In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) released a report to President Barack Obama titled “Aging America and Hearing Loss: Imperative of Improved Hearing Technologies.” In the report, the council informed the president that untreated age-related hearing loss is a significant national problem. The advisors provided recommendations to decrease cost; enhance innovation; and improve the convenience, capability, and use of devices for individuals with mild to moderate hearing loss. 

Soon after, in June 2016, the National Academies of Science, Engineering, and Medicine (NASEM) released a report titled “Hearing Health Care for Adults: Priorities for Improving Access and Affordability.” 

Both the PCAST and NASEM reports included a recommendation that the Food and Drug Administration (FDA) implement a class of over-the-counter (OTC) hearing devices. These reports—along with mounting evidence regarding the comorbidity of hearing loss and other health conditions including depression, cognitive decline, diabetes, and cardiovascular disease—amplified attention about adult hearing loss and the need to improve pathways to treatment and affordability. 

Typically, it takes many years for the types of recommendations made in the PCAST and NASEM reports to become law. It took less than two years for this to occur for OTC hearing devices. The Food and Drug Administration Reauthorization Act (FDARA), signed into law in August 2017, included language that required the FDA to establish a new category of OTC hearing devices.  

This federal law will permit consumers with self-perceived mild to moderate hearing loss to purchase OTC products without the involvement of a licensed hearing health-care professional. The law requires the FDA to publish proposed regulations for these devices by August 18, 2020, and once the regulations are drafted, to allow a period for public comment. Typically, public comments are accepted for 30 to 180 days, with the FDA required to publish final regulations within 180 days after the close of the comment period. 

The last public update on the issue came from the FDA in July 2018, when the agency sent letters to manufacturers of hearing devices stating that, until the effective date of a final published regulation, OTC devices do not exist.

Are You Prepared for OTC Devices?

Although OTC hearing devices are not yet available, this is an opportune time for audiologists to prepare for the entry of this technology into the market place. This new pathway to hearing help joins a growing list of changes made over the past decade to the traditional delivery and payment model for amplification. 

We’ve seen hearing aid manufacturers purchase and own their own clinics, the number of third-party administrators (TPAs) increase, and even some third-party payers providing products directly to their beneficiaries. We’ve also seen the expanding sales of hearing aids at big box stores and the continued growth of online hearing aid sites. These changes, including the availability of OTC devices, have many audiologists concerned about the financial viability of their practices—and concerned about the sustainability of the profession of audiology. 

Accessibility and affordability were the primary drivers for the creation of an OTC device category. Still, we can’t negate the significant role that changes in the delivery of health care in the United States have played. Health care is no longer simply provided in face-to-face encounters with a physician or a  health-care professional. 

Improvements in technology and innovation are partly responsible, but generational changes in those seeking and receiving health care are also in evidence today. Consumers want convenience, quicker service, and shorter wait times. We’re seeing more health-care providers use telemedicine to accommodate these needs and more consumers interested in self-directing their care through digital applications and health-care “shopping” for lower-cost options. 

It was only natural that audiology would experience these changes, too. Certainly, OTC hearing devices will allow patients to self-direct their hearing care. However, we don’t have evidence yet to support that they will be able to do so effectively. 

Some audiologists have expressed concern about the affect OTC hearing devices will have on their practice. Data compiled over the past decade indicates that we are only serving a small percentage, perhaps as little as 10 percent, of the individuals with mild to moderate hearing loss.

At this point, many questions remain: Will more individuals with mild to moderate hearing loss seek help if it becomes more convenient to do so? Is an inability to easily access care, or the cost of hearing aids, the reason that only a small percentage of individuals with this degree of hearing loss seek help? If individuals with mild to moderate hearing loss decide to begin their journey to amplification, would they continue to use and be satisfied with a device that was self-fit?

How We Prepared to Provide OTC Devices

We began to consider some of these questions at the University of Akron Audiology and Speech Center in late 2016, after the introduction of the Over-the-Counter Hearing Aid Act by Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa). We wondered if currently available personal sound-amplification products (PSAPs) might assist some of our patients. 

According to the FDA consumer guidance regarding PSAPs, they are designed to “enhance normal hearing,” rather than address hearing loss. As such, PSAPs are not subject to FDA regulation. We speculated that currently available PSAPs may offer some benefit for patients who would not otherwise choose traditional hearing aids or assistive listening devices.  

We decided it would be worth offering the products in the Center, even if only a few of our patients with mild to moderate hearing loss might benefit from them. We believed an option should be available for those patients who did not perceive significant communication difficulties warranting the use of traditional amplification. Additionally, we speculated that some of the adult patients we evaluated with self-reported “hearing difficulties” who had normal pure-tone hearing thresholds might benefit from some type of amplification. Finally, we questioned if our adult patients with auditory processing disorders, who had not sought treatment with mild high-frequency gain hearing instruments, might be well served with a PSAP. 

Our first step was to contact our state licensure board to determine if there were any concerns with the sale of PSAPs in our Center. When we learned there were none, we began evaluating the pros and cons of offering these products. We identified several advantages to offering PSAPs to our patients. Of primary importance was the ability to help patients hear better who weren’t ready to pursue traditional hearing aids. 

We also believe that audiologists should “own” hearing care, from a patient’s initial need to any advancement to significant hearing loss. With patients entering the hearing-care market sooner, we might expand our patient base and increase revenue for the Center.  

We knew there might also be a down side to offering these products in the Center. What if the patient didn’t  do well? Might they never return to try other products in the future? 

