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.

Cochlear11 sites in 4 countries48 target enrollmentJune 17, 2024

ConditionsHearing Loss, Bilateral Sensorineural Hearing Loss, Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss, Bilateral Sensorineural
Sponsor: Cochlear
Enrollment: 48
Locations: 11
Primary Endpoint: Difference in the mean monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 6 months post-activation
Status: Active, Not Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 17, 2024

End Date

May 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)
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(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(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(Pre-implantation, 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(Intraoperative, at activation and 3, 6 and 12 months post-activation.)
Difference in the mean estimated sound processor battery life for CI622D compared from activation to post-activation with CI622(0, 3, 6,12 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(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(Pre-implantation, 3, 6, 12 months post-activation)