Table 2.
Timepoint | Description | Weeks after CI activation | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
# | −4 | −3 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 10 | 12 | 16 | 20 | 26 | 30 | 34 | 52 | ||
Enrollment | |||||||||||||||||||||
Clinical pre-assessment | CI screening selection | X | |||||||||||||||||||
Informed consent | X | ||||||||||||||||||||
Surgery | X | ||||||||||||||||||||
CBCT scan | X | ||||||||||||||||||||
Interventions | |||||||||||||||||||||
CI experimental phase | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||
HA experimental phase | X | ||||||||||||||||||||
Clinical fitting phase | X | X | |||||||||||||||||||
Assessments | |||||||||||||||||||||
Primary outcomes | |||||||||||||||||||||
Patient preference | 10-point VAS | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
Word recognition | CNC | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Sentence recognition in quiet | Dutch Matrix Sentence Test | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
Secondary outcomes | |||||||||||||||||||||
Sentence recognition in noise | Dutch Matrix Sentence Test | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
Spatial hearing | SSPIN | X | X | X | X | ||||||||||||||||
Listening effort | X | X | X | X | X | X | |||||||||||||||
Loudness scaling | ACALOS | X | X | X | X | X | |||||||||||||||
Frequency selectivity | SMRT | X | X | X | X | ||||||||||||||||
Questionnaires | SSQ-12, HUI-3, ICECAP-A | X | X | X | X | ||||||||||||||||
Sound quality | X | X | X | X | X |
CBCT cone-beam computed tomography, CI cochlear implant, HA hearing aid, VAS visual analogue scale, CNC consonant-nucleus-consonant, SSPIN spatial speech perception in noise, ACALOS Adaptive Categorical Loudness Scaling, SSQ-12 Speech, Spatial and Qualities of Hearing, HUI-3 Health Utilities Index-3, ICECAP-A Icepop Capability Measure for Older People