What is required for Prescription Hearing Aids according to the FDA?

Prescription hearing aids must be sold only on the prescription or order of a licensed practitioner. This requirement ensures that individuals receive the appropriate level of care tailored to their specific hearing loss needs. By mandating a licensed practitioner's involvement, the FDA aims to enhance the safety and effectiveness of hearing aids. This regulation helps ensure that users receive professional guidance on the selection, use, and adjustments of their devices, which can be crucial for achieving optimal hearing outcomes.

The other choices, while related to aspects of hearing aids, do not correctly capture the specific regulatory requirement set forth by the FDA regarding prescription hearing aids. For instance, selling directly to consumers does not align with the prescription model, as it necessitates professional oversight. Registration with the FDA is a broader requirement applicable to medical devices but does not specifically address the conditions under which prescription hearing aids must be sold. Fitting by a licensed audiologist is important for overall hearing health, but the core requirement the FDA emphasizes is the necessity of having a prescription from a licensed practitioner.