Will OTC hearing aids help address a public health concern in the U.S.?

Research Audiologist, Dr. Elizabeth Stewart, looks at a recent study examining the association between untreated hearing loss and health care costs. The good news? OTC hearing aids have the potential to increase awareness and bring more people to hearing healthcare.

If you live in the U.S., you almost certainly heard the recent news regarding the final rule issued by the Food and Drug Administration (FDA), which establishes a new category of over-the-counter (OTC) hearing aids.  

The new rule reflects the full implementation of the Over-the-Counter Hearing Aid Act of 2017, which allows adults with perceived mild to moderate hearing loss to obtain hearing aids without a prescription. It not only establishes this new category, but also sets forth regulatory requirements that hearing devices must meet in order to be classified as OTC devices.

Will the new OTC rule address hearing loss as a public health concern?

Dr. Nicholas Reed and colleagues from the Cochlear Center at Johns Hopkins Bloomberg School of Public Health, have a strong interest in topics related to utilization and accessibility of hearing care, including how OTC hearing aids will impact Americans.

They consider the OTC Hearing Aid Act a direct result of increased recognition of hearing loss as a public health concern in the U.S.  

They also point out the following:1

  • Prevalence of hearing loss is high, but hearing aid uptake is remarkably low. Over 38 million U.S. adults are currently living with hearing loss (a number expected to only increase) yet there are low rates (<20%) of hearing aid use.
  • Hearing loss has the potential to increase health care costs. A number of negative health outcomes–including cognitive decline, fall risk, poorer mental health – all have the potential to increase the use of health care resources, and therefore, drive up costs.

Not only does the final rule from the FDA contribute to increased awareness of hearing loss as a public health concern, it also allows adults with perceived mild-to-moderate hearing loss to access hearing aids without a prescription. This has the potential to increase hearing aid use nationwide and reduce rates of untreated hearing loss.

What does untreated hearing loss cost Americans today?

Since there is not a great understanding about exactly how much hearing loss costs Americans collectively, Reed and his colleagues conducted a study to examine the association between untreated hearing loss and health care costs and utilization over a 10-year period.1

Over the course of the 10-year follow-up period in the study:

  • Total medical costs for the group with untreated hearing loss were 46.5% higher than those of the group without hearing loss.

As for healthcare utilization, untreated hearing loss was associated with:

  • More outpatient visits and more days spent hospitalized
  • 17% increased risk of an emergency department visit
  • 44% increased risk of hospital re-admission within 30 days

OTC devices offer another ‘entry point’ to hearing care

Dr. Reed spoke about this study in more detail in an episode of ASHA Voices.2  In it, he emphasizes that we don’t yet know whether greater uptake of hearing devices could alleviate healthcare spending.

He does note, however, that OTC devices offer another “entry point” to hearing care.

While the new OTC rule will take effect in October 2022, it might be several years before we observe any potential effects on healthcare spending overall.

Background to study
The design of this study was a retrospective cohort study – retrospective meaning that the researchers intended to address the research question by analyzing pre-existing data in a novel way, and cohort indicating that the study sample would consist of the same group of individuals, followed over time (in this case, 10 years).

Out of a data warehouse containing insurance claims for 125 million de-identified individuals enrolled in private insurance plans and Medicare Advantage*, the researchers identified two groups of adults 50 years of age and older: (1) those who had, in a 2-year period, at least two claims in associated with a diagnosis code for age-related hearing loss, and (2) those with no insurance claims indicating a diagnosis of hearing loss at any time. At the time of the 10-year follow-up, there were 2,364 individuals in each group.

For each group of adults, the researchers used the information in the data warehouse to determine the total cost – that is, the amount paid by insurance and what the individuals had to pay out of pocket – of medical services over the 10-year period. They also examined hospital admission and 30-day re-admission rates (i.e., being re-admitted to the hospital for the same problem, soon after being discharged the first time), as well as number of days hospitalized, and number of emergency department and outpatient visits.


  1. Reed, N. S., Altan, A., Deal, J. A., Yeh, C., Kravetz, A. D., Wallhagen, M., & Lin, F. R. (2019). Trends in health care costs and utilization associated with untreated hearing loss over 10 Years. JAMA Otolaryngol Head Neck Surg, 145(1), 27-34.
  2. Gray, J. D. (Host). (2021, February 18). Audiologist Nick Reed talks unaddressed hearing loss and health care outcomes [Audio podcast episode]. In ASHA Voices. The Leader. https://leader.pubs.asha.org/do/10.1044/2021-0221-podcast-reed-access-disparity-outcome/full/

*Yeah, I had to look it up; it’s the one that sounds like federally-funded healthcare but typically involves a monthly premium and is managed by private insurance companies but has to follow federal rules… I think.

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