What side effects are associated with this type of intervention?

Cochlear implants, which involve electrical stimulation of the auditory nerve, are a common treatment for severe hearing loss. Known side effects of cochlear implants include surgical risks such as infection, bleeding, and device malfunction. Post-surgical side effects can include dizziness, tinnitus, and changes in taste. Additionally, there may be a risk of meningitis, particularly in children, and some patients may experience facial nerve damage. Despite these risks, cochlear implants can significantly improve hearing and quality of life for many individuals with severe hearing loss.

What prior FDA approvals exist?

Cochlear implants are FDA-approved devices used to treat severe to profound sensorineural hearing loss by electrically stimulating the auditory nerve. These implants bypass damaged hair cells in the cochlea, directly stimulating the auditory nerve to provide a sense of sound. The FDA has approved several cochlear implant systems from manufacturers such as Cochlear Limited, Advanced Bionics, and MED-EL. These devices have been shown to improve hearing and speech perception in individuals who do not benefit from traditional hearing aids.

What other types of research exist?

One promising novel alternative to cochlear implants for cochlear hearing loss patients is transcranial direct current stimulation (tDCS). This technique involves stimulating the cortex with a weak polarizing electric current using electrodes applied to the scalp. Studies have shown that tDCS can enhance naming accuracy and augment the effects of speech and language therapy in patients with chronic poststroke aphasia. Although primarily studied for aphasia, its potential benefits for auditory processing and communication suggest it could be a viable alternative for cochlear hearing loss patients.

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Diagnostic Auditory Tests for Hearing Loss in Cochlear Implantees

N/A

Waitlist Available

Led By Matthew J. Goupell, PhD

Research Sponsored by University of Maryland, College Park

Eligibility Criteria Checklist

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

Must have

Post-lingual onset of deafness

post-lingual onset of deafness

Must not have

History of neurological disorders

Severe hearing loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies older adults using cochlear implants to understand why some benefit more than others. It looks at how aging and the health of hearing pathways affect their ability to process sounds. The goal is to improve guidance and outcomes for older adults using these devices.

Who is the study for?

This trial is for older adults with post-lingual deafness who have been using a Cochlear-brand cochlear implant for over a year. Candidates should have normal to moderate hearing loss and must not be pregnant, use non-Cochlear implants, or have severe hearing loss or neurological disorders.

What is being tested?

The study tests how aging, health of auditory pathways, and the placement of cochlear implant electrodes affect speech perception in older users. It involves diagnostic tests on cochlear implant function and auditory processing using various sounds.

What are the potential side effects?

Since this trial focuses on diagnostic testing rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing testing equipment or fatigue from participating in the study sessions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I became deaf after learning to speak.

Select...

I became deaf after learning to speak.

Exclusion Criteria

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

Select...

I have a history of neurological disorders.

Select...

I have severe hearing loss.

Select...

I have had problems with my middle ear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Amplitude modulation detection performance

Perceptual amplitude discrimination thresholds

Perceptual duration discrimination thresholds

+3 more

Secondary study objectives

Cortical auditory evoked potential - N1 and P2 amplitude

Cortical auditory evoked potential - N1 and P2 latency

Electrically evoked compound action potential (ECAP)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Enrolled Participants - Older adults with cochlear implantsExperimental Treatment1 Intervention

Individuals who already use at least one cochlear implant.

Group II: Enrolled Participants - Adults with typical hearingExperimental Treatment1 Intervention

Control group to provide baseline or comparison data

0 / 5Eligibility 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

Cochlear implants treat cochlear hearing loss by electrically stimulating the auditory nerve, bypassing damaged hair cells in the cochlea. This direct activation of the auditory nerve allows the brain to perceive sound, making it a vital option for patients whose hearing loss is too severe for traditional hearing aids to be effective. This mechanism is essential as it provides a means to restore hearing function, significantly improving the quality of life for individuals with profound hearing loss.

[Biological therapies in otology. German version].