Revised draft guidance document explains difference between hearing aids, regulated as medical devices, and personal sound amplification products, which aren’t. Guidance published with draft to allow hearing aids to be sold OTC.

In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more.

The company recalled its Transseptal Needle and Transseptal Needle with Catheter on 18 October because there could be rust on the outside or inside of the product.

A guidance document proposed by the US agency on 20 October explains the difference between hearing aids, which are regulated as medical devices, and personal sound amplification products – or PSAPs – which aren’t.

FDA’s proposed rule aims to get more hearing aids into the ears of consumers who need them by allowing OTC sales of the devices. Proposal follows a a July executive order by President Biden directing HHS to issue proposed rules for OTC hearing aids within 120 days.

The US FDA’s proposed reg, released on 19 October, aims to get more hearing aids into the ears of those who need them by allowing the devices to be purchased over the counter.