Are PSAPs Legal and/or Dangerous?
This post on PSAPs is the second in a series of three by Miles Goldsmith, MD. In Part I of this series he commented that he thought the recent FDA Guidance Document was overreaching, and threatened the viability of affordable hearing options – rather than protecting the consumer, the proposed FDA document would create a barrier to access.
In this post he writes in defense of PSAPs, mail-order hearing aids, and over-the-counter hearing aids. He also questions the danger of such products that have been alleged by those opposed to their direct-to-consumer distribution. Dr. Goldsmith is a practicing neurotologist at the Georgia Ear Institute and co-founder of the International Center for Otologic Training (ICOT), which is comprised of both a non-profit and for-profit activities related to helping the hearing impaired.
Hearing Health and Technology Matters welcomes principled debate on this subject matter.
Wayne Staab, Section Editor
In Defense of PSAPs – Part II
Miles Goldsmith, M.D.
Are OTC Sales Lawful?
Pre-programmed hearing devices and PSAPs are increasingly available over the counter in retail centers, by direct mail order, and through Internet sales. Some states have passed laws prohibiting OTC and mail order sales without a dispensing license, indicating that it is within the power of the state to pass such rules as a public safety and welfare issue.
Such a state law was contested in a very important 2006 case, Missouri Board of Examiners for Hearing Instrument Specialists v. Hearing Help Express. In this case, Hearing Help Express, an out-of-state mail order/Internet hearing aid seller, asked the 8th Circuit Court of Appeals to review a lower federal district court decision. The lower court had stopped Hearing Help Express from selling hearing aids to the residents of Missouri without prior audiologic testing or fitting as required by State law. On review of the lower court’s decision, the US Court of Appeals for the 8th Circuit reversed the district court’s ruling. According to Liang et. al.,1 the court held that the Missouri State law was invalid because it was pre-empted by the federal Medical Devices Amendment (MDA) to the Food, Drug & Cosmetics Act, 21 U.S.C. §360(k). The MDA indicates that:
No State … may establish … any requirement – (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
Regarding hearing aids, under federal regulations implementing the MDA, an adult patient who wishes to purchase a hearing aid must either undergo an auditory evaluation or execute a signed waiver prior to being allowed to purchase the hearing aid (21 C.F.R. §801.421(a)). Hence, under federal law, an auditory examination is optional prior to hearing aid purchase.
The Missouri law was in direct conflict with the federal regulations. The State law directed that “no person shall (1) sell through the mails, hearing instruments without prior fitting and testing by a hearing instrument specialist” (Missouri Statute §346.110(1)). Audiological fitting and testing by a “hearing instrument specialist” (i.e., an audiologist) was mandatory under State law before a patient could purchase the device.
The federal appellate court noted that if acts that are simply permitted by federal law are made mandatory by State law, the State law requirements would be deemed “in addition to the federal requirement.” Applying this principle to the Missouri State law (Missouri Statute §346.110(1)), the court held:
Since the language used in [the MDA] expressly prohibits certain types of state regulation, we … conclude that the requirements in the Missouri statute are ‘different from or in addition to’ those prescribed by the MDA. The Missouri statute therefore ‘interfere[s] with the execution and accomplishment of the objectives of the FDA’s hearing aid regulation,’ … and must be deemed preempted by the MDA.
The federal appellate court reversed the federal district court ruling, and ordered the federal district court to enter judgment in favor of Hearing Help Express.
The federal appellate court decision essentially held that adult patients might purchase hearing aids online or through mail order with a signed waiver and without an audiologic fitting or testing. According to this federal appellate court ruling, the federal law in the form of MDA trumps State law, and as such it is lawful for companies to sell hearing aids independently OTC in retail outlets, through mail order, or online, provided that the consumer is a legal adult, and has medical clearance or a signed waiver.2 These requirements are not necessary for the sale of PSAPs.
Do OTC Sales of PSAPS and Other Hearing Systems Constitute a Dangerous Health Care Policy?
There are three issues to cover in this section: 1) Will important medical conditions relative to your ears go undiagnosed if you purchase an OTC or online PSAP, and, if so, what are the ramifications? 2) Will PSAPs hurt or damage ears? 3) Should PSAPs be banned to protect consumers from the sale of “bad” devices?
