Personal Hearing Devices

President Joe Biden signed an Executive Order on Promoting Competition in the American Economy on July 9, 2021. This sweeping Executive Order includes 72 initiatives. It specifically calls out the U.S. 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. While the FDA is well beyond the deadline for…

President Joe Biden signed an Executive Order on Promoting Competition in the American Economy on July 9, 2021. This sweeping Executive Order includes 72 initiatives. It specifically calls out the U.S. 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. While the FDA is well beyond the deadline for…

The FDA has proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.

This Hearing Review article discusses President Biden's summer 2021 executive order relevant to the proposed FDA regulations for OTC hearing aids.

In this blog post, Nick Hunn discusses the current state and future of the hearables industry and market, which essentially got its start a mere six years ago. Nick Hunn is a self-described technology strategist and wireless evangelist. He also chairs the Hearing Aid Working Group in the Bluetooth SIG.