Dexamethasone-Eluting Cochlear Implant for Hearing Loss

No longer recruiting at 22 trial locations

Overseen By Minal Global Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Abnormal ear anatomy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new type of cochlear implant that releases dexamethasone, a corticosteroid, to reduce ear swelling. The goal is to determine if this approach improves hearing by reducing inflammation, the body's response to injury, after implantation. Researchers are testing two different implant designs to compare their effectiveness. Individuals with moderate to severe hearing loss in both ears may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance hearing solutions for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cochlear implant device is safe for hearing loss?

Research shows that the dexamethasone-releasing cochlear implant is generally safe for people. One study aimed to assess the device's safety while also evaluating its impact on hearing preservation and implant resistance levels. The results revealed no major safety concerns.

Another report highlights that this implant, which slowly releases dexamethasone, helps reduce swelling. Less swelling can lead to better hearing outcomes after implantation. Further findings from a series of cases suggest that dexamethasone protects against damage during the implant procedure.

Overall, these reports indicate that the dexamethasone-releasing cochlear implant is well-tolerated, effectively reduces swelling, and protects hearing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the dexamethasone-eluting cochlear implant because it offers a novel approach to managing hearing loss. Unlike traditional cochlear implants, which solely focus on electrical stimulation to enable hearing, this innovative device combines the implant with dexamethasone, a steroid, to potentially reduce inflammation and improve outcomes. This dual-action approach not only aids in hearing restoration but also aims to enhance the overall success and longevity of the implant by minimizing the body's inflammatory response. The combination of these features could lead to better preservation of residual hearing and improved auditory performance.

What evidence suggests that this cochlear implant with dexamethasone is effective for reducing inflammatory responses in hearing loss?

Research has shown that cochlear implants with dexamethasone, a type of medication, may help reduce swelling after surgery. In this trial, participants will receive either the CI632D Investigational Medical Device, which includes a dexamethasone-eluting electrode array, or the CI632 Comparator Device. One study found that implants with dexamethasone can lower the body's usual swelling response after receiving a cochlear implant. This decrease in swelling might help protect hearing and lead to better outcomes for patients. However, another study found that they did not always prevent hearing loss after surgery. Despite these mixed results, researchers continue to explore the benefits of using dexamethasone in these implants. ^{1 2 4 6 7}

Who Is on the Research Team?

Aaron Parkinson

Principal Investigator

Cochlear

Are You a Good Fit for This Trial?

This trial is for adults who have developed moderate to profound sensorineural hearing loss after learning language. They must not be allergic to dexamethasone, pregnant, or planning pregnancy. Participants should be able and willing to follow study requirements and have normal cochlear and middle ear anatomy without previous cochlear implant surgeries.

Inclusion Criteria

I have severe hearing loss in both ears, worse in high frequencies.

I have severe hearing loss in both ears, worse in high frequencies.

Exclusion Criteria

Unable/unwilling to comply to study requirements

I am not pregnant and do not plan to become pregnant.

My inner and middle ear structures are not typical.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the cochlear implant with dexamethasone eluting electrode array

6 months

Regular follow-up visits as per standard cochlear implant protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits to measure impedance and speech perception

Extended Follow-up

Participants are monitored for adverse events and long-term outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant
• Dexamethasone Eluting Electrode Array

Trial Overview The study is testing a new type of cochlear implant electrode array called CI632D that releases the drug dexamethasone to reduce inflammation in the ear. It's being compared with a standard electrode array, CI632, to see if it can improve hearing outcomes.

How Is the Trial Designed?

Group I: CI632D Investigational Medical Device (IMD) Experimental Treatment 1 Intervention

Group II: CI632 Comparator Device Active Control 1 Intervention

Cochlear Implant is already approved in United States, European Union for the following indications:

Approved in United States as Cochlear Implant for:

• Single-sided deafness (SSD) in children aged 5 years and older
• Severe to profound sensorineural hearing loss in both ears

Approved in European Union as Cochlear Implant for:

• Severe to profound sensorineural hearing loss in both ears
• Single-sided deafness (SSD) in children and adults

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Published Research Related to This Trial

In a study using guinea pigs, dexamethasone-eluting silicone rods were found to be safe for use in cochlear implants, showing no signs of bacterial infection or increased macrophage presence, which indicates a low risk of inflammation.

The study demonstrated that the dexamethasone-eluting electrodes resulted in less hearing threshold shift (1 dB) compared to non-eluting electrodes (10 dB), suggesting that the dexamethasone may help mitigate hearing loss associated with electrode insertion trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implant and inflammation reaction: Safety study of a new steroid-eluting electrode. Astolfi, L., Simoni, E., Giarbini, N., et al.[2018]

The dexamethasone-eluting electrode (DEXEL) demonstrated a protective anti-inflammatory effect in normal hearing macaques, resulting in lower threshold shifts and impedance values compared to conventional cochlear implants after 6 months.

The DEXEL group showed significantly higher electrically evoked compound action potential (eCAP) amplitudes and reduced tissue reactions like fibrosis and ossification, indicating improved safety and efficacy in preserving hearing function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear Implantation With a Dexamethasone Eluting Electrode Array: Functional and Anatomical Changes in Non-Human Primates. Manrique-Huarte, R., Zulueta-Santos, C., Calavia, D., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11160184/

Outcomes following cochlear implantation with eluting ... Use of a dexamethasone‐eluting electrode did not significantly protect against postoperative hearing loss. Week 1 Group 2 threshold shifts ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378595525000747

Cochlear implantation with a dexamethasone-eluting ... Here we present the results from a first-in-human feasibility study of the CIDEXEL system (the Mi1200 SYNCHRONY cochlear implant combined with the FLEX28 DEX ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04750642

Study Details | NCT04750642 | Cochlear Implant With ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4. nature.com nature.com/articles/s41598-025-10739-y

Dexamethasone-eluting cochlear implants reduce ... In summary, the data presented here demonstrate the remarkable effectiveness of dexamethasone-eluting electrode arrays to suppress the universal ...

5. medrxiv.org medrxiv.org/content/10.1101/2024.10.11.24315311v1

Cochlear implants with dexamethasone-eluting electrode ... This study aims to investigate the long-term efficacy of dexamethasone eluting cochlear implant and locally delivered dexamethasone, a potent anti-inflammatory ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06598059

NCT06598059 | Safety and Efficacy of a Drug Eluting Slim ... This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue ...

7. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.892777/full

Safety and audiological outcome in a case series of tertiary ... Electrode array-eluted dexamethasone protects against electrode insertion trauma induced hearing and hair cell losses, damage to neural ...