Hearing loss significantly affects quality of life for tens of millions of adults in the United States and contributes to high health care costs. Untreated hearing loss can lead to isolation, and it has been associated with serious conditions such as depression, anxiety, low self-esteem, dementia, reduced mobility, and falls. Yet only one in four adults who could benefit from hearing aids has ever used them. Making hearing health care more accessible and affordable is a public health priority, especially as the number of older adults in the U.S. continues to grow.
Leading experts in science, technology, and hearing health care have been working with researchers, health professionals, and consumers to find safe and effective ways to improve access to hearing health care for adults. They suggested changing some regulations that studies showed were barriers to adults getting the hearing help they need. They also recommended that the FDA create guidelines and quality standards for OTC hearing aids.
A law established on August 18, 2017, as part of FDA Reauthorization Act of 2017, directed the FDA to create a category of OTC hearing aids for adults who might have mild-to-moderate hearing loss. As part of this process, the FDA must issue a proposed rule by August 18, 2020, and a final rule within six months of the close of the comment period on the proposed rule.