Cochlear Implant for Single-Sided Deafness

Overseen By Study Coordinator

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Conductive hearing loss, Cochlear nerve deficiency, 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: 1

Duration: Surgery and initial programming

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cochlear implants, a type of auditory prosthesis, are a safe and effective treatment for infants and toddlers with single-sided deafness. Researchers will monitor the auditory development of children who receive the implant until they turn five. The study will compare these children to those with normal hearing and those with single-sided deafness who do not receive implants. Children with single-sided deafness, who have not benefited from traditional hearing aids and have hearing loss in one ear, could be suitable candidates for this trial.

As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance treatment options for young children with single-sided deafness.

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 prior data suggests that cochlear implants are safe for infants and toddlers with single-sided deafness?

Research shows that cochlear implants are generally safe and well-tolerated. Studies on adults with hearing loss in one ear have found that these implants can improve hearing without causing serious side effects. While most research focuses on adults, some studies on children with hearing loss in one ear show mixed results regarding their benefit from the implants. However, these studies have reported no major severe problems linked to the implants.

It's important to know that receiving a cochlear implant involves surgery, which carries the usual risks. Overall, cochlear implants have been used for many years to help people hear better, suggesting their safety. If the implant is approved for other conditions, it usually means it has passed safety tests for those uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of cochlear implants for single-sided deafness because this approach could transform how we address the condition. Unlike traditional treatments like hearing aids or bone-anchored hearing systems, which amplify sound or transmit it through bone conduction, cochlear implants directly stimulate the auditory nerve. This direct stimulation may offer clearer sound perception and improved spatial hearing, potentially leading to better speech understanding in noisy environments. This innovative approach could provide a significant quality-of-life improvement for individuals with single-sided deafness.

What evidence suggests that cochlear implants are effective for single-sided deafness in infants and toddlers?

Research shows that cochlear implants can help treat hearing loss in one ear. Studies have found that adults with hearing loss in one ear often hear speech better and can locate sounds more accurately after receiving an implant. In children, early cochlear implantation has been linked to improved hearing and language skills. Although most research focuses on older patients, these findings suggest potential benefits for infants and toddlers as well. This trial will evaluate the effectiveness of cochlear implants in children with single-sided deafness. Overall, cochlear implants are considered a promising option for hearing loss in one ear. ^{2 3 5 6 7}

Who Is on the Research Team?

Lisa Park, AuD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant

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.

How Is the Trial Designed?

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.

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?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Med-El Corporation

Industry Sponsor

Trials

27

Recruited

2,100+

Published Research Related to This Trial

Cochlear implants for patients with single-sided deafness (SSD) have shown positive outcomes, including reducing tinnitus and improving speech perception in noisy environments.

A notable benefit observed is the restoration of functional hearing in the previously deaf ear, which may enable surgical options for the only-hearing ear, as demonstrated in a case study of a 50-year-old man.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implantation leading to successful stapedectomy in the contralateral only-hearing ear. Mikals, SJ., Schuchman, GI., Bernstein, JG., et al.[2016]

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]

In a study of 10 adult cochlear implant (CI) users, combining a contralateral hearing aid (HA) with the CI significantly improved speech discrimination in both quiet and noisy environments compared to using the CI alone.

The results suggest that individuals with residual hearing in the non-implanted ear should use a HA, as it enhances auditory perception, especially when the benefit from the HA decreases due to progressive hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of contralateral hearing aid in adult cochlear implant bearers. Bouccara, D., Blanchet, E., Waterlot, PE., et al.[2017]

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]

Cochlear implantation in a patient with single-sided deafness led to significant improvements in sound localization accuracy and reduced tinnitus handicap over an 18-month period, indicating enhanced auditory processing and quality of life.

The study highlighted the effectiveness of using spatial release from masking (SRM) as a measure for assessing speech intelligibility and binaural hearing, suggesting it could be a valuable method for evaluating larger groups of individuals with similar hearing conditions.

NCBI (Pubmed)

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. Gartrell, BC., Jones, HG., Kan, A., 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]

Cochlear implants are now recommended for adults with single-sided deafness (SSD), where one ear has profound hearing loss and the other ear has normal hearing, expanding treatment options for this condition.

A systematic review of studies showed that cochlear implants can improve speech recognition in quiet and noisy environments, enhance sound localization, reduce tinnitus perception, and improve overall quality of life for adults with SSD.

NCBI (Pubmed)

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. Dillon, MT., Kocharyan, A., Daher, GS., et al.[2023]

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]

Cochlear implantation significantly improved monosyllabic word recognition from 11.3% preoperatively to 48.7% at 3 months postactivation in patients with single-sided deafness, indicating effective enhancement of hearing ability.

Most patients with tinnitus reported improvement after cochlear implantation, suggesting that the procedure may also alleviate tinnitus symptoms in individuals with single-sided deafness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implantation for single-sided deafness: A multicenter study. Sladen, DP., Frisch, CD., Carlson, ML., et al.[2018]

In a study of 81 adults with single-sided deafness (SSD), cochlear implants significantly improved speech understanding in noisy environments and localization abilities, enhancing overall functional outcomes.

Patients reported a notable improvement in quality of life and a reduction in tinnitus symptoms as early as 3 months after receiving the cochlear implant, highlighting its effectiveness in addressing both emotional and social challenges associated with SSD.

NCBI (Pubmed)

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. Távora-Vieira, D., Wedekind, A.[2023]

Cochlear implants (CIs) significantly benefit single-sided deaf individuals by reducing tinnitus and improving subjective listening experiences, as shown by positive ratings from 48 users on the Bern Benefit in Single-Sided Deafness Questionnaire.

While single-sided deaf CI users can achieve good speech understanding, their performance is generally lower compared to bilaterally implanted CI users, suggesting that while CIs are effective, those with normal hearing in the other ear may still have an advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech intelligibility and subjective benefit in single-sided deaf adults after cochlear implantation. Finke, M., Strauß-Schier, A., Kludt, E., et al.[2022]

Cochlear implants significantly enhance directional hearing and speech perception in noise for patients with single-sided deafness, with measurable improvements in correct source identification and signal-to-noise ratio.

The study involved 20 patients with varying degrees of hearing loss and at least 6 months of cochlear implant experience, demonstrating that cochlear implants can greatly improve audiological performance in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implantation in recipients with single-sided deafness: Audiological performance. Hoth, S., Rösli-Khabas, M., Herisanu, I., 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]

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Single-sided deafness (SSD) impacts over 345,000 adults in the United States, with an estimated 5.2% experiencing some degree of unilateral hearing loss.