This issue of HR covers several aspects related to alternate delivery models in hearing health care, and in particular, the recent entry into the market by hi HealthInnovations, a subsidiary of United Healthcare, Minnetonka, Minn. Thus, in an effort to present a balanced perspective, HR interviewed Lisa Tseng, MD, in late March for the second time, as well as the company’s chief audiologist, Noreen Gibbens, AuD.
However, one week after this interview took place, the US Food and Drug Administration (FDA) on March 28 issued a letter to hi HealthInnovations stating that its online hearing test was in violation of FDA regulations because it should have received 510(k) premarket clearance from the Agency (see HR Online News). The company voluntarily removed the At-Home test from its Web site while it is working with the Agency (presently, it only allows consumers to enter values from an audiogram). Therefore, the comments in this article do not reflect Drs Tseng and Gibbens’ knowledge about these more recent developments. When provided an opportunity to comment on the FDA actions, hi HealthInnovations declined.
For more background on hi HealthInnovations’ tests and devices, see the October interview with Dr Tseng, published in the HR Online News.1 Additionally, in our January 2012 edition, HR published an article by Dianne J. Van Tasell, PhD, that details both the At-Home and Clinical versions of the hi HealthInnovations prescriptive fitting method and hearing test, respectively.2 More recently, longtime HR contributor Mark Ross, PhD, offered his perspective on the company’s programs in the March/April edition of Hearing Loss, the journal of the Hearing Loss Association of America (HLAA, formerly SHHH).3
HR: Can you give us an update on hi HealthInnovations’ activities since we last talked in October?
Dr. Tseng: The last time we talked, we spoke a lot about our online hearing test, which is really only one component of our program. Recently, we’ve introduced a hearing test kit for the primary care setting. This is for physicians and nurses to incorporate the hi HealthInnovations testing as part of a physical exam.
As you know, many people’s primary engagement with the health care system is through their primary care provider. In fact, in a recent AARP/ASHA survey4 of 2,232 AARP members, 70% of them would prefer to talk first with their primary care provider about hearing loss.
So we’re very excited about the opportunity to engage more doctors and nurses in such an important part of health care. As we all know, hearing loss has a lot of consequences for the social, medical, and economic status of an individual, and also impacts family and friends. So we think it’s great that this element of the program is out in the marketplace, and we’ve received some very positive feedback from the physician community about this important testing option that they now have.
HR: So, both doctors and nurses can administer this new test?
Dr. Tseng: It depends on the state. Many states recognize nurses and nurse practitioners for a broader scope of activities, and a lot of clinics have a physician [overseeing activities] that involve nurses and physician assistants. So, just as long as there is physician oversight in those areas in which [the state allows for those provisions, then they’re allowed to] perform different tests.
HR: Would the nurse or nurse practitioner be examining the ear for medical problems or abnormalities, as well?
Dr. Tseng: Again, it depends on the state. Many community care clinics, for example, allow the nurses—particularly nurse practitioners and physician’s assistants—to perform a wider range of activities that are traditionally more in the scope of the physician. However, as you know, the shortage of physicians [means that] all these ancillary health care providers now have expanded roles in health care, or otherwise we just could not serve the growing demands of the aging population and the Baby Boomers, in particular.
Once again, the thing I’d like to emphasize is that these are just additional options for the consumer. It doesn’t replace the need to have specialists like audiologists, ENTs, and other hearing care professionals. These are just additional ways to get people more interested about their hearing health. And when individuals would benefit from specialized services that ENTs, audiologists, and hearing professionals offer, the pathway exists for those individuals to continue on to referral.
HR: I know you’re excited about and want to address your network of hearing health care providers. Can you tell us about it?
Dr. Tseng: Yes, another important element of our program that is not as widely known is the terrific audiologists and hearing care professionals that we have on staff throughout the country. Dr Gibbens [works in] the Knoxville/Nashville area, and we’re very lucky to have these professionals who provide counseling, education, and aural rehab support on the phone, over the Web, and in person. Our professionals have had great feedback from customers and members…. I know that Dr Gibbens has been helping several of our customers. So we’re very happy to continue to grow our team of professionals who provide more hands-on support for the people who would like [that support].
HR: How many people do you currently have on staff for hearing support?
Dr. Tseng: We can’t share the number of people we have on staff, the number of people we have engaged in the program, or the number of hearing aids we’ve dispensed. It’s our corporate policy that we don’t share this type of specific information.
HR: Are you planning on having dispensing professionals throughout the United States or are you centralizing support functions?
Dr. Tseng: We are trying to build as broad a support base as possible. So we’re not centralizing these professionals [in any one place], per se, but instead looking at the most populated areas of our membership and also the general public and just really wanting to serve these individuals. We’re rapidly growing and expanding, and we continue to recruit [hearing care professionals].
HR: How is the recruiting going? One frequent gripe among hearing industry manufacturers is that there is a dearth of hearing care professionals available for hire.
Dr. Tseng: We really haven’t had that challenge. It’s going well. I have a lot of resumes and applicants for each of the jobs we’ve posted. So I think we’ve been lucky to have the opportunity to talk with many, many individuals, and it further highlights the fact that—although there may be professionals who may not be comfortable with our model—many professionals see this as a significant consumer need and want to be part of a movement that is increasing access and affordability for consumers.
HR: How are your network physician providers responding to that part of the program?
Dr. Tseng: Very positively. They see our in-place staff as yet another source they can turn to. Typically, a lot of our network provider physicians have professionals who they already work with, and now they have additional specialists they can refer to.
One of the most common obstacles that primary care physicians run into is not having enough specialists in their referral base. So they love the fact that we have our own employed professionals who are very interested in helping them test patients and provide incremental support.
HR: It has always been an issue that PCPs are not always as up-to-date as our field would hope on issues that involve hearing care and amplification. Are you supplying them with information about this?
Dr. Tseng: Yes. We actually do trainings with PCPs and continue to provide enhanced training about our hearing testing process and so forth. The next step involves hearing health and [consequences of hearing loss]. In fact, our audiologists and hearing care professionals are reaching out to the local GPs in their areas and offering brown-bag lunch seminars with physicians and their teams.
HR: Can you tell us more about the actual new screening test for use by primary care providers and the reason behind the new system?
Dr. Tseng: The system is actually described pretty well by Mark Ross’s article2 in the recent edition of Hearing Loss magazine [published by the Hearing Loss Association of America], but let me talk a little more about it.
This is an air-conduction test with calibrated earphones and equipment, and the goal of this test is to incorporate hearing testing into the physical exam, because most people’s primary engagement in the health care system is with their primary care providers. Since 2005, Medicare has required providers to do hearing screening as part of the IPPE [Initial Preventive Physical Examination] or Welcome to Medicare exam.
Our goal is to provide them with a [hearing screening tool] and also give them something that is easy to adopt. As you know, learning how to use a traditional audiometer isn’t [simple], so what we’ve developed is easy-to-use software for physicians and their staff to be able to administer to their patient population.
The user interface was designed with the senior population in mind. We really wanted to keep it very simple and easy for the patient to follow the directions, and then very easy for the primary care providers to learn how to apply it.
HR: Is this a test in which the patient sits in front of a computer?
Dr. Tseng: It has a user interface that is similar to our At-Home hearing test or online hearing test. You use a mouse to move the knob to [sound levels] where you can barely hear [the tone].
Very soon we’ll have another version for the iPad where you can use your finger to manipulate the touchscreen. So, we’re continuing to expand our portfolio set of different testing tools that we can provide to the medical community.
HR: How have hi HealthInnovations’ hearing aids been received? Do you have any customer satisfaction data or return figures that you can share?
Dr. Tseng: Again, it’s our policy not to share any specific figures, but I can tell you that customer feedback has been extremely positive, especially people who have previous experience using hearing aids. They can tell the value they’re getting [with our hearing aids] is really high compared to what they had in the past.
For example, a gentleman in Nashville told me personally that the hearing aid he received from us was better than the hearing aid that he’d bought for several times the price in the past, and he really appreciates the aftercare support that both our corporate call center and Dr Gibbens were providing to him in his local area. So, we’re getting a lot of great feedback from experienced users of hearing aids because those are the people who really have a comparison. For the new users, the kind of feedback we’re getting are comments like, “Wow, I never knew that I could get hearing aids at this price and have them work this well for me.”
