An historical perspective on hearing aids, PSAPs, and DTC hearing aids

The hearing aid industry has a long history of companies seeking to fundamentally change our field through the circumvention of traditional professional dispensing channels. As new direct-to-consumer (DTC) Internet distributors and large entities like United Healthcare continue to enter our market, dispensing professionals need to remember that it is their skills and services that define our industry’s collective value to the consumer.

One of the more interesting aspects of my now 50-year audiology career has been watching the parade of new entrants to the hearing aid market slowly meet their demise for one reason or another. Somehow, during all these years, it seems to me that the real problem has been the confusion of choices that confront the aspiring new hearing aid buyer. There is such an array of entry points to be navigated by the hearing-impaired public it must be difficult for a buyer to know where to start.

Jerry L. Northern, PhD, is professor emeritus at the University of Colorado School of Medicine in Denver. A founding member and the third president of the American Academy of Audiology (AAA), Dr Northern has worked in many capacities within the hearing care field, including in medical clinics, academia, industry, and dispensing networks, and as editor of Audiology Today and Seminars in Hearing. His and Marion Downs’ textbook, Hearing in Children, is perhaps one of the most-used publications in hearing-related curriculums. Dr Northern worked most recently as the director of special projects in education and training at Starkey Laboratories, Eden Prairie, Minn, and now serves as an independent consultant for the field.

So you want to buy hearing aids? One of the first hurdles is to decide where to go to buy hearing aids. Should one go to a hearing care professional or opt for an online Internet purchase? What about saving money by buying hearing aids at a discount warehouse? Who to buy from can be a difficult question as there are thin lines separating various providers with little unbiased guidance available. And what benefits will the health insurer provide—if any?

So, is it any wonder that some hearing-impaired consumers wait 8 to 12 years before purchasing a hearing aid? And, of course, wanting to avoid a serious financial mistake, or alarmed by the fear of being scammed, the hearing-impaired consumer further delays the decision and postpones taking any action to seek help for their hearing problems.

The earliest mail-order enterprise I recall was the Hush-Tone debacle of the late 1960s to early 1970s, although I suspect it was by no means the first. According to the September 21, 1971 St Petersburg Times,1 Gilbert Calkins filed a patent in 1964 for a “hearing device” described as a “speech clarifier,” which consisted of a clear plastic earmold containing a miniature tuning fork within a hollow “resonating chamber.” The inventor advertised that his Hush-Tone device was “not a hearing aid, required no batteries, and carried a money-back 5-year warrantee” [sic].

Calkins claimed that his hearing device was “effective in suppressing internal sounds or noises which cause great annoyance and discomfort to persons afflicted therewith.” Researchers of that time showed that consumers using a look-alike placebo device with no acoustical properties (ie, no internal tiny tuning fork) “heard” well compared to the actual Hush-Tone device.

Following some legal skirmishes concerning the product’s usefulness and truth in advertising, the FDA swooped in and confiscated 6,500 Hush-Tone hearing devices from Calkins. Three days later, Calkins was dead, the victim of a heart attack.

Internet Hearing Aids vs PSAPs

Hopefully, none of today’s Internet hearing aids resemble the historic Hush-Tone story, but one must be impressed at the similarity of performance claims that have persisted through the intervening years.

There seems to be an obvious effort to circumvent identifying some Internet hearing devices as “hearing aids.” The US Food and Drug Administration (FDA) issued a guidance in February 2009 that attempted to clarify the distinctions between hearing aids and personal sound amplification products (PSAPs). However, the FDA mostly muddied the hearing aid waters by opening a significant loophole that was quickly noted and enjoined by some manufacturers and mass retailers.

The FDA defines a hearing aid as a wearable sound-amplifying device intended to compensate for impaired hearing. As such, hearing aids are subject to different types of pre-market review requirements. Potential buyers of hearing aids (age 18 or older) must be advised that it is in their best interest to see a physician prior to purchasing a hearing aid, or they must sign a waiver to indicate that they are explicitly declining this suggestion—a long-standing FDA requirement that is easily dealt with in dispensing offices where few patients choose to seek medical clearance. The FDA has recognized this potential issue by requiring online hearing aid sites to provide a box that may be checked off by the buyer, thereby achieving “medical clearance.” The FDA also has largely abstained from interfering with Internet hearing aid sales other than posting a buyer advisory.2

A PSAP, on the other hand, is defined by the FDA guidelines as a wearable electronic product not intended to compensate for impaired hearing. It is, according to the FDA, designed to be used by non-hearing-impaired consumers to amplify sounds related to various “recreational activities” (eg, hunting and eavesdropping).

