Overview and History
For more than two decades, the authors have been involved in assessing and reporting on issues related to "mail order" hearing aid sales.
Earlier reports concluded that due to the enormous complexity of human hearing, the tremendous range of human communication needs and the elaborate federal and state regulatory systems, that hearing aids acquired through mail order venues represented a cruel hoax on the unsuspecting consumer!
In other words, purchasing hearing aids without appropriate face-to-face professional services (including, but not limited to: otoscopic examination, audiometric testing, analysis and interpretation of results by a licensed health care professional, patient-to-professional relationship, hearing loss counseling, assistive listening device education, aural rehabilitation programs and most importantly - a diagnosis!) makes little sense and may indeed be dangerous.
So, here we are, years later, and we find ourselves essentially in the same debate over what should be a settled issue. But, this time - there's a new twist. The Internet provides additional opportunity for unsuspecting consumers to acquire hearing aids and "alternative" amplification devices, without regulatory safety nets and without professional services, and without much chance of success! Alas, whether by mail order, Internet, or carrier pigeon, we find ourselves talking about the very same issues as before. So, for the benefit of all those who weren't privy to the previous discussion - "Here we go again..."
Imagine if you were to simply purchase the engine, transmission and body of an automobile, and then you had to build the car in your driveway - no mechanic. Imagine buying the components and supplies for your dishwasher, and then building and installing it yourself - no plumber. Can you imagine buying a fast-drying compound and filling your own dental cavity without having a dentist involved? Seems pretty dangerous! Of course, these are silly examples, but the point is, hearing healthcare is much more than simply buying a hearing aid!
The acquisition of hearing aids and amplification devices requires professional knowledge, tools and services. To bypass the hearing healthcare professional or to go around the state and federal guidelines is analogous to bypassing the mechanic, the plumber and the dentist. And yes, it is pretty dangerous!
Same Fatal Flaws Exist Today
Without exception, there are fatal flaws in the marketing and acquisition of hearing aids outside legitimate, duly licensed, authorized hearing health care delivery systems.
Some of the flaws include (but are not limited to):
- Complete circumvention of state and federal laws and professional codes of ethics (all of which were designed to protect the consumer). When consumers acquire hearing aids through non-traditional sources, many state and federal laws are broken, and after participating in these practices, the consumer has few (if any) options to receive satisfaction in the event of dissatisfaction or injury.
- Substandard cost/benefit ratio, relative to ergonomics, technology and applications. To paraphrase..."The joy of a low price is quickly dashed through the ongoing disdain of poor quality and a lack of services!"
- Total absence of professional guidance, cautions, diagnosis, referral system, auditory rehabilitation programs, and ongoing professional care. Simply stated, some hearing problems are indeed medically treatable, and some hearing losses are an early presentation of serious medical conditions, which need medical attention (more on this later). Audiologists and hearing instrument specialists are trained and licensed to know what to look for and to maximize the opportunity for consumer/patient safety. These professionals look for specific test results (types and degrees of hearing loss) visible findings (from the otoscopic ear examination, such as ear wax, perforated ear drums, debris in the ear, infection etc), historical indicators (personal and family history, medicines, noise induced hearing loss, arthritis, head injuries) and other issues, to determine the most appropriate path for the consumer/patient. Hearing aids are wonderful, amazing and useful tools - but if applied incorrectly or inappropriately, the consumer/patient can potentially be placed at an additional disadvantage, and even in danger.
Online Hearing Tests
Something new, available across the Internet, is the promise of "a quick and easy hearing test." The online hearing test is a marvel indeed. It has value as it allows reluctant consumers to participate in a screening test at home, and may inspire the consumer to seek professional guidance.
However, online hearing screenings do not replace otoscopy, middle ear assessment, calibrated pure-tone testing and speech audiometry, a sound controlled environment (a sound booth), nor are they diagnostic, nor do they replace professional audiometric interpretation!
It is impossible to obtain the necessary information for determining hearing aid candidacy without a sound-controlled environment, calibrated equipment, and a licensed professional who has demonstrated competence in the testing of human hearing!
