Cochlear Implant for Single-Sided Deafness

(PAS-SSD Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cochlear

Disqualifiers: Cochlear anomalies, Previous implantation, Pregnancy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

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

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinator for more details.

What data supports the effectiveness of the treatment Cochlear™ Nucleus® Cochlear Implant (CI) System for single-sided deafness?

Research shows that cochlear implants can improve hearing in people with single-sided deafness, with studies reporting better hearing performance after the implant compared to before. Additionally, children using a similar implant system showed significant improvements in speech perception, indicating the potential effectiveness of the treatment. ^{1 2 3 4 5}

Is the Cochlear Implant generally safe for humans?

Cochlear implants, including various models like the Nucleus 22-channel and Nucleus 24 Contour, have been used safely in thousands of patients worldwide, including both adults and children. While there have been recalls and reports of device failures, these implants are generally considered safe, with ongoing improvements in their design and performance. ^{4 6 7 8 9}

How is the Cochlear Nucleus Cochlear Implant System treatment different from other treatments for single-sided deafness?

The Cochlear Nucleus Cochlear Implant System is unique because it directly stimulates the auditory nerve, providing a sense of sound to individuals with single-sided deafness, unlike traditional hearing aids that amplify sound. This system is specifically designed to improve hearing in one ear, which can help with sound localization and understanding speech in noisy environments. ^{1 2 4 10 11}

Research Team

Jillian Crosson

Principal Investigator

Cochlear

Eligibility Criteria

This trial is for children (5-17 years) and adults (18+ years) with severe unilateral hearing loss or single-sided deafness. Participants must have tried conventional treatments like hearing aids, bone-conduction devices, or CROS technology for at least two weeks. They should not have cochlear anomalies that prevent electrode insertion, previous cochlear implants, neural origin hearing loss, long-term (>10 years) profound sensorineural HL, middle-ear infections or be pregnant/breastfeeding.

Inclusion Criteria

I have tried or am willing to try hearing aids or devices for single-sided deafness for at least two weeks.

English spoken as a primary language

I am 18 years old or older.

Exclusion Criteria

Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator

Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling

Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implantation

Participants undergo pre-implantation assessments and preparations

4 weeks

Cochlear Implantation

Participants receive cochlear implants

1 week

Post-activation

Participants are monitored for changes in hearing abilities post-activation

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• The Cochlear™ Nucleus® Cochlear Implant (CI) System (Cochlear Implant)

Trial Overview The study evaluates the Cochlear™ Nucleus® Cochlear Implant System's safety and effectiveness in individuals aged 5 and above with Unilateral Hearing Loss/Single-Sided Deafness. It aims to support a change indication for use of this system by assessing its continued efficacy.

Participant Groups

Group I: Children and adults with unilateral hearing loss/single-sided deafness Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Findings from Research

Cochlear implants (CIs) for patients with single-sided deafness (SSD) significantly improve quality of life, as evidenced by reduced scores on the Tinnitus Handicap Inventory and Dizziness Handicap Inventory after at least 6 months of follow-up.

In a study of 138 patients, CI not only alleviated tinnitus and dizziness but also enhanced social, physical, and emotional well-being, highlighting its efficacy as a treatment for SSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implantation in single-sided deafness: a single-center experience of 138 cases. Morelli, L., Fancello, V., Gaino, F., et al.[2023]

Cochlear implantation (CI) significantly improves auditory function in patients with unilateral severe-to-profound sensorineural hearing loss, as evidenced by enhanced CNC word and AzBio sentence scores post-surgery.

For patients with Ménière's disease experiencing vertigo, simultaneous labyrinthectomy and CI not only resolves vertigo attacks but also improves sound localization, demonstrating a dual benefit of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Ménière's disease. Hansen, MR., Gantz, BJ., Dunn, C.[2022]

Cochlear implants (CIs) significantly improve speech understanding and subjective hearing outcomes in adults with asymmetric hearing loss (AHL) and single-sided deafness (SSD), even when preoperative word recognition scores exceed the current FDA criteria of 5%.

