20Q: Embracing Change in Audiology Practice

From the Desk of Gus Mueller

Yes it is true.  The audiogram is still upside down, some clinics still record thresholds in X’s and O’s (maybe even color coded), and audiologists are still in love with conducting speech testing in quiet. But, change is inevitable. Consider that as recently as 2001, your cell phone was only for making calls, not taking photos and browsing the Internet.

Change will happen in audiology too—probably sooner rather than later.  That’s our topic for discussion this month here at 20Q. We’ve touched on this topic before. Five years ago, Robyn Cox authored a 20Q where she concluded:

“I think that if audiology and audiologists do not change and adapt, we are likely to be overtaken by circumstances. At this point, we do not have a unique identity, quite a few existing patients are not very satisfied with our services, and we are not attracting many new patients.  Hearing-impaired boomers are looking for a better mousetrap, and there are more than a few smart individuals who are trying to figure out how to provide it in a way that does not include audiology.”      

Robyn’s comments ring ever more true today than they did in 2014. Here to tell you why is Kevin Franck, PhD, Director of Audiology for Massachusetts Eye and Ear/Harvard Medical School. While his current positon is a practicing clinician, Dr. Franck’s training certainly qualifies him to expertly examine the impact of potential change from many areas related to audiologic practice. He holds an MBA (healthcare management) from the Wharton School of Business, a PhD (hearing science) from the University of Washington, an MSE (biomedical engineering) from the Johns Hopkins University, and a BA (engineering) from Dartmouth College. 

Dr. Franck’s diverse work experience includes directing the cochlear implant program at The Children’s Hospital of Philadelphia, product development at Cochlear Ltd, and directing research at the start-up company Ear Machine, which led to his position leading marketing and product management for the hearing device business at Bose. 

I’ve heard that the Chinese symbol for change is composed of two parts: danger and opportunity. In this 20Q, Keven talks us through how we can embrace the latter.

Gus Mueller, PhD
Contributing Editor

Browse the complete collection of 20Q with Gus Mueller CEU articles at www.audiologyonline.com/20Q

20Q: Embracing Change in Audiology Practice

Learning Outcomes 

After this course, readers will be able to:

• Describe the prospect of change in audiology within the perspective of other industry changes.
• Explain a business model that positions audiology practices for success now and in the future.
• List products and services an audiology practice may consider offering to respond to changes in the industry.

         Kevin Franck, PhD

1. I keep reading about things that could fundamentally change what I do as an audiologist. How do I not feel overwhelmed by all that’s on the horizon?

The tenet that survival is dependent on change is widely used. While healthcare in general and audiology specifically may change more slowly due to regulation, we’re not immune from it. And there’s really great reason to change. The gap between those who need hearing health care and those who get it grows larger every day. And these same people are relying on their hearing longer as they extend their professional and social lives. Audiologists are well-positioned to help these people, but there aren’t nearly enough of us.

Despite the relatively young age of the profession, the field of audiology has lived in a substantial equivalence reality for some time. Substantial equivalence, simply put, means devices are deemed as safe and effective in the FDA approval process when they are comparable to a legally marketed device ("predicate device"). In our industry, hearing-related diagnostic and intervention products have come from a relatively stable group of vendors whose products are marketed for relatively stable benefit claims. New devices are brought forth based on previous models. But recently, there has been an increase in De Novo applications of new device and drug products from new vendors to help individuals with hearing loss. The De Novo process provides a pathway to classify a novel medical device where there is reasonable assurance of safety and effectiveness for its intended use, but for which there is no legally marketed predicate device. There may be more change happening in this industry in the next few years as compared to the last several decades.

Back to your question - the way you avoid feeling overwhelmed by change is to drive it. Accept its inevitability, anticipate it, prepare for it and be confident that the services you provide are valuable to those who need them.

2. That advice sounds like a reasonable mindset, but where do I start? 

While there may be some things that change very little over time, technology-based tasks tend to change often. Scan your day and think about the technology-based tasks that you are performing the same way that you were taught to years ago. Start there and see if there is a better alternative that could save you time or money. Also, we work in a more integrated context than ever. Collaborating with people outside of audiology can likely lead to opportunities to learn from them. They may have faced similar challenges or created solutions to change that can benefit you and your practice.

