Approximately 100 children and adolescents will be enrolled in this study (each of 5 device types will involve approximately 20 patients (and their parents/caregiver)). Participation will require two in person or phone interviews with study staff, approximately 6 months apart. In person visits will take place at one of three study sites, including the Food and Drug Administration (FDA) Parklawn Building in Rockville, Maryland, The Arkansas Children’s Hospital in Little Rock, Arkansas, and The Cleveland Clinic in Cleveland, Ohio.

The study is also available to allow for telephone interviews if a subject cannot attend an appointment in person.

Questionnaires will be either provided at the in person visit or sent out following each phone interview for completion. The questionnaires will include questions about general quality of life. Each in person visit or phone interview is expected to last approximately one hour.

No monetary compensation or reimbursement for food and travel to and from the study site will be provided. The child will receive an FDA T-shirt and a gift card for study participation. The T-shirt will be given following return of completed questionnaires after the first visit, and the gift card will be issued following the return of completed questionnaires after the second visit.

American Sign Language interpreters are available for study participants who are deaf or hard-of-hearing.