Abstract
While hospital and emergent use environment sound levels and corresponding design inputs (including stakeholder and system requirements) for alarms and other auditory feedback mechanisms have historically been the subject of extensive research, sound levels and design input requirements for in-home medical devices and combination products have received arguably less attention. In-home settings are generally considered to be relatively quiet, so there is little expected interference with device auditory feedback. In actuality, home settings vary in loudness and the types of distractor and background noises that can be reasonably expected while a user is operating a device. This variation—coupled with a growing effort to address the needs of aging intended user groups—highlights the importance of understanding and researching in-home use environments and using that knowledge to develop appropriate and feasible device design input requirements. Data collected from an in-home actual-use study was combined with an analysis of age-related hearing loss, in-home ambient noise levels, and analyses of early lift-off use error data. A device prototype was tested with representative users in a representative use environment. The prototype was evaluated for audibility of the auditory feedback and reduction of early lift-off use errors. Collectively, these data were used as key inputs to develop design input requirements for the autoinjector auditory feedback.
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