3. Let’s get specific. One task I perform the same way that I was taught is fit hearing aids. I use validated prescriptive measures with real-ear verification. Should I question it?

Yes. Published studies have shown that there are other ways to fit hearing aids that also could be successful.

4. Really? Do you have an example of the research you’re referring to?

Sure. When I worked with Ear Machine, we validated a method in the first phase of a National Institutes of Health-funded Small Business Innovation Research (SBIR) grant to fit hearing aids that required no audiogram and no real-ear measures. This method produced results no worse (and often preferred) to those fit by an audiologist. The method involves having participants adjust two controllers that navigate them through a comprehensive set of wide dynamic range compression parameters that sound like volume and bass/treble.

We introduced this technology to Bose to suggest they combine this with occlusion-mitigating noise-canceling earphones to pursue hearing aids. Bose then bought this technology and used the second phase of the SBIR grant to gain the de novo approval of the first self-fit hearing aid. Compared to the pro-fit group (fitting done by an audiologist using real-ear measures), the results with the self-fit hearing aid showed non-inferiority in APHAB, SSQ-12 and QuickSIN measures. In addition, there was significant correlation with gain measures (r=0.65), with only 1.9 dB average difference in gain settings among 75 subjects with mild to moderately-severe hearing loss (FDA approval of submission DEN180026, May 2018). This means that soon, many people may have access to good ways to fit their own hearing aids.

5. Are there other ways to self-fit hearing aids?

Most certainly. A number of personal sound amplification products (PSAPs) encourage their users to do a self-hearing test, then the devices apply fitting algorithms based on the test. The accuracy of the self-hearing tests will depend on known challenges such as the level of background noise and headphone calibration. Also, the effects of ear canal variation may be made worse by the larger ear canal variation caused by the relatively shallow insertion depth of consumer earbuds in these PSAPs. But for some people (likely those with milder hearing loss), this might work just fine. Other products simply use the “few-sizes-fit-most" approach. If you’re lucky enough to need these gain settings, then you may be well-served—this was demonstrated in the research from Humes et al. (2017). And, you can be sure that there will be new methods, and refinements on our existing methods in the future, including methods that will differ based on the etiology and severity of hearing loss.

6. What about Internet-purchased hearing aids?

While some internet-purchased hearing aids can use professionally measured hearing thresholds, and then pre-program the hearing aids to a given prescriptive method, they can’t accommodate the ear canal (physically or acoustically). I think many consumers will be well-served by these models if they don’t have unusual physiology.  Audiologists have an opportunity to provide the needed finetuning, and other in-person fitting services, for devices purchased online.

7. Can you elaborate? If self-fit and Internet-purchased hearing aids might actually work for some people, what exactly am I to do in my practice?

Segment your patient population. Promote simple devices for people with simple needs. Provide services when they want it, like validated fittings based on audiometric data and real-ear measures. For patients who need more complex services and products, provide value far beyond what they can get on their own. Guide them to the right product. Teach them how to integrate other useful communication strategies and hearing products. When they bring in an inappropriate product, help them get refunded and provide them with a product that’s right for them. Diversify your offerings to include products that aren’t so easily consumerized, like servicing cochlear implants.

8. Can cochlear implants also be self-fit?

Yes. Cochlear implant companies and academic clinicians have demonstrated self-fitting. It may take a while for implant companies to seek and attain regulatory approval to enable these capabilities, but I believe they will eventually if clinicians and patients demand it. Like with self-fit hearing aids, self-fit cochlear implants won’t work for everyone. Likely, self-fitting features will be enabled by the clinician.

9. Are hearing self-assessment tools accurate?

The widespread availability of tablets and smartphones is enabling a wave of really good hearing self-assessment tools. They are more sophisticated than simply turning the audiometer interface around. Good systems that measure thresholds both monitor noise levels and show you how they might influence the results. They monitor attention through the consistency of responses. And, they attempt to account for the wide variation of headphone quality through calibrations. However, threshold tests, in general, may not be the best way to attempt hearing assessment outside of a calibrated environment, depending on their use.

