Same-Day Cochlear Implant Activation (SDA-CI)

Condition(s) studied

Investigational drug(s) / intervention(s)

Same-Day Cochlear Implant Activation: 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.

Standard Day-14 Cochlear Implant Activation: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Electrode Impedance Development — Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
  Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions.

Trial sites (1)

More University of Aarhus trials in Denmark