Same-Day Cochlear Implant Activation (SDA-CI)

Sponsor
University of Aarhus
Study ID
NCT07681830
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cochlear Implantation
  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Same-Day Cochlear Implant Activation — PROCEDURE
    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 — PROCEDURE
    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 Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Same-Day Activation
    Participants randomized to this arm will have their cochlear implant activated on the day of surgery once clinically stable. Following activation, participants will continue with routine cochlear implant programming and rehabilitation according to standard clinical practice.
  • Active Comparator: Standard Day-14 Activation
    Participants randomized to this arm will have their cochlear implant activated approximately 14 days after surgery according to current standard clinical practice. Following activation, participants will continue with routine cochlear implant programming and rehabilitation according to standard clinical practice.

Primary Outcome Measure

Electrode Impedance Development [ Time Frame: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively ]

Central Contacts

Related Studies