10. What other choices are there for hearing assessment?

Methods that use suprathreshold tests (such as noise masked psychophysical tuning curves or closed-set speech perception in noise) can do a good job of finding people with more hearing trouble than others. At Mass Eye and Ear, professionals are learning how to use self-hearing assessment tools in our Emergency Department and ENT clinics when audiologists aren’t available. This can allow physicians to make some hearing-related decisions faster.  We can also use these tools to assist in making qualified referrals from primary care offices. Patients at risk for hearing loss, or those who have fluctuating hearing loss, can monitor their hearing over time with self-assessment tools, and seek assistance when needed.

11. Is there any good research to back up self-assessment of hearing?

Yes. Modern self-hearing tests have been shown to produce audiometric air conduction thresholds in agreement with audiologist-administered tests (see Saliba et al., 2016; Thompson, Sladen, Borst, & Still, 2015). These systems use calibrated headphones and continuously monitor ambient noise to reduce error, and employ catch trials. As long as the person taking the test is motivated to complete the test accurately, results can be acceptable at the resolution to make a variety of clinical decisions.

12. If self-assessment of hearing tools work that well, what am I to do in the clinic?

Self-assessment of hearing tools can play a role to identify and monitor hearing ability at a scale audiology clinics could never attain. So, when people do come and see you for diagnostic testing, provide a level of service unattainable any other way. Ensure a level of quality that is derived by constant attention to the patient’s engagement in the test, chased-down conflicting results and repeatable methodologies. With this quality, patients can be confident to follow-up on your counseling and referring practices can make their clinical decisions with certainty. Use a full battery of diagnostic tests.

13. There are so many hearing-related smartphone apps these days that I've lost track. What are some of their functions?

Some smartphone apps and computer programs enable hearing aid signal processing on their respective platforms. There are crowdsourced apps that collect noise profiles of restaurants and public transportation systems. Crowdsourced refers to the fact that people using the app can input measures, data, and feedback that is then aggregated and can be used by others. These apps can help advise us where (and where not) to go based on our preferences for safe and/or comfortable listening. There are also smartwatches and smartphone apps that perform noise dosimetry and provide notifications so that we change our behavior when appropriate.

For example, the Noise app on the Apple Watch will notify you when the average sound level over a period of three minutes reaches or exceeds 90 decibels. By default, you’ll feel a gentle buzz on your wrist and an alert will pop up on the watch's display.  There are a wide variety of options today to help people protect their hearing.

14. Switching gears to more futuristic changes. Are there any drug treatments for hearing loss on the horizon that might impact audiology practice?

Recently, a level of investment and human clinical trial activity in pharmaceutical treatment for hearing loss has spiked. When pharmaceutical treatments enter the market, it may increase the demand for diagnostic and hearing monitoring services. They will be required to document drug efficacy for what will likely be narrow indications for these drugs. If such treatments become available that actually result in improved hearing or that delay the progression of hearing loss, people with hearing loss may get more benefit from the products we dispense.  

15. How do I differentiate myself when so many outside forces are impacting my business?

Hearing health is connected to so many things - from entertainment to employment, across mental health to health economics. Hearing has broad relevance. The more people who are armed with good information and intervention regarding hearing health, the more we can do as audiologists to achieve better hearing on a large scale. Audiology can be a clearinghouse of information and context for a variety of allied clinical professionals and can be the profession who people go to last.

16. What kind of business model is required for audiologists to be successful in light of all these changes we've been discussing?

I believe there are three interconnected components of a business model for audiology to be successful: 1.) Diversified products and services; 2.) Products sold separately from diversified services; and, 3.) Varied referral sources.

Audiologists don’t need to only sell hearing aids. They can also sell consumer hearing products to help people protect and use their hearing. If the counseling and fitting services are sold separately from products, then the audiologist can be more agnostic about the price of what is sold. Separately-billed services can be sold to direct people to the right things they need based on complete diagnosis and needs assessment, and to provide custom physical and acoustic fittings. Implanted hearing products can be serviced outside the center where they were implanted when there is good communication and clear relationships with the center. And, if audiologists are effective at empowering referral sources to know when they can serve customers with hearing loss themselves and when to refer, they can enjoy more qualified referrals.

