Dexamethasone-Eluting Cochlear Implant for Hearing Loss

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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special hearing implant that releases a medication to reduce inflammation. It aims to help patients who need cochlear implants by improving their hearing and reducing complications.

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 data supports the effectiveness of the treatment Dexamethasone-Eluting Cochlear Implant for Hearing Loss?

Research shows that using a dexamethasone-eluting cochlear implant can reduce inflammation and tissue growth in the ear, which helps protect hearing after the implant is inserted. Studies in animals have demonstrated that this treatment can decrease damage and preserve hearing better than implants without dexamethasone. ^{1 2 3 4 5}

Is the Dexamethasone-Eluting Cochlear Implant safe for humans?

Studies in animals suggest that the Dexamethasone-Eluting Cochlear Implant is generally safe, showing no significant infection or inflammation and reducing damage from implant insertion. ^{1 2 3 5 6}

How is the Dexamethasone-Eluting Cochlear Implant treatment different from other treatments for hearing loss?

This treatment is unique because it combines a cochlear implant with a slow-release anti-inflammatory drug, dexamethasone, which helps reduce inflammation and tissue growth caused by the implant, potentially preserving more of the patient's natural hearing compared to standard cochlear implants. ^{1 2 3 6 7}

Research Team

Aaron Parkinson

Principal Investigator

Cochlear

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Immune Response After Cochlear Implantation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Cochlear Implantation With a Dexamethasone Eluting Electrode Array: Functional and Anatomical Changes in Non-Human Primates. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Protecting against electrode insertion trauma using dexamethasone. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Dexamethasone-Eluting Electrode Array on the Post-Implant Cochlear Fibrotic Reaction by Three-Dimensional Immunofluorescence Analysis in Mongolian Gerbil Cochlea. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Otoprotection to Implanted Cochlea Exposed to Noise Trauma With Dexamethasone Eluting Electrode. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Cochlear implant and inflammation reaction: Safety study of a new steroid-eluting electrode. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Development of a safe dexamethasone-eluting electrode array for cochlear implantation. [2014]