Cochlear Implant for Unilateral Hearing Loss

Recruiting at 5 trial locations

Overseen By Laura Holden, AuD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Medical condition contraindicating surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a cochlear implant (a device that provides a sense of sound) compared to a standard hearing aid in children with asymmetric hearing loss or single-sided deafness. Researchers aim to determine if the implant improves hearing more than the hearing aid and assess the effectiveness of combining the implant with a hearing aid in the other ear. Eligible children have experienced noticeable hearing loss in one ear for at least six months and currently use a hearing aid. The goal is to determine if the cochlear implant can enhance hearing and improve life for these children. As an unphased trial, this study offers a unique opportunity for children to potentially experience improved hearing and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the study coordinators for guidance.

What prior data suggests that cochlear implants are safe for children with unilateral hearing loss?

Research has shown that cochlear implants have been thoroughly studied for treating single-sided deafness (SSD) and asymmetric hearing loss (AHL). These implants are generally considered safe. Studies in adults have demonstrated improvements in hearing, including better speech understanding and sound localization.

As with any medical procedure, some risks exist. The FDA lists possible side effects of cochlear implants, such as dizziness, infections, or device failure, though these issues are uncommon.

Overall, cochlear implants have a strong safety record. The FDA has already approved them for other types of hearing loss, indicating they are well-tolerated by most people. This information can reassure those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The cochlear implant for unilateral hearing loss is unique because it directly addresses the hearing deficit in one ear, which is not typically targeted by standard treatments like hearing aids or sound therapy. Most treatments for single-sided deafness focus on amplifying sound or rerouting it to the better ear, but the cochlear implant stimulates the auditory nerve directly, offering a more natural hearing experience. Researchers are excited about this treatment because it has the potential to significantly improve sound localization and speech understanding in noisy environments, which are major challenges for those with unilateral hearing loss.

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

Research shows that cochlear implants can greatly improve hearing for individuals with hearing loss in one ear (single-sided deafness) or uneven hearing in both ears (asymmetric hearing loss). Studies have found that children using cochlear implants for two years hear better than when relying solely on their stronger ear. Adults with hearing loss in one ear also understand speech better and locate sounds more accurately after receiving a cochlear implant. These improvements enhance overall quality of life by reducing issues like tinnitus and making it easier to understand speech in noisy environments. Success in both adults and children highlights the potential benefits of cochlear implants for those with single-sided or uneven hearing loss. ^{1 6 7 8 9}

Who Is on the Research Team?

Jill B Firszt, PhD

Principal Investigator

Washington University School of Medicine in St Louis

Are You a Good Fit for This Trial?

This trial is for children aged 4 to nearly 15 with asymmetric hearing loss (AHL) or single-sided deafness (SSD). They must have a certain level of hearing loss in one ear and be currently using a hearing aid. The better ear must meet specific hearing criteria, depending on whether it's AHL or SSD. Participants need stable hearing, fluency in English, and parents willing to comply with study requirements.

Inclusion Criteria

Before getting a cochlear implant and continuing the study, the ear being implanted must have normal cochlear nerve and anatomy, allowing the electrode to be fully inserted. Also, your hearing in the better ear must be stable during the hearing aid phase.

My hearing in my better ear is good and stable for the last 6 months.

I am between 4 and 14 years old and can follow the study's procedures.

Exclusion Criteria

My ear structure allows for full cochlear implant electrode insertion.

Your ear's cochlear nerve is not normal.

I have hearing loss that is not due to ear damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hearing Aid Phase

Participants use a hearing aid for a minimum of 4 months prior to obtaining a cochlear implant

4 months

5 visits (in-person)

Cochlear Implant Phase

Participants receive a cochlear implant and are monitored for performance and safety over a 15-month period

15 months

5 visits (3, 6, 9, 12, and 15 months post-implant)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant

Trial Overview The study tests how well children with AHL or SSD hear before and after getting a cochlear implant compared to their current performance with a hearing aid. It also looks at the benefits of having both a cochlear implant in one ear and either normal hearing or using a hearing aid in the other.