Both AHL and SSD groups showed similar improvements in objective measures (like word and sentence recognition) and subjective measures (like hearing and tinnitus handicap questionnaires), indicating that candidacy for CIs should focus on the ear to be implanted rather than the overall hearing ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(Even Off-Label) Cochlear Implantation in Single-Sided Deafness and Asymmetric Hearing Loss Results in Measurable Objective and Subjective Benefit. Sydlowski, SA., Farrokhian, N., Carrozza, M., et al.[2022]

In a study of 411 patients, the Cochlear Nucleus Freedom CI24RE series implant showed a cumulative failure percentage of 0%, indicating high reliability, while the Nucleus N5 CI500 series had a significantly higher failure rate of 9.8%.

The failure rate for the Nucleus N5 implants manufactured after a voluntary recall was notably higher at 25.0%, suggesting that the recall may have impacted device performance, as this rate is nearly six times higher than the company's reported global failure rate of 4.2%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nucleus N5 CI500 series implant recall: hard failure rate at a major Cochlear implantation center. Hildrew, DM., Molony, TB.[2013]

In a study of 159 subjects implanted with the Cochlear™ Nucleus® CI532, there was a significant average gain of 44% in monosyllabic word recognition scores in quiet environments at 6 months post-surgery, indicating effective speech recognition improvement after implantation.

Younger patients showed better preoperative word recognition scores despite having poorer hearing thresholds, and they also achieved higher postoperative scores, suggesting age-related factors may influence outcomes in cochlear implant performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes for a clinically representative cohort of hearing-impaired adults using the Nucleus® CI532 cochlear implant. Hey, M., Neben, N., Stöver, T., et al.[2021]

In a study of 434 children who underwent cochlear implantation, 9.9% experienced complications, with delayed complications being more common (65.1%) and occurring on average 2.2 years after surgery.

Major complications, such as severe infections and meningitis, were significantly associated with trauma to the mastoid area and inner ear malformations, while the age at which children received the implant did not correlate with complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and surgical complications in pediatric cochlear implantation. Loundon, N., Blanchard, M., Roger, G., et al.[2022]

Cochlear implants, specifically the Nucleus Mini-22 system, are an effective treatment for profoundly deaf individuals, converting sounds into electrical signals that stimulate auditory nerves, allowing for hearing sensations.

The Nucleus cochlear implant has been implanted in over 3000 patients globally and is continually being improved for better performance and user experience, demonstrating its ongoing evolution and commitment to enhancing auditory rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nucleus 22-channel cochlear implant system. Patrick, JF., Clark, GM.[2019]

Cochlear implantation (CI) in children with single-sided deafness (SSD) shows significant improvement in speech perception, with mean word recognition scores increasing to 56% after at least one year of device use, indicating its efficacy as a treatment option.

Patients demonstrated better performance in understanding speech in background noise with the CI activated compared to when it was off, suggesting that CI can enhance auditory experiences in challenging listening environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear Implantation in Children with Single-Sided Deafness. Deep, NL., Gordon, SA., Shapiro, WH., 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

Cochlear implantation in single-sided deafness: a single-center experience of 138 cases. [2023]

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

Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Ménière's disease. [2022]

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

Pediatric outcomes with the nucleus 24 contour: North American clinical trial. [2019]

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

(Even Off-Label) Cochlear Implantation in Single-Sided Deafness and Asymmetric Hearing Loss Results in Measurable Objective and Subjective Benefit. [2022]

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

Nucleus N5 CI500 series implant recall: hard failure rate at a major Cochlear implantation center. [2013]

7. Germany pubmed.ncbi.nlm.nih.gov

Outcomes for a clinically representative cohort of hearing-impaired adults using the Nucleus® CI532 cochlear implant. [2021]

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

Medical and surgical complications in pediatric cochlear implantation. [2022]

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

The Nucleus 22-channel cochlear implant system. [2019]

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

Cochlear Implantation in Children with Single-Sided Deafness. [2021]

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

Prospective Multicentric Follow-up Study of Cochlear Implantation in Adults With Single-Sided Deafness: Tinnