These devices would be available over-the-counter, without the supervision of a hearing health care professional. This law is intended to increase consumer choice and access to devices that treat mild to moderate hearing impairment.
FDA’s Congressional mandate is to draft regulations that ensure these medical devices will be safe and effective, protecting consumers from health risks associated with over amplification or ineffective products.
There will be many new choices on the market. Consumers need information to make an informed decision and ensure a safe and effective experience.