Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

Condition
Hearing Loss
Intervention / Treatment

-

Contacts and Locations

Englewood

Rocky Mountain Ear Center, Englewood, Colorado, United States, 80113

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

St. Louis

Washington Univeristy, St. Louis, Missouri, United States, 63141

New York

Northwell Health Long Island Jewish Medical Center, New York, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cochlear,

Aaron Parkinson, PhD, STUDY_DIRECTOR, Cochlear

Study Record Dates

2026-08