Hearing Aid

New Executive Order on Hearing Aids

August 21, 2021

The Hearing Health Foundation estimates that 48 million Americans have some degree of hearing loss, ranking just behind arthritis and heart disease as a leading cause of disability. Based on some research, hearing loss may point to increased risk of dementia, cognitive decline and falls. Social effects can also be impacted, such as causing social isolation because taking part in conversations can be troubling to those with hearing issues.

About 27 million Americans age 50 and older have some type of hearing loss, but only one in seven use a hearing aid as a solution. On average, hearing aid users wait 10 years before getting help for hearing loss. According to a new study by the University of Michigan Institute for Healthcare Policy & Innovation, 80 percent of Americans over the age of 50 have not been asked about their hearing by their primary care physician in the past two years.


The purchase price for hearing aids is quite expensive. Many insurance plans do not consider hearing aids to be a ‘covered’ benefit, so the entire out-of-pocket expense is typically borne by the patient. The average cost for a pair of hearing aids ranges from $2,000 on up to more than $10,000, depending on the technology. Medicare parts A and B do not cover hearing aids. The four largest hearing aid manufacturers control 84 percent of the market, and due to the high cost of hearing aids, only 14 percent of 48 million Americans with hearing loss use them.

President Biden’s new executive order of 72 initiatives includes a directive to Health and Human Services to consider issuing proposed rules within 120 days for allowing low-costing hearing aids to be sold over the counter (OTC). OTC hearing aids, by the way, will allow adults with mild-to-moderate hearing loss to purchase hearing aids without consulting a hearing professional.


In 2017, Congress passed a bipartisan proposal – signed into law by President Trump – to allow hearing aids to be sold over the counter. The FDA, however, did not issue the proposed rules by the deadline because of the ongoing COVID-19 pandemic. Because the FDA gave no further guidance on this issue, the Biden executive order includes the FDA to issue guidance within 120 days.

Once the FDA issues its ruling and the proposed timeline, consumers should soon be able to purchase OTC hearing aids at their local pharmacy without first being required to visit a medical provider. The specifics are still unknown at this time, but the goal of this initiative is to lower hearing aid prices for consumers, so more affordable hearing aid alternatives should make their way to consumers in the near future.

Article reproduced with permission of David P. Lind.  Full article can be found at New Executive Order on Hearing Aids: Music to my Ears! | Heartland Health Research Institute (hhri.net)