FDA Finalizes Rule Enabling Access to OTC Hearing Aids for Millions of Americans
The Food and Drug Administration on Tuesday finalized regulations to make available hearing aids to millions of Americans without them requiring to see a doctor.
The FDA’s move comes years after President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which would create a new category of hearing aids and replace state-level regulations that require patients to visit a physician for prescriptions and fittings.
The new regulations will expand access to affordable health care while aiming to lower the costs of hearing aids for people with mild to moderate hearing loss, and allow them to get hearing aids over-the-counter (OTC) or online nationwide. Consumers could see OTC hearing aids available in traditional retail and drug stores by mid-October when the rule will take effect, according to the FDA….