What side effects are associated with this type of intervention?

Common treatments for hearing loss, particularly those involving cochlear implants and alternative modes of electrical stimulation, can have several side effects. These may include dizziness, tinnitus, and a sensation of fullness in the ear. Some patients might experience discomfort or pain at the implant site, and there is a risk of infection following surgery. Additionally, there can be device-specific issues such as electrode migration or device malfunction. It's important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for hearing loss, including cochlear implants, which are devices that provide direct electrical stimulation to the auditory nerve. Traditional cochlear implants use monopolar (MP) stimulation, but recent studies are exploring alternative modes such as focused multipolar stimulation to optimize hearing performance. While specific drugs for hearing loss are limited, some pharmacologic agents like corticosteroids are used off-label to treat sudden sensorineural hearing loss. The ongoing research aims to enhance the efficacy of cochlear implants through improved electrical stimulation patterns.

What other types of research exist?

Promising novel alternatives to optimizing electrical stimulation patterns in cochlear implants for hearing loss patients include: 1) Focused multipolar stimulation, which aims to improve hearing performance by iteratively adjusting device parameters. 2) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity in migraine patients and may have potential applications in auditory nerve stimulation. 3) Remote electrical neuromodulation, which uses nonpainful electrical skin stimulation and has been effective in reducing acute migraine pain, suggesting potential for auditory applications.

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Device

Focused Multipolar Stimulation for Hearing Loss (SASC Trial)

N/A

Recruiting

Research Sponsored by Cochlear

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Be older than 18 years old

Must not have

Diagnosis of auditory neuropathy

Deafness due to lesions of the acoustic nerve or central auditory pathway

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new methods for sending sound signals through cochlear implants to help people with severe hearing loss. The goal is to improve how well users can understand speech by making the electrical signals more precise. Researchers will adjust and test different settings to find the best ones for better hearing performance and usability. Cochlear implants are medical devices that electrically stimulate the auditory nerve to help deaf and severely hearing-impaired individuals hear again.

Who is the study for?

This trial is for adults over 18 with bilateral sensorineural hearing loss who are candidates for unilateral cochlear implantation, fluent in the speech testing language, and willing to follow study requirements. Excluded are those with acoustic nerve lesions, additional handicaps affecting evaluations, unrealistic expectations about the procedure's outcomes, or current participation in other interventional trials.

What is being tested?

The study tests a new Focused Multipolar Stimulation (FMS) strategy against the standard Monopolar stimulation in cochlear implants. It aims to improve hearing by adjusting device parameters and fitting based on ongoing reviews within technical limits.

What are the potential side effects?

As this is an early feasibility study focusing on device parameter adjustments rather than drugs or invasive procedures, specific side effects are not detailed but may include typical risks associated with cochlear implant surgery and device use.

Eligibility Criteria

Inclusion Criteria

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

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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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I have been diagnosed with auditory neuropathy.

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I am deaf because of issues with my hearing nerve or brain pathways.

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I experienced severe hearing loss in one ear before I turned five.

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I have had severe to profound hearing loss for over 20 years in one ear.

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My inner ear has a condition that could interfere with a hearing device's surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean difference across Spectral resolution (QSMD)

Mean difference across maximum map stimulation (C) levels

Mean difference across phoneme discrimination (LIT- Language independent test)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adult Cochlear implantExperimental Treatment1 Intervention

Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters

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 hearing loss, particularly in patients with severe to profound hearing loss, include cochlear implants and various modes of electrical stimulation. Cochlear implants work by bypassing damaged parts of the ear and directly stimulating the auditory nerve with electrical signals. The trial on alternative modes of stimulation, such as focused multipolar stimulation, aims to optimize these electrical patterns to improve hearing performance. This matters for hearing loss patients because optimizing electrical stimulation can enhance sound quality, speech understanding, and overall auditory experience, leading to better communication and quality of life.

[Biological therapies in otology. German version].The CD2 isoform of protocadherin-15 is an essential component of the tip-link complex in mature auditory hair cells.