OTC Hearing Aids May Provide Cost-Effective Alternative to Traditional Hearing Aids


Untreated hearing loss can affect communication, loneliness, and lead to severe illness, such as dementia.

OTC hearing aids are associated with improved health for patients with hearing loss (HL), according to the results of a recent study published in JAMA. Provision of OTC hearing aids was considered cost-effective at the population level if utility benefit (quality of life [QoL]) was 55% to that of traditional hearing aids, the investigators suggest.

Credit: Alexander Raths - stock.adobe.com.

Credit: Alexander Raths - stock.adobe.com.

“[OTC hearing aids] represent an important shift in US audiologic and otologic care,” the study authors wrote in the article.

There are 60 million people with HL in the United States, but more than 1.5 billion people worldwide have HL, according to the study authors. They added that untreated HL can affect communication, loneliness, and lead to severe illness, such as dementia. The 2022 OTC Hearing Aid Act allowed USFDA-regulated OTC hearing aid devices to be sold without medical examination or fitting by a specialist, making it easier to access this technology.

However, experts still do not fully know the effectiveness—considered health-related QoL; also called utility benefit—of OTC hearing aids, or the population-level outcomes of these new devices. Investigators conducted a cost-effective analysis on a previously validated decision model to understand the economic (cost) and clinical (effectiveness) outcomes of new OTC hearing aids compared to traditional hearing aids.

The team conducted a base-case to find hearing aid eligibility, and related utility benefits and cost ($200 to $1400 per pair, 5% to 38% of the cost of traditional hearing aids). In the base-case, investigators assumed that patients with perceived mild or moderate hearing loss would purchase OTC hearing aids about 5 years post-HL acquisition.

After analysis, investigators discovered that OTC hearing devices cost an average of $200 to $1000 a pair. OTC hearing aids are also associated with a $70 to $200 lifetime discounted cost.

Additionally, the provision of OTC hearing aids was associated with greater hearing aid use, and hearing aid use at an earlier age than traditional hearing aids, at ages 77.6 and 78.9, respectively. However, QALYs may significantly increase if a person adopts hearing aids at an earlier age (73.7).

OTC hearing aid provision was more cost-effective than traditional hearing aids in most simulations; however, the relative effectiveness of these products is still lesser known. Evidence suggests that some people can manage their devices well, but there are not enough data that show their utility and effect on QoL.

The decision model simplifies aspects of the sensitivity analysis, which is a study limitation. Other limitations include making assumptions that adults with OTC hearing aids will keep them until HL severely worsens; not altering long-term discontinuation rates of OTC devices; and not varying the uptake rate of OTC hearing aids based on cost.

There continues to be stigma and ageism about HL, preventing people with HL from adopting hearing aid devices, according to the study authors. They added that improving access to technology, particularly via OTC hearing aids, may reduce these factors and age-related disparities. There should be continued efforts to identify ways to reduce HL and hearing aid stigma to improve the health of patients with HL, the investigators concluded.

“In this cost-effectiveness analysis, provision of OTC hearing aids was associated with greater uptake of hearing intervention and was cost-effective over a range of prices so long as OTC hearing aids were greater than 55% as beneficial to patient quality of life as traditional hearing aids,” they wrote.


Borre E, Johri M, Dubno J, et al. Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US. JAMA Otolaryngol Head Neck Surg. Published online May 18, 2023. doi:10.1001/jamaoto.2023.0949

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