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Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

NCT06598059 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-02

No results posted yet for this study

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

Interventions

DEVICE

Cochlear implant

CI632D cochlear implant

DRUG

Dexamethasone

CI632D, dexamethasone-eluting cochlear implant

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • LWB Consulting

    collaborator UNKNOWN

  • Althea Anagnostopoulos Harrington

    collaborator UNKNOWN

  • MV Clinical Research, LLC

    collaborator UNKNOWN

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Aaron Parkinson, PhD · Cochlear

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-03
Primary Completion
2026-02-02
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598059 on ClinicalTrials.gov