Over-the-Counter Hearing Aids – The Consumer View

Hearing Loss Association of America

The ability to effectively communicate is the foundation for nearly all of our daily life activities. For the 48 million Americans who have hearing loss, affordable and accessible hearing health care services and technology that meet their individual needs are critical.

In 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) published Hearing Health Care for Adults – Priorities for Providing Access and Affordability.

The NASEM made a clear, evidence-based case that over-the-counter (OTC) hearing devices should be available for adults with mild to moderate hearing loss through its Recommendation #7Implement a New Food and Drug Administration Category for Over-the-Counter Wearable Hearing Devices. As a result, the Over-the-Counter Hearing Aid Act of 2017 was signed into law as section 709 of the FDA Reauthorization Act of 2017 (the OTC Hearing Aid Act). HLAA welcomed and supported the passage of this legislation.

The Hearing Loss Association of America (HLAA) supports a regulated market for OTC hearing devices that are intended for adults with mild to moderate hearing loss and meet performance and labeling criteria to ensure their safety, effectiveness and quality. We believe that OTC hearing devices will provide accessible and affordable hearing health care to millions of people who otherwise might not seek help. Or, for those who have sought help, OTC hearing devices could provide an affordable option.