By David H. Kirkwood
MARSHALL, TX–The Texas Hearing Aid Association (THAA) has brought a federal class-action lawsuit against Wal-Mart Stores Inc., charging that the world’s largest retailer is selling hearing aids in Texas without the state-mandated license. The plaintiffs, who filed suit last month in U.S. District Court for the Eastern District of Texas in Marshall, are asking the court to stop Wal-Mart’s hearing aid sales in Texas immediately.
In an August 21 interview with Hearing News Watch, Bill Chamblee, who is lead counsel in the case, said that Wal-Mart stores in Texas are violating state law in having non-licensed employees dispensing the devices. He said that the Texas law, which is supported by federal law, “serves a legitimate public health interest.”
In an earlier statement, Chamblee, who is managing partner of the Dallas-based firm Chamblee, Ryan, Kershaw & Anderson, said, “Wal-Mart knew it was required under Texas state law to become licensed in order to dispense hearing aids in Texas stores, yet the corporation has failed to take all necessary steps to ensure their ability to do so.”
“There’s a reason the state allows only licensed dispensers and audiologists to fit and dispense hearing aids in Texas. When an individual suspects they have hearing loss, a licensed hearing professional will be able to give a complete examination of the patient’s auditory health in order to detect infections and other problems that aren’t addressed by simply wearing a hearing aid.” –Bill Chamblee, lead counsel
Non-Custom Hearing Aid Products
The hearing aids that Wal-Mart sells in its Texas stores are non-custom devices, made by General Hearing. When a customer buys a hearing aid, no testing is conducted to determine what the person’s hearing loss is, whether or not the person is a candidate for hearing aids, or if the device being sold is appropriate for the particular customer’s hearing problems.
Many amplifying devices are sold this way both in stores and online. If they are marketed as personal sound amplification products (PSAPs), they are exempt from Food and Drug Administration (FDA) regulations and state dispensing laws. However the products that Wal-Mart sells in its Texas stores—and also on its web site for prices ranging from about $350 to $500 a piece—are specifically called hearing aids and are expressly intended for the purpose that hearing aids serve—to help people compensate for a hearing loss.
In some cases, Wal-Mart is requiring that purchasers first sign a waiver saying that they have chosen not to get a medical examination before buying hearing aids. However, Chamblee told this blog, he has many eye witness accounts from people who purchased the hearing aids from a Wal-Mart store in Texas without signing a waiver.
Many audiologists and hearing aid specialists routinely offer their patients such waivers, but the signing of a waiver does nothing to override a state law stating that only a licensed professional can dispense hearing aids.
Lawsuit Demands Wal-Mart Return Hearing Aid Sale Profits
In addition to asking the Federal District Court to stop Wal-Mart from selling hearing aids without a license, the plaintiffs want the court to require the Bentonville, AR-based company to return the profits from prior unlicensed sales. Although Chamblee would not estimate how many hearing aids Wal-Mart has sold illegally on Texas, he said there have been many thousands such sales.
The attorney charged that the company has chosen profits over the health interests of Texans. He said, “The State of Texas estimates that more than 3.8 million residents are deaf or hard of hearing. That’s a tremendous potential customer base that Wal-Mart apparently couldn’t resist.”
Wal-Mart has until August 27 to respond to the suit. While attempts by this blog to reach the company were unsuccessful, Dan Fogleman, a Walmart spokesperson, has said that his company’s mission is to help people save money and live better, and that offering inexpensive hearing aids serves that mission.
This could be the tip of the iceberg, as Wal-Mart is clearly not alone in this endeavor. Despite changes in definition of PSAPs by the FDA in recent years, this is still a very gray area that needs to be more clearly defined for the sake of the professional and the consumer.
FDA did not change the definition of PSAP, they created it in 2009. The FDA distinction between PSAPs and hearing aids is clear. It is about intended use. This is a quote from the guidance document issued by FDA for consumers”
“Hearing aids and personal sound amplification products (PSAPs) can both improve our ability to hear sound,” says Eric Mann, M.D., Ph.D, deputy director of FDA’s Division of Ophthalmic, Neurological, And Ear, Nose, and Throat Devices. “They are both wearable, and some of their technology and function is similar.”
Mann notes, however, that the products are different in that only hearing aids are intended to make up for impaired hearing.
Perhaps “changing the definition” was a poor choice of words on my part, since as we both know this was a newly created category by the FDA back in 2009. That being said, I’m not opposed to PSAPs at all, as they do serve a purpose and can provide benefit to some people. However, my comment was simply the fact that despite this intended ‘distinction’ by the FDA, there has been an increase the past few years in marketing and advertising PSAPs as hearing aids or indicating their use specifically for impaired hearing.
