The Food and Drug Administration (FDA) has ordered hi HealthInnovations to immediately cease marketing its "Online Hearing Test" until it submits a formal application to the agency and obtains premarket approval. But the company can continue its hearing aid sales, provided they comply with FDA regulations.
Because the test is considered a "device," hi HealthInnovation's marketing was found to be in violation of the federal Food, Drug, and Cosmetic Act. The Act states that "manufacturers of devices are not exempt from marketing approval or clearance for their products by the FDA before they may offer them for sale." The FDA has asked hi HealthInnovations to respond in writing within 30 days with the specific steps it is taking to address the violations.
Stay tuned to this ASHA Leader "Newswatch" site for further updates.