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

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.

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

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.

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]