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Hearing LossDEE-REXNCT06598059

Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

A study testing Cochlear implant and Dexamethasone in people with Hearing Loss, run by Cochlear at 11 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue injury, which is common after any type of surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss
What is being tested?
Cochlear implant and Dexamethasone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
11 sitesUnited States
Study dates
3 Jan 2025to Sep 2026
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

  • 18 years or older, at time of consent.
  • Postlinguistic moderately severe to profound sensorineural hearing loss, defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) ≥ 60 decibels hearing level (dB HL), in the ear to be implanted (For this study, moderately severe is defined by a four-frequency, pure-tone average threshold (PTA4) over the range 500 through 4000 Hz of more than 55 dB HL through 70 dB HL, inclusive. Profound is defined by a PTA4 of more than 90 dB HL).
  • Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.
  • Preoperative aided word score ≤ 40% correct in the ear to be implanted.
  • Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines.
  • Candidate is proficient in the language used to assess speech perception performance.
  • Willing and able to provide written informed consent.

Who cannot join

  • 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.
  • Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
  • 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.
Show all 22Show fewer
  • Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
  • Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
  • Previously reported diagnosis 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. (For this study, severe is defined by a PTA4 of more than 70 dB HL through 90 dB HL, inclusive).
  • Severe, or poorer, sensorineural hearing loss for 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.
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
  • Women who are pregnant.
  • Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
  • Unable or unwilling to comply with all 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.
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University Hospitals

    Cleveland, Ohio, 44106

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Rocky Mountain Ear Center

    Englewood, Colorado, 80113

  • University of Iowa

    Iowa City, Iowa, 52242

  • UCLA Medical Center

    Los Angeles, California, 90095

  • New York Eye and Ear Infirmary

    New York, New York, 10010

  • NYU Langone Health

    New York, New York, 10017

  • Northwell Health Long Island Jewish Medical Center

    New York, New York, 11042

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Washington University

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: A Pivotal, Prospective, Multicentre, Single-arm Study Evaluating the Safety and Efficacy of a Dexamethasone Eluting Slim Modiolar Electrode Array (EA32D).

This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue injury, which is common after any type of surgery. The goal is to learn if the dexamethasone in the CI632D implant lessens these reactions inside the ear following surgery and if this makes the implant work as well, or even better, in improving hearing than what would be expected with a standard cochlear implant. 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 nerve that carries sound signals from the ear to the brain). The study participants will receive the CI632D experimental implant and will complete tests to see how well they are hearing and how well the implant is working.

Conditions
Hearing Loss
Being tested
Cochlear implant, Dexamethasone
Keywords
cochlear implant, dexamethasone, fibrosis
Medical subject headings
Hearing Loss, Fibrosis

What participants receive

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

  • Cochlear implantDevice

    Also called CI632D, Slim modiolar dexamethasone-eluting electrode array

    CI632D cochlear implant

  • DexamethasoneDrug

    Also called CI632D, Slim modiolar dexamethasone-eluting electrode array

    CI632D, dexamethasone-eluting cochlear implant

Study groups in NCT06598059
Study groupRoleWhat they receive
Drug-eluting electrode array (CI632D)ExperimentalParticipants will be implanted with the slim modiolar dexamethasone-eluting electrode array.
Receives: Device: Cochlear implant; Drug: Dexamethasone

What is being measured

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

  1. Coprimary endpoint 1: Mean monopolar 1 plus 2 (MP1+2) impedances (kOhms) at 3 months postactivation

    Impedance will be measured across the active electrodes of the implant for each participant.

    Measured: On day of implantation and at 1- and 3-months postactivation

  2. Coprimary endpoint 2: Mean change in word recognition score in the best unilateral listening mode in quiet from preimplantation to 3 months postactivation

    Within-subject change in consonant-nucleus-consonant (CNC) words in quiet (% correct) calculated as the average across 2 runs of the test conducted on each participant. CNC word score ranges from 0-100%, higher the score the better the outcome.

    Measured: Preoperative baseline and 3-months postactivation

Secondary outcomes (3)

  1. Mean within-subject change in the global score of the Speech, Spatial, and Qualities of hearing scale (SSQ12) from preimplantation to postimplantation

    Within-subject change in Global SSQ12 scores at 6-months postactivation compared with preoperative baseline. The global SSQ12 score ranges from 0-10, higher the score the better the outcome.

    Measured: Preoperative baseline and 6-months postactivation

  2. Mean within-subject change in sentence recognition score in the best unilateral listening mode in noise from preimplantation to postimplantation

    Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome.

    Measured: Preoperative baseline and 6-months postactivation

  3. Mean within-subject change in sentence recognition score in the best bilateral listening mode in noise from preimplantation to postimplantation

    Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome.

    Measured: Preoperative baseline and 6-months postactivation

Timeline

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

  1. First posted19 Sep 2024
  2. Study start3 Jan 2025
  3. Primary completion2 Feb 2026
  4. Study completionSep 2026 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598059
Sponsor's protocol ID
CLTD5849
Acronym
DEE-REX
Status last verified
Sep 2025
First submitted
12 Sep 2024
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear implant and Dexamethasone in people with Hearing Loss, run by Cochlear at 11 sites in United States.

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 7 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 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 United States. 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?

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?

Coprimary endpoint 1: Mean monopolar 1 plus 2 (MP1+2) impedances (kOhms) at 3 months postactivation (time frame: On day of implantation and at 1- and 3-months postactivation). The study lists 2 primary outcomes in all. 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 NCT06598059.

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 Mar 2026.

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