It is apparent that vendors deliberately obfuscate the “intended” use of a PSAP, especially when the sale involves some sort of hearing test. As Mark Ross, PhD, pointed out, the advertising and marketing clearly suggest that many PSAP devices are actually designed for use by persons with hearing loss.3 This, in spite of the small print that explicitly states that the device is not a hearing aid—no matter that its appearance may be indistinguishable from a behind-the-ear or ear-level hearing aid.

Apparently, in the view of the FDA, manufacturers and vendors of these devices are under no legal obligation to clarify for prospective purchasers the distinction between hearing aids and PSAPs. The fact that there are so many of them available through so many sources suggests a large and profitable marketplace. It is not difficult to understand their appeal to hearing-impaired people; prices start at $39.95, far less than true hearing aids purchased through traditional distribution channels.

The lure of sizable financial opportunity, based on the oft-quoted unmet amplification needs for tens of millions of hearing-impaired Americans, has repeatedly attracted the attention of venture capitalists, entrepreneurs, and, of late, numerous big name corporate giants looking to expand their bottom lines by entering new enticing markets. The estimate of hearing loss prevalence in the United States varies between 34 million (about 13% of the total US population) as cited by MarkeTrak4 to the more recent estimate of 48 million (20% of the US population) estimated by Lin et al.5 These numbers must make business developers weak in the knees as they salivate over the big revenue increases to be expected in the hearing aid business! (For more details, see the article by Amlani and Taylor in this issue.)

So it comes as no surprise when well-financed corporate entities and global brand companies dive into this marketplace. Over the years, we have seen various innovative products and/or new distribution schemes set up with business plans to carve out a substantial piece of the hearing aid marketplace, some with more success and staying power than others.

Certainly, the market potential is sizable. Growth of the hearing device market is largely dependent on technological innovations that are offered by the manufacturers to encourage younger buyers and to meet the needs of the increasing numbers of the age 65+ population. Banner-name distributors who have entered the hearing aid market at one time or another include Lens Crafters, Pearl Vision, Costco, and Wal-Mart/Sams, to name just a few, with continued rumors of CVS, Walgreens, and/or Rite-Aid drug stores possibly soon to be in the mix.

At the manufacturing level, we have seen several major efforts in recent years to produce and sell new hearing aid products. Bausch & Lomb acquired 80% of Veroba’s Quantum Hearing Aid and Programmable Auditory Comparator Hearing Systems in 1989, then bailed out just a couple of years later. Johnson & Johnson invested in the Sarnoff Corporation, which invented the Songbird Disposable Hearing Aid in 2000. Its most recent device (Songbird Flexfit) was still available until March when, for at least the second time, the owners announced their exit from the hearing aid market. However, to further add to its confusing legacy, Songbird’s Web site lives on.

New to the Game

The latest big-name entry into the hearing aid marketplace is United Healthcare, a large US health insurer that recently announced a plan to sell hearing aids directly to their members through their subsidiary, hi HealthInnovations. UnitedHealth Group is the parent of United Healthcare and is a diversified managed health care company headquartered in Minnetonka, Minn. A major player in the health insurance business, the UnitedHealth Group offers a spectrum of products and services through its family of subsidiaries and divisions serving approximately 70 million individuals nationwide.

Two hearing programs were recently announced by hi HealthInnovations to “facilitate earlier detection and treatment of hearing loss for their insured members.” One program is conducted through an online home hearing test (the At-Home Version) where interested persons can determine their need for hearing aids and make their purchase immediately through the Internet. The second hearing aid program, the Clinic Version, is offered in primary care medical offices where an automated audiogram is obtained and hearing aid purchases are available.

Both versions of the automated hearing test identify individuals with possible serious otologic problems such as asymmetrical, severe, or low-frequency hearing loss that may require further medical evaluation or referral to a hearing care professional for additional examination.

In both the At-Home and Clinic versions, hi HealthInnovations sells hearing aids direct to hearing-impaired consumers. In press releases, it has been stated they will “bypass supply chain intermediaries, and pass savings on to the consumer through their comprehensive hearing aid benefit program.” In addition to their own on-site hearing health team, hi HealthInnovations reports that it will facilitate access to hearing professionals through a predetermined referral network. These additional services provided by network professionals will be paid for directly by consumers at the time of service. In their own words, their program “takes advantage of technology provided by the internet providing a self-service approach to better personal health management.”

The goals of the hi HealthInnovations hearing tests are to accurately assess the hearing levels of potential users to identify those people who could benefit from open-fit hearing devices. Individuals who are not candidates for open-canal hearing aids, because of their degree of hearing loss, are referred to the professional network for earmold-required fittings. The small print at the bottom of the hearing test screen advises participants to consult with medical professionals if they have sudden or unilateral hearing loss, injury to the ear, active drainage or pain from the ear, or dizziness.

hi HealthInnovations has gone to considerable effort and expense to provide a “scientifically validated, user-friendly” protocol. The research design and the methods of the online and office hearing tests, as well as a description of the method of determining gain for the hi HealthInnovations hearing devices, have been detailed by Van Tasell6 in the January 2012 HR. The hi HealthInnovations At-Home online procedure purports to combine several self-administered minimally related sources of data, including the self-reporting Hearing Screening Inventory (HSI)7 and the consumer’s gender and age to determine hearing aid recommendations. The At-Home online hearing test results, however, are not used to create an audiogram, but rather to estimate the severity and slope of hearing loss, which are then used to program the recommended hearing aids. The online hearing test uses a visual slider response to bracket the listener’s auditory thresholds and is described as an “adaption of the Carhart-Jerger method of adjustments.” As mentioned, the At-Home hearing test purpose is not to obtain an audiogram (although the online text refers to the results of this self-assessment procedure as an “audiogram”) and is described as an “accurate method of prescribing hearing device gain that does not require calibration.” The HSI questionnaire attempts to determine the participant’s hearing difficulties through 12 questions about their hearing acuity in various everyday situations. The consumer responds to the questions in a 5-choice scale (“never,” “seldom,” “occasionally,” “frequently,” or “always a problem”).

Of course, I couldn’t resist the opportunity to challenge hi HealthInnovations’ At-Home program by manually entering a variety of different threshold “audiograms” to simulate increasing degrees of hearing loss. My results were similar to those recently reported by Shaw.8 Following entry of normal hearing thresholds online, complete with positive responses (or totally negative responses) to the HSI questionnaire about my hearing difficulties, I was advised that my hearing was indeed normal—and yet the program showcased hearing aids to help me hear better in noisy environments. I was advised that, if the time comes that I might benefit from hearing aids, I should remember that hi HealthInnovations offers “custom-programmed hearing devices at a fraction of the retail price.”

With more significant degrees of audiometric hearing loss, I found the “diagnosis” and recommendations to not be influenced by my answers to the HSI questionnaire. With manual audiogram entries that represent increased hearing loss, it appeared that the threshold levels seemed to drive the prescription while the HSI results were not considered. When I indicated my age to be younger than 18 years, there was no recognition of my being “under age” and needing medical clearance.

Although, admittedly, absolute thresholds cannot be ascertained in an uncalibrated system, the relative difference between thresholds at 2 and 4 kHz (slope) is quantified and used with the score from the HSI (used to predict severity of hearing loss), along with the consumer’s age and gender, and public health NHANES demographic data to “reconstruct the three most likely audiograms.”

Each of the three memories of the hi HealthInnovations hearing aids is then programmed with NAL-NL2 parameters appropriate for each of the three possible audiograms—albeit based on “threshold” measures obtained at only two frequencies. The buyer is instructed to listen carefully to the three memories in the hearing aid and to use the memory that “sounds the best.”6

The rationale behind the development of these procedures appears well-planned, but it must be remembered that hearing aid output targets represent group average values, rather than specifically individualized targets. This fact has been corroborated through several studies.9-12 In addition, the direct-to-consumer (DTC) system cannot account for the common adage expressed among experienced dispensing professionals that “the same audiogram from different individuals often requires very different hearing aid fittings.”

At this writing (mid-April 2012), hi HealthInnovations’ At-Home version has been pulled for “enhancements” by the company. However, one can still enter an audiogram and purchase hearing aids, and it appears that the company remains committed to distributing online hearing aids using its At-Home and Clinic test systems.

The Role of the Professional

Although Van Tasell6 has made every effort to ensure accuracy of the Internet system, her plan presupposes that hearing aids can be considered an electronic commodity and successfully fitted without professional intervention. This supposition overlooks an important component recognized in a number of recent surveys that analyze hearing aid users’ satisfaction with their devices. That component stresses professionalism and patient focus at the center of the encounter rather than making the fitting all about the hearing aid itself.

Taylor and Rogin13 reported on a Hearing Industries Association (HIA) sponsored online survey with nearly 900 satisfied hearing aid users who indicated that the top reason for “delight” with their hearing aids was the professional who provided their hearing services. Advice provided by the Hearing Loss Association of America (HLAA) Web site14 cautions buyers to obtain appropriate, well-fitted hearing aids through “a certified hearing professional.” Further, the HLAA advises buyers to verify that the hearing professional is following the “best practices guidelines” as recommended by the American Academy of Audiology (AAA) and the American Speech-Language-Hearing Association (ASHA). (Note: It should be acknowledged, however, that HLAA has taken a “wait and see” stance to hi HealthInnovations’ program.15)

In 2009, Consumer Reports16 followed a small group of actual patients for 6 months as they shopped for and purchased hearing aids. The magazine also conducted a national survey of 1,100 people who had purchased hearing aids in the past 3 years. Among their conclusions was the advice to potential hearing aid buyers that “the most consequential decision is finding the proper professional from whom to buy them because it’s likely to be a long-term relationship.”

Sergei Kochkin, PhD, has long searched for the elements that lead to a satisfied hearing aid buyer and user. In his latest effort, Kochkin et al published the 2011 MarkeTrak VIII survey entitled “The Impact of the Hearing Healthcare Professional on Hearing Aid User Success.”17 The results obtained in this extensive survey suggested, among other conclusions, that the implementation of comprehensive protocols by hearing care professionals has a major impact on the utility of hearing aids, satisfaction with benefit achieved, hearing handicap reduction, and increase of hearing aid usage. Lastly, this research indicated that those not utilizing many of these best practices are vulnerable to disruptive technologies, such as direct mail, Internet distribution, and over-the-counter devices.

Further, the study17 reported that hearing aid users with above-average success were most likely to receive from their hearing professional an objective benefits measure, a subjective benefits measurement, a loudness discomfort measurement, a real-ear measurement, and a post-fitting patient satisfaction measurement, and to have their hearing evaluated in a sound booth. Obviously, these client-oriented factors are not readily available through online hearing aid fitting programs.

The Role of Price

An important element absent in the three consumer satisfaction publications cited above is that the cost of the consumers’ hearing aids was not a major consideration or impediment in achievement of hearing aid satisfaction. Although the hi HealthInnovations online program seeks to supply “affordable” hearing aids to buyers, their costs are not cheap; the devices range from $745 to $945, which comes to $1,500 to $1,900 for a pair of self-fit Internet hearing aids. Several mainline digital entry-level hearing aids are available in dispensing offices for less than $500.

A number of recent papers have raised questions regarding the price of hearing aids as a negative influence on market penetration and their use by those with hearing impairment. No matter the price of the hearing aid, price becomes an easy excuse for the unmotivated individual, and it no doubt becomes a matter for many people in priorities of how they wish to spend their money. MarkeTrak VII18 indicated that the retail price of hearing aids was one factor considered by users, but not the most important factor in their decision to purchase.

The hearing aid marketplace has been identified as “inelastic,” meaning that lowering the price of hearing aids will not result in appreciative increases in the number of devices sold, nor will increasing the price of hearing aids markedly decrease the number of hearing aids sold.19-21 And although countries (eg, UK, France, Germany, Denmark, Australia) where hearing aids are “free” or discounted through government subsidies appear to have higher market penetration rates than the United States, the rate is still less than stellar when compared to the number of hearing-impaired people in those countries who would benefit from amplification.22 Ramachandran et al23,24 conducted a large scale chart review at Henry Ford Hospital to investigate the influence of cost on the acquisition of hearing aids. These authors note that the factors that contribute to the lack of hearing aid adoption are numerous and complex. Many people with hearing loss do not use hearing aids because they simply believe they do not need them; some people, for reasons of vanity, cite the negative image of wearing hearing aids; others are confused by the necessary navigation to access hearing services. The researchers found that reducing hearing aid cost did not influence device acquisition, but that insurance coverage does indeed play a significant role in encouraging patients to obtain hearing aids. Their findings suggested that the behavior of patients with insurance coverage for hearing aids is complex and motivated by other factors than the cost of the hearing aids per se.

