United Health extends its direct-to-consumer hearing aid offer to a larger market

MINNETONKA, MN– UnitedHealth Group Inc. announced last week that its direct-to-consumer offering of less expensive hearing aids has been extended to 26 million people covered by employer-sponsored and individual health insurance plans through UnitedHealthcare. The original program, unveiled 11 months ago, made the discounted hearing aids available only to people in Medicare-based plans.

The hearing aids, which are priced as low as $479 apiece for UnitedHealthcare participants, are being provided through a collaboration between UnitedHealthcare and hi HealthInnovations, sister companies in the UnitedHealth Group. Retail consumers can pay from $749 to $949 for the devices, which are manufactured by IntriCon Corp. of Arden Hills, MN.

UnitedHealthcare is the nation’s largest health insurance company in terms of membership

Sam Ho, MD, the company’s chief medical officer, said, “Cost is a significant barrier for millions of Americans suffering from hearing loss, and this new discount will help make hearing aids more accessible and affordable for more people nationwide.”

Last October, when UnitedHealth announced its plans to sell lower-price hearing aids directly to consumers, it set off a storm of protest from audiologists and hearing instrument specialists. They warned that allowing hearing aid purchasers to bypass the licensed hearing professional violated the Food and Drug Administration (FDA) hearing aid rule and would lead to poorly fitted hearing aids. They also warned that if consumers were not seen by a healthcare professional, any medical conditions that underlie their hearing loss might go undiscovered.

The Better Hearing Institute, the consumer education wing of the Hearing Industries Association, issued a warning to consumers last fall against what it termed “do-it-yourself hearing care.” It pointed to “the inherent risks associated with purchasing over-the-counter, one-size-fits-all hearing aids instead of consulting a hearing healthcare professional.”

 

ONLINE TESTING CHALLENGED

When it first began offering the UnitedHealth hearing aids, hi HealthInnovations also introduced an online hearing test that consumers could take at home on their computer so that the devices could be programmed to their individual hearing loss.

Although hearing professionals challenged the validity of the online testing, hi HealthInnovations continued to promote it. However, on March 28, the FDA advised Lisa Tseng, MD, CEO of Hi HealthInnovations, that the online test was being marketed without necessary approval from the agency. The warning letter said, “Your firm should not continue to market the device [i.e., the online test] until it receives FDA clearance… Continuing to market an unapproved device violates the Act…and the FDA could initiate regulatory action, such as seizure, injunction, or civil money penalties against your firm.”

The company quit offering the online test at least temporarily. In April, Will Shanley, the director of public relations for UnitedHealthcare, said in a response to Hearing News Watch, “We remain committed to offering people affordable, effective ways of understanding and addressing their hearing health issues. We are in discussions with the FDA regarding the Online Hearing Test and have voluntarily removed this test from our web site while we work with the agency. We hope to bring an online testing option back in the near future.”

To date, the online test has not been revived. Now, the company advises consumers to get tested through one of the company’s hearing professionals or another healthcare provider.

The company is continuing to sell its devices directly to consumers, rather than selling them through hearing professionals, as the major hearing aid manufacturers do.

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2 Comments

  1. I think regardless of the whole debate about the online hearing test–how about the fact that this DTC model flies in the face of established dispensing laws and practices in all 50 states. How is it that state departments of health just look the other way? Audiologists and HIS should be outraged!

    These dispensing laws are in place to protect consumers; however, if this DTC model is allowed it undoubtedly puts a serious competitive disadvantage to legitimate businesses that dispense hearing aids:

    1) By law any dispensing clinic has to have equipment, sound booth, etc.
    2) Equipment has to be calibrated annually to ensure proper function
    3) Staff has to be trained, professionals have to be licensed bonded and insured
    4) Your business has to be insured and bonded with the state
    5) Many, many other business related expenses (marketing, etc, etc)

    If UHC is going to dispense “hearing aids” and not “PSAPs”, then they MUST follow established guidelines and practices in every state. Period.

    Every professional should be up in arms and contacting their state DOH and state representatives to ensure this isn’t allowed in your state.

  2. What the various hearing aid professional groups fail to understand about the hi HealthInnovations online hearing test is that it is .NOT. designed to diagnose hearing loss: Instead, just like the Master Hearing Aid function on audiometers, their web-based app is a tool designed to aid in setting the gain and response of the hearing aids.

    In an e-mail responding to this thread from program development leader Dianne Van Tasell PhD, she asked me to post the following:

    You mentioned in your first e-mail that there was a technical discussion going on. As I read through the comments, though, it seemed to me that the bulk of the discussion had to do with professional and business issues, very important ones that are stimulating a lot of discussion around delivery models. I led the development of the two versions of the hi Health Innovations hearing tests, so I can respond to the technical issues. I am not an employee of hi Health Innovations, however, so I don’t have much information about how they have set up their order fulfillment or customer service system, so I can’t respond in those areas.