I’d also like to point out that audiologists and hearing instrument specialists are doing a lot of seminars in their communities, especially for our membership. We’re getting a lot of great feedback about the seminars they’re conducting, and they’re really opening the door [to better hearing health care] that consumers never previously knew existed. Because, in their minds…they thought hearing aids don’t work very well, and in fact there is still that misconception in many parts of health care. So it boils down to a lot of outreach that our team has been doing…
HR: So you are currently sending people, including those who are not able to obtain open-fit hearing aids, to those dispensing professionals in your referral provider network?
Dr. Tseng: Yes, and we will be showing even more information about our referral providers very shortly, as well as [presenting] an overview to the different hearing-related organizations. We [detailed] some of this in February, but we now have an even more robust program because we’re continuing to learn and incorporate new elements. What will be very exciting is that people will have access to a lot more providers than today using unbundled pricing models that many professionals, as well as consumer organizations, have advocated for in the past.
The idea is that [consumers] can go to the providers of their choosing, drawn from a list of those who sign up with us and have access to our software and equipment. Referrals are provided at no charge to professionals, but they need to agree to some very basic guidelines that we will be sharing soon.
HR: Presumably, part of the guidelines would be that the dispensing professional recommends your device?
Dr. Tseng: They’re not tied to using our devices, but the customer who typically comes to us is very interested in using our devices. So, [network providers] need to be at least open to using our products, because the customer is coming in and asking for them—especially at the co-pay price of the health plan. We’re definitely open to [dispensing professionals] working with other devices, but our customers themselves are very interested in using our devices.
One of the things we want to highlight is that our model really could do what has been attempted [unsuccessfully] in the past. We can truly maximize the time that audiologists, hearing instrument specialists, and ENTs spend with the patient by helping them with all the administration tasks, time getting payment from different third-party providers, and so forth. We think our program will bring all these pluses without having any incremental referral charges for the providers who work with us.
In addition, the advantage of our model is that consumers will pay for only those things that will be beneficial to them. For example, some consumers may not need a lot of follow-up visits to get their hearing aids working [optimally]; other consumers might need to see a hearing care professional every 3 to 6 months. In our program, consumers pay for the services that they need and value. There isn’t this one-size-fits-all or cross-subsidizing system that we see in a lot of the current models.
I think there are many positives to being part of our referral provider network. We will also be sending the devices to the patients and really helping them understand how to use the devices [via] videos, with our User Guides, and also through webinars and seminars that our audiologists and hearing care providers will be conducting. So, the user will have familiarity with, for example, how to open the battery door and replace a battery, how to clean the ear tubing, etc. This is designed to save valuable time for the more high-level counseling and aural rehabilitation, and leaving the granular items and basics for us to help educate people before they get to the professional.
Some of the great positives working with our staff audiologists and hearing instrument specialists is understanding their support needs, and we’ve created materials that allow them to have more time to focus on their patients. On our Web site is a library of videos about how to use each of our devices. Very soon, we’ll also be adding regular webinars to help new users answer any questions they may have, and audiologists and other professionals in the field will hold regular seminars for consumers. These [types of activities] will continue to evolve from being more basic and educational to more specific “How To” formats. Obviously, consumers have different needs in learning.
HR: Can you summarize your entire program and the actual number of different ways for people to obtain hi HealthInnovations hearing aids?
Dr. Tseng: Yes, there are four basic elements to the program:
- The hearing testing at primary care clinics;
- The At-Home test that we have online and is available to consumers 24/7;
- Our staff audiologists and hearing care providers in many cities; and
- Our extended referral provider program, which will be very beneficial for the providers who sign up with us, as well as for our customer base.
People who access hi HealthInnovations from any of these channels will be able to get support from our staff audiologists and hearing care providers, whether they’re getting initial testing at a PCP office or visiting our preferred providers. Our professionals will be available to supply additional support in person, over the phone, or via the Web, and those services are provided free of charge.
Additionally, if you’d like to send your devices back to us for adjustments or reprogramming, these services are free of charge as well. So, our aftercare and support are robust and much of it is free of charge to the consumer.
