Cochlear Implant for Hearing Loss

Overseen By Phillip Gander, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Phillip Gander

Must not be taking: Papaverine, Ginkgo biloba

Disqualifiers: Seizure disorder, Head injury, Neurologic, others

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

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how people with cochlear implants understand speech in noisy environments. It aims to uncover the brain's role in helping these listeners identify words and sounds. Participants with cochlear implants, who have had them for over a year and experience severe hearing loss that began after age 16, are a good fit. Additionally, the trial includes people with typical hearing for comparison. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could improve communication for those with hearing challenges.

Will I have to stop taking my current medications?

If you are taking medications that affect blood flow in the brain, like papaverine, ginkgo biloba, or acetazolamide, you may need to stop them to participate in the trial.

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

Studies have shown that cochlear implants are generally safe. In one study with children, about 26% experienced some issues, but most were not serious, with only 5% facing major problems.

For adults, both young and old, research indicates that cochlear implants are safe and can enhance hearing and quality of life. Another study found that the devices have a long lifespan, with more than 96% still functioning after 10 years and over 91% remaining effective after 20 years.

This evidence suggests that cochlear implants are well-tolerated and have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cochlear implants are unique because they directly stimulate the auditory nerve, bypassing damaged parts of the ear, which is different from traditional hearing aids that simply amplify sound. This can be particularly beneficial for individuals with severe to profound hearing loss who don't benefit from conventional hearing aids. Researchers are excited about cochlear implants because they can significantly improve hearing and speech comprehension, allowing recipients to better understand speech in noisy environments and enjoy a richer auditory experience.

What is the effectiveness track record for cochlear implants in treating hearing loss?

Studies have shown that cochlear implants work very well for people with hearing loss. One study found that 94% of users still experienced noticeable hearing improvements even five years after receiving the implant. Another review found that 82% of adults who lost their hearing after learning to speak understood speech better after receiving a cochlear implant. The benefits extend beyond quiet places; implants also help with understanding speech in noisy environments. These findings suggest cochlear implants can greatly improve hearing and communication for many users. Participants in this trial will include either experienced cochlear implant recipients or age-matched individuals with typical hearing, allowing for a comprehensive evaluation of the implant's effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Phillip E. Gander, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults with severe hearing loss who received a cochlear implant more than a year ago, or those with typical hearing aged between 18 and 99. Participants must understand the study and consent to join. Pregnant women, individuals with certain illnesses or on medications affecting cerebral blood flow are excluded.

Inclusion Criteria

Eligible for research under the Iowa Cochlear Implant Project VIII

Cochlear Implant subjects:

Have a cochlear implant activated for more than one year

Exclusion Criteria

Female self-reporting pregnancy. A urine pregnancy test will be performed prior to injection of the radiopharmaceutical

Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator

I have a history of seizures, head injury, or heart issues, but might get approval.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging Session

Participants undergo PET neuroimaging to study brain regions related to speech-in-noise processing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging session

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant

Trial Overview

The study examines how people with cochlear implants perceive speech amidst noise by exploring the underlying neural processes. It includes both subjects with implants and those with normal hearing as part of the Iowa Cochlear Implant Project VIII.

How Is the Trial Designed?

Group I: Cochlear implant Experimental Treatment 1 Intervention

Experienced (greater than 1 year) cochlear implant recipients

Group II: Age-typical hearing control Active Control 1 Intervention

Age-matched, age-typical (normal) hearing control participants

Who Is Running the Clinical Trial?

Phillip Gander

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

Cochlear implants significantly improve auditory performance and speech production compared to hearing aids, as shown in a study of 84 patients, highlighting their effectiveness in enhancing quality of life for children with severe to profound hearing loss.

Younger implantation age is associated with better health-related quality of life outcomes, but even older children can achieve good results with proper selection and training, indicating that cochlear implants can be beneficial across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life in cochlear implanted patients in Romania. Necula, V., Cosgarea, M., Necula, SE.[2015]

Cochlear implants significantly improve hearing in profoundly hearing-impaired patients, with performance in a study of 63 patients showing a wide range of outcomes, including up to 62% correct word recognition and 98% enhancement in lipreading.

Prelingually deaf children benefit from cochlear implants but take longer to show improvements compared to postlingually deaf individuals, highlighting the need for tailored rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can we learn about hearing aids from cochlear implants? Tyler, RS.[2019]

A study analyzing adverse event reports for cochlear implants found that most incidents involved patient injury (16,736 cases) and device malfunction (10,760 cases), highlighting areas for potential safety improvements.

Using machine learning algorithms, researchers achieved high prediction accuracy (up to 88.6%) in identifying the cochlear implant manufacturer and type of adverse event based on the descriptions, suggesting that data analysis can enhance understanding of device performance and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. Crowson, MG., Hamour, A., Lin, V., et al.[2021]

Cochlear implants are advanced devices that electrically stimulate the hearing nerve, making them suitable for individuals with severe to profound hearing loss who do not benefit from hearing aids.

These implants replace the function of damaged hair cells in the cochlea, leading to improved hearing and communication abilities for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implants]. Demanez, L., Renglet, T., Bernard, C., et al.[2015]

The Ineraid multichannel cochlear implant provides a significant opportunity for individuals with bilateral profound sensorineural hearing loss to perceive sound, potentially improving their quality of life.

