Outcome domains | Investigator administered | Patient-reported outcome measures (PROMs) | Unclear | |||||
---|---|---|---|---|---|---|---|---|
Psychophysical instruments | Objective instruments | Technical and lab measures | Investigator observation / judgement | Numerical rating scale | Multi-item questionnaire | Diary | Unclear | |
Physiological or clinical core area, 6: ear and labyrinth outcomes | ||||||||
Hearing thresholds | 8 | 1 | – | – | – | – | – | – |
Speech in noise | 47 | – | – | – | – | 2 | – | – |
Speech in quiet | 18 | – | – | – | – | 2 | – | – |
Speech hearing | 6 | – | – | – | – | 3 | – | – |
Tinnitus loudness | 1 | – | – | – | 2 | – | – | – |
Spatial hearing | 1 | – | – | – | – | 3 | – | – |
Localisation | 33 | – | – | – | – | 1 | – | – |
Quality of hearing | – | – | – | – | 2 | 1 | – | 2 |
Reverberation | – | – | – | – | 1 | 1 | – | – |
Life impact core area, 30: global quality of life | ||||||||
Tinnitus symptom severity | – | – | – | – | – | 9 | – | – |
Hearing disabilities | – | – | – | – | – | 9 | – | – |
Disease-specific quality of life | – | – | – | – | – | 6 | – | – |
Life impact core area, 32a: delivery of care—satisfaction / patient preference | ||||||||
Device benefit | – | – | – | – | 2 | 8 | – | – |
Device use | – | – | 3 | – | 1 | 2 | 1 | 1 |
Satisfaction | – | – | – | – | 2 | 5 | 1 | – |
Aversiveness | – | – | – | – | – | 1 | – | |
Adverse events core area, 38: adverse events / effects | ||||||||
Adverse effects | – | – | – | 1 | – | 2 | – | 6 |