If a simple "beep-based" hearing test was all that was truly required to appropriately select and fit hearing instruments, consumers would be buying hearing aids from electronics stores and mass merchants where efficiency, mass production and one-size-fits-all takes precedence over customization, calibration, and professional guidance. However, the "beep-based" test is nothing more than a screening, and it does not yield enough information upon which to base the candidacy or recommendations for hearing aids!
Safety Does Matter
There are many good reasons why we have the United States Food and Drug Administration (FDA) Hearing Aid Regulation. Not the least of which is to assure the public health and safety. For instance, under the "Red Flag" conditions alone, there have been at least 250 known otopathological conditions (ear diseases and disorders) identified, which require medical referral.
Most of these diseases and disorders exist without pain or fever, so self-discovery by the consumer is unlikely. Appropriate suspicion, referral and management is usually afforded only after otoscopy (the examination of the ear with a special flashlight designed for ear examination), medical examination and completion and interpretation of a comprehensive audiometric test battery.
Bypassing these important detection protocols allows undetected conditions to develop into a variety of potentially life threatening and significantly more complicated conditions.
For example:
-Tumors, such as; cholesteatoma, glomus jugulare, glomus tympanicum , osteoma, ulcerated squamous carcinoma, hematoma, acoustic neuroma, and vestibular schwannoma.
-Infections, such as pseudomonas, candida, staphylococcus aureus, otomycosis, meningitis, or neuritis statoacoustica.
-Undetected trauma, such as; temporal bone fracture, labyrinthine concussion, acute acoustic trauma.
-Undiagnosed inner ear conditions that could cause sudden and complete hearing loss, such as; Meniere's disease or syndrome, cochlear stroke, allergy, large vestibular aquaduct syndrome, or ototoxic reactions from medication.
Detection and treatment of these conditions often requires the services of clinical audiologists and otolaryngologists. Hearing instrument specialists are also required to undergo extensive training to detect these "Red Flag" conditions, and to make referral when any of these conditions present during the hearing test.
To intentionally bypass well-established consumer safeguards is unethical and is clearly illegal under many state and federal regulations. And -- that is precisely what is done when some consumers and marketing concerns purchase and sell hearing aids across the Internet!
The American Academy of Audiology (AAA), in March, 2000, adopted their
"Pre-purchase Assessment Guideline for Amplification Devices." Paraphrasing from that document, the AAA stated:
It is the position of the American Academy of Audiology that every person seeking treatment of hearing disorders through the use of amplification devices (for example, hearing aids) receive a comprehensive audiological evaluation prior to purchase. This evaluation must include any and all necessary procedures to determine: (a) thorough history of hearing loss, (b) auditory sensitivity (thresholds), (c) speech recognition capabilities, (d) type of hearing loss, (e) need for referral to a physician, (f) need for referral to other professionals or agencies, and (g) candidacy for amplification devices. The comprehensive audiological evaluation must be performed by an audiologist who is licensed or registered in the state wherein the evaluation is completed. The diagnostic evaluation is not conducted for the purposes of selecting or fitting a hearing aid, but to rather assess the functional status of the auditory system, and to assure that amplification or other assistive listening devices are an appropriate treatment strategy.
Do Improperly Fitted Hearing Instruments Really Pose a Threat?
Yes, they really do! Back in the mid-nineties, the senior author (MSC) was requested by several state attorneys general to investigate potential harm to consumers, while they wore hearing aids obtained through mail order. The manufacturer of those devices claimed they were "non-hearing aids," and they claimed exemption from the law.
We were sent samples of several of these "non-hearing aids" and we measured their electroacoustic parameters. We analyzed the data with respect to possible etiologies (causes of hearing loss) experienced by potential hearing impaired consumers. We found the following:
- Over-Amplification (too much sound) to the ear could cause permanent tinnitus (ringing in the ears), hearing loss, and/or additional hearing loss.
- Like wearing inappropriate eyeglasses, harmful physical and harmful sensory changes can occur to the ear, resulting from a poorly fitted instrument.
- Since these devices were purchased without benefit of proper examination, life-threatening conditions continued undetected and untreated. Of course, less serious conditions existed and were also undetected!
Additional Issues
When consumers obtain hearing aids through non-traditional venues, opportunities arise for other unfavorable events. Consider:
- Unnecessary hearing aids purchased, ostensibly to correct hearing loss, which may have resulted from a medically treatable condition. Of course, we've already discussed this issue (above), but the additional point for consideration is that AFTER the hearing loss is medically treated, the hearing may return to normal, and the hearing aid(s) may prove to be unnecessary, and a waste of money.
