Drug-Releasing Cochlear Implant for Hearing Loss

(DEE-REX Trial)

Not currently recruiting at 13 trial locations

Overseen By Paul Reinhart, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Must not be taking: Corticosteroids

Disqualifiers: Autoimmune disease, Otitis media, Meniere's, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cochlear implant that slowly releases dexamethasone, a corticosteroid, to reduce swelling and tissue damage after surgery. The implant aims to determine if these benefits improve hearing more effectively than standard implants in adults with sensorineural hearing loss, which results from damage in the inner ear or hearing nerve. Individuals with long-standing moderate to severe hearing issues who struggle to hear words clearly might be suitable candidates. Participants will receive the experimental implant and undergo hearing tests to assess its effectiveness. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research in cochlear implant technology.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on active immunosuppressive therapy, you may not be eligible to participate.

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

Research has shown that cochlear implants with dexamethasone can be safe for people. In animal studies, these implants helped preserve hearing and reduce post-surgery ear issues. Early human studies also showed positive results, with the implants being well-tolerated and not causing significant side effects.

Dexamethasone reduces swelling and tissue damage. The FDA has already approved it for other uses, indicating its general safety. This supports the idea that its use in cochlear implants should be well-tolerated. While no serious side effects were reported, minor issues such as discomfort or temporary changes in hearing can occur, as with any surgery. Overall, early findings suggest that this treatment could be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard cochlear implants that primarily focus on sound amplification, the drug-releasing cochlear implant is unique because it incorporates dexamethasone, a corticosteroid, directly into the electrode array. This allows for localized, sustained release of the drug, potentially reducing inflammation and promoting healing right at the site of implantation. Researchers are excited about this treatment because it could improve implant outcomes and hearing restoration by directly addressing issues like tissue response and fibrosis, which are common challenges with traditional cochlear implants.

What evidence suggests that this cochlear implant is effective for hearing loss?

Research has shown that cochlear implants releasing dexamethasone can improve hearing. In this trial, participants will receive a drug-eluting electrode array that releases dexamethasone. These implants protect hearing by reducing swelling and damage in the ear after surgery. Many participants experienced only a small hearing loss of 15 decibels or less after receiving the implant. Tests on speech understanding showed similar results to those with regular implants, indicating they work just as well. Overall, these dexamethasone-releasing implants appear to keep the ear healthier after surgery, potentially leading to better hearing. ^{1 2 3 4 6}

Who Is on the Research Team?

Aaron Parkinson, PhD

Principal Investigator

Cochlear

Are You a Good Fit for This Trial?

Adults with sensorineural hearing loss, which is caused by damage to the inner ear or auditory nerve, are eligible for this trial. Participants must be suitable candidates for cochlear implant surgery.

Inclusion Criteria

Willing and able to provide written informed consent.

I have received the pneumococcal vaccine as recommended.

Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear

Exclusion Criteria

I have had bacterial meningitis before.

I have brain lesions or deafness in the ear I plan to have an implant in.

I am allergic to dexamethasone or corticosteroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants receive the CI632D experimental implant

1 day

1 visit (in-person)

Postactivation Monitoring

Participants are monitored for changes in hearing and implant performance at 3-, 6-, and 12-months postactivation

12 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The study tests a new cochlear implant (CI632D) that releases dexamethasone to reduce inflammation and tissue injury post-surgery. The aim is to see if it improves hearing more effectively than standard implants.

How Is the Trial Designed?

Group I: Drug-eluting electrode array (CI632D) Experimental Treatment 2 Interventions

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

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

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

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

LWB Consulting

Collaborator

Trials

2

Recruited

110+

Althea Anagnostopoulos Harrington

Collaborator

Trials

2

Recruited

110+

MV Clinical Research, LLC

Collaborator

Trials

2

Recruited

110+

Published Research Related to This Trial

In a study of 35 adult patients undergoing cochlear implantation, those receiving intravenous dexamethasone showed a high rate of partial hearing preservation (77.8%), indicating its effectiveness in maintaining residual hearing post-surgery.

The combination of intravenous dexamethasone and oral prednisone also resulted in significant hearing preservation (61.5%), while the control group without steroid treatment had a higher incidence of no measurable hearing (38.5%) after 12 months, highlighting the potential benefits of steroid therapy in cochlear implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Effect of Steroid Therapy on Preserving Residual Hearing after Cochlear Implantation with the Advanced Bionics HiRes Ultra 3D Cochlear Implant System. Skarzynska, MB., Kolodziejak, A., Gos, E., et al.[2022]

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]

In a study of 147 adult patients undergoing cochlear implantation, those who received steroids (either dexamethasone or a combination with prednisone) showed significantly better hearing preservation, with 62% achieving partial or complete hearing preservation compared to only 33% in the control group without steroids.

