What is the classification for a non-wireless air conduction hearing aid?

The classification for a non-wireless air conduction hearing aid is Class II, which requires premarket review. Class II devices are those that are considered to have a moderate level of risk and typically require a 510(k) submission to demonstrate that they are substantially equivalent to a predicate device already on the market.

Devices that fall under Class I are generally seen as low-risk and are often exempt from premarket review; however, they still must adhere to general controls such as manufacturer registration and complying with quality system regulations. It’s important to note that hearing aids, including air conduction types, involve a certain level of risk associated with their use and their effect on auditory health, thus qualifying them for Class II rather than Class I.

Class III devices typically require a more rigorous premarket approval process because they pose the highest risk. Examples include devices that support or sustain human life or are of substantial importance in preventing impairment. Class IV is not a recognized classification under the FDA.

By understanding the inherent risks and regulations tied to hearing aids, it becomes clear that they require a different level of scrutiny compared to devices that may be classified as Class I.