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)

NCT06424262 | Active Not Recruiting

• 1 other identifier: CLTD5815
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 11

Brief 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. 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.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Loss, Cochlear; Hearing Loss, Bilateral Sensorineural

Outcome Measures

Primary Outcomes (1)

• Difference in the mean monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 6 months post-activation

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

  6 months post-activation

Secondary Outcomes (12)

• 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

  Pre-implantation, 3, 6, 12 months post-activation

• Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency with CI622D and CI622

  Throughout study (12 months)

• Difference in the mean unaided acoustic hearing thresholds pre-operatively, and from activation to post-activation between CI622D and CI622

  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

  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

  Pre-implantation, 3, 6, 12 months post-activation

Study Arms (2)

CI622D

EXPERIMENTAL

Investigational Medical Device (IMD)

Device: CI622D

CI622

ACTIVE COMPARATOR

An approved medical device

Device: CI622

Interventions

CI622D DEVICE

A dexamethasone-eluting Slim Straight electrode

CI622D

CI622 DEVICE

A standard Slim Straight electrode

CI622

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cochlear: lead
• QbD Clinical: collaborator
• Avania: collaborator

Study Sites (11)

Macquarie University

Sydney, New South Wales, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Location

Westmead Private Hospital

Sydney, New South Wales, Australia

Location

St Vincent Private Hospital

Melbourne, Victoria, Australia

Location

Royal Victorian Eye and Ear Hospital

Melbourne E., Victoria, Australia

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

Hôpital Universitaire Pitié-Salpêtrière

Paris, France

Location

Centre Hospitalier Universitaire Toulouse

Toulouse, France

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Freiburg Im Breisgau, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

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

Study Officials

• Antje Aschendorff

  Universitätsklinikum Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: June 17, 2024
• Primary Completion: November 5, 2025
• Study Completion: May 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); FR (3); DE (2); GB (1)