We weren’t familiar with the quality of the products available or where we would purchase them. We also knew the warranty periods would likely be shorter than those offered with traditional hearing aids and that this could present problems for the patient later.  

Other considerations that needed to be explored were the type of delivery model we would choose, the candidacy requirements, the type of payment model most appropriate in our facility, and the specific products we would choose to dispense. 

Some practices might want to offer PSAPs without the involvement of a licensed professional. In this scenario, the products would be purchased without an audiological evaluation and sold to consumers by front-office staff. Other practices might decide to offer these products for sale online on their website. 

Neither of these options worked for our Center. We felt it is important to involve an audiologist in every step of the process. Therefore, we decided to offer these products only after a face-to-face encounter with the patient and following a full diagnostic evaluation to determine the degree of hearing loss. With this delivery model, underlying medical conditions could be identified, the correct amount of amplification could be provided, and hearing losses would meet (and not exceed) the candidacy criteria for the device.

Fitting a PSAP to a patient with hearing loss is considered an off-label use of the product. As such, we wanted to inform our patients of this off-label fitting and develop our own candidacy criteria. 

We only offered PSAPs to patients if their thresholds were no poorer than 40 dB HL from 500-4000 Hz. We also used the patient’s perception of their hearing loss as part of our candidacy criteria. If the patient perceived significant difficulties and the objective measures indicated a hearing loss of mild degree (or more), we discussed traditional hearing aid options. We wanted to fit patients ready for amplification with the best devices available to meet their communication needs. 

Finally, we had the patients rate their hearing difficulties on a scale of one to 10. A rating of one indicated their hearing ability to be quite poor and 10 indicated they had little, if any, communication difficulties. Patients who scored one to five would likely be ready to pursue traditional amplification and those who scored eight to 10 would likely not be ready for traditional hearing aids. For those with scores of six or seven, a clinical judgment of the type of device to offer would be warranted. Also, when a patient had a mild hearing loss (pure-tone hearing thresholds between 25-40 dB HL) and a score of less than 10 on the Hearing Handicap Inventory for the Elderly (or adult) screening version (Ventry and Weinstein, 1983), we would present PSAPs as an option. 

We used an itemized payment model, in which the patient paid separately for the audiological evaluation, the selection of the device, the verification of the device, fitting and instruction, and a fee for the device (percentage over invoice). If the patient returned the device, he or she would receive a refund of the device fee in full. All other service fees were non-refundable. 

Patients were encouraged to return for follow-up visits if they were struggling to manage the device or otherwise needed support. They would be charged separately for these appointments based on the service provided. 

We knew that some patients might not return. We were comfortable if this should occur, as patients were provided with a wealth of information about the benefits of amplification, the limitations of the selected devices, and the next steps if they continued to experience hearing difficulties. Written information was provided to the patient at the initial selection-and-fitting appointment. Patients were urged to return in one year for reevaluation of their hearing. PSAP purchasers were provided a 30-day return period in order to keep consistent with hearing aid fittings in the Center. 

What Products Should You Offer?

If you decide to offer PSAPs in your practice, you will need to determine which specific products to offer. This was the most challenging of all of the decisions we made regarding the program. 

We reviewed articles evaluating PSAPs. Many of these articles made recommendations based on electroacoustic analysis and/or probe-mic measurements. We often did not agree with the authors’ assessments of good performance on probe mic measures. Some investigators only required the gain to be within 10 dB of NAL-NL2 prescriptive targets. Because we would not accept this as a good fit for our hearing aid fittings in the Center, we were uncomfortable accepting this for the PSAPs we would be dispensing. 

One study we reviewed simulated the OTC environment and investigated consumer reactions. Much like the MarkeTrak IX results, the study found that patients did better with the PSAP products when they had professional guidance. 

If we were starting this project today, we would also consider the resource guide that Oaktree Products, Inc. offers online. Investigators working with Oaktree Products did a combination of subjective assessment, electroacoustic analysis, and verification with probe-mic measurements. They provide additional information online regarding their vetting process.

At our Center, we made decisions about the products we would offer based on three criteria: style/price, verification/electroacoustic analysis, and consumer ratings. We felt it was important to have different price points and styles to meet patient needs. 

We wanted to fit only the products that met what we considered to be acceptable targets for our hearing-instrument fittings. We chose to rate PSAP performance acceptable if the probe-mic measured gain was within 5 dB of NAL-NL2 targets. If we were unable to meet these targets, the patient was told that the product was not suitable. 

Finally, we also evaluated consumer ratings of the selected products. This was challenging, as not all products had consumer ratings. If a product met our other criteria, a lack of consumer ratings did not deter it from consideration for use in the clinic.

The Future of OTC Devices

As consumers continue to drive changes in health care, we must be ready to meet their needs when treating hearing loss. Although OTC hearing aids are not yet available, we know “business as usual” in audiology will not be enough. We must own the non-medical treatment of hearing loss. And, very soon, that will include managing OTC hearing devices. 

Embracing change in our profession is essential for its continued viability. While offering PSAPs in your practice may not be something you want or can pursue at this time, we will all need to be prepared for OTC hearing aids when the federal regulations are finalized. 

Our Center did not see a large uptake of PSAPs after we began offering this product line. Many patients who came to the Center with mild hearing loss, within our fitting criteria, pursued traditional amplification even after being offered PSAPs. We speculate that offering these less expensive products, while still including what we believe to be necessary professional services to maximize hearing health-care benefits, helped patients appreciate the value of professional audiology services.