I don’t want to ban PSAPs by any stretch–in fact, I think more audiologists should embrace them. But, there are valid reasons every state in the union has consumer protection laws regarding the fitting and dispensing of hearing aids by state-licensed professionals. If Wal-Mart is guilty and has been selling OTC “hearing aids” then they should be subject to the same state penalties any other business would incur in Texas or any other state they may have been in violation of the law.
I find it interesting the position of embracing PSAPs considering Etymotic is a sponsor advertising on this site. The real difference between PSAPs and hearing aids is that if you call the device a hearing aid the product is under the watchful eye of the FDA. If they call it a PSAP all bets are off and they can do whatever they want. I would rather have a product that is monitored by the FDA than not, don’t you think. If everyone keeps pushing this issues all these companies are going to do is change the devices to PSAPs and you won’t be able to touch them. WAKE UP!
As a hearing aid wearer with a friend that’s an audiologist I wonder:
1.How come there are not articles about how audiologist get free TV’s and iPads for the amount of hearing aids they buy from a hearing aid manufacturer. The audiologist buys 6 high dollar hearing aids from a manufacturer so they can get a free iPad “to help their practice” and the next few people that come through their door are going to get $8,000 units even if they don’t need them because the audiologist needs to unload inventory.
2.How come these large manufacturers can offer free equipment and financial loans basically owning the soul of the audiologist limiting the options to the patient.
3.How come the sound quality of these device are not getting better. All the industry seems to care about is bells and whistles that they can pack into the device charging me more for a hearing aid that does not sound better than my analog hearing aids from 15 years ago.
And you want to talk about doing the right thing………ethics………..morals……………
Audiologist just care about their wallet (sorry Bill) bottom line. Address what I’ve stated above first then worry about competition that is making things better for me the patient. You know the person you got in this industry for to help.
Robbie, you make several points in your comment, so I’d like to respond from an audiologist’s perspective.
Personally, I think PSAPs can serve a purpose (for example I have plenty of patients who use them for hunting). However, I am adamantly opposed to misleading advertising (which is rampant in the industry) and believe that companies should be punished accordingly if they are doing so. Consumers need to know they are not buying a hearing aid and should be educated as such.
Considering you have a friend who is an audiologist, I don’t think s/he would appreciate your generalization of the profession as a bunch of crooks and thieves. The examples you give of manufacturer incentives and forcing expensive devices upon unsuspecting patients is pretty offensive. Nearly all of the examples you provide would be considered ethical violations by AAA, ADA or ASHA. These occurrences are not the norm in my experience, so I’m not sure what your friend is telling you about the profession of audiology and I’m sorry if you ever felt like you’ve had this sort of experience as a hearing aid user. Based upon your descriptions, audiologists should be living in luxury…however, the profession of audiology is one of the lowest paid doctoral professions, with average pay equivalent to dental hygienists.
When someone commits 8 years to a degree in audiology, it’s often because they genuinely want to help people. It if was all about money, they would have chosen a profession with higher pay and less educational requirements.
I’ve been tested for hearing aids, after the test was over, the price of what the test showed I needed was in the $9000.00 range. I decided , like many other Americans who can’t afford to spend that kind of money, to buy a set from Walmart, for $900.00.
They work very well, and I’m happy with them. I honestly don’t see any difference with these $900 hearing aids, and the set costing 10 times as much. I really don’t see why this is a bad thing for people who need help. It’s no different then buying a pair of reading glasses for $20.00 at Walmart versus $500.00 at a professional optician.
The high price of hearing aids is the problem. Make them cheaper, and people will buy them. Everyone wants to gouge the public, you’re hurting yourselves. I hope your lawsuit gets thrown out.
One point that has not been mentioned is that the pricing for hearing aids purchased at a clinic or private practice is often “bundled.” In other words, the hearing aid evaluation and subsequent verification and follow-up visits and services are factored into the asking price. At our facility, we do not charge for any reprogramming visits, and we will see an individual as often as needed to insure they are receiving maximum benefit from amplification. We do not charge for the initial hearing aid consultation, during which an individual’s hearing loss, amplification options, levels of technology, etc. are discussed. It is disheartening to spend a lengthy period of time with someone, help them make a decision regarding amplification, provide literature, etc., and yet they ultimately elect to purchase the recommended device online in order to save money. What they fail to realize is they will then have to pay for reprogramming and follow up services elsewhere, and the total cost of the hearing aids basically ends up close to our original price. The audiologists I know are honest, hardworking individuals who genuinely care about the communicative needs of their patients. For some to imply that we are money-hungry and dishonest is insulting and demonstrates a lack of knowledge. People additionally fail to realize the research that has contributed to the development of current hearing aids, and if they could listen to the quality of sound through a PSAP and a properly fitted hearing aid, they would hear a world of difference. The same is true for an entry level versus a high-end device, particularly in a noisy situation. These are things that an audiologist or experienced fitter/dispensing can discuss. Most of the time, you truly “get what you pay for.”