Accessibility and Ease of Use in Neuromodulation Devices

Abstract

Background: The utilization of neuromodulation therapy continues to grow as therapeutic indications expand. These conditions often present with comorbid physical, visual, and auditory impairments. Patients with disabilities in these categories may have difficulty operating their devices. Thus, reviewing the accessibility and inclusive design of neuromodulation devices is imperative to ensure equal access for patients of all ability levels. To date, the literature provides little insight into this topic.

Materials and methods: Manufacturers of Food and Drug Administration-approved neuromodulation devices in the United States completed our electronic survey to assess neuromodulation device features, universal/inclusive design guidelines, and methods used to make the device accessible to patients with disabilities.

Results: We assessed 11 devices from seven manufacturers. Of those, there were six spinal cord, two peripheral nerve, and three deep brain stimulators. Of all respondents, 91% used universal inclusive design guidelines. Of the studied devices, 91% have an interface that uses visual feedback, and 82% have an interface that uses auditory feedback. All surveyed devices were reported to have an interface that requires physical handling.

Discussion: Our study found that most devices incorporate auditory signals, buttons with raised indentations, speech commands, or other useful features to assist those with visual disabilities. Visual interfaces may be sufficient for a patient with hearing impairment to use all the surveyed devices. However, dual sensory impairment presents a significant limitation in all devices surveyed. Furthermore, the biggest barrier to using neuromodulation devices was physical impairment because all surveyed devices require physical handling.

Conclusions: Manufacturers have awareness of universal inclusive design principles. However, our study was unable to find a device that is accessible to all users regardless of ability. As such, it is critical to involve universal design principles to ensure that inclusive devices are available to improve patient adherence, treatment efficacy, and outcomes.

Keywords: Accessible design; disability; medical devices; neuromodulation; universal design.