This is supported by recent MarkeTrak VIII data25 about factors that would persuade non-users of hearing aids who have self-described hearing loss to purchase a hearing aid. The study shows that 3 of the top-5 factors are related to financial concerns, with “100% insurance coverage” being the number-one factor, and “price not more than $500” and “$1,000 insurance coverage” being the fourth and fifth most-important factors, respectively. However, the rest of the top-15 factors are largely dominated by product- and fitting-related issues, such as reliability, feedback, and comfort—issues unlikely to be addressed by an online distributor.

Standard of Care Practices

Direct-to-consumer hearing aid sales bypass the single most important part of acquiring hearing aids: personal consultation with a hearing care professional.

There is little question that we have reached a point in technology development where automation and default programs guide the hearing aid fitting process. Where the professional once made decisions for gain and output with analog hearing aids on a hit-or-miss method, we now configure our hearing aids to absolute decibel values through elaborate and complex software. We used to counsel patients on volume control use to modulate incoming signal levels; we now have hearing aids that automatically adjust gain as a function of input levels. We once had a set of limited adjustments to make in terms of filter settings and output controls; we now have an almost infinite range of computerized hearing aid gain and frequency settings that have revolutionized the fitting process.

These innovative developments speak volumes for the engineers who design hearing instruments, but the innovations require a professional to make the individual hearing aid fittings meet the standards of care required for maximum comfort and optimal benefit for each patient’s personal hearing disabilities. The inclusion of the professional in the hearing aid fitting process cannot be overstated and is a far more important consideration than the technology of the device or its cost.

The majority of the retail cost of hearing aids is in return for professional services of selecting and fitting the devices, the counseling information, and the follow-up aftercare. VanVliet26summed up the new hi HealthInnovations hearing aid program as being of no particular advantage to consumers. He noted that utilizing existing technology, offering it through the Internet to eliminate professional services, and implying that there is considerable cost benefit are “grossly misleading and unfair to consumers, is not in their best interests, and is certainly not an improvement over the existing distribution model.”26The professional audiology organizations have developed general guidelines to be followed as the necessary standard-of-care for hearing aid patients. The guidelines recommend an evidence-based step-by-step process specifically developed for the fitting of hearing aids:


  1. The Needs Assessment during which the professional fully evaluates the patient to determine the extent and cause of the hearing loss and the patient’s need for hearing aids. This is most often accomplished with standardized questionnaires and evaluation of the patient’s speech recognition performance in quiet and background noise conditions.


  • In the Hearing Aid Selection period, the professional matches the patient’s audiogram and listening needs with the best choice of hearing aids based on amplification characteristics, style, and technology of the devices. During this period, the hearing aids are properly fitted for maximum comfort and performance.
  • Verification of the hearing aid performance is accomplished by electroacoustic measures such as probe-microphone real-ear procedures. These objective tests verify that the amplification programs provide satisfactory audibility for soft, medium, and loud sounds. Subjective speech recognition tests also can be utilized.
  • Orientation and Counseling procedures ensure that the patient and the family understand the care and operation of the hearing aids, and that they have appropriate expectations about the time needed for the patient to fully adjust to hearing aid listening.
  • Post-fitting Care is a necessary component of the guidelines and requires opportunities for follow-up visits from the patient to re-validate and confirm the fitting parameters, and to ensure patient comfort with and the proper use of the hearing aids.
  • Tests of Outcome Validation are utilized during each follow-up visit to verify that the hearing aids are performing as programmed and that the patient is achieving benefits for using amplification.
  • Hearing Aid Fitting Guidelines, formulated by experts from the American Academy of Audiology,27 state that best practices require real-ear measures be implemented to verify appropriate prescriptive gain or real-ear aided response in SPL from the patient’s ear canal. In this same regard, ASHA considers it a breach in their codes of ethics28 for members not to follow best practice guidelines. Consumer Reports16 also strongly recommended that hearing aid buyers insist on having real-ear measurements taken to ensure proper fit of the hearing aids. In their extensive MarkeTrak VIII report, Kochkin et al17 showed that person-to-person clinical activities, including real-ear probe microphone verification of the hearing aid fitting, have proven to be an important element to achieve consumer satisfaction with hearing aids.