HR: How many people are actually getting their hearing aids free of charge?
Dr. Tseng: Once again, this is confidential information that I can’t provide, except to tell you the range of our offerings. So, we have Medicare Advantage Members who have hearing aids as a benefit, and they can get [the devices] at very low co-pays, and there are also a lot of other members who get a significant discount on hearing aids—the official term is VAIS or value-added item service—for their plans at mostly $479 each. However, even for the general public, the devices are generally $749 each.
HR: hi HealthInnovations’ use of the word “devices” has prompted some in our industry to wonder if you’re attempting to market the product as a PSAP, particularly with the online At-Home version. So, once and for all, are your devices PSAPs or hearing aids?
Dr. Tseng: They are hearing aids. The reason we’ve been calling them hearing devices, as you know, is there is a stigma attached to the word “hearing aids,” and we thought that consumers would be more open to the term “hearing devices,” [which sounds more like] their iPads that assist them in various facets of their lives…We want to remove that stigma by reducing the use of words that might have negative connotations…And you also know that the difference between a hearing aid and personal sound amplifier is the purpose for which they’re marketed [relative to a device that compensates for impaired hearing versus a “hearing enhancer,” respectively].
HR: A good deal of the objections to your online test revolve around safety concerns—and these might also apply to the nurses and providers you mentioned in our discussion about the clinical test—and the test’s ability to recognize certain medical conditions and Red Flags. For example, Eric Hagberg of ADA labeled your test as “unsound, unsafe, and unreliable.” How do you respond to this?
Dr. Tseng: I think consumers today want to have more at-home testing and different tools that they can use to continue to monitor their own health care, and I think [the At-Home test] is a great new way for people to assess whether their hearing is good or has changed and if they’d like to see a professional. They may also move forward with hearing devices, understanding that they don’t have any of the Red Flags that the FDA has outlined.
So I think a lot of this is very much in line with what we’re seeing in health care, in general. For example, if we have a headache, many of us will examine our past experiences. Is this headache so severe that I need to see a doctor? Is this a headache that Tylenol or some other pain medication will help me with? There is an element of consumer judgement, and our goal is to provide the most robust information for the consumer.
You’ll see this throughout our Web site and throughout our online hearing test. It makes it clear that, if you have pain, drainage, dizziness, sudden or one-sided hearing loss, you should see a medical professional before moving forward. In fact, if you have an asymmetrical result from our online hearing test, the first thing that we do is refer you to a medical professional, and you cannot move forward in our model until you have a medical assessment stating that your hearing loss isn’t something that needs further workup or further treatment besides a hearing aid.
We’re very careful about educating our consumers and making sure that people are seeing medical professionals when they notice changes in their health, including hearing health, that is outside the norm.
Dr. Gibbens: We audiologists and hearing instrument dispensers are responsible for reviewing all the results that come in [to the company], and we pay particular attention to them to [ensure we’re recognizing potential problems like] asymmetry.
HR: There have been some reports that the online test is not properly rejecting people who are under age 18. Have you encountered this?
Dr. Tseng: If you’re under age 18, we do not dispense hearing aids to you via our online model. So, even if you’re able to take the test and check your hearing [you can’t obtain hearing aids from the program].We have people on our staff whose teenagers have taken the test to see if their iPods and loud music were damaging their hearing. So, although these younger people can check their hearing status, they are not allowed to move forward in getting hearing aids.
HR: There has also been criticism about your online test in that, if you’re a normal-hearing person, you still get product recommendations.
Dr. Tseng: I don’t think that’s the case. If you have normal hearing, we tell them “Congratulations, you have normal hearing.” However, we do advise people with normal hearing to check their hearing periodically.
HR: State-by-state laws vary considerably throughout the United States. Are you able to dispense in all states online or are you prohibited from dispensing online hearing aids in some states? How are you complying with these state-by-state laws?
Dr. Tseng: We’ve done a comprehensive regulatory review before we enter into any business. And, given how large our corporate parent is, we are very good and careful about being compliant with all applicable federal and state laws. We feel very good about our ability to serve a wide net of consumers across the different states.
