“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.
It appears that the creation of an FDA-sanctioned category of over-the-counter (OTC) hearing aids is a fait-accompli (which is a French-Audiology expression meaning “The End is Near”).
For those of us who plan to survive this end-time, I wonder if it might be a useful exercise to imagine what a world with OTC devices might look like and how the professional community might respond.
So, I’m suggesting we perform a small thought experiment. And here are the assumptions:
- OTC hearing aids are approved for adults with mild to moderate hearing loss
- A hearing test is required as a condition of purchase (I know, this is probably a stretch from an enforcement perspective but this is my thought experiment)
What, then, might be some ways that the consumer can purchase an OTC hearing aid? There appear to be 3 possible models. The American Academy of Audiology (AAA) published a brief description of a few direct-to-consumer (DTC) delivery models.
- Predominately online
- Predominately brick & mortar
- Some combination of the two
The online model will involve some level of remote selection and programming based on a recent audiogram. This option is really not a “thought experiment” as it already exists.
An example of this model is provided to UnitedHealthcare insurance subscribers through its HealthInnovations (hi) subsidiary. Subscribers can call a toll-free number to get a hearing test scheduled through one of their participating specialists or, if the member already has had a hearing test completed within the last year, they can send it (fax, mail, scan) to hi after which someone will contact the subscriber with a device recommendation. If the consumer agrees to purchase a device, a pre-programmed hearing aid will be mailed to them. In terms of support, the company provides text-based information, instructional videos and daily group Q&A sessions through their website or the consumer can call, FaceTime, or video chat with an “expert.”
Other examples of this model include America Hears and HearSource, both of which will mail a pre-programmed hearing aid to the consumer based on a recent audiogram. Post-sales support, including assistance with their self-programming kits, are available through phone communications. The ability of OTC users to successfully self-fit their hearing aids is an issue that was recently explored by Wayne Staab in a recent HHTM post.
Predominately Brick & Mortar
I’m envisioning a kiosk at a big box store (next to the blood pressure machine) which will test the consumer’s hearing and recommend a particular device from among a color-coded selection of OTCs on a rotating display (you know, similar to how readers are displayed). For example, the screen on the kiosk will read:
“Based on your test results, we recommend the WhisperTone 450 model in the yellow package.”
If the consumer buys the device, post-sales support would be available online or via a toll-free number. A variation on this theme might include a questionnaire as part of the hearing test. The answers would determine the “appropriate” level of technology:
“Based on your answers to our questions and your hearing test results, we recommend the WhisperTone EX-450 model. Please choose your method of payment.”
This would involve either the testing or device delivery and programming being provided at a physical location or online. A few possibilities:
- The consumer completes an online test at WhisperTone.com and brings the results to an approved provider who sells WhisperTone devices.
- The consumer receives an evaluation at a clinic and purchases their device and self-fitting kit online.1
Audiologists in the Models
How does the audiologist fit into any of these models? Each practitioner will need to determine the extent to which they want to be involved in DTC sales. But the delivery models described above provide some real opportunities for the audiologist.
For example, following the hearing evaluation the audiologist can guide their patient toward an appropriate OTC purchase (which might include a selection for sale in the practice). This approach means NO MORE FREE HEARING TESTS. Another opportunity is to provide post-purchase services to consumers who need counseling, education, adjustments, repairs, etc. for devices they’ve purchased on line. This approach means NO MORE BUNDLING. AAA published a brief guide on how to manage patients who have purchased their hearing aids through a DTC vendor.
The End Isn’t as Near as It Looks
There’s still plenty of time and many steps ahead before OTC hearing aids become the law of the land:
- The Senate needs to pass their version of the legislation
- The two houses need to reconcile any differences
- The President needs to sign the bill into law
- The FDA has to create and publish a draft OTC regulation consistent with legislative intent
- The draft regulation needs to be made available for public comment
- The FDA needs to consider those comments after which the final version will be published and entered into the Congressional Record.
So, in the time we have remaining prior to the final promulgation of the FDA regulation, let’s engage in some more thought experimentation to envision how we can take full advantage of a new opportunity for our profession.
1By the way, I just checked and the WhisperTone.com domain name is still available for purchase!
Harvey Abrams, PhD, is a consulting research audiologist in the hearing aid industry. Dr. Abrams has served in various clinical, research, and administrative capacities in the industry, the Department of Veterans Affairs and the Department of Defense. Dr. Abrams received his master’s and doctoral degrees from the University of Florida. His research has focused on treatment efficacy and improved quality of life associated with audiologic intervention. He has authored and co-authored several recent papers and book chapters and frequently lectures on post-fitting audiologic rehabilitation, outcome measures, health-related quality of life, and evidence-based audiologic practice. Dr. Abrams can be reached firstname.lastname@example.org