Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622) (DETECT)

July 9, 2026 updated by: Cochlear

A Pivotal, Prospective, Multi-centre, Randomised Controlled, 6-month Blinded Investigation Followed by a 6-month Open-label Phase Evaluating the Efficacy of a Dexamethasone Eluting Slim Straight Electrode (CI622D) in the Reduction of Impedance as Compared to a Standard Slim Straight Electrode (CI622) in a Newly Implanted Adult Population With Post-linguistic, Bilateral, Moderately Severe to Profound Sensorineural Hearing Loss.

This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Westmead Private Hospital
      • Sydney, New South Wales, Australia
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia
        • Macquarie University
    • Victoria
      • Melbourne, Victoria, Australia
        • St Vincent Private Hospital
      • Melbourne E., Victoria, Australia
        • Royal Victorian Eye and Ear Hospital
  • France
      • Lille, France
        • Centre Hospitalier Universitaire de Lille
      • Paris, France
        • Hôpital Universitaire Pitié-Salpêtrière
      • Toulouse, France
        • Centre Hospitalier Universitaire Toulouse
  • Germany
    • Freiburg Im Breisgau
      • Freiburg im Breisgau, Freiburg Im Breisgau, Germany
        • Universitätsklinikum Freiburg
    • Lower Saxony
      • Hanover, Lower Saxony, Germany
        • Medizinische Hochschule Hannover
  • United Kingdom
      • Manchester, United Kingdom
        • Manchester Royal Infirmary

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or older (at time of consent)
  • Clinically established post-linguistic bilateral moderately severe to profound sensorineural hearing loss
  • Meets local candidacy criteria for cochlear implantation
  • Compromised functional hearing with a hearing aid in the ear to be implanted
  • Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
  • Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines prior to randomisation
  • Candidate is proficient in the language used to assess speech perception performance
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Planned for a partial insertion of the electrode array
  • Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted
  • Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment
  • Active autoimmune disease or active immunosuppressive therapy
  • Any of the following in the ear to be implanted within 3 months prior to enrolment: history of prior otologic surgery including grommets, or tympanic membrane perforation
  • Previously reported diagnosis of auditory neuropathy, in the ear to be implanted
  • Previously reported diagnosis, in the ear to be implanted, of Large Vestibular Aqueduct Syndrome (LVAS), Meniere's disease, or cochlear hydrops
  • Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by imaging, in the ear to be implanted
  • Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, temporo- parietal skull fracture or CSF leaks
  • History of bacterial meningitis
  • Known allergic reaction or contraindication to dexamethasone or corticosteroids
  • Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the subject
  • Severe, or poorer, sensorineural hearing loss of more than 20 years, as reported by the subject, in the ear to be implanted
  • Prior cochlear implantation, in either ear
  • Medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted
  • Medical or psychological conditions that contraindicate general anaesthesia, surgery or participation in the clinical investigation, as determined by the investigator
  • Women who are pregnant
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
  • Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the Investigator
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling to the study candidate
  • Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
  • Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by investigator or Sponsor to not impact this investigation)
  • Subjects recruited at a French site who are not affiliated with social security
  • Subjects recruited at a French site who are under legal protection.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CI622D
Investigational Medical Device (IMD)
Device: CI622D
A dexamethasone-eluting Slim Straight electrode
Active Comparator: CI622
An approved medical device
Device: CI622
A standard Slim Straight electrode

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in the mean monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 6 months post-activation
Time Frame: 6 months post-activation
The impedance will be measured across the active electrodes of the implant for each participant.
6 months post-activation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency with CI622D and CI622
Time Frame: Throughout study (12 months)
Adverse events will be recorded as overall, by severity, by relatedness to device or procedure, or by seriousness. Device deficiency will be recorded as overall and by type.
Throughout study (12 months)
Difference in the mean unaided acoustic hearing thresholds pre-operatively, and from activation to post-activation between CI622D and CI622
Time Frame: Pre-operative, 0, 3, 6, 12 months post-activation
Unaided acoustic hearing thresholds will be measured pre-operatively, at activation, and 3, 6 and 12 months post-activation.
Pre-operative, 0, 3, 6, 12 months post-activation
Mean within-subject change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Word recognition scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation
Mean change (within-subject) in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Word recognition scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Change in word recognition score will be measured from pre-implantation to 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Change in word recognition score will be measured from pre-implantation to 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in sentence recognition score in noise in the preferred unilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Change in sentence recognition score (Matrix test + 10 SNR) will be measured from pre-implantation to 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in sentence recognition score in noise in the preferred bilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Change in sentence recognition score (Matrix test + 10 SNR) will be measured from pre-implantation to 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation
Difference in the mean estimated sound processor battery life for CI622D compared from activation to post-activation with CI622
Time Frame: 0, 3, 6,12 months post-activation
The estimated sound processor battery life (hours per day) will be measured at activation, 3, 6, and 12 months-post activation.
0, 3, 6,12 months post-activation
Difference in the mean nested bipolar impedances and MP1+2 impedances between CI622D and CI622 measured intraoperatively and from activation to post-activation
Time Frame: Intraoperative, at activation and 3, 6 and 12 months post-activation.
Nested bipolar impedances will be measured intraoperatively, at activation and 3, 6 and 12 months post-activation. MP1+2 impedances will be measured intraoperatively, at activation and 3 and 12 months post-activation
Intraoperative, at activation and 3, 6 and 12 months post-activation.
Difference in mean within-subject changes in global score on the Speech, Spatial, and Qualities of Hearing Scale (SSQ12) from pre-implantation to post-activation between CI622D and CI622
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Global SSQ12 scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation
Difference in mean within-subject changes in global Health Utilities Index III (HUI3) from pre-implantation to post-activation between CI622D and CI622
Time Frame: Pre-implantation, 3, 6, 12 months post-activation
Global HUI3 scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.
Pre-implantation, 3, 6, 12 months post-activation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cochlear

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avania
QbD Clinical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antje Aschendorff, Universitätsklinikum Freiburg

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLTD5815

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

product manufactured in and exported from the U.S.

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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