How Is the Trial Designed?

Group I: AHL/SSD Experimental Treatment 1 Intervention

Children with asymmetric hearing loss or single-sided deafness

Cochlear Implant is already approved in United States, European Union for the following indications:

Approved in United States as Cochlear Implant for:

• Single-sided deafness (SSD) in children aged 5 years and older
• Severe to profound sensorineural hearing loss in both ears

Approved in European Union as Cochlear Implant for:

• Severe to profound sensorineural hearing loss in both ears
• Single-sided deafness (SSD) in children and adults

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Hearts for Hearing

Collaborator

Trials

4

Recruited

160+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Hearts for Hearing

Collaborator

Trials

6

Recruited

200+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

St. Louis Children's Hospital

Collaborator

Trials

30

Recruited

83,200+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

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 can significantly improve sound localization and speech understanding in patients with unilateral deafness, even when their better ear has some hearing loss, as demonstrated in a study of three patients.

The findings suggest that the use of cochlear implants is expanding to include more diverse cases of hearing impairment, indicating their potential effectiveness for patients with unique hearing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear Implants in Patients with Fluctuant or Progressive Hearing Loss on the Better Ear. Mangabeira-Albernaz, PL., Malerbi, AFDS.[2021]

Cochlear implants (CIs) are effective for severe hearing loss, but complications like implant exposure can occur; this study reviewed three cases requiring surgical intervention for exposed CIs.

Using local scalp flaps for reconstruction after CI exposure proved to be a reliable method, resulting in successful recovery and functional implants for all patients over a 1-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvaging Exposed Cochlear Implants. Arab, K., Altamimi, L., Al-Otaibi, H., et al.[2022]

Cochlear implants (CI) significantly improved cortical auditory evoked potentials (CAEP) and auditory performance in adults with unilateral hearing loss, showing the greatest impact compared to other rehabilitation systems like CROS and BAHA.

The study found that CI enhanced speech understanding in challenging listening conditions, indicating its effectiveness in improving auditory processing and performance for individuals with unilateral hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical auditory responses according to hearing rehabilitation in unilateral hearing loss. Legris, E., Roux, S., Aoustin, JM., et al.[2020]

Unilateral cochlear implantation is more cost-effective in improving quality of life for adults with profound hearing loss compared to bilateral implantation, with cost-utility ratios indicating greater benefits for unilateral procedures.

The study involved 70 normal-hearing volunteers and 202 patients, showing that while bilateral implantation offers some additional quality of life benefits, the cost per quality-adjusted life-year gained is significantly higher than for unilateral implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost-utility scenario analysis of bilateral cochlear implantation. Summerfield, AQ., Marshall, DH., Barton, GR., et al.[2022]

Cochlear implants can significantly improve speech understanding in noisy environments for individuals with unilateral hearing loss, as demonstrated in a case report involving four men aged 48 to 57.

This case report suggests that unilateral cochlear implantation may be a viable treatment option for patients with unilateral hearing loss, expanding the criteria for cochlear implant candidates and encouraging further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary speech recognition results after cochlear implantation in patients with unilateral hearing loss: a case series. Stelzig, Y., Jacob, R., Mueller, J.[2021]

Cochlear implantation (CI) can significantly enhance binaural hearing for patients with severe-to-profound unilateral sensorineural hearing loss, improving sound localization and speech recognition in noisy environments.

CI may also provide some relief from tinnitus, but further research is needed to understand its long-term effects and to refine patient selection criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress on cochlear implantation in patients with unilateral deafness]. Shi, Y., Li, YX.[2018]

Cochlear implantation (CI) significantly improves speech comprehension in background noise and localization ability in patients with single-sided deafness compared to conventional hearing aids and untreated patients, based on data from 11 patients after 12 months.

