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doi: 10.1097/01.HJ.0000411241.61284.ac
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Breaking News: hi HealthInnovation's Foray into Hearing Aid Market Sparks Controversy

Shaw, Gina

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I took a hearing test yesterday. On my home computer, in my third-floor office, directly below the flight path for Newark International Airport. With jumbo jets making their approach overhead and the traffic on my semi-busy suburban street whizzing by outside, I listened to a series of tones and turned the “wheel” on the screen up or down until I could no longer hear the tones or could just barely hear them, depending on what the instructions said.

Figure. Lisa Tseng, ...
Figure. Lisa Tseng, ...
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At the end of the test, I was told that my hearing was perfectly normal. But then I was advised that “noisy environments like busy restaurants, sporting events, or conferences … are challenging even for people with good hearing like [myself].”

And I was presented with an exciting menu of “devices to enhance [my] hearing in challenging listening environments.” Each device was listed as being for people with “mild to moderately severe” or “severe” hearing loss. I could buy any of the above devices right then, online.

This whole experience was brought to me — and consumers everywhere — by hi HealthInnovations, a new program from mega-insurer UnitedHealth Group. Introduced in early October, the direct-to-consumer do-it-yourself hearing test and online purchasing model quickly provoked a remarkably unified response from the not-always unified community of hearing health professionals. They shared their dismay in a flood of news releases and letters to UnitedHealth Group and the Food and Drug Administration, which regulates hearing aids.

From Academy of Doctors of Audiology President Eric Hagberg, AuD: “This undermines every good practice with regard to hearing health care as this diagnosis and delivery model is unsound, unsafe, and unreliable. Without the proper diagnosis, counseling, hearing aid fitting, and follow-up evaluations, successful treatment for hearing loss cannot be achieved.”

Better Hearing Institute Executive Director Sergei Kochkin weighed in: “Today's state-of-the-art hearing aids should be programmed to the individual's specific hearing loss requirements in order to provide good levels of benefit and customer satisfaction. The process requires a complete in-person hearing assessment in a sound booth; the training and skills of a credentialed hearing health care professional in order to prescriptively fit the hearing aids using sophisticated computer programs; and appropriate in-person follow-up and counseling. This is not possible when consumers purchase one-size-fits-all hearing aids over the Internet or elsewhere.”

The International Hearing Society sent a letter from its general counsel to hi HealthInnovations, that said, in part: “It has been brought to our attention that you are marketing a ‘hearing device’ over the Internet without, in our opinion, fully complying with the United States Food and Drug Administration's requirements for the sale of hearing aids. Further, we believe your organization's actions violate most individual State licensing laws regarding the sale of hearing aids. At this time, we ask that you immediately cease and desist the sale of hearing aids through the hi Healthlnnovations website.”

The ADA and the American Academy of Audiology joined forces in a letter to hi HealthInnovations: “An online hearing screening and a preprogrammed hearing device, which by definition is limited in its capability, cannot be effective for the vast majority of patients. Our patients and your consumers need and deserve so much more to meet their medical needs than the hype that a $700 or $900 hearing device can address their complex hearing needs.”

The list goes on. The NJ Association of Hearing Health Professionals, the NJ Academy of Audiology, and the NJ Speech Language Hearing Association, said in a joint news release that it was “questionable” for an insurance company to profit from selling medical devices to its members. “With no professional guidance, assessment, or examination by hearing aid specialists, consumers run the risk of purchasing ineffective or ill-fitting devices that can further damage their hearing,” they wrote.

The Illinois Academy of Audiology echoed the comments of other organizations, noting that an online hearing test did not meet the state-mandated standard of conventional audiometry. Even the Minnesota Department of Health, where UnitedHealth Group is based, took action, warning consumers in a news release that “before hearing aids can be sold to consumers, [state and federal] laws require practitioners to... visually inspect the consumer's ears and ear canal.”

Figure. The hi Healt...
Figure. The hi Healt...
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Litany of Concerns

What's the problem with selling hearing aids directly to consumers online, using a self-administered computer test? Greg Frazer, AuD, hardly knows where to begin. He outlined a comprehensive list of more than a dozen problems with the hi HealthInnovations approach in a letter to Rhonda Meadows, UnitedHealth's chief medical officer.

