Disruptive Hearing Technologies and Mild Sensorineural Hearing Loss II: Current Research on Affordable Hearing Technologies and Direct-to-Consumer Models.

Recently, President Trump signed into law the Food and Drug Administration (FDA) Reauthorization Act of 2017, which included the Over-the-Counter Hearing Aid Act designed to provide greater public accessibility to and affordability of amplification for individuals with self-identified mild and moderate hearing loss through the provision of over-the-counter (OTC) hearing aids (HAs) with a direct-to-consumer (DTC) delivery model. American Speech-Language-Hearing Association and American Academy of Audiology Position Statements on OTC HAs state that these devices should only be used for adults with mild hearing losses. DTC amplification and service delivery has been available to consumers in a variety of forms for a significant period of time. However, FDA-regulated OTC HAs will not be available as described in the new law until the FDA publishes the required guidance related to the technology, safety, and labeling of such devices. With the clear similarities in mind between present and future amplification options, a literature search was conducted to review studies assessing outcomes for low-cost and DTC HAs and service-delivery models to inform what we may expect as OTC HAs enter the market. Nine studies were identified which assessed: (1) electroacoustic capabilities of low-cost and DTC HAs, (2) use of these devices in field trials, or (3) efficacy of DTC models. None of the studies reported outcomes specifically for participants with mild hearing loss. The studies had poor external validity because none included all factors that would exist in realistic uses of OTC HAs within a DTC model. Additional research will be needed as OTC HAs become available and different delivery models are proposed.