Personal Hearing Devices

In her article, Mareike Scholze writes, "Progress in miniaturizing sensor technology has opened up new possibilities for monitoring vital signs outside the hospital environment. A subset of wearables is the so-called hearables – in-ear devices that are well suited for long-term monitoring as they are non-invasive, inconspicuous, and easy to fasten. Hearables offer two major benefits: their…

Senator Elizabeth Warren (D-MA) introduced the Over-the-Counter Hearing Aid Act to the Senate in August 2017.

Lauren Dragan, a senior staff writer at Wirecutter, spent two years researching and preparing this article. Wirecutter is a product review and recommendation website from the New York Times.

The FDA Rule Establishing Over-the-Counter Hearing Aids will take effect in October 2022.

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.