    Here are a few comments I have in regard to the questions of a technical nature:

    1. I just want to clear up a few misconceptions evident from Dr. [Jason] Galster’s comments and those of some others. The challenge of the home test is to get enough information in order to program a hearing aid so that the user will find it beneficial. [Emphasis added: DLS] I personally think that there are probably many different paths to this that would lead to success (say, filtered speech tests or speech in noise tests or just having the user adjust the hearing aid him/herself), but the method that is the most extensively researched requires an audiogram. Since we wanted to stick with the method that had the largest body of supporting research, the problem became how get a sufficiently accurate estimate of the audiogram over the internet. The interesting issue that arose immediately was: how accurate to you need to be? Remember, the purpose of the test is not to get the audiogram, but to put appropriate gain into the hearing aid. [Emphasis added: DLS] If you take any gain prescription method for nonlinear hearing aids (NAL-NL2 is the one we used) you will quickly see that there are many audiograms — themselves quite different — for which the gain prescription is essentially identical. This is because those methods use thresholds at all frequencies (not just one as in the early linear methods) to determine a frequency response that will maximize speech intelligibility and still provide acceptable loudness. Turns out that there are a lot of audiograms for which this frequency response is very similar. A different way of saying this is that a large audiogram space collapses into a much smaller prescribed gain space.

    So, it became clear that one would not have to get an absolutely accurate audiogram in order to get very close to the NAL-NL2 gain prescribed for the user had one actually known what the accurate audiogram was. For purpose of hearing aid programming the method does not, as Dr. Galster describes, sort users into groups. On the contrary, it works like this: 1) we begin by assuming that the actual audiogram is one of the modal audiograms reported by Ciletti & Flamme (Journal of the American Academy of Audiology, 2008. 19(9): p. 672-85). There are different possible audiograms for males and females; since we know the gender of the user we know which set to use. 2) we then estimate the PTA from the user’s score on the Hearing Screening Inventory in the manner described in the Hearing Review article; this allows us to eliminate all the candidate audiograms that have PTAs outside the expected error range of the estimate. 3) we use the estimate of audiogram slope between 2 and 4 kHz to eliminate further all audiograms that have slopes outside the expected error range of the estimate. This process usually results in only one or two candidate audiograms, although there are some cases in which the set of candidate audiograms reduces to 3. We cannot know which is the best estimate, so we program each of the 3 hearing aid memories with gain corresponding to each of the candidate audiograms and instruct the user to listen to all until he/she decides which is the most beneficial. As reported in the article, when we analyzed our subject population we discovered that in at least one of the 3 memories we were within a dB or so of NAL-NL2 prescribed gain.

    Since we can’t know the exact audiogram, we never report one to the user. [Emphasis added: DLS] We can, however, estimate what general degree of hearing loss the user has once we know what the set of candidate audiograms is. This is no different, in principle, from the estimate of hearing loss severity that one gets when one takes the BHI Quick Check and then receives the results. So we do give the user some general information about how much they are hearing based on the results of our estimation procedure. But we do not program the hearing aids that way from the home test. In the office test, we know what the audiogram is so we don’t need to use the estimation procedure.

    2. In response to Dr. Gosalia: what can I say? If he had read the article he would have known that the threshold measurement procedure produces thresholds very close to standard audiometric techniques. This is because the method of adjustment used in both tests is modeled after the Hughson-Westlake search procedure: the user first hears tones audibly, then they are reduced to inaudible levels, and then there are at least two ascending threshold measurements. The user has to respond consistently on two ascending runs in a row before the threshold can be estimated. So it is not surprising that this procedure produces thresholds similar to those obtained with manual techniques.

    3. The other comments in the thread all have to do with the business model and the fact that there are many best clinical practices excluded when the user does not interact with an audiologist. This latter cannot be disputed, of course. But as [BHI Director] Sergei [Kochkin] has pointed out, the important issue is whether the hi HealthInnovations method (or any direct-to-consumer method, for that matter) produces results that provide equal or more benefit to the user than a visit to an audiologist or dispenser. You might argue that even if you hit NAL-NL2 targets every time, individual users require adjustment and I do not dispute that. But how many audiologists/dispensers are there out there who are hitting “first fit” and then calling it a day? Given the significant effect of price on users’ perception of benefit (there’s that now-famous Killion figure), I would submit that in those cases the differences in benefit would be very small, and might even significantly favor direct to consumer.

    Dan Schwartz,
    Editor, The Hearing Blog

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