Cochlear Implant for Unilateral Hearing Loss

Recruiting at 4 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

Trial Summary

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 data supports the effectiveness of the treatment Cochlear Implant for Unilateral Hearing Loss?

Research shows that cochlear implants can improve speech understanding in noisy environments and help with sound localization for people with unilateral hearing loss. Patients have reported better hearing abilities and a significant improvement in their quality of life after receiving the implant. ^{1 2 3 4 5}

Is the cochlear implant generally safe for humans?

Cochlear implants are generally considered safe, but there are some risks. Common issues include implant exposure and device malfunction, and there have been rare reports of patient injury and death. It's important to discuss potential risks with your healthcare provider. ^{1 6 7 8 9}

How is the cochlear implant treatment unique for unilateral hearing loss?

Cochlear implants are unique for unilateral hearing loss because they can improve sound localization and speech understanding in noisy environments, which is not typically achieved with other treatments like hearing aids. This treatment directly stimulates the ear, providing better binaural (two-ear) hearing and potentially relieving tinnitus, offering benefits that other options may not provide. ^{1 2 10 11 12}

What is the purpose of this trial?

This is a two-phase study that compares performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a cochlear implant (CI) in children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study also evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

Research Team

Jill B Firszt, PhD

Principal Investigator

Washington University School of Medicine in St Louis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 (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]

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]

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]

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 (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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preliminary speech recognition results after cochlear implantation in patients with unilateral hearing loss: a case series. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Cochlear Implants in Patients with Fluctuant or Progressive Hearing Loss on the Better Ear. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Cortical auditory responses according to hearing rehabilitation in unilateral hearing loss. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Unilateral deafness and cochlear implantation: audiological diagnostic evaluation and outcomes]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Bilateral or unilateral cochlear implantation for deaf children: an observational study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Salvaging Exposed Cochlear Implants. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effect of unilateral cochlear implant use on contralateral electrically evoked auditory brainstem responses to round window membrane electrical stimulation. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Treatment of single-sided deafness by cochlear implantation]. [2021]

11. China pubmed.ncbi.nlm.nih.gov

[Research progress on cochlear implantation in patients with unilateral deafness]. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

A cost-utility scenario analysis of bilateral cochlear implantation. [2022]