Eargo is a hearing aid. Eargos are Class 1 medical devices and regulated by the FDA. This means we’ve taken the necessary steps to make sure our devices meet certain standards, the same ones that all traditional hearing aid brands have to meet. Amplifiers, or Personal Sound Amplifiers (PSAPs), do not meet these criteria and are not subject to FDA regulations. By their definition, PSAPs are meant to amplify environmental sounds for “non-hearing-impaired” consumers. In our case, we have a team of talented engineers whose sole focus is designing leading-edge solutions for those with mild to moderate hearing loss.