AzTrials
AzTrials

Hearing Loss, Bilateral SensorineuralDETECTNCT06424262

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)

A study testing CI622D and CI622 in people with Hearing Loss, Bilateral Sensorineural and Hearing Loss, Sensorineural, run by Cochlear at 11 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CI622D and CI622
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
11 sitesin 4 countries
Study dates
17 Jun 2024to 6 May 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

Australia5 sites

  • St Vincent Private Hospital

    Melbourne, Victoria

  • Royal Victorian Eye and Ear Hospital

    Melbourne E., Victoria

  • Macquarie University

    Sydney, New South Wales

  • Royal Prince Alfred Hospital

    Sydney, New South Wales

  • Westmead Private Hospital

    Sydney, New South Wales

Other trials in Australia

France3 sites

  • Centre Hospitalier Universitaire de Lille

    Lille

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris

  • Centre Hospitalier Universitaire Toulouse

    Toulouse

Other trials in France

Germany2 sites

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Freiburg Im Breisgau

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony

Other trials in Germany

United Kingdom1 site

  • Manchester Royal Infirmary

    Manchester

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
CI622D, CI622
Medical subject headings
Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CI622DDevice

    A dexamethasone-eluting Slim Straight electrode

  • CI622Device

    A standard Slim Straight electrode

Study groups in NCT06424262
Study groupRoleWhat they receive
CI622DExperimentalInvestigational Medical Device (IMD)
Receives: Device: CI622D
CI622Active comparatorAn approved medical device
Receives: Device: CI622

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in the mean impedance between CI622D and CI622

    Mean monopolar impedance measured across the active electrodes of the implant for each participant.

    Measured: 6 months post-activation

Secondary outcomes (12)

  1. Incidence of Treatment-Emergent Adverse Events of the CI622D and CI622

    Percentage of the number of participants who experience an adverse event for the CI622D group and the CI622 group

    Measured: Throughout study (12 months)

  2. Difference in the proportion of participants with preservation of low frequency residual hearing with CI622D compared with CI622

    The proportion of participants achieving ≤ 30 dB change in the low frequency pure tone average (LFPTA) (250 Hz and 500 Hz). This measure will be applied to the subgroup of participants who have a LFPTA < 80 dB HL at the pre-operative baseline.

    Measured: Pre-implantation to 6 months post activation

  3. Mean change (within-subject) in word recognition score in the preferred unilateral listening mode in quiet with the CI622D

    Change in percent correct word recognition score

    Measured: Pre-implantation to 6 months post-activation

  4. Mean change (within-subject) in word recognition score in the preferred bilateral listening mode in quiet with the CI622D

    Change in percent correct word recognition score

    Measured: Pre-implantation to 6 months post-activation

  5. Difference in mean (within-subject) change in word recognition score in the preferred unilateral listening mode in quiet with the CI622D compared with CI622

    Change in percent correct word recognition score

    Measured: Pre-implantation to 12 months post-activation

  6. 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

    Change in percent correct word recognition score

    Measured: Pre-implantation to 12 months post-activation

  7. 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

    Change in percent correct sentence recognition score (Matrix test + 10 SNR)

    Measured: Pre-implantation to 12 months post-activation

  8. 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

    Change in percent correct sentence recognition score (Matrix test + 10 SNR)

    Measured: Pre-implantation to 12 months post-activation

  9. Characterization of four-point nested impedances and monopolar impedance of the CI622D and CI622

    Group mean impedance measured across the active electrodes for four-point nested impedance and MP1+2 impedance for the CI622D and CI622

    Measured: Activation, 12 months post-activation

  10. Characterization of mean estimated sound processor battery life for CI622D and CI622

    The estimated sound processor battery life (hours per day) as calculated by the programming software

    Measured: 12 months post-activation

  11. Difference in mean within-subject changes in global score on the Speech, Spatial, and Qualities of Hearing Scale (SSQ12) between CI622D and CI622

    Speech, Spatial, and Qualities of Hearing Scale global score (SSQ-12). Scores range from 0 to 10, where higher scores indicate greater ability (less hearing disability).

    Measured: Pre-implantation to 12 months post-activation

  12. Difference in mean within-subject changes in global Health Utilities Index III (HUI3) between CI622D and CI622

    Health Utilities Index (HUI 2/3) global score. Scores range from -0.36 to 1.00, where a negative score represents a state "worse than dead" and a top score of 1.00 is "perfect health".

    Measured: Pre-implantation to 12 months post-activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2024
  2. Study start17 Jun 2024
  3. Primary completion5 Nov 2025
  4. Study completion6 May 2026

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06424262
Sponsor's protocol ID
CLTD5815
Acronym
DETECT
Status last verified
Oct 2026
First submitted
16 May 2024
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CI622D and CI622 in people with Hearing Loss, Bilateral Sensorineural and Hearing Loss, Sensorineural, run by Cochlear at 11 sites in 4 countries.

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 8 inclusion and 25 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia, France, Germany, United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the mean impedance between CI622D and CI622 (time frame: 6 months post-activation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06424262.

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 8 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in