What are the two categories of hearing aids defined by the FDA?

The FDA defines hearing aids primarily in two categories: prescription hearing aids and over-the-counter (OTC) hearing aids. This classification reflects the regulatory approach and the intended use of the devices.

Prescription hearing aids are those that require an evaluation by a licensed audiologist or physician and are designed for individuals with diagnosed hearing loss. The evaluation ensures that users receive the appropriate level of amplification based on their specific hearing needs.

On the other hand, over-the-counter hearing aids are available directly to consumers without the need for a professional consultation. This category has emerged to make hearing assistance more accessible and affordable for individuals with perceived mild to moderate hearing loss. The FDA's introduction of OTC hearing aids is aimed at simplifying the purchasing process and enabling more individuals to address their hearing issues on their own terms.

This distinction is particularly important as it shapes how consumers access hearing aids and the overall market dynamics for auditory devices, making option B the correct answer.