Table 5.
Study calendar
| 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 | ||||||
aThe adverse event documentation period for this trial begins upon first administration of the IMP(s) and ends 30 days after the last application of the investigational medical product. In case of continuation of any adverse event the documentation period will be prolonged until all adverse events are resolved or until the investigator assess the adverse events as “chronic” or “stable”
bThe physical examination includes: medical history, audiometry, otoscopy, imaging (e.g., DVT)
cThe IMP will be taken 2 days preoperatively until 103 days postoperatively
dThis timepoint takes 5 days (from Monday to Friday). All assessments are made only once
ACEMg vitamins A, C, E and magnesium, AS acoustic stimulation, DVT digital volume tomography, EAS electric acoustic stimulation, ES electric stimulation, IMP investigational medicinal product, NCIQ Nijmegen Cochlear Implant Questionnaire, OLSA Oldenburger Satztest