Table 4 Overview of study visits, treatment and follow-up

Between 6 months and 2 days preop

CI screening Including:

Hearing tests

Air-conducted and bone-conducted threshold, speech test best aided (with hearing aids) and unaided

x

Study audiologist evaluates if audiological inclusion criteria for study are fulfilled

Informing the senior physician

x

Medical talk

Results are discussed

x

Possibilities are explained: hearing preservation/conventional electrodes

x

Decision about hearing preservation electrode

x

Identification for the study

Passes potential patients to: assistant physician/study nurse/study audiologist

x

Information about the CI technique

x

Introductory meeting and, when indicated, recruitment (hand out Informed Consent Document)

x

Following

In critical cases the patient’s documents are shown to the chief physician

x

Cost assurance must be checked

x

If CI surgery is indicated, the surgery appointment will be made

Imaging (e.g., DVT)

x

Between screening and 2 days preop

Study approval

Patient agrees to Informed Consent Document

x

Study audiologist will be informed

x

Blood sample

For pregnancy test, if necessary

x

Blood sample

For γ-GT, transaminases, creatinine

x

Blood sample

Vitamin E baseline detection

x

Questionnaire

The patients complete the NCIQ

x

Imaging (e.g., DVT)

x

Pre-decision of electrode length (for study patients FLEX-electrodes are fixed)

x

Between screening and 3 days preop

Operation appointment

The appointment for operation is sent to the patient

x

Approximately 5 days preop

Patient demonstration

All planned surgeries of the coming week are presented

x

Overview of the planned study patients, if necessary participating at the discussion

x

Between 10 and 2 days preop

Randomization

Fill out patient inclusion form in web-randomization tool

Inclusion of the patient in the eCRF database

x

Inform the HCTC about patient’s inclusion in the study

x

2 days preop

Treatment start

Treatment

Starting taking IMPs

x

1–2 days preop

Prefinal diagnostics and patient information

Patient reception

x

Hearing tests

Air-conducted and bone-conducted threshold, speech test best aided (with hearing aids, if available)

x

Vestibularis, BERA, PT

x

Information about the surgery

x

Day 0

Cochlear implant surgery

Between 1 day preop and day 0

Blood sample

Vitamin E blood level

x

Surgery

The patient has a FLEX-electrode implanted

x

1–5 days postop

Hearing tests

Hearing tests

Air-conducted (if possible) and bone-conducted threshold

x

Test tone

Technical check of the implant

x

Patients return packing of IMPs taken

x

Appointment for the first activation

x

Usually 4 weeks postop, depending on wound healing

First Fitting

Hearing tests

Air-conducted (if possible) and bone-conducted threshold

x

Speech tests in quiet and in noise

x

x

Fitting

Technical check of the implant

x

Blood sample

Vitamin E blood level

x

Questionnaire

The patients complete the NCIQ

x

Patients return packing of IMPs taken

x

Appointment for the 3 months post FF follow-up

x

3, 6, 9 and 12 months post-FF (±14 days each)

Follow-up

Patients return packing of IMPs taken

x

Hearing tests

Speech tests in quiet and in noise

x

x

Air-conducted and bone-conducted threshold, (aided threshold)

x

Fitting

Technical check of the implant

x

103 days postop

End of IMP intake

x

Only month 6 post FF

Blood sample

Vitamin E blood level

x

Only 3 and 12 months post FF

Questionnaire

The patients complete the NCIQ

x