The effectiveness of hearing preservation varied by cochlear implant brand, with Med-El and Advanced Bionics patients showing better outcomes (45% and 43% respectively) compared to those with Oticon implants (20%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Effect of Steroids for Hearing Preservation in Cochlear Implantation: Conclusions Based on Three Cochlear Implant Systems and Two Administration Regimes. Skarżyńska, MB., Kołodziejak, A., Gos, E., et al.[2022]

A single dose of a sustained release dexamethasone hydrogel administered one day before cochlear implantation significantly reduced hearing threshold shifts at various frequencies, indicating improved hearing preservation post-surgery.

Increased outer hair cell counts were observed in the cochlear apex of guinea pigs treated with dexamethasone, suggesting that timely glucocorticoid application can enhance cochlear health, although it was also associated with a higher rate of electrode translocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sustained release dexamethasone hydrogels in hearing preservation cochlear implantation. Honeder, C., Zhu, C., Schöpper, H., 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]

Dexamethasone can be effectively released in a controlled manner from silicone used in cochlear implant electrode carriers, which may help protect residual low-frequency hearing after implantation.

In both in vitro and in vivo studies, the sustained release of dexamethasone was observed, lasting up to 20 weeks in vitro and 1 week in vivo, indicating potential for improved safety and performance of cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and in vivo pharmacokinetic study of a dexamethasone-releasing silicone for cochlear implants. Liu, Y., Jolly, C., Braun, S., et al.[2018]

Incorporating dexamethasone (DXM) into cochlear implant arrays does not affect the insertion forces, indicating that it can be safely used without increasing the risk of trauma during the implantation process.

The study tested four different cochlear implant models with a total of 140 insertions, and found that the DXM-loaded arrays maintained similar friction forces compared to drug-free models, suggesting potential benefits for reducing inflammation and fibrosis post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of embedded dexamethasone in cochlear implant array on insertion forces in an artificial model of scala tympani. Nguyen, Y., Bernardeschi, D., Kazmitcheff, G., et al.[2018]

Dexamethasone can be effectively embedded in cochlear implant electrode carriers, allowing for controlled and sustained release of the drug over several weeks, which helps reduce inflammation after surgery.

Higher concentrations of dexamethasone (1% and 10%) resulted in significantly greater and longer-lasting drug levels in the perilymph compared to lower concentrations, suggesting that a dose range of 50 to 100 ng/ml is effective for managing inflammation during cochlear implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term in vivo Release Profile of Dexamethasone-Loaded Silicone Rods Implanted Into the Cochlea of Guinea Pigs. Liebau, A., Schilp, S., Mugridge, K., et al.[2020]

Local drug application to the inner ear, such as through cochlear implants, offers advantages over systemic delivery by improving drug targeting and reducing side effects, particularly for therapies like glucocorticosteroids and neurotrophins.

Two case reports demonstrated successful use of a biocompatible, resorbable drug-delivery system for controlled release of dexamethasone in cochlear implant patients, which helped address issues like reduced speech discrimination and increased impedance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracochlear drug delivery in combination with cochlear implants : Current aspects. Plontke, SK., Götze, G., Rahne, T., et al.[2019]

Local drug application to the inner ear, such as through intracochlear delivery, offers significant advantages over systemic delivery, particularly in enhancing cochlear implant (CI) rehabilitation by delivering therapeutic agents directly to the site of action.

In two case reports, patients with cochlear implants benefited from the intracochlear placement of a biocompatible, resorbable drug delivery system that released dexamethasone, leading to improved speech discrimination and reduced impedance, demonstrating the potential for targeted therapy in managing CI-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intracochlear drug delivery in combination with cochlear implants : Current aspects]. Plontke, SK., Götze, G., Rahne, T., et al.[2018]

Citations

1. 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 ...

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

Outcomes following cochlear implantation with eluting ... The application of dexamethasone and other anti‐inflammatory and anti‐apoptotic drugs have shown significant improvement in preservation of ...

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

Cochlear implantation with a dexamethasone-eluting ... In most participants good preservation of residual hearing (≤15 dB hearing loss) was achieved. •. Showed speech perception test results were comparable to those ...

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

Dexamethasone-eluting cochlear implants reduce ... This study aims to investigate the long-term efficacy of dexamethasone-eluting cochlear implant and locally delivered dexamethasone, a potent ...

5. mdpi.com mdpi.com/2039-4349/15/5/112

Use of the FLEX 28 Dexamethasone-Eluting Cochlear ... In addition, several preclinical studies showed favorable outcomes for DEX in reducing electrode insertion trauma as assessed by HP, decreasing impedance change ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04750642

Study Details | NCT04750642 | Cochlear Implant With ... Also called a data safety and monitoring board, or DSMB. ... These trials gather additional information about a drug's safety, efficacy, or optimal use.