- If hearing aids were obtained through non-traditional venues, and they were tried and rejected by the consumer/patient (which is often the case with mail order and Internet obtained hearing aids), it may delay the legitimate securing of appropriate amplification for the consumer/patient. In other words, if the consumer/patient finds themselves tied-up in mail-order or credit card issues, the main focus (the hearing aid) may get rejected along with the frustration of the non-traditional venue. In fact, negative hearing aid experiences may turn the patient into an "anti-hearing aid" person, as they may believe they have "tried it" and perceive that it wasn't of much assistance.
- It is virtually impossible to make and fit a proper earmold without a professionally-taken ear impression (a cast of the ear). Even when professionals take ear impressions, just like dental, eyeglass and other prosthetics, it is common for physical adjustments to be made (by the professional) during the fitting process to maximally accommodate physical comfort issues of the consumer/patient. Every ear is different. Being "off" by just 1 millimeter can cause discomfort, loss of natural ear canal resonance and failure to correct hearing difficulties.
- Auditory rehabilitation is a complex and customized process. It requires the guidance of professionals. Listed below are some references to help the reader get a better picture of the vast considerations when designing an effective counseling and rehabilitative program for the hearing impaired, hearing instrument patient.
- Internet marketing requires no up-to-date or specialized training on the part of the merchandisers. All one needs to do is attend any of the thousands of seminars and workshops at the American Academy of Audiology, International Hearing Society, American Academy of Otolarynoglogy-Head & Neck Surgeons, and many other professional organizations to find out why hearing professionals stay informed and up-to-date with regards to amplification issues and technology!
- Regulatory Enforcement Issues
Historically, the primary deterrent to the abolition of mail order and now Internet sales of hearing aids has been lack of regulatory enforcement, at the state and federal level. It is the firm opinion of the authors, under the existing regulatory scheme, that legitimately licensed professionals would not be allowed by these agencies to sell and fit hearing aids in this manner without severe consequences.
The question arises why those not licensed, and essentially outside the legitimate channels, are allowed to do so without consequence?
Certainly, the Federal Trade Commission (FTC), under the aegis of existing Food & Drug Administration (FDA) regulation, would have a strong case for misleading and fraudulent advertising claims, if only such authority were exercised.
The complete disregard of the FDA Hearing Aid Rule should also constitute grounds for action, not merely warning letters, by the FDA.
Perhaps the overriding issue in not the delivery system (mail order, Internet etc), but instead is whether the provisions required by state and federal regulation, especially those applicable to consumer health and safety, are met in the process of selling hearing instrumentation. These laws did not occur frivolously. They resulted from many years of concomitant individual and collective experience. Diagnostic, technologic, and rehabilitative advances require no less.
Missing Pieces
Perhaps the biggest reason for any actual price differential is what is being left out of the experience. Specifically, consumer protections, professional services, and an auditory rehabilitation program, all of which help consumers make the most of their hearing health investment.
Ross and Beck (2001) noted some of the services and safety checks professionals typically include in their hearing aid delivery. When hearing aids are delivered through professional channels, these professional services significantly impact the quality of the experience, the hearing aids selected, and overall patient satisfaction.
Some of the services Ross and Beck addressed included:- Review the patient's history and concerns in detail, including their personal audiometric history, noise exposure, tinnitus, vertigo, aural pain and aural drainage, ototoxic medications and otologic surgery and recent audiometric changes.
- Explore the possibility of hearing loss in their family, including their parents, siblings, and their children as well, urging audiometric evaluations for all children.
- Provide a thorough otoscopic evaluation of their external auditory canal and tympanic membrane, with appropriate cautions about cotton swabs and OTC cerumenolytics.
- Check their insurance status and call the insurance provider (as needed) to verify benefits and to maximally understand how to file for benefits on behalf of the patient.
- Administer a diagnostic audiometric evaluation for the purpose of diagnosing the specific type and degree of hearing loss.
- File a HCFA-1500 (insurance forms) when indicated.
