Hearing LossSDA-CINCT07681830
Same-Day Cochlear Implant Activation (SDA-CI)
A study testing Same-Day Cochlear Implant Activation and Standard Day-14 Cochlear Implant Activation in people with Hearing Loss and Cochlear Implantation, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Cochlear Implantation
- What is being tested?
- Same-Day Cochlear Implant Activation and Standard Day-14 Cochlear Implant Activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aarhus University Hospital
Aarhus, 8200
Louise Devantier, MD, PhD, +45 7845000, Louise.Devantier@aarhus.rm.dk
About this study
Official title: 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.
- Conditions
- Hearing Loss, Cochlear Implantation
- Being tested
- Same-Day Cochlear Implant Activation, Standard Day-14 Cochlear Implant Activation
- Keywords
- Cochlear Implant, Same-Day Activation, Early Activation, Electrode Impedance, Stable Cochlear Implant Map, Cochlear Implant Mapping
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-Day Cochlear Implant ActivationProcedure or surgery
Also called SDA
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 ActivationProcedure or surgery
Also called Day-14
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 group | Role | What they receive |
|---|---|---|
| Same-Day Activation | Experimental | 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. Receives: Procedure: Same-Day Cochlear Implant Activation |
| Standard Day-14 Activation | Active comparator | 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. Receives: Procedure: Standard Day-14 Cochlear Implant Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrode Impedance Development
Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions.
Measured: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
Secondary outcomes (8)
Behavioural Stimulation Levels
Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming.
Measured: 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.
Measured: At follow-up visits up to 2, 6 and 12 months postoperatively
Residual Hearing Preservation
Change in pure-tone audiometric thresholds following cochlear implantation.
Measured: Preoperative baseline and 6 months postoperatively
Tinnitus Severity
Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Through study completion, up to 12 months following cochlear implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681830
- Sponsor's protocol ID
- AUH-CI-SDA-ADULT_2026
- Other IDs
- 1-10-72-53-26
- Acronym
- SDA-CI
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT07681830
- Acronym / sponsor ID
- SDA-CI / AUH-CI-SDA-ADULT_2026
- Conditions
- Hearing Loss, Cochlear Implantation
- Keywords
- Cochlear Implant, Same-Day Activation, Early Activation, Electrode Impedance, Stable Cochlear Implant Map, Cochlear Implant Mapping
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same-Day Activation | Experimental | Procedure: Same-Day Cochlear Implant ActivationParticipants 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. |
| Standard Day-14 Activation | Active comparator | Procedure: Standard Day-14 Cochlear Implant ActivationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same-Day Cochlear Implant ActivationAlso: SDAActivation 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. | Procedure or surgery | Same-Day Activation |
| Standard Day-14 Cochlear Implant ActivationAlso: Day-14Activation 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. | Procedure or surgery | Standard Day-14 Activation |
Primary outcome
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.
8 secondary outcomes
Behavioural Stimulation Levels
Time frame: 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
Residual Hearing Preservation
Time frame: Preoperative baseline and 6 months postoperatively
Tinnitus Severity
Time frame: 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.
Patient Experience of Initial Activation
Time frame: 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.
Rehabilitation Trajectory
Time frame: Through study completion, up to 12 months following cochlear implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same-Day Cochlear Implant Activation and Standard Day-14 Cochlear Implant Activation in people with Hearing Loss and Cochlear Implantation, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Devantier, MD, PhD (+45 78450000, Louise.Devantier@aarhus.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrode Impedance Development (time frame: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.