Validation of In-Ear Sensor

Starkey Laboratories, Inc1 site in 1 countryJanuary 4, 2022

Overview

The purpose of this study is to clinically validate noninvasive in-ear sensor.

Registry

clinicaltrials.gov

Start Date

January 4, 2022

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•Subject must have the ability to understand and provide written informed consent
•Subject is an adult over 18 years of age (18 to 50 for Induced Febrile Subjects)
•Subject must be willing and able to comply with study procedures and duration. Subject must be willing and able to comply with study procedures and duration. Must be available for at least 2 visits for ear molds and study conduct.
•Male or female of any race

•Subject is considered as being morbidly obese (defined as BMI \>39.5)
•Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
•Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study (For Induced Febrile Subjects only)
•Subjects with known respiratory conditions such as:
•uncontrolled / severe asthma,
•pneumonia / bronchitis,
•shortness of breath / respiratory distress,
•respiratory or lung surgery,
•emphysema, COPD, lung disease
•Subjects with self-reported heart or cardiovascular conditions such as: