PSAPs – In Defense Of – Part I

Editor’s comment:  Discussions of hearing aids versus PSAPs (Personal Sound Amplification Products) have heated up again since the FDA (Food and Drug Administration) issued its Draft Guidance for Industry and Food and Drug Administration Staff on November 7, 2013.  The Guidance Document was distributed for comment purposes only, and rapidly became a lightening rod for arguments both in favor of and in opposition to the Draft Guidance language. 

HearingHealthMatters.org has published numerous posts related to PSAPs versus hearing aids, allowing discussion on both sides of the issue.  Log on to the site and type in “PSAP” or any other word that you imagine can relate to this topic, and numerous posts will pop up that you can read and download as free .pdf files.  However, HHTM has never published a post by PSAP principals in which they provide their rationale for the sale of such products – until now.  Miles Goldsmith, M.D. submitted this article, “In Defense of PSAPs,” for publication.

Dr. Goldsmith believes that the FDA has overreached in its latest draft marketing guidance for personal sound amplification products (PSAPs).  He feels that the new FDA guidelines clearly threaten the viability of affordable hearing options, and rather than protecting the consumer, they will provide a barrier to access.

He asks, “Why can’t you try on hearing assistive devices much as you would try on eyeglasses in a pharmacy?”  Dr. Goldsmith objects to the reasons cited by regulatory bodies, believing that they are overstated to protect the financial interests of a lucrative industry.  He feels that their cited “ethical” rationale appears to emphasize the provision of the best hearing solution to those who can afford, rather than more affordable options to the most in need.

In this updated treatise in defense of mail order hearing aids, over-the-counter hearing aids and PSAPs, he lets his voice of dissent be heard.  Dr. Goldsmith believes that this issue demands public scrutiny and debate, particularly in these difficult economic times where health care access is in sharp focus.  This “Defense of PSAPs” will appear as a three-part post.  Parts II and III will follow in consecutive weeks.

                                                                     Wayne Staab, Section Editor

Miles Goldsmith, M.D.

In Defense of PSAPs

Miles Goldsmith, M.D.

Abstract

This article offers an opposing opinion in the growing debate on whether there is a legitimate role for online and OTC retail sales of more affordable digital hearing systems.  Personal Sound Amplification Products (PSAPs) have recently burgeoned in the hearing marketplace, providing an affordable and safe hearing solution for those unable to afford premium priced fitted solutions.  The new FDA proposed guidelines are overreaching; in some instances they are inaccurate; but more importantly, they largely reflect the bias and lobbying efforts of a hearing aid industry that is threatened by the intrusion of these more affordable hearing options.  As such, the result of these new restrictive guidelines on promotional marketing of PSAPs will not provide consumer protection, but rather a barrier to access.  This issue demands public scrutiny and debate.

Introduction to the Debate

Why are hearing aids so expensive?  Why can’t one walk into a pharmacy or other retail outlet and try on a more reasonably priced hearing aid without medical clearance or a signed waiver, much as one may currently try on lower priced eyeglasses without a prescription?  The answers given by regulatory bodies and other advocates of the hearing aid industry often cite consumer protection from bad devices and potentially missed medical conditions.  But why then do they not invoke similar rationale for those patients with visual loss and ocular conditions who try on over the counter (OTC) eyeglasses?

As a hearing professional, I am morally compelled to write this essay in support of more affordable hearing systems such as PSAPs, and to counter the many treatises offered on the Internet and in social media that have purported the supposed dangers and pitfalls of these lower cost devices which bypass the hearing professional.  These articles largely reflect the interests of a well-established network of licensed hearing professionals and the so-called “Big 6” hearing aid manufacturers that supply them, which collectively represent a lucrative multi-billion dollar industry.

In a microcosm, this hearing aid debate curiously mirrors the current health care debate in America.  Those who can now afford the best technologies desire the status quo, while the voices for the marginalized demand reform to achieve some degree of universal access.  Should we have a world of Mercedes and BMWs for a select few who represent the so-called “viable markets?”  Or, should we include Volkswagens for a majority of the eligible market that cannot afford access to premium devices?  Indeed, can America have two co-existent lines in which the “haves” and the “have-nots” may stand separately, yet mutually access a health benefit?  Or, will the collusive lobby of lucrative special interests prevail in protecting only a premium line?

I feel that there is a seldom-voiced ethical perspective in this hearing aid debate that needs to be heard.

Who Am I to Say?

But first, who am I to make this point?  I am a practicing neurotologist, or ear specialist, at The Georgia Ear Institute in Savannah, Georgia.  I trained at The University of North Carolina at Chapel Hill, served briefly on the faculty at Johns Hopkins, and then took my neurotology fellowship under Dr. Malcolm Graham at The Georgia Ear Institute.  Together with Drs. Graham and William F. House, I co-founded The International Center for Otologic Training ( ICOT ).  This is a non-profit foundation with a mission to positively impact the management of otologic diseases and deafness in the developing world through education and research.  Over the past 16 years, ICOT has helped train over 300 otologists from the developing world.  A significant part of our foundation’s research has involved efforts to develop affordable hearing solutions for the vast majority of the world’s hearing impaired who cannot possibly afford the expensive rehabilitative technologies in the current hearing health care market.

It is important for me to also disclose that I have a bias, or that is to say, a “dog in this hunt.”  I have recently formed a for profit company, ICOT Hearing Systems, whose mission is to fund and develop high quality, affordable hearing systems targeting the vast middle markets who cannot afford currently available technologies.  These hearing systems involve conventional hearing aids and high end personal sound amplification products (PSAPs), in addition to surgically implantable hearing devices such as cochlear implants, bone anchored hearing aids, and direct drive middle ear systems.  Profits from ICOT Hearing Systems will in part fund the ICOT Foundation in its continuing and expanding efforts to educate developing world physicians as well as our collective research quest to solve global deafness.

