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NCT Number: NCT07681830

Same-Day Cochlear Implant Activation (SDA-CI)

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.

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Key information

Conditions

Hearing Loss Cochlear Implantation Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Indication for cochlear implantation according to national guidelines
  • Ability to provide written informed consent

Exclusion criteria

- Medical or surgical conditions rendering SDA unsuitable, including postoperative wound complications requiring pressure dressing, cognitive or communicative barriers precluding safe activation, or other clinical considerations (e.g. meningitis) assessed by the treating clinician.

-

Treatment and study plan

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.

Other names: SDA

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.

Other names: Day-14

Primary outcomes

  1. Electrode Impedance Development

    Time frame: 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.

Secondary outcomes

  1. Behavioural Stimulation Levels

    Time frame: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively

    Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming.

  2. Time to Stable Cochlear Implant Map

    Time frame: At follow-up visits up to 2, 6 and 12 months postoperatively

    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.

  3. Residual Hearing Preservation

    Time frame: Preoperative baseline and 6 months postoperatively

    Change in pure-tone audiometric thresholds following cochlear implantation.

  4. Tinnitus Severity

    Time frame: Through study completion, up to 12 months following cochlear implantation.

    Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI)

  5. Cochlear Implant-Related Quality of Life

    Time frame: Through study completion, up to 12 months following cochlear implantation.

    Quality of life assessed using the QOL-CI-35 questionnaire

  6. Patient Experience of Initial Activation

    Time frame: Through study completion, up to 12 months following cochlear implantation.

    Patient-reported experience of first cochlear implant activation and activation-related discomfort assessed using visual analogue scales (VAS)

  7. Device- or Wound-Related Complications

    Time frame: Through study completion, up to 12 months following cochlear implantation.

    Frequency of postoperative complications related to the cochlear implant device or surgical wound

  8. Rehabilitation Trajectory

    Time frame: Through study completion, up to 12 months following cochlear implantation.

    Duration of rehabilitation and functional rehabilitation level obtained from municipal hearing and communication centres

Study contacts

Contact information is provided by the study sponsor or research team.

Louise Devantier, MD, PhD

CONTACT

[email protected]

+45 78450000

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients

Acronym: SDA-CI

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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