A poor outcome after inappropriate use of an over-the-counter fetal listening device.

Home monitoring devices have been available for years, as far back as the introduction of the thermometer in the late 1800s. As technology has advanced, a large number of home monitoring devices and diagnostic tests have become available to the general public. The Food and Drug Administration (FDA) oversees this industry and has established two primary criteria for approval of such items: ease of use and the ability to safely and effectively interpret the results. Recently, listening devices have become available that allow for auscultation of fetal heart tones during pregnancy. These devices are not deemed medical devices and hence do not fall under regulatory constraints of the FDA. However, as with herbal products and other nonregulated devices, inappropriate usage has the potential for harm.