Same-Day Cochlear Implant Activation (SDA-CI)

NCT07681830 | Not Yet Recruiting

• 2 other identifiers: AUH-CI-SDA-ADULT_20261-10-72-53-26
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss; Cochlear Implantation

Keywords

Cochlear Implant; Same-Day Activation; Early Activation; Electrode Impedance; Stable Cochlear Implant Map; Cochlear Implant Mapping

Outcome Measures

Primary Outcomes (1)

• Electrode Impedance Development

  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 Outcomes (8)

• Behavioural Stimulation Levels

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

• Time to Stable Cochlear Implant Map

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

• Residual Hearing Preservation

  Preoperative baseline and 6 months postoperatively

• Tinnitus Severity

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

• Cochlear Implant-Related Quality of Life

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

Study Arms (2)

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.

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.

Procedure: Standard Day-14 Cochlear Implant Activation

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.

Also known as: SDA

Same-Day Activation

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.

Also known as: Day-14

Standard Day-14 Activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Louise Devantier, MD, PhD

CONTACT

+45 78450000; Louise.Devantier@aarhus.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: July 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)