Full list of data to be collected in the EVOTION clinical study
| Generic data type | Specific data type | Means of capture | Retrospective | Prospective | |||
| HA | Sensor | Mobile | Clinic | ||||
| HA logging | Periods of HA usage | X | X | X | |||
| Use and adjustment of HA controls | X | X | |||||
| TTS episode related | Predicted TTS values due to noise exposure and time required for recovery | X | X | X | |||
| Time of occurrence and severity of actual TTS episodes | X | X | X | X | X | ||
| Self-administered PTA at 4 kHz | X | X | |||||
| Audiological | PTA in quiet | X | X | X | |||
| Speech in Noise | X | X | |||||
| Reaction time (in Speech in Noise and Digit Span tests) | X | X | X | X | |||
| Satisfaction with HA usage | X | X | X | ||||
| Physiological | Heart rate | X | X | ||||
| Respiratory rate | X | X | |||||
| Pulse | X | X | |||||
| Cognitive | Cognitive assessment | X | X | ||||
| Digit recall test for auditory working memory | X | X | |||||
| Mood and QOL | Mood and anxiety monitoring | X | X | ||||
| QOL | X | X | |||||
| Clinical and medication | Diabetes | X | X | X | |||
| Obesity | X | X | X | ||||
| Family history of HL | X | X | X | ||||
| History of medications | X | X | X | ||||
| Duration of HL | X | X | X | ||||
| Cause of HL | X | X | X | ||||
| Behavioural and lifestyle | Watching television | X | X | X | |||
| Participating in conversations and meetings | X | X | X | ||||
| Rating of HA ease or difficulty to use | X | X | |||||
| Socioeconomic status | X | X | |||||
| Personal | Education level | X | X | X | |||
| Presence of significant others | X | X | X | ||||
| Age | X | X | X | ||||
| Gender | X | X | X | ||||
| Personal carer | X | X | X | ||||
| Occupational | Employment history and current status (including noise exposure) | X | X | X | |||
| Environmental | Location | X | X | X | |||
| Noise type, frequency spectrum and level | X | X | |||||
| Outdoor activities (eg, conversations) | X | X | X | ||||
How these data will be collected (ie, automatically logged on the HA, via the wearable biosensor, the mobile phone application or at the clinic) and whether they will be collected at the retrospective (part 1) or the prospective (part 2) study is specified. Also see the ‘Study design’, ‘Prospective data collection: EVOTION HA fitting pathway’ and ‘Equipment’ sections for details.
HA, hearing aid; HL, hearing loss; PTA, pure tone audiometry; QOL, quality of life; TTS, temporary threshold shift.