What is the FDA's primary role when regulating hearing aids?

The FDA's primary role when regulating hearing aids is to ensure their safety and effectiveness through classification and premarket approvals. This involves evaluating whether the devices meet specific standards before they can be marketed to the public. The classification process helps determine the level of regulation necessary based on the risks associated with the device.

This oversight is crucial because hearing aids are medical devices that directly impact the health and quality of life of consumers. By requiring premarket approval, the FDA helps to ensure that only safe and effective products reach the market, which can protect consumers from substandard or unsafe devices.

The other options refer to functions that are not the FDA’s primary responsibilities in this context. Annual inspections of manufacturing facilities, while part of the regulatory process, are not the central focus. Controlling pricing is not within the FDA's scope; rather, it is more related to market dynamics and economic regulations. Promoting the marketing of hearing aids is also not a primary function of the FDA, as their role is more about regulation and oversight rather than promotion.