Which regulation defines the standards for over-the-counter hearing aids?

The regulation that defines the standards for over-the-counter hearing aids is articulated in 21 CFR 800.30. This section specifies the requirements that manufacturers must follow when producing and marketing these devices without the need for a prescription. The focus on over-the-counter hearing aids has become increasingly important, especially with recent developments aimed at increasing accessibility for individuals with hearing loss.

This regulation ensures that the products are safe, effective, and manufactured to a certain quality standard, thereby protecting consumers. The clear definition and guidelines help both manufacturers in the development of their products and consumers in understanding what to expect from an over-the-counter hearing aid.

The other regulations mentioned deal with different aspects of medical products or classifying medical devices, which do not specifically pertain to the standards set for over-the-counter hearing aids. Thus, option B is aligned with the current framework governing these devices.