What side effects are associated with this type of intervention?

Common treatments for sensorineural hearing loss include cochlear implants and the use of dexamethasone to reduce inflammatory responses. Cochlear implants can lead to surgical and medical complications such as infections, including meningitis, and device-related issues. The use of dexamethasone, particularly in eluting electrode arrays, aims to mitigate inflammation but may not completely prevent hearing threshold shifts and tissue responses. Other side effects of dexamethasone can include local irritation and potential systemic effects if absorbed in significant amounts.

What prior FDA approvals exist?

The FDA has approved several treatments for sensorineural hearing loss, including cochlear implants, which are devices that provide direct electrical stimulation to the auditory nerve. One notable advancement is the Cochlear Implant Electrode Array with Dexamethasone Elution, designed to reduce inflammatory responses and improve outcomes. While specific drugs targeting sensorineural hearing loss are limited, corticosteroids like dexamethasone are commonly used to manage inflammation and improve hearing outcomes in various inner ear conditions.

What other types of research exist?

Promising novel alternatives to the Cochlear Implant Electrode Array with Dexamethasone Elution for SNHL patients include: 1) Gene therapy targeting specific genetic mutations associated with hearing loss, which aims to restore or preserve hearing function. 2) Stem cell therapy, which involves the regeneration of damaged hair cells in the cochlea. 3) Pharmacological treatments such as neurotrophic factors or small molecules that promote hair cell regeneration and protect against ototoxicity. 4) Advanced auditory brainstem implants (ABIs) for patients who are not candidates for cochlear implants due to anatomical reasons. These alternatives are in various stages of research and clinical trials, showing potential for improved outcomes in SNHL treatment.

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Dexamethasone-Eluting Cochlear Implant for Hearing Loss

N/A

Waitlist Available

Research Sponsored by Cochlear

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.

Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500 and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.

Must not have

Abnormal cochlear and middle ear anatomy

History with cochlear implant surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include local reactions at the surgery site due to dexamethasone release such as pain or infection, general discomfort from the implant procedure itself, and possible changes in taste sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My inner and middle ear structures are not typical.

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I have had cochlear implant surgery.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CI632D Investigational Medical Device (IMD)Experimental Treatment1 Intervention

Group II: CI632 Comparator DevicePlacebo Group1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sensorineural Hearing Loss (SNHL) include cochlear implants and the use of corticosteroids like dexamethasone. Cochlear implants work by directly stimulating the auditory nerve, bypassing damaged hair cells in the cochlea. Dexamethasone, a corticosteroid, is used to reduce inflammation and protect auditory nerve fibers, as inflammation can exacerbate hearing loss and impede the function of cochlear implants. The combination of a cochlear implant with a dexamethasone-eluting electrode array helps to minimize inflammatory responses, potentially improving the overall effectiveness of the implant and preserving residual hearing. This is crucial for SNHL patients as it can lead to better hearing outcomes and a higher quality of life.

Long-term effects and potential limits of intratympanic dexamethasone-loaded hydrogels combined with dexamethasone-eluting cochlear electrodes in a low-insertion trauma Guinea pig model.Protecting against electrode insertion trauma using dexamethasone.