HR: Are some of the dispensers you’re recruiting an effort to get professionals “on the ground” in those states [to comply with state laws]?
Dr. Tseng: I think all states require licensed individuals, so we are very good about making sure our consumers get the best care possible, and even though many of these consumers do not need further help from our audiologists or hearing care professionals, to Dr Gibbens’ point, their information is reviewed by [hi HealthInnovations’ staff] before they can move forward with an order.
HR: What do you say to dispensers who are reluctant to provide services to those people who will ultimately be purchasing a hearing aid from hi HealthInnovations?
Dr. Tseng: When our patients ask for local audiologists or hearing care professionals to do a hearing test for them, if it is referral from the primary care provider, that service will be paid. I think it’s a good thing for the patient, because the existing referral program and the existing testing options that patients have are still there. To Dr Gibbens’ point, if we have more engagement with the consumers and PCPs, more people are going to be aware of the available hearing services. Ultimately, we’re going to see a lot more referrals than even today.
Dr. Gibbens: And that speaks to the opportunity of the primary care physicians. I had the opportunity recently [to speak to a group of physicians] and one of the first things I do is to demonstrate hearing loss with the filtered speech test. The looks that I get from primary care physicians and nurses are very telling; it’s obvious that they have little idea about how a mild hearing loss can impact speech reception. So these opportunities to explain hearing loss to PCPs are very important.
HR: What are you most encouraged or excited about regarding your program? What things have worked exceptionally well?
Dr. Tseng: I think I’d point to the consumer response. I worked in the health care industry, as well as in financial services, and it’s not that common when you’re in a call center and you get a customer service call where the customer thanks you 10 times throughout the call and says, “I hadn’t realized that I could get hearing aids at this price and now I can finally go out and talk with friends, and so forth.”
On a more negative note, I had a person tell me how their parents were assessing how much longer they’d live in order to make an $8,000 purchase of hearing aids, to make sense for them as a family. They were valuing this against things like their grandkids’ college education. I think those types of stories helped me realize there are many individuals who could benefit from our program. One of those individuals was actually a United Healthcare employee, and it was just very touching for her to share the things her parents were going through. Many people who have good-paying jobs and are considered middle-class still have substantial financial commitments like mortgages, putting kids through college, or caring for their aging parents. We all have a lot of financial demands, so it’s truly rewarding to be able to hear stories about how our program is impacting lives and making a difference.
Dr. Gibbens: One of the things I’m most excited about is talking with primary care physicians, and some of the concerns about reduced referrals are really inaccurate. If anything, I see more referrals occurring, because we now have a quick test [for the PCP] in the clinic that often confirms what a patient suspects. So, I see an increase in referrals. In fact, yesterday, one of the tests that we received from the outside [not online] clearly indicated that the individual needed to see [an ENT].
HR: Anything else you’d like to share?
Dr. Tseng: Overall, I think we’re very happy with how we’re serving our customers and members, and we look forward to continuing our work with audiologists, hearing instrument specialists, and ENTs to increase access to hearing health—as well as continue to improve affordability and quality.
Dr. Gibbens: And, if we can succeed in those things related to affordability, it’s also possible that we can get some more neckloops and FM systems [into consumers’ hands]. It’s traditionally been a huge issue when people spend $4,000 for hearing aids, and then we tell them they could really benefit from other assistive devices. You get that look from them that says, “Are you serious?” That’s a big challenge we have in the profession, as well as simply not having the time to demonstrate and work with those products that complement hearing aids. —KES
- UnitedHealth enters hearing market: HR interviews hi HealthInnovations CEO Lisa Tseng, MD. HR Online News, October 11, 2011. Available at: www.hearingreview.com/news/2011-10-11_01.asp
- Van Tasell DJ. Methods for prescribing gain for hi HealthInnovations’ hearing devices: reliability and accuracy. Hearing Review. 2012;19(1):18-27.
- Ross M. Direct-to-consumer services: comments on the hi HealthInnovations hearing aid dispensing program. Hearing Loss. March-April 2011:28-30. PDF available at: http://tinyurl.com/bpgma33
- AARP/American Speech Language Hearing Association. National poll on hearing health results summary. PDF download at: http://tinyurl.com/cxf664r