Same-Day Cochlear Implant Activation (SDA-CI) (SDA-CI)

June 30, 2026 updated by: University of Aarhus

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
Other Names:
  • SDA
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.
Procedure: 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.
Other Names:
  • Day-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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.
At follow-up visits up to 2, 6 and 12 months postoperatively
Residual Hearing Preservation
Time Frame: Preoperative baseline and 6 months postoperatively
Change in pure-tone audiometric thresholds following cochlear implantation.
Preoperative baseline and 6 months postoperatively
Tinnitus Severity
Time Frame: Through study completion, up to 12 months following cochlear implantation.
Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI)
Through study completion, up to 12 months following cochlear implantation.
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
Through study completion, up to 12 months following cochlear implantation.
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)
Through study completion, up to 12 months following cochlear implantation.
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
Through study completion, up to 12 months following cochlear implantation.
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
Through study completion, up to 12 months following cochlear implantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUH-CI-SDA-ADULT_2026
  • 1-10-72-53-26 (Registry Identifier: VEK Region Midt)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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