ReSound image
ReSound image

Over-the-Counter (OTC) Hearing Aids Shown Cost-Effective in Simulation Model, Says JAMA Study

Using computer simulations and various models with a focus on cost-effectiveness, researchers concluded that over-the-counter (OTC) hearing aids are likely to stimulate greater hearing aid use, and OTC hearing aid provision may increase overall population health in a cost-effective manner. However, as noted below, they caution the cost-effectiveness of OTC hearing aids will likely depend on their increased uptake, utility benefit, and device cost.

“Our modeling analysis showed that OTC hearing aids have great potential to be cost-effective, but their clinical usefulness will be most impacted by their quality-of-life impacts and uptake rates,” lead-author Ethan D. Borre, MD, PhD, of Massachusetts General Hospital told HearingTracker.

The paper titled “Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US” was conducted by researchers at Duke University, the Medical University of South Carolina, and the University of Arkansas, and was published in the May 18 online edition of JAMA–Otolaryngology-Head and Neck Surgery.

Otc Mashup

OTC hearing aids only became available as an official FDA device category in October 2022, and studies continue to assess their effectiveness at treating mild-to-moderate hearing loss.

OTC hearing aids for U.S. adults with mild to moderate hearing loss have been proposed as a cost-effective alternative to traditional hearing aids. In October 2022, the FDA’s regulations for OTC hearing aids finally went into effect after years of deliberation, giving consumers for the first time access to hearing aids without the requirement of a medical examination or fitting by an audiologist or hearing aid specialist.

Clinical and economic outcomes for OTC hearing aids are still being conducted, and questions remain about their overall effectiveness, as well as uptake, by consumers compared to traditional hearing aids fit by hearing care professionals.

Methods in simulating cost-effectiveness of OTC hearing aids

The authors state this is the first cost-effectiveness analysis of OTC hearing aids in the U.S. that they're aware of. They used a previously validated decision model of hearing loss (DeciBHAI) and known epidemiological patterns to simulate the lifetime experiences of U.S. adults aged 40 and older in primary care facilities. The analysis incorporated yearly probabilities of acquiring hearing loss, worsening of the condition, diagnosis, and uptake of traditional hearing aids and cochlear implants.

For OTC hearing aid provision and simulation, individuals with perceived mild-to-moderate hearing loss were assumed to purchase the devices 5 years after acquiring their hearing loss, and this was based on conversations with professionals. It was also assumed OTC users would continue using the devices until reaching the severe hearing loss status (at 1 dB decline/year), at which time some would then move to prescription-fit hearing aids. Given all the uncertainties involved, the simulations used for the OTC devices ranged in quality-of-life effectiveness and cost by 9-100% and 5-38% ($200-1,400) compared with traditional hearing aids, respectively.

To be of value, an OTC hearing aid needs to perform at least 55% as well as a traditional aid

The study found that OTC hearing aid provision resulted in comparable quality-adjusted life-years (QALYs) to traditional hearing aid provision, with a slightly higher lifetime cost due to increased hearing aid uptake. OTC hearing aids were considered cost-effective if they were at least 55% as beneficial to patients' quality of life as traditional hearing aids. In probabilistic uncertainty analysis, OTC hearing aids were cost-effective in 53% of simulations conducted. The authors write:

“However, the cost-effectiveness of OTC hearing aid provision will likely depend on their increased uptake, utility benefit, and device cost. At the population level, increasing access to hearing aids through OTC hearing aid provision would be beneficial as long as OTC hearing aids are at least half [55%] as effective in improving quality of life as traditional hearing aids…Understanding that OTC hearing aids need not be perfectly effective to improve health may inform patient-clinician conversations around future hearing loss treatment.”

With these caveats, the findings suggest that OTC hearing aids can be a cost-effective alternative that expands consumer access to hearing loss treatment. However, the authors are careful to note that further research and real-world data are necessary to understand better the long-term effectiveness and outcomes of OTC hearing aids.

“All modeling analyses have simplifying assumptions, but a strength of our analysis is the clear delineation of those assumptions and the testing of our assumptions in sensitivity analysis,” said Dr. Borre. “For example, we tested the assumption of increased uptake of OTC hearing aids – from rapid uptake to no increased uptake – and reported the impacts of that variation on cost-effectiveness results.”

Traditional hearing aids have a well-established track record for improving communication and quality of life, but these factors with OTC hearing aids are still relatively unknown. Some people will be able to self-fit their OTC hearing aids, while others may either succeed in various degrees or fail.

The bottom line is more studies are needed. While OTC hearing aids offer promising opportunities for expanded access to hearing loss treatment, ongoing monitoring and evaluation will be crucial to ensure the effectiveness and safety of these devices in real-world settings. With the implementation of the FDA's final rule on OTC hearing aid regulations, understanding the population-level health outcomes of these devices is extremely important.

Some parallels to previous MarkeTrak data about the issue of value

Although not mentioned by the authors, their findings bear some resemblance to those of MarkeTrak VI research published in 2003 by Sergei Kochkin, PhD. That paper essentially showed that consumers' perceptions of hearing aid value followed a very rational trajectory: if you divide the out-of-pocket price of a hearing aid by the improvement in a person's hearing disability, Kochkin found exceptionally close relationships between value and customer satisfaction.

This probably should not come as a shock: a very low-priced hearing aid that supplies a modest amount of hearing improvement might be judged by consumers to have comparable value to a very high-priced hearing aid. Citing Figure 7 in his paper, Kochkin stated, "At $5 per hearing disability improvement point, the hearing instrument is virtually guaranteed an 85% overall satisfaction rating; however, at $500 or more, it is unlikely that satisfaction above 45% can be achieved. As price per hearing disability improvement point increases, satisfaction with “value” is seen to drop precipitously compared to overall satisfaction or satisfaction with benefit.”

Kochkin also found that, on average, a 50% hearing disability improvement equates to 57% satisfaction with value, 72% overall satisfaction, and 85% satisfaction with benefit. Further, while nearly perfect restoration of hearing results in about 95% overall satisfaction, satisfaction with value peaked at about 85%. With hearing aid benefit playing such an outsized role in customer satisfaction, this data from two decades ago also underscored the case for hearing care professionals' adherence to best practice protocols for optimal outcomes.

The present paper, which focuses on quality-of-life improvement, points out that OTC hearing aids may have the potential to address some barriers to treatment, such as cost and stigma, and improve the overall well-being of individuals with hearing loss. As more people come into hearing healthcare centers asking about OTC options, their findings along with future research can help guide recommendations and inform patient decision-making, say the researchers.

Original article citation: Borre ED, Johri M, Dubno JR, et al. Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US. JAMA Otol Head Neck Surg. 2023. Published May 18, 2023.


Editor in Chief

Karl Strom is the Editor in Chief of HearingTracker. He has been covering the hearing aid industry for over 30 years.