The key to the “smart” regulation of Over-the-Counter (OTC) Hearing Aids is to promulgate a series of requirements that provide consumers with adequate assurances of safety and effectiveness by ensuring that OTC devices (1) are used as intended (2) provide clinically significant positive results and (3) do not cause increased consumer confusion about hearing assistance devices. To achieve these goals, the FDA will need to (1) require potential users of OTC hearing aids to take a self-administered test to determine if they would benefit from the device and (2) require that the dispensing of traditional, non-OTC hearing aids be limited to ear
specialists, audiologists and dispensers as defined by FDA and licensed under state law. It is also critically important for the FDA to establish an effective enforcement program that addresses the potential pitfalls inherent in user-fitted, user-adjusted hearing aids. The introduction of OTC hearing aids could result in the emergence of novice manufactures located throughout the world who will attempt to enter the US market. The key to designing and implementing a smart regulatory program is to recognize immediately that FDA, acting alone, will not have sufficient resources to ensure that all new products meet relevant safety standards. Manufacturers, working with affected consumers, must be involved in the enforcement on a continuing basis.