Biden's corporate scrutiny order prods dormant decision on over-the-counter hearing aids

Since President Donald Trump signed a Congress bipartisan propsal into law in 2017 to allow hearing aids to be sold over the counter, the world has been waiting for the Food and Drug Administraion to issue rules…and waiting… Covid meant the issue has dragged on way past the August 2020 originally set.

Now responding to this inaction, Biden's new executive order includes a directive to the US Department of Health and Human Services (HHS) to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.

The executive order states that the four largest hearing aid manufacturers now control 84% of the market and that hearing aids are "so expensive that only 14% of the approximately 48 million Americans with hearing loss use them."

This clearly underlines the main motive behind adminstration moves to open up OTC: affordable devices. But at the other end of the see-saw—upon which a number of perceived benefits sit counterweighed by safety and economic concerns—is that professional help from a qualified professional given in the right conditions is essential if a device is to work effectively. Calming the manufacturers is the thought voiced by several that OTC hearing aids will entice a significant number of hearing loss sufferers who would otherwise ignore their condition, and that the hearing journey for a proportion of these might lead to buying better devices and visiting audiologists.

Writing on the site hearinghealthmatters.org, hearinghealthmatters.org hearing tech consultant and composer, Richard Einhorn, sides with the view that the benefits from OTC outweigh the risks.

On the prospect of Biden's shake-up making OTC a reality anytime soon, the online medical technology site MedTechDive quotes financial analysts Jefferies as anticipating the implementation of the OTC hearing aid category to start between March and and July 2022.

Source: NY Times/MedTechDive