Audioscan recently introduced a unique over-the-counter / direct-to-consumer (OTC/DTC) device verification test suite for their Verifit2 system.
Dr. John Pumford, Au.D., Director of Audiology, Education, and Clinical Research, answers key questions about this innovative tool and offers his expert perspective on the future of hearing care.
What is the Audioscan OTC/ DTC test suite for Verifit2?
Great question! The Audioscan OTC/DTC test suite is an Industry-first, dedicated test box test that objectively measures the capabilities of OTC and DTC devices. It was developed in response to the FDA ruling authorizing OTC devices to offer clinicians a way to engage with these types of products.
Specifically, it provides an efficient and accurate method to assess the quality and safety of OTC devices relative to the FDA criteria for these products and allows clinicians to screen the audibility capabilities of these systems for the intended patient population of adults with mild to moderate hearing loss.
Needless to say, when this device category was established and the FDA ruling occurred, there were a lot of questions regarding the impact of OTCs on clinical practice and what, if anything, clinicians could do to engage in this product category if they chose to do so.
How was this test suite developed?
The test suite was developed by considering the essence of the final FDA ruling in October 2022, including the specified technical requirements for this category of device, not to mention the hearing loss and age of the client these devices were intended for.
On the technical side, we’ve provided in the software an ANSI/CTA-2051 evaluation feature based on the methodology of the ANSI/CTA-2051-2017 standard and the ANSI s3.22-2014 standard included in the final FDA ruling.
As part of this, there is guidance regarding aspects like how the devices should be measured, the signals that should be used, any associated transforms – and, importantly, pass/fail criteria on several electroacoustic measures designed to ensure the safety and effectiveness of these devices knowing that they would likely be fitted without professional care.
The nice aspect of our development of this test is the clinician can quickly and easily evaluate the performance of OTCs in the test box and see a pass / fail indication for each measure relative to the FDA ruling criteria on the screen. The test suite simplifies interpretation and allows those less familiar with electroacoustic measures and the FDA final rule criteria to run the test.
How can the Audioscan OTC/DTC test suite enhance clinical practice?
The test suite was developed to provide several opportunities for clinicians to engage in this product category. For instance, it can be used as a way for clinicians to evaluate what they may want to stock in their product offerings should they decide to include OTCs as an option for those patients not yet interested in purchasing traditional devices.
As we know, with conventional hearing aids, not all devices are created equal. It’s no different with OTCs, and it can be challenging to know which devices have the quality and performance that meet our clinical standards as possible offerings.
The test suite can also be used to efficiently gather information about an OTC product purchased elsewhere by a patient, determine the device’s capabilities, or support them in their use of these products.
This information could then be used to guide treatment options depending on the measurement findings – be it an opportunity to provide an alternative, more suitable OTC or perhaps speak to the benefits of a traditional hearing instrument and associated professional care.
All of this could be marketed to the community, depending on the services and products the clinic wants to provide. Several clinics are now promoting their ability to evaluate and service OTC devices for current and new patients. This test suite offers an efficient and easy method to engage in this device category.
No doubt, there are other creative ways that clinicians could use the OTC / DTC test suite beyond what I’ve mentioned. It will be interesting to see how clinicians leverage this tool now that it is commercially available.
What styles of OTC devices can be verified?
The nice thing about this feature is that all styles of OTC devices can be verified in the test box. Various coupling options are available, including puttyless coupling for RICs and slim tube devices. The coupling setup also allows for two devices to be verified simultaneously using our unique binaural test box for added efficiency.
Clinicians then simply need to select the device type from the provided drop-down list to apply the proper mathematical calculations and transforms. And if the clinician is using the ’Audibility Evaluation’ feature, they can select the on-ear venting of the device, so it is applied to the simulated real-ear measurement in the test box.
What is the Audibility Evaluation feature?
I think of the Audibility Evaluation Feature as a quick amplification screener that allows the clinician to determine if the OTC or DTC device can provide ‘appropriate’ audibility for an adult patient with mild to moderate hearing loss. What is deemed ‘appropriate’ comes from considering the aided output relative to the soft, average, and loud speech input targets a validated, generic fitting formula would recommend for someone with mild to moderate hearing loss.
Should the measured output of the device fall within a shaded output target range that we show on the screen for the chosen input level, the device would be deemed capable of providing appropriate audibility at the current settings.
The nice thing about this feature is the clinician can choose from either flat or sloping hearing losses with NAL-NL2 or DSL5 adult targets and immediately see the impact on the desired output target range. It’s a great learning and counseling tool regarding the capability of a device to help an adult with mild to moderate hearing loss and so can help guide clinical decision-making regarding the best next steps.
Are there any other important Audioscan updates HCPs should be aware of?
Well, I should mention we are now at a point where support for our original Verifit1 has ended as of the end of 2023. The last produced units are over 10 years old, so these systems have ended their life cycle for available repair parts and SW support.
Owners of these systems should contact their local e3 Diagnostics representative or Audioscan’s head office if they have any additional questions. Trade-in promotions are also available for a limited time for upgrades to Verifit2 should anyone be interested.
As for other updates, we continue developing new features and technologies to expand the verification capabilities of Audioscan products. For instance, in the near future, users can expect significant enhancements to our bone conduction device verification tools, including new capabilities for our skull simulator.