The study followed five postlingually deafened adults for one year after implantation, highlighting the long-term impact of cochlear implants on auditory awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ineraid (Utah) multichannel cochlear implants. Youngblood, J., Robinson, S.[2019]

A consensus of 30 international specialists developed 20 evidence-based statements on the use of unilateral cochlear implants for adults with severe to profound sensorineural hearing loss, highlighting the clinical effectiveness and best practices for implantation.

The study, which reviewed 6492 articles and included 74 relevant studies, emphasizes the need for further research to establish guidelines for various cochlear implantation scenarios, aiming to improve hearing outcomes and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements. Buchman, CA., Gifford, RH., Haynes, DS., et al.[2021]

Cochlear implants (CIs) provide significantly better hearing improvement for patients with severe to profound hearing loss compared to conventional hearing aids, making them a more effective treatment option.

The MED-EL multichannel CI system has shown high reliability, with no technical failures reported over a 5-year observation period, highlighting the advancements in implant technology and design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. Baumann, U., Stöver, T., Weißgerber, T.[2022]

A retrospective analysis of cochlear implant adverse events over a 10-year period revealed a significant increase in cases with multiple or unknown causes, particularly gradual idiopathic loss of performance, indicating a shift in the nature of reported issues.

Despite improvements in manufacturing and surgical techniques, the rise in complex adverse events suggests a need for further research to understand and address these idiopathic cases to enhance cochlear implant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. Causon, A., Verschuur, C., Newman, TA.[2013]

Cochlear implantation is a safe procedure with a low overall complication rate of 12.2%, and no cases of postoperative meningitis or facial nerve palsy were reported, indicating a favorable safety profile for both adults and children.

The study analyzed 342 operations over a 9-year period, revealing that while the majority of patients experienced no major issues, there is a notable risk of device failure, particularly higher in children (13.92%) compared to adults (7.07%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical considerations in cochlear implantation in children and adults: a review of 342 cases in Vienna. Arnoldner, C., Baumgartner, WD., Gstoettner, W., et al.[2019]

In a study of 84 adults with severe to profound hearing loss, those who received multichannel cochlear implants showed a significant improvement in speech understanding and quality of life, with most benefits occurring within the first 6 months after implantation.

The cost-effectiveness of cochlear implants was favorable, with a marginal cost per quality-adjusted life-year (QALY) calculated at $14,670, indicating that the intervention provides good value for the health benefits it delivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of the cost-utility of the multichannel cochlear implant. Palmer, CS., Niparko, JK., Wyatt, JR., et al.[2022]

Cochlear implants effectively restore partial hearing in profoundly deaf individuals, enabling them to communicate and understand speech without relying on lip-reading, and even allowing some to talk on the phone.

The best outcomes are seen in patients who had developed speech and language skills before losing their hearing and those with a shorter duration of deafness, while gradual improvements are also noted in prelingually deafened individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to cochlear implants. Loizou, PC.[2019]

Cochlear implantation is an effective procedure for restoring hearing in patients, particularly children, with a significant improvement in the time from diagnosis to implantation, decreasing from 34.6 months in 2002 to just 10 months in 2007.

While complications occurred in 13% of patients, most were successfully resolved, indicating that with proper management, cochlear implants can be safely administered to patients with various causes of hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implantation at the Ear, Nose and Throat Clinic of the Clinical Center of Vojvodina]. Komazec, Z., Dankuc, D., Vlaski, L., et al.[2019]

A study of 3,417 cochlear implant recipients over 23 years revealed that the cumulative survival rates (CSRs) for cochlear implants vary significantly between different models and brands, particularly at the 6-year mark.

Common causes of device failure include impact, electronic dysfunction, and leakage, but explant-reimplant procedures are considered safe and effective for addressing these failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. Battmer, RD., Linz, B., Lenarz, T.[2022]

Cochlear implantation (CI) in infants under 12 months old has a comparable safety profile to that of older children, with a 30-day postoperative surgical complication rate of 3.6% for infants compared to 3.2% for those aged 12 to 18 months.

Long-term follow-up (mean of 3.7 years) showed a 13.5% incidence of surgical complications in infants under 12 months, which is similar to the 12.7% rate in older children, indicating that CI is a safe procedure for very young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of cochlear implantation before 12 months of age: Medical University of South Carolina and Pediatric American College of Surgeons-National Surgical Quality improvement program outcomes. O'Connell, BP., Holcomb, MA., Morrison, D., et al.[2016]

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Cochlear implantation outcomes in adults: A scoping review

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tandfonline.com/doi/full/10.1080/14670100.2025.2516932

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A meta-analysis confirmed statistically significant benefits in speech perception (in quiet, 12.6 percentage point [95% confidence interval: 7.1 ...

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pmc.ncbi.nlm.nih.gov

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Results revealed 60 adverse events in 41 children and 227 ears implanted (26%) of which 14 major events occurred in 11 children; all were ...

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accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED)

A Cochlear Nucleus Cochlear Implant (CI) is not suitable for individuals with the following conditions: • Absence of cochlea development. • ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11932275/

Long-Term Outcomes Following Cochlear Implantation

In the survival analysis, the overall device survival rates were more than 96% in 10 years and 91% in 20 years. These data imply that CIs remain ...

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sciencedirect.com/science/article/pii/S1672293016300022

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Outcomes studies regarding CI in older adults have shown excellent improvements to speech perception, quality of life, and even cognition. Overall, currently ...

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Research suggests that cochlear implants can be safe and effective for both younger and older adults [21,22,23,24,25].