This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery. Adult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety. The purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Activation of the cochlear implant sound processor on the day of surgery after the participant is fully awake and clinically stable. Initial activation is performed according to routine clinical practice and followed by standard cochlear implant programming and rehabilitation.
Activation of the cochlear implant sound processor approximately 14 days after surgery according to current standard clinical practice. Subsequent programming and rehabilitation follow routine cochlear implant care pathways.
Aarhus University Hospital
Aarhus, Denmark
Electrode Impedance Development
Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions.
Time frame: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
Behavioural Stimulation Levels
Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming.
Time frame: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
Time to Stable Cochlear Implant Map
Time from initial cochlear implant activation to achievement of a stable clinical cochlear implant map, defined as no clinically relevant need for further adjustment of stimulation levels at routine programming visits.
Time frame: At follow-up visits up to 2, 6 and 12 months postoperatively
Residual Hearing Preservation
Change in pure-tone audiometric thresholds following cochlear implantation.
Time frame: Preoperative baseline and 6 months postoperatively
Tinnitus Severity
Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI)
Time frame: Through study completion, up to 12 months following cochlear implantation.
Cochlear Implant-Related Quality of Life
Quality of life assessed using the QOL-CI-35 questionnaire
Time frame: Through study completion, up to 12 months following cochlear implantation.
Patient Experience of Initial Activation
Patient-reported experience of first cochlear implant activation and activation-related discomfort assessed using visual analogue scales (VAS)
Time frame: Through study completion, up to 12 months following cochlear implantation.
Device- or Wound-Related Complications
Frequency of postoperative complications related to the cochlear implant device or surgical wound
Time frame: Through study completion, up to 12 months following cochlear implantation.
Rehabilitation Trajectory
Duration of rehabilitation and functional rehabilitation level obtained from municipal hearing and communication centres
Time frame: Through study completion, up to 12 months following cochlear implantation.
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