OTC hearing aids coming to the U.S.

OTC hearing aids coming to the U.S.

President Biden signed an Executive Order yesterday to make hearing aids available to the American people over the counter. The historic order from the White House directs the Department of Health and Human Services (HHS) to issue proposed rules for over-the-counter hearing aids within 120 days.

Audientes A/S CEO, Steen Thygesen says, “The US is back on track with OTC legislation. This is wonderful news, and, at Audientes, we could not be happier for the American people. We look forward to participating in this new market for affordable, self-fitting hearing aids.”

The Executive Order, which includes 72 initiatives, indicates that the Biden administration wants to make hearing aids less expensive and more readily available to the approximately 25 million Americans who suffer from disabling hearing loss.

”This confirms the validity of our continued efforts to gain FDA approval for our self-fitting hearing aid,” says Steen Thygesen. “It is a powerful acceleration to our planned strategy to make our devices available to the American people and therefore save Americans with hearing loss thousands of dollars by allowing hearing aids to be sold over the counter at drug stores and other retail outlets.”

The drive to switch hearing aids from prescription-only to OTC has been gaining momentum for several years now. In 2017, for example President Trump signed the Over the Counter Hearing Aid Act authorizing the OTC sale of hearing devices and giving the Food and Drug Administration(FDA) until 2020 to establish specific guidelines for non-prescription consumer sales of hearing aids. Unfortunately, the deadline was missed, meaning that the regulations were never put forward. The Biden order, however, will now change this.