Let us discuss the so-called “red flag” medical conditions that are cited by regulatory agencies as likely to be missed if one purchases a PSAP. These red flag conditions include acoustic neuromata, wax impactions, foreign bodies in the ear canal, chronic ear infections, cholesteatoma, otitis externa (swimmer’s ear), and medically treatable hearing losses. At first glance, these seem to be a lot of scary terms, so let us break them down a bit to have a clearer perspective.
First, let’s look at the prevalence of some of the cited disorders in the general population. Acoustic neuromata are benign tumors of the balance nerves that can threaten hearing, but rarely life. They occur at a rate of 5-10 per million people, and they are suspected when hearing tests indicate asymmetry of hearing, or progressive unilateral hearing loss. Sudden sensorineural hearing loss is another medical condition, which is found at a rate of 20 per 100,000 people. Usually viral, it is an important disorder to pick up early because it is treatable with steroids, and roughly, half of these patients improve their hearing as a result. Other medically treatable conditions generally involve conductive hearing losses due to ossicular (ear bone) pathologies. These can be associated with chronic ear infections and a draining ear, or inherited conditions such as otosclerosis, which stiffens the sound transmission through the third ear bone, or stapes. The latter condition occurs at a rate of 20 per 100,000 people, and the resultant conductive hearing loss can be surgically corrected, with some small risk to hearing. Wax impactions and swimmer’s ears are more common acute ear conditions whose signs and symptoms are intuitive, and, in my view, are less relevant for the present discussion, as the symptoms generally prompt the need for professional evaluation.
While the above-mentioned more chronic conditions are important to pick up, they are: 1) comparatively rare, 2) rarely life threatening, and 3) most importantly, they are generally not aggravated or exacerbated by wearing a hearing aid. I am not saying that a person with suspicious symptoms such as unilateral progressive hearing loss, ear pain, and drainage, etc. should not seek and have professional evaluation. I am simply saying that it is uncommon for the clinically unsuspected and unattended case to be picked up incidentally on a professional evaluation for fitting a hearing aid. And, wearing a hearing assistive device, in the absence of such professional evaluation, rarely makes things worse.
Secondly, is it possible for hearing assistive devices that are not professionally dispensed to damage hearing, as is often claimed? There is evidence that noise, specifically cumulative noise exposure, damages hearing. Recent data points to early losses in young adults who overuse iPod and headphones to listen to music. However, the data with hearing aid related loss is sketchier, as it is hard to separate the continuing effects of the original pathology, which brought the hearing loss to device use in the first place. Suffice it to say, that “toxic” noise usually physically hurts one ears. So, if a hearing aid hurts one’s ears, one is likely to take it off before incurring damage to hearing.
Finally, we come to the proposal that only licensed hearing professionals are able to sell hearing aids so that the consumer will not get “bad devices.” The economic forces of free market capitalism, and not regulatory agencies of our government, should determine the viability of products in the hearing aid market. We do not license car dealers or vacuum cleaner sales persons for this reason. Furthermore, seeing a hearing professional is no guarantee against getting a “bad” device, only a more expensive one. Reputable retailers will not continue to carry devices if they prove to be “bad,” for sales will wither as return rates soar. With online sales, it is advisable to choose a product with a return policy and a warranty, both of which mitigate this non-issue.
In summary, my professional opinion is that one is not likely to damage their ears by trying on a hearing assistive device, and this risk is far overplayed in the present debate. Furthermore, the important red flag medical conditions are relatively rare conditions that are more likely to be found when clinical symptoms seek professional attention, and less likely to be incidentally discovered while having a hearing aid fitting. Although these conditions can have serious consequences and should be professionally evaluated if such symptoms arise, relief from hearing loss in these instances will not exacerbate the condition. By analogy, trying on a pair of eyeglasses will not exacerbate glaucoma, an ocular tumor, or an eye infection. Lastly, the marketplace should differentiate device quality, not the hearing professional.
Next week, part three of ”In Defense of PSAPs” will conclude Dr. Goldsmith’s posts addressing: “Why the Proposed New FDA Marketing and Labeling Guidelines Need Revision.”
1Liang, Bryan A. Law, financial arrangements, and implications for audiology, 2/5/2007.
2Missouri Board of Examiners for Hearing Instrument Specialists v. Hearing Help Express, Inc., 447 F.3d 21 C.F.R.§791,421(a) (2006).