Considerations for the Over-the-Counter Hearing Aid Delivery Model

Abstract

Purpose: The U.S. Food and Drug Administration (FDA) introduced the Reauthorization Act that included provisions for self-fitting hearing aids to be sold over the counter in 2017, and in August 2022, the FDA published the final regulatory guidelines for the safety and efficacy of the devices. The American Speech-Language-Hearing Association and other professional organizations provided feedback to proposed regulations before they were finalized. This article updates hearing health care and related professionals on the history and state of hearing aid delivery models and addresses considerations for clinicians, physicians, and consumers. Conclusions: Direct-to-consumer (DTC) hearing devices can vary largely in quality and performance capability. Some might meet the finalized FDA safety and performance criteria for over-the-counter hearing aids and be able to provide accurate amplification for mild-to-moderate hearing loss but most likely cannot meet the needs of more severe hearing losses, for which they are not approved. Other DTC devices may not meet the FDA criteria and may not provide accurate amplification for many degrees of hearing loss. It is important that these devices are correctly advertised and marketed to those with hearing loss no worse than mild to moderate. Consumers and health care providers also need to know how to identify quality devices that can meet patients' hearing needs. The DTC hearing devices may be difficult to program; thus, manufacturers should provide support for consumers to properly fit these devices. Lastly, hearing health care professionals should take the time to verify that any current and soon-to-come DTC hearing devices can be useful for a given patient population.