17. How do I diversify my product offerings?

If you mostly sell hearing aids, you can diversity by providing diagnostic services for hearing and balance. Work with local ENTs who do not employ their own audiologists to assist in their patient management. Audiologists can independently bill for services referred by providers from a number of payers.

If you separate the services you provide from the hearing aids, you may find that you can provide some of those services without products, or with other kinds of products. For example, patients value the process of translating their hearing and communication needs into the relevant actions they can take to manage them. And, you can provide fitting services to people who need help with their self-fit hearing aids.

You can work with hospitals where patients receive implanted products to provide post-initial fitting adjustments and other services. This requires clear definition of roles with the implanting center.

18. How do I separate the costs of services?

Unbundling has been discussed widely in the audiology business literature, and the audiology professional associations have resources to support you through this process. We are going through this process at our hospital now. It requires new communication and billing practices, and new relationships with our patients. It requires a level of financial awareness of the costs of providing products and services. We are often challenged that we are moving toward fee-for-service when other areas of healthcare are moving toward bundled payments based on outcomes. But, audiology will need to be compatible with consumer products. Implanted products are already unbundled. Providers can separate their covered clinical services from others that can be provided by user groups or manufacturers themselves.

19. I’ve had trouble attracting varied referral sources? Any ideas?

Focus on places where people with hearing loss are underserved or more frequently present with common comorbidities. Provide referrals to these centers using results of simple screening tools such as the Timed Up and Go test (TUG) for people with balance or mobility problems, and tests such as the Mini-Cog for people with cognitive issues. At the same time, provide these clinics with communication strategies and low-cost amplifiers (such as SuperEar9000) to help people who do not know how to advocate for their own hearing loss. With these relationships established, these clinics can better help their patients and may refer those who benefit and seek additional services.

20. It all sounds so intimidating. Any final words of advice?

Start small and perform experiments. For example, try selling a few high-quality PSAPs. Choose one or two that have the ability for you to adjust, and have many of the same features of high-quality hearing aids. Track patient satisfaction with the same outcome measures you use for other products and compare. How do the return rates compare? Do the products cannibalize other sales? We have found that patients appreciate a wider range of options, and some select these less costly products. It has not impacted our hearing aid sales. Of course, this may change over time, and when OTC hearing aids with different product features enter the market.

Another example – encourage patients who complain of episodic hearing loss to monitor their own hearing with self-testing apps. Establish an initial comparison of self- and clinician-driven audiograms that could account for each patient’s headphones. Differences from that baseline might inform how hearing changes over time.

The bottom line is this: We live in a changing time. Technology has led to many innovations that improve our lives, and business models have to change to take full advantage of them. Technology shouldn’t be adopted just for technology’s sake. Audiology is well-positioned to advocate for our patients and provide many more people with better hearing than ever before if we're able to adapt our practices accordingly.

References

Humes, L.E., Rogers, S.E., Quigley, T.M., Main, A.K., Kinney, D.L., & Herring, C. (2017). The effects of service-delivery model and purchase price on hearing-aid outcomes in older adults: A randomized double-blind placebo-controlled clinical trial. Am J Audiol, 26(1), 53-79. 

Saliba, J., Al-Reefi, M., Carriere, J.S., Verma, N., Provencal, C., & Rappaport, J.M. (2016). Accuracy of mobile-based audiometry in the evaluation of hearing loss in quiet and noisy environments. Otolaryngol Head Neck Surg, 156(4), 706-711. doi: 10.1177/0194599816683663

Thompson, G.P., Sladen, D.P., Borst, B.J., & Still, O.L. (2015), Accuracy of a tablet audiometer for measuring behavioural hearing thresholds in a clinical population. J of Otolaryngol Head Neck Surg, 153(5), 838-842. doi: 10.1177/0194599815593737