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A number of consumer health devices have been advertised as effective means to manage individual stress. However, objective evidence of their efficacy is not readily available. We present a critical analysis of evidence related to efficacy of stress management devices based on comprehensive literature review and information provided by the vendors. The analysis was conducted along four dimensions: metrics, theoretical frameworks, evaluation, and FDA clearance. The review resulted in identification of critical issues including limited information on operational characteristics, controversial theoretical underpinnings, and lack of systematic evaluation. Efficacy of these consumer devices has yet to be established.
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