Subjective assessments also indicate that patients experience a clear benefit from CI, highlighting the importance of careful patient selection for successful treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Unilateral deafness and cochlear implantation: audiological diagnostic evaluation and outcomes]. Arndt, S., Laszig, R., Aschendorff, A., et al.[2021]

Single-sided deafness significantly impacts auditory performance, affecting speech understanding in noisy environments and sound localization, which can lead to a reduced quality of life for patients.

Treatment options include CROS hearing aids for pseudostereophonic hearing and cochlear implants for restoring binaural hearing, with a focus on the cochlear implant as a promising solution for improving auditory function in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of single-sided deafness by cochlear implantation]. De Maesschalck, T., Daskalou, D., Stieger, C., et al.[2021]

In a study of 45 children with severe or profound hearing loss, those who had used a unilateral cochlear implant (CI) for 24 months or more showed longer latencies in their electrically evoked auditory brainstem responses (eABR) compared to those with shorter CI use or no CI, indicating potential negative effects on the contralateral auditory pathway.

The study suggests that long-term unilateral CI use may lead to degeneration in the contralateral auditory pathway, highlighting the importance of monitoring auditory function in children with hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of unilateral cochlear implant use on contralateral electrically evoked auditory brainstem responses to round window membrane electrical stimulation. Zhang, JG., Chen, L., Li, P., et al.[2022]

Children with bilateral cochlear implants showed significantly better listening skills, with an 18.5% improvement in sound localization accuracy and a 3.7 dB enhancement in speech perception in noise compared to those with unilateral implants, based on a study of 50 deaf children.

Despite the improved listening skills, there were no significant differences in health-related quality of life or overall quality of life ratings between children with bilateral and unilateral implants, indicating that while bilateral implants enhance auditory performance, they may not impact perceived quality of life as much.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral or unilateral cochlear implantation for deaf children: an observational study. Lovett, RE., Kitterick, PT., Hewitt, CE., et al.[2022]

In a study of 113 patients with Advanced Bionics Ultra cochlear implants, 17.7% experienced device failure, primarily in children, highlighting the need for ongoing monitoring of at-risk devices.

After revision surgeries, patients generally maintained stable auditory performance, indicating that revision procedures are effective and safe, with most patients opting to stay with the same manufacturer for their new devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. Winchester, A., Kay-Rivest, E., Friedmann, DR., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39159037/

Cochlear Implantation in Single-Sided Deafness and ... The objective of this multicenter study is to evaluate the effect of a cochlear implant (CI) in adults with single-sided deafness (SSD) or asymmetric hearing ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36879386/

Two-Year Outcomes of Cochlear Implant Use for Children ... This study investigated performance over 24 months of CI use in young children with SSD as compared to the better hearing ear alone and to children with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02204618

Cochlear Implantation in Single Sided Deafness and ... The efficacy of cochlear implantation has thus been validated in the treatment of single sided deafness and asymmetrical hearing loss. The investigators assume ...

4. blog.medel.pro blog.medel.pro/audiology/cochlear-implantation-outcomes-in-adults-with-unilateral-deafness-speech-perception-tinnitus-sound-localization-and-quality-of-life/

Cochlear Implantation Outcomes in Adults With Unilateral ... Adults with unilateral deafness often see improvements in speech recognition, sound localization, tinnitus, and quality of life after CI.

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1247269/full

Cochlear implantation in unilateral hearing loss: impact of ... This prospective study explores how measured auditory performance relates to real-world experience and device use in a cohort of SSD-CI subjects.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10440208/

Asymmetric Hearing Loss in Adult Cochlear Implant ... A multi-site clinical trial was conducted to obtain cochlear implant (CI) efficacy data in adults with asymmetric hearing loss (AHL)

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P000025S104B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) Below is a list of potential adverse effects (e.g., complications) associated with the implantation and use of the MED-EL Cochlear Implant ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02203305

Cochlear Implantation in Cases of Single-Sided Deafness The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11733687/

Cochlear implantation in adults with acquired single-sided ... Cochlear implantation in adults with acquired single-sided deafness improves cortical processing and comprehension of speech presented to the non-implanted ...