Cochlear Implant for Single-Sided Deafness

Recruiting in Palo Alto (17 mi)

Overseen by Lisa Park, AuD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Conductive hearing loss, Cochlear nerve deficiency, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your child's doctor.

What data supports the effectiveness of the treatment Cochlear Implant for Single-Sided Deafness?

Research shows that cochlear implants can improve speech understanding in noisy environments and help with sound localization for people with single-sided deafness. Many users report satisfaction and perceive benefits in various listening situations, indicating that cochlear implants can be a beneficial treatment option for this condition. ^{1 2 3 4 5}

Is the cochlear implant generally safe for humans?

Research shows that cochlear implants, including the HiRes Ultra series, have been used in humans, but there have been instances of device failure leading to recalls. However, surgical and auditory outcomes after revision have been reported, indicating ongoing monitoring and management of safety issues. ^{6 7 8 9 10}

How is the cochlear implant treatment unique for single-sided deafness?

Cochlear implants for single-sided deafness are unique because they restore hearing in the deaf ear, improving sound localization and speech understanding in noisy environments, and can also help reduce tinnitus (ringing in the ears). Unlike other treatments like CROS hearing aids, which only route sound from the deaf ear to the hearing ear, cochlear implants provide true binaural (two-eared) hearing. ^{1 3 11 12 13}

Research Team

Lisa Park, AuD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for infants and toddlers aged 7 months to under 3 years with severe-to-profound hearing loss in one ear, which isn't getting better with hearing aids. They should be generally healthy, have normal development and cognition, and their families must speak English at home. Kids can't join if they have certain inner ear abnormalities, lack of cochlear nerve, or conditions that make surgery risky.

Inclusion Criteria

Your cochlear nerve looks normal in the images taken by the doctor.

You have severe hearing loss in one ear that started before you turned 2 years old.

Parents have practical expectations.

Exclusion Criteria

I have a problem with the nerve that connects my ear to my brain.

I have a history of severe ear infections or a condition that makes anesthesia risky.

My inner ear has hardening that prevents implant surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cochlear implantation and receive programming of the device

Surgery and initial programming

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness, including auditory development and device-related adverse events

5 years

Regular visits for auditory testing and device monitoring

Testing and Evaluation

Participants undergo various auditory and cognitive tests, including localization, hearing in noise, and word recognition testing

Ongoing during follow-up

Treatment Details

Interventions

• Cochlear Implant (Prosthesis)

Trial Overview The study tests the safety and effectiveness of cochlear implants in young children with single-sided deafness. It involves implanting a device into the child's ear and monitoring their hearing abilities up until age five compared to kids without implants or those with normal hearing.

Participant Groups

Group I: Study Group Experimental Treatment 1 Intervention

This group of children with single-sided deafness will receive a cochlear implant.

Group II: Typical Hearing Control Group (THCG) Active Control 1 Intervention

This group of five-year-old children will have typical hearing in both ears.

Group III: Single-Sided Deafness Control Group (SSDCG) Active Control 1 Intervention

This group of five-year-old children will have single-sided deafness and no cochlear implant.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Children's Cochlear Implant Center at UNC Durham, NC

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1588

Patients Recruited

4,364,000+

Med-El Corporation

Industry Sponsor

Trials

27

Patients Recruited

2,100+

Findings from Research

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]

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]

References

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

Cochlear implantation in recipients with single-sided deafness: Audiological performance. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

Cochlear implantation leading to successful stapedectomy in the contralateral only-hearing ear. [2016]

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

Single-Sided Deafness: Emotional and Social Handicap, Impact on Health Status and Quality of Life, Functional Hearing, and the Effects of Cochlear Implantation. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Speech intelligibility and subjective benefit in single-sided deaf adults after cochlear implantation. [2022]

6. 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]

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

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

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

Cochlear implantation for single-sided deafness: A multicenter study. [2018]

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

Investigating long-term effects of cochlear implantation in single-sided deafness: a best practice model for longitudinal assessment of spatial hearing abilities and tinnitus handicap. [2021]

10. France pubmed.ncbi.nlm.nih.gov

Benefit of contralateral hearing aid in adult cochlear implant bearers. [2017]

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

American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Adult Cochlear Implantation for Single-Sided Deafness. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

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