“First of all, no one is looking in the person's ear to see if they have ear wax. Studies have shown that anywhere between 26 percent and 34 percent of people will have impacted cerumen in their ears; that gets worse in the seventh and eighth decades,” said Dr. Frazer, the owner of California-based Pacific Specialists Hearing and Balance Center and a member of the board of AuDNet. “People doing a hearing test online also don't have the benefit of a professional consultation to pick up pathological problems that may be related to the hearing loss. Our ears mirror our health, and between five percent and 10 percent of people with hearing loss are going to have a condition that requires some type of medical or surgical treatment: a brain tumor, a thyroid condition, Meniere's disease, even syphilis. These conditions are treatable, but if you just put a hearing aid on the person, they aren't going to go back to a doctor and will remain undiagnosed.”

He said hearing tests are not reliable unless they are done in a sound booth away from ambient noise, and he said he was unimpressed with UnitedHealth's solution: hiring a hearing and speech scientist to make sure the test would be valid and reliable. “But even if the test is reliable, if you have a bad test environment, that's not going to happen,” Dr. Frazer said. “Besides, hearing aids cannot be fitted accurately using only pure tone thresholds, which is all that the hi HealthInnovations test involves.”

Indeed, several hearing health professionals reported taking the test online and “failing” it, though they passed a test with an audiologist with flying colors.

And these concerns are just the tip of the proverbial iceberg that fail to take into account fitting issues, consumer education, and service, critics said. UnitedHealth and hi HealthInnovations have advertised their devices (they alternate between calling them hearing aids and devices) as selling for $750 to $950 apiece, far less than most hearing aids bought from a hearing health professional. And they may even be free for subscribers to UnitedHealth's Medicare Advantage plan.

But something's missing, said Kim Cavitt, AuD, the owner of Chicago's Audiology Resources and a vice president of governmental affairs for the Illinois Academy of Audiology. “Is service provided? A warranty? Do they provide education on how to insert the batteries and replace them and how to properly place the hearing aid in the ear?” she asked.

Seeking answers to these and many other questions, the Hearing Journal attempted on several occasions to interview hi HealthInnovations CEO Lisa Tseng, MD, but she did not return calls. In a written statement and in a video on the company's website, however, she stresses UnitedHealth's “smart, affordable, and convenient solutions” to improve hearing health.

“Our goal is to put better hearing within reach of more Americans, including the 47 million with Medicare, which does not cover the significant cost of hearing devices. Because early detection and treatment of hearing loss often lead to better outcomes, hi HealthInnovations will seek to engage more primary care physicians in the care of a condition that affects the daily life of millions of Americans,” Dr. Tseng said in the statement.

She noted in the website's video that the hi HealthInnovations hearing test is easy to use, and takes only about five minutes. “It provides a clear explanation of the person's hearing status, and if applicable, the test results allow us to custom-program the hearing devices tailored to the person's hearing needs,” Dr. Tseng said.

She has declined to divulge specifics about the online hearing test in other interviews, saying the company has filed a patent application for the tool.

Dr. Cavitt predicted that consumers getting hearing aids online for $900 or less will not get the three years of service, the custom fitting, or the consumer education that audiology professionals provide. “They're going to get a manual. That's it,” she said. “And that's not enough. My mom could not program an outgoing message on an answering machine. My father-in-law won't use an iPad. One-third of my patients, even when we work with them, have trouble putting hearing aids in their ear and changing the battery.”

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Is It Legal?

The International Hearing Society suggested that hi HealthInnovations has stepped over the line of regulations laid down in the Medical Device Act of 1977, which mandates that a seller cannot sell a hearing aid unless the prospective user has presented a written statement signed by a licensed physician, preferably one who specializes in diseases of the ear, within the past six months.

Many hearing health professionals agreed. “Right now, it appears to us that hi HealthInnovations is attempting to state, at least on their website, that they are selling PSAPs — personal sound amplification devices, not hearing aids,” said Carole Rogin, the executive director of the Hearing Industries Association. “But when the site was first up, it referred to in-the-ear hearing aids and behind-the-ear hearing aids. Now it's been modified to say devices, but their collateral material still says hearing aids.”

A PSAP, as most hearing health professionals know, is a “wearable electronic product not intended to compensate for impaired hearing,” while a hearing aid is intended to compensate for impaired hearing. “The difference is one of intent — not design, not performance, not patient benefit,” Ms. Rogin said.

But if hi HealthInnovations is selling their devices as PSAPs, not hearing aids, which presumably they would need to do to skip the FDA's requirement to involve a licensed physician's diagnosis in prescribing a hearing aid, then why offer a hearing test online? And why does the resulting menu suggest different devices for “mild to moderately severe hearing loss” and “severe hearing loss?”

