Focus Ear - Personal Sound Amplifier - White

This personal sound amplifier features speech enhancement circuitry and high-definition digital sound processing to help you hear clearly even in a noisy, crowded room, such as a restaurant or at a social gathering.Personal Sound Amplification Products (PSAPs), or sound amplifiers, increase environmental sounds for non-hearing impaired consumers. Examples of situations when these products would be used include hunting (listening for prey), bird watching, listening to a lecture with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). PSAPs are not intended to amplify speech or environmental sound for individuals with impaired hearing or to compensate for hearing impairment. Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products.