Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

NCT06598059 | Active Not Recruiting FDA Device

• 1 other identifier: CLTD5849
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 11

Brief 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. 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

Keywords

cochlear implant; dexamethasone; fibrosis

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  Preoperative baseline and 3-months postactivation

Secondary Outcomes (3)

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

  Preoperative baseline and 6-months postactivation

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

  Preoperative baseline and 6-months postactivation

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

  Preoperative baseline and 6-months postactivation

Other Outcomes (1)

• Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency throughout the study

  From implantation to 12-months postimplantation (study end)

Study Arms (1)

Drug-eluting electrode array (CI632D)

EXPERIMENTAL

Participants will be implanted with the slim modiolar dexamethasone-eluting electrode array.

Device: Cochlear implant; Drug: Dexamethasone

Interventions

Cochlear implant DEVICE

CI632D cochlear implant

Also known as: CI632D, Slim modiolar dexamethasone-eluting electrode array

Drug-eluting electrode array (CI632D)

Dexamethasone DRUG

CI632D, dexamethasone-eluting cochlear implant

Also known as: CI632D, Slim modiolar dexamethasone-eluting electrode array

Drug-eluting electrode array (CI632D)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cochlear: lead
• University of Iowa: collaborator
• LWB Consulting: collaborator
• MV Clinical Research, LLC: collaborator
• Althea Anagnostopoulos Harrington: collaborator

Study Sites (11)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Rocky Mountain Ear Center

Englewood, Colorado, 80113, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Washington University

St Louis, Missouri, 63141, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10010, United States

Location

NYU Langone Health

New York, New York, 10017, United States

Location

Northwell Health Long Island Jewish Medical Center

New York, New York, 11042, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hearing Loss; Fibrosis

Interventions

Cochlear Implants; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Aaron Parkinson, PhD

  Cochlear

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: January 3, 2025
• Primary Completion: February 2, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)