“In our view, this isn't just an implied claim, but an out-and-out statement that these products are intended to compensate for impaired hearing,” Ms. Rogin said. “We are extremely concerned, and are seeking a meeting with the FDA about the use of the PSAP guidance document to skirt the FDA hearing aid regulation. That certainly was not the agency's intention.”

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Taking Action

Audiologists and other hearing health professionals also should be challenging the program at the state level, Dr. Cavitt said, because dispensing is governed by the state. “While you can define it at the national level, the state can more distinctly define or regulate it at their level. For example, I'm licensed in the state of Illinois. Walgreen's is one of this program's outlets, and that company is based here in Illinois. It's the job of the Board of Dispensers in Illinois to determine whether or not, if Walgreen's were to provide this device, they would be in violation of the state dispensing law.”

That's a matter the board will be taking up for review at its next meeting, in fact. If they find that hi HealthInnovations is indeed running afoul of Illinois state dispensing laws, they would need to file a complaint with the state Attorney General.

But Dr. Cavitt said hearing health professionals cannot just assume that the FDA and state enforcement mechanisms will shut down the UnitedHealth program. “In the end, if an insurer is going to provide you a device at no charge or with a deductible of $110, you might well consider it if your finances are in poor shape. There are pros of getting hearing aids this way: it's cheaper. We can't say it's all bad because if cheaper is what drives a particular consumer, we can't judge them for their situation.”

The hearing health community needs to counteract the commoditization of the field, said David Smriga, the founder and president of NOWiHEAR, Inc., a consumer marketing organization for audiologists that is owned by AuDNet. “The population of people who could potentially be patients or buyers of hearing aids is large and growing, and the hearing health care industry has historically never had significant market penetration. A lot of new players see a significant new opportunity from a business perspective.”

That includes businesses like UnitedHealth, which may not realize much of a profit on the hearing aids themselves but clearly want to enroll more subscribers in their Medicare Advantage plan by providing a novel hearing aid benefit.

“But this isn't a commodity; it's health care,” Mr. Smriga said. “Until an individual is properly diagnosed by a qualified professional, you don't know whether the cause of that hearing loss is one that should be treated differently than with hearing aids. That's putting the consuming public at risk, and that's one of the things audiologists object to. We need to get this message out as effectively as or more effectively than UHC is getting their message out.”

Mr. Smriga conceded a portion of the hearing-impaired population will always seek low-cost alternatives. “That has always been the case. But this particular message may take people who would normally see a hearing health professional, and steer them away because it comes from a health insurance company.”

One way the community is trying to counter the hi HealthInnovations message is to promote the Better Hearing Institute's Quick Hearing Check (see FastLinks), which asks consumers 15 questions about their hearing and predicts risk for hearing loss. “It doesn't indicate that you have one, it doesn't suggest a treatment strategy, and it doesn't try to sell you anything,” he said. “It simply says that based on your answers, the likelihood that you have a hearing loss is mild, moderate, or significant, and recommends you to a professional in your area to get properly evaluated.”

The ADA and AAA requested a meeting at the end of October with UnitedHealth Group and hi HealthInnovations to discuss the program and alternatives. At press time, there had been no response, according to Therese Walden, AuD, the AAA president and the chief of the audiology clinic at the Army Audiology and Speech Center at Walter Reed Medical Center. “We would like to open up a dialogue with them. Perhaps some people may be served well by this model, just like some people in their 40s can get away with drugstore reading glasses before they start to need prescription glasses, but you won't know this until you're seen by an audiologist.

“From a safety and efficacy perspective, the consumer needs more,” Dr. Walden said. “We're all about affordability and accessibility of health care, and we know about escalating costs, but self-diagnosing of individuals who may have real medical issues to deal with doesn't seem like a good way to address those things.”

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FastLinks

• Access the Better Hearing Institute's Quick Hearing Check at http://bit.ly/BHItest. It is also available through the www.NOWiHEAR.com learning app for the Android.

• Watch a video in which hi HealthInnovations CEO Lisa Tseng, MD, explains the company's program at http://prn.to/hiHearingTest.

• Comments about this article? Write to HJ at HJ@wolterskluwer.com.

• Follow us on Twitter at twitter.com/hearingjournal.

• Click and Connect! Access the links in The Hearing Journal by reading this issue on thehearingjournal.com.

© 2012 Lippincott Williams & Wilkins, Inc.

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