    This leads to the conclusion that a major weak link in all Internet hearing aid DTC sales is the inability to verify audibility provided by the hearing aid fitting. The consumer really has no way to know if he/she has the best aided prescription in the devices; the hearing aid might be under-fit and causing the wearer to persist with difficulties in understanding speech. Without verification of fit, the consumer might be over-fit and suffer with the loud and painful amplification produced by the hearing aids.

    No matter how simple and clear the instructions for Internet hearing aids might be, there are a lot of seniors who are still baffled by their cell phones and computers, and they are likely to find the self-fitting of hearing aids to be beyond their abilities.

    “Chaos Breeds Opportunity”

    Obviously, DTC sales of hearing aids give little heed to recommended professional standard-of-care practices. In fact, the Internet systems focus on the devices themselves, with limited attention to the other fitting needs that dispensers recognize as important parts of the hearing aid process.

    Therein, we find our opportunity to win the battle and separate ourselves from the Internet crowd through the provision of exceptional services. It has been said over and over and supported substantially by consumer surveys: although there will always be price-motivated buyers and Internet shoppers, the majority of hearing aid users will continue to seek professional services.

    Now is the time for hearing care providers to step up and ensure that outstanding service is our finest product, and that technology and cost do not become the primary purchasing considerations for hearing aid users. As we have been told for years by Kasewurm,29 exceptional hearing services create the best word-to-mouth marketing, which results in additional referrals.

    Certainly, everyone involved in the provision of hearing aids has an opinion on these changes to the existing chaos of systems for hearing aid delivery. Brenda Battat, executive director of the Hearing Loss Association of America (HLAA), assumed a politically correct position about the hi HealthInnovations hearing aid program stating that it is “new and untried” and, in the end, consumers will be the ultimate judge whether the program works.15 Success of the program, in the HLAA view, rests with the success of first-time buyers without face-to-face care.

    HLAA consultant Mark Ross30 concludes that there are both positive and negative elements to the hi HealthInnovations program. On the positive side, he suggests that this program might introduce hearing aids to a heretofore unserved hearing-impaired population, while on the negative side, Ross is concerned about the lack of professional contact in the fitting process. He argues that some hearing aid help, albeit maybe not the best solution, is perhaps a better opportunity than for persons with hearing impairment continuing to go without hearing aids.

    Granville31 points out that people who seek professional help for their hearing loss and ultimately purchase hearing aids are, in fact, called patients; however, people who buy their hearing aids online in a DTC sale are called consumers.

    What’s Ahead?

    Will the hi HealthInnovations Internet program be a great success or just survive on the edge of profitability? The hearing aid industry is famous for sinking new players, losing vast investments, and few have made a significant impact or changed the way hearing aids are purchased.

    Although they are deeply invested into their online hearing test and hearing aid sales programs, hi HealthInnovations has a difficult road to travel. All of the major professional hearing services providers (AAA, ASHA, IHS, HIA, ADA, etc) have expressed their concerns and publicly challenged this DTC program. It remains to be seen if hearing healthcare providers will enjoin the hi HealthInnovations referral network. In the meantime, the FDA seems to be standing back with a wait-and-watch posture. It would appear that hi HealthInnovations got their foot into the doorway because of the ever-present chaos of our current hearing aid distribution system.

    The future remains unclear. To make a prediction, I see the proposed system of remote screening and resulting DTC sales of hearing aids failing to achieve much traction in today’s hearing aid climate. I fully believe that it is the involvement of the hearing care professional that is the key to successful hearing aid utilization. Additionally, it is likely that remote hearing screening will prove a successful referral mechanism that drives patients into local clinics and dispensing offices.

    Regardless of this speculative future, professionals must be aware of—and take seriously—these changes in the delivery of hearing care. What separates us from the Internet is our professional service; what separate our patients from consumers are our professional services.

    Correspondence can be addressed to HR or Dr Northern at [email protected].

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    Citation for this article:

    Norther L.J. The Secret Is Service Hearing Review. 2012;19(05):16-27.