit, or simply to gain a political advantage.

This movement also seeks to drive a wedge between the professional and the patient. Ironically it is the professional who provides the keys to better hearing and successful hearing aid fitting. The hearing professional focuses on developing and maintaining good relationships with their clients. They get to know their customer in order to deliver meaningul and effective hearing solutions that count. A hearing aid professional simply cannot be put in the same category of a vendor peddling low-cost, innefective hearing aids!


If you find yourself in the predicament described in this article, call Vincent, Amanda, or Michelle for a no-obligation friendly discussion to see if we can find a great solution to your hearing challenges.

Because we also offer FREE HEARING TESTS with no obligation to do business with us, you can only gain by coming to see us before you make your next expensive mistake!

The levels of professional advice, service and attention to detail that we provide for our valued customers at Lifetime Hearing Denton, is priceless and certainly cannot be compared to over-the-counter hearing devices, no matter how cheap they are. Those who know us can testify to the levels of service, attention to detail, and sound professional advice they get once they come through our doors!. Our customers become our friends, and have no hesitation in refering us to their family, friends, and colleagues.

We are so confident of the great customer experience enjoyed by many, that we will put you in contact with one or more of our customers so that you can get first hand testimonials from them.

So what have you got to lose?

Call AMANDA, MICHELLE, or VINNY now on (940) 2432766, or visit us at Lifetime Hearing Denton, 301 Dallas Dr #126, Denton, TX, 76205

listening to music with hearing aids


Listening to Music With Hearing Aids

Listening to music with hearing aids can be frustrating. Folks with normal hearing enjoy musical celebrations this time of year, but for us with hearing loss, it presents difficulty.  Be it a concert at U.N.T.or an unexpected caroler come a wassailing, it can be unnerving.  I have worn hearing aids for several years now and find that listening to music tends to lose its luster on any “automatic adjusting” program.  But why is this the case? Hearing aids get confused on the automatic program while listening to music. Hearing aids have trouble distinguishing between musical notes played from a violin or piccolo, versus actual feedback created by the physical product itself. The short answer is that hearing aids create artifacts when attempting to correct the “perceived” feedback while in automatic program mode.

Switch to Music Program Mode

The best way to listen to music is by using hearing aids with an integrated music program. This enables you to enjoy the full dynamic ranges of the music. Have your hearing aid dispenser install a “Music” program for your hearing aid. When you listen to music you can then simply change the program on your hearing aids to music mode, and the result will be great sound quality without any feedback.

Recently my wife and I attended an exuberant packed-house holiday musical performance at the Margot and Bill Winspear Performance Hall at U.N.T.  I was enjoying the concert, but it wasn’t until I adjusted my hearing aids to the “Music” program via my iPhone that I could really enjoy the full and complex musical sounds of the music.

Its Time to Listen to the Music Again

One of the greatest novelists of all time, Leo Tolstoy once said that “music is the shorthand of emotion” and for most of us, being able to listen to music is indeed one of life’s great joys — and something we often take for granted.

If you’ve suffered some degree of hearing loss, you’ll know that listening to music is no longer what it used to be. How we hear music is subjective and individual, making it difficult to reproduce authentically and naturally through a hearing aid. The good news is that hearing your favorite music the way you remember it is within reach.

Get Your Hearing Aid Music Program From Lifetime Hearing Denton

Come and see us at Lifetime Hearing Denton so that we can advise you on the best solution for your needs. Don’t miss out on the joy of music this Christmas!





Hearing loss and dementia in ageing adults

There appears to be a link between hearing loss, dementia, and cognitive decline in ageing adults.

So which came first, the chicken or the egg? Or better stated after reviewing the 2016  White paper ACTA Otorhinolarngol Ital 2016 ; 36 : 155-166, which came first hearing loss or cognitive decline?

The summary states:

Age related hearing loss (ARHL) has multi-factorial pathogenesis and it is an inevitable hearing impairment associated with reduction of communicative skills related to ageing. Increasing evidence has linked ARHL to more rapid progression of cognitive decline and incidental dementia.

It also states:

Long term hearing depravation of auditory inputs can impact cognitive performance by decreasing the quality of communication leading to social isolation and depression and facilitate dementia. On the contrary, the limited cognitive skills may reduce the cognitive resources available for auditory perception, increasing the effects of HL. In addition, hearing loss and cognitive decline may reflect a ‘common cause’ on the auditory pathway to the brain.

Hearing loss increases a person’s tendency towards dementia

This report is endorsing the fact that hearing loss increases a persons’ tendency towards dementia, something that new studies have been demonstrating that impaired hearing can contribute to cognitive load and therefore affect attentional and cognitive resources that are important for maintaining posture and balance.  However, it also states to the contrary that cognitive decline outside of hearing loss can contribute to the onset of other contributing factors such as hearing loss. Either way, going on without hearing help for auditory depravation simply put, is destined for a cascade of progressive risks to mortality.

Hearing loss contributes to isolation and social withdrawal

In general, we know that hearing loss contributes to isolation and social withdrawal, but new evidence indicates there is so much more. The decline in older adults with untreated moderate to profound hearing loss may develop a cascade of conditions including communication difficulties, social isolation, depression, an association with falls, and declines in physical functioning, decreased quality of life and even cognitive decline, that can be counteracted by a hearing aid. There is this “cascading hypothesis” among professionals where the relationship of HL and cognitive decline, the natural consequence is that the use of hearing aids or a cochlear implant should be associated with better cognitive performance.

Hearing loss and cognitive decline interferes with good health

Hearing loss and cognitive decline as a consequence interferes with good health and reports have found that HL is associated with a 20% increase in mortality compared with normal hearing in community dwelling older adults aged 70-79. Staying active is critical in maintaining ones well being and sense of worth.

Robust evidence suggests that HL in the elderly is independently associated with the development of cognitive decline and dementia. Several hypotheses on the pathogenic relationship between HL and cognitive decline have been argued and summarized in conceptual thinking where the hearing impairment impacts cognitive load, alters brain structure and function, leads to social isolation and depression related with common genetic and environmental factors.

HL and its general effects on cognition are highly prevalent in older patients and the effects there of may be preventable and treatable with rehabilitative devices like hearing aids or cochlear implants, which remains to be widely underutilized.  HL is something that goes undetected in many cases, therefore, it is the recommendation of the medical community and this specialist to have your hearing tested early.