Study approval | ACEMg treatment | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Period/visit | CI screening | Baseline | Baseline audiometry | Surgery | |||||||
Point of time | Between −6 months and −3 days |
| −2 days | −(1–2) days | Day 0 | Days 1–5 | First fitting (FF) Days 42–46 (±14 days)d | Month 3 after FF (±14 days) | Month 6 after FF (±14 days) | Month 9 after FF (±14 days) | Month 12 after FF (±14 days) |
Assessment | |||||||||||
Inclusion/exclusion criteria | x | ||||||||||
Demographic data (subject identification) | x | ||||||||||
Medical history | x | ||||||||||
Concurrent medications | x | x | x | x | x | x | x | x | |||
Imaging (e.g., DVT) | x | ||||||||||
Anticipated electrode length | x | ||||||||||
Adverse event assessmenta | x | x | x | x | x | x | x | ||||
Physical examinationb | x | ||||||||||
Aetiology of hearing loss | x | ||||||||||
Informed consent | x | ||||||||||
Blood sample (ACEMg) | x | x | x | x | |||||||
Questionnaire (NCIQ) | x | x | x | x | |||||||
Tinnitus Questionnaire | x | x | x | x | x | x | x | x | |||
Pregnancy test | x | ||||||||||
Blood sample for γ-GT, transaminases, creatinine | x | ||||||||||
IMP intakec | x | x | x | x | x | x | |||||
Number of returned IMP | x | x | x | x | x | x | |||||
Implantation date | x | ||||||||||
Surgeon | x | ||||||||||
Implanted electrode length | x | ||||||||||
Audio processor activation | x | ||||||||||
Technical check of the implant (impedances) | x | x | x | x | x | x | x | ||||
Audio processor fitting | x | x | x | x | x | ||||||
Audiometric test: air and bone conduction (unaided condition) | x | x | x | x | x | x | x | x | |||
Audiometric test: warble-tone air conduction in free field ES/AS (if possible) | x | x | |||||||||
Speech test: OLSA best aided (like) preoperatively | x | ||||||||||
Speech test: ES only, AS only (if available), ES + residual hearing or EAS (if available) condition | x | x | x | x | x |