- Counsel the patient based on their needs, their hearing loss, their concerns, and our knowledge of audiology, hearing loss, hearing aids and related communication issues. This would include information about high and low frequency sounds, different voices, background noises, audibility and clarity, and effective listening strategies.
- Discuss the rationale behind monaural versus binaural fittings. Discuss possible binaural interference and possible auditory deprivation issues and implications.
- Review different styles, options, technologies, and prices of hearing aids.
- Address 'reasonable expectations' in detail. Specifically, address what hearing aids can and can't do. Define 'noise reduction' in realistic terms.
- Explore and demonstrate various kinds of hearing assistive technologies, including telephone and television devices, personal and large area assistive listening devices (ALDs), and signaling and warning devices. Based on our clinical impression, and the needs and desires expressed by the patient, select specific devices, which appear to best meet the needs of the patient.
- Take the proper care while making earmolds, remake any impression that is not one hundred percent perfect.
- Refer to a physician as needed and explain to the patient why we are doing so.
- Ensure that the hearing aids arrive in a timely fashion from the factory and schedule the patient to return after the hearing aids have arrived and been preliminarily checked in, tuned-up and verified.
- 'Fine-tune' the acoustic output of the hearing aids to maximally amplify speech and other desirable sounds, while addressing occlusion, feedback and the patient's 'own voice' issues.
- Perform sound-field tests, real-ear, and other acoustic verification tests.
- Address physical characteristics of the amplification system to ensure the hearing aids fit comfortably.
- Teach the patient to care for and maintain their hearing instruments, including how to store and keep the batteries from wearing unnecessarily and how to use a dry-aid kit.
- Tell the patient (and chart that we did so) the battery caution and provide them with the written manufacturer's instruction booklet.
- Advise the patient how to initially get used to hearing aids (such as not wearing them if they are uncomfortable, not wearing them in noisy situations etc.).
- Practice inserting and removing the hearing aids and the batteries and practice adjusting the hearing aids, with the patient and their significant other.
- Schedule appropriate follow-up within 3 to 5 days of the hearing aid dispensing appointment for new users. Audiologists and patients vary. Our advice is early follow-up is best!
- Enroll them (and their significant other) in a group program, where everyone can review the information and issues covered in the previous individual sessions and use the group opportunity to help everyone share and learn from each other.
- Administer standardized self-assessment scales, those that sample the impact of the hearing loss upon the person's life and those that evaluate benefits and satisfaction with hearing aids.
- Address issues and needs that arise from the responses to the self-assessment scales.
- And, finally, 'listen' to the patient, to the needs they express and imply, and respond appropriately.
Summary
From a financial point of view, Internet and mail order hearing aids are not the bargain they pretend to be. Their proponents cannot build and market custom fit or "one size fits all" quality instruments for any less than the legitimate, well-established system does. Yet they claim to do so in their literature. Furthermore, a closer look at prices reveals, that indeed, when apples are compared with apples, differences in price are negligible.
Professional services should not be ignored. If leaving them off was a feasible method of delivering hearing aids there would be no need for the myriad regulations and well-defined protocols that were put in place to protect the consumer. It is time for fairness and forthrightness to address this issue, for the health and safety of consumers and patients.
Suggested readings
Carmen, R., "The Consumer Handbook on Hearing Loss & Hearing Aids: A Bridge to Healing. Auricle Ink Publishers, 1998.
Chartrand, M.S., "Video Otoscopy Observation & Referral: The FDA Red Flags", Hearing Professional, Jan.-Feb. (2003).
Chartrand, M.S., and Chartrand, G.A., The Nuts & Bolts in Solving Problem Fitting Cases, a 12-hour continuing education course,
Livonia, MI: International Institute for Hearing Instruments Studies, (2002).
Chartrand, M.S., Hearing Instrument Counseling: Practical Applications in Counseling the Hearing Impaired, Livonia, MI: International Institute for Hearing Instruments Studies, (1999).
Durrant, J.D., and Lovrinic, J.H., Bases of Hearing Science, 2dn edition, Baltimore: Williams & Wilkins, pp. 248-250 (1984).
Kricos, P.B., "Group Support Programs for New Hearing Aid Users: 2003."
Ross, M, and Beck, D.L., "Expensive Hearing Aids: Investing in Technology and the Audiologist's Time", Archives www.audiologyonline.com 3/26/01.