This treatise will focus only upon the debate within the field of conventional hearing aids and hearing systems, and specifically, whether there is a legitimate role for online and OTC hearing systems that bypass the audiologist or hearing professional.  We will leave the discussion of more accessible implantable hearing devices for a later date.

Ethics

Much has been written about the dangers and pitfalls of mail order and OTC/Internet retail hearing systems for the consumer.  Alarming claims are made that their sale is unlawful, unethical, and unsafe.  While some of these points have validity and merit, these strongly worded articles are largely overstated and fail to mention the legitimate value of more affordable hearing systems.  We will soon address each of these claims.

 Academically, I believe that my professional colleagues are technically correct in stating that the “best fit” for a hearing aid occurs when a patient’s hearing aid is tuned by a licensed hearing professional based upon a formal audiometric assessment.  In a world of infinite resources and universal access to health care, this approach clearly represents the best technology available, and from this perspective, it is the most “ethical” method by which to assist our hearing impaired.

But the practical reality is that there are limited resources amongst the hearing impaired, and this market is vastly under penetrated.  Indeed, an estimated 36 million Americans need hearing aids, but only 19% consistently have purchased them.  The reasons cited are myriad, but the single most influential reason relates to the prohibitive cost of professionally programmed hearing devices.  A $2000-4000 hearing instrument is beyond the reach of the majority of the hearing impaired in the USA, the most affluent country in the world.  And what about the rest of the world?  In my opinion, ethics, or what we “ought to do,” demands a more universal and pragmatic lens, whereupon the focus is to serve the greater good for the most people in need, rather than the greater good only for those who can afford it.

Regulatory Issues

If a person chooses to bypass a licensed professional, the FDA has required a signed waiver by a legal adult for the purchase of a hearing aid since 1977.  This process was upheld and continued after a petition by Dr. Killion et. al. in 2004.  The FDA’s reasoning was that such a requirement for medical clearance, or a signed waiver, protected the consumer from certain “red flag” medical conditions that may otherwise go undiagnosed if a consumer purchased a hearing aid without a medical examination.  Such red flag conditions include cerumen ( wax )  impactions, chronic otitis externa, acoustic neuroma, foreign bodies of the ear canal, and medically treatable hearing loss, among others.

This is an interesting regulatory position that was strongly lobbied for by hearing aid dispensers/audiologists and representatives of the hearing aid industry.  In the aforementioned analogous case of eyeglasses, if a consumer had ocular pain, unilateral progressive visual loss, eye drainage, etc., that patient would be expected to seek professional evaluation of the medical condition.  But, we do not require such a patient to seek medical clearance or sign a waiver before seeking relief of associated visual loss by purchasing a pair of OTC eyeglasses.  Why should policy be any different for vision versus hearing?  I suggest that the reasons for this inconsistency of policy relate more to protection of the special interests of a lucrative health network under the pretense of protecting the consumer.

The Concept of Pre-programmed Hearing Aids

Signed Waiver Required

There are digital hearing instruments now on the market from very reputable companies that can satisfy the vast majority of mild-to-moderate hearing losses in need of hearing assistance.  These devices are pre-programmed with settings in digital memory that “approximately fit” the usual down-sloping high frequency hearing losses that commonly afflict the aging ear.  That is to say, they are not perfectly tuned, but are often close enough that they represent a great value for the consumer.

These devices often come with the same high end “bells and whistles” such as directional microphones, noise and feedback cancellation software, and telecoils that are found in premium, more costly hearing aids.  Indeed, most come with the same warranty and trial period considerations.  Because they are pre-programmed, or pre-fitted, they bypass the hearing professional, and therefore cost 2-5 times less than the premium programmable devices.  With these devices, one simply inserts the hearing aid properly, selects the clearest sounding program, and adjusts the volume to comfort, and off you go.  If it does not sound right, then bring it back for a complete refund.  As discussed previously, a waiver must be signed by a legal adult in order to purchase such a device.  Typical warranties are one year, excluding crush, chewing, and water damage.

Personal Sound Amplification Products ( PSAPs )

No waiver required

A personal sound amplification product  (PSAP) is an electronic product whose labeled intended use is to help non-hearing impaired consumers amplify sounds for a variety of reasons.  Perhaps they may help one listen better in background noise, or hear soft sounds of a bird chirping, or more clearly hear a distant speaker.  Recognizing that the technology and function of PSAPs and hearing aid devices may be very similar, an FDA regulatory Guidance Document was issued on February 25, 2009, to clarify and establish regulatory requirements for distinguishing the two.  The FDA recognized that both hearing aids and PSAPs affect our ability to hear sound, but the products have different intended use, and thus different regulatory controls.  Following is that document’s description of a PSAP:

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.

However, PSAPs are subject to applicable provisions of the Radiation Control for Health and Safety Act of 1968, under which FDA regulates electronic products that emit sonic vibrations, such as sound amplification equipment (Code of Federal Regulations – CFR 1000.15).  Manufacturers of PSAPs must report defects and adverse events and take other measures described in 21 CFR Part 1003.  Manufacturers of PSAPs must also comply with the requirements to repurchase, repair, or replace electronic products required under 21 CFR Part 1004.

Thus, because PSAPs are not “devices” intended to diagnose or rehabilitate hearing loss, they are not subject to FDA regulatory requirements.  No medical clearance and no signed waiver are necessary for their purchase and use.  A high end PSAP may be very effective in providing listening assistance for those in need.

Next week, part two of  “In Defense of PSAPs” will address the questions “Are OTC Hearing Aid Sales Lawful?” and “Do OTC Sales of PSAPs and Other Hearing Systems Constitute a Dangerous Health Care Policy?”