We also continue to enhance ProbeGUIDE, our software-assisted probe tube placement tool, with an upcoming improved algorithm for use with a broader range of patients, particularly pediatric patients. These upcoming developments and others I can’t mention right now will keep us at the forefront of verification systems in the industry for years to come.
In your opinion, how have OTC devices impacted and will continue influencing the hearing industry?
Well, there’s no doubt the FDA’s final ruling on OTCs has created a lot of interest in the hearing industry – and, depending on who you talk to, with consumers. I feel the jury is still out on the ultimate impact.
I do feel it has created additional awareness of hearing aid treatment options overall for consumers. That said, there are varied opinions on the effect of OTCs on traditional hearing aid sales.
Recent reports I’ve seen suggest little to no impact of OTCs on traditional hearing aid sales, and some have suggested that OTCs are not selling to the level anticipated. Others have suggested HIA data hasn’t captured the true story regarding OTC impact and that low-cost OTC providers may be prospering.
But it is early days, and opinions vary. I think it’s fair to say that those in the market for OTC devices are entirely different consumers than those in the market for traditional hearing aids, and there are enough patients in the latter category for clinics to survive and prosper.
Perhaps OTCs are a gateway to more clinical growth and an opportunity to engage with more patients sooner. Time will tell. But the good news is there will always be a place for traditional, best-practice clinical care. As we’ve touched on, some patients just are not candidates for OTCs and can benefit from clinical services, including verification and counselling that illustrates the relative value of traditional devices and the importance of hearing healthcare providers.
How can hearing care professionals differentiate themselves in the evolving landscape of hearing care?
From my perspective, a crucial part of differentiation comes down to the services and professional care the clinician provides. With the evolution of the hearing care industry, there are now many channels for patients to purchase hearing devices and many clinical competitors.
For a clinic to survive and succeed, it will come down to more than selling a product. This is where clinical service will be essential to stand out above the competition – and, of course, to offer services that have been shown to make a positive impact on patients’ hearing healthcare needs.
Thankfully, we have a lot of evidence showing that verification services, such as real-ear measurement, provide significant value to patients and providers, including improved audibility, improved patient outcomes, improved satisfaction, and, as a result, improved loyalty to the provider and positive word of mouth.
What has been the most exciting thing you’ve experienced in your career as an audiologist?
Well, that’s a difficult question to answer. I’ve been blessed with many positive experiences over my 26 years in the industry and have been able to work with and learn from many wonderful patients and colleagues in various clinical, research and industry roles.
If I look at it through the lens of verification, one exciting thing was being a part of the team that developed and launched the first Verifit in 2001. That product represented the first-time real speech was available for hearing instrument verification in a clinical test system.
I remember the excitement of clinicians at conferences the first time they saw the product and realized they could verify hearing aids using the gold standard test signal – speech. Before that, it was all swept tones, dynamic roving pulses, and composite noises that were trying to predict speech output – and here we were launching the first system with speech – with great success.
As a result, the carrot passage has become well-known globally and is associated with the company. I always thought a carrot was colored orange, but apparently, it’s reddish yellow – who knew? I was also excited that the team selected my proposed name for the product ‘Verifit’ from a long list of options. ‘Verification,’ ‘Fitting,’ blend them together, and there you go!
What excites you when you think about the future of hearing care?
I think there is a lot to be excited about. Off the top, I’d say one aspect is the ongoing demand and need for hearing care professionals (HCPs) going forward. Looking at demographic trends, we can see that with an aging population and the associated increased prevalence of hearing loss, HCPs will be in demand.
The challenge, I think, will be ensuring that we have enough HCPs filling the pipeline to meet this ever-growing demand, as we see from workforce analysis data from Bray, Amlani, and others.
We also see recent exciting evidence from the ACHIEVE study with Frank Lin and colleagues supporting the positive impact that properly fit hearing aids may have on the occurrence of cognitive decline and dementia. Data from this study and associated areas will only increase patient interest in seeking care from audiologists and other HCPs for hearing loss.
Technological advancements in all areas of hearing care, from diagnostics tools to hearing instrument capability to rehabilitative tools, all support the perspective that HCPs will be able to make an ever-increasing positive impact on the lives of those with hearing loss.
In our space, we have the recent development of new tools that enable easier and more efficient best practice verification of hearing aids and should increase the uptake of verification for those who are not currently doing it routinely, including software-assisted probe tube placement tools, automated fit-to-target tools, and enhanced simulated real-ear measurement capabilities to name a few.
To learn more about the Audioscan Verifit2, please contact your local e3 Diagnostics sales representative.
Please click the links below to watch the video version of this Q&A:
- Part 1: https://www.youtube.com/watch?v=LgtVkyrnsu8
- Part 2: https://www.youtube.com/watch?v=dJ7aj3JscrU
Dr. John Pumford, Au.D., is the Director of Audiology, Education and Clinical Research at Audioscan. Previously, Dr. Pumford held senior audiology, clinical research, and management positions for some of the industry’s leading hearing instrument companies. He has also held clinical audiology positions in hospital and private practice settings and worked as a research audiologist at the National Centre for Audiology at Western University (London, Canada) where he investigated compression processing, directional microphone technology and contributed to the development of the DSL version 5 prescriptive formula. Dr. Pumford has presented extensively internationally on hearing instrument technology and best-practice verification procedures and has authored numerous articles, peer reviewed papers, and book chapters on these topics.
