Clinical Research Directory

Inclusion Criteria: * Ability to provide Informed Consent/Assent * Adults (age +18 years) and children (8-17 years) can be enrolled in this study * If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities * Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit * English language proficiency as determined by the investigator Exclusion Criteria: • Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints