FDA-Registered vs. FDA-Cleared vs. FDA-Approved

Hearing Devices: What’s the Difference?

The U.S. Food and Drug Administration (FDA) ensures that certain products, including medical devices such as hearing aids, will perform safely and consistently for American consumers. But did you know there are distinctions between devices that are FDA-Registered, -Cleared, and -Approved?

Having been created in October 2022, the over-the-counter (OTC) hearing aids category is relatively new and still taking shape. As a result, there’s ambiguity and confusion around the requirements for each of these FDA classifications.

But knowing the distinctions between FDA-Registered, -Cleared, and -Approved hearing devices is crucial to understanding what information the FDA does or doesn’t review before a manufacturer can market a device. Let’s dig into each of these terms.

FDA Registration vs. Clearance vs. Approval

Every single medical device must be FDA-registered, regardless of the level of FDA review it will ultimately receive. Beyond Registration, there are also the Clearance and Approval review levels. These review processes are in place to protect consumers and foster trust among the public in these essential medical devices.

From a regulatory standpoint, companies that manufacture medical devices may come under the FDA’s tight scrutiny regarding their device’s claims, performance, and safety features before or after going to market. The level of FDA review is dictated by the device’s class. There are three classifications: Class I, Class II, and Class III.

Hearing aids, which the FDA classifies as medical devices, can be Class I, II, or III. The device’s specific class and review level determine when the manufacturer must communicate with the FDA (i.e., whether or not the manufacturer must provide documentation of the device’s safety and effectiveness before it goes to market), and how extensive the documentation must be that the manufacturer provides to the FDA.

Registration

“FDA Registration” is a mandatory administrative process that tracks the facilities that manufacture, process or package drugs, medical devices, and certain food products. Facilities registered with the FDA are subject to inspections by FDA.

All medical devices must be FDA-Registered and meet general safety requirements. “FDA-Cleared” and “FDA-Approved” devices are subjected to additional review of applicable product testing and clinical data before those products can be made available to consumers. Not all medical devices are subject to inspections or the higher degree of review as FDA-Cleared and FDA-Approved devices.

Clearance

All hearing devices designated as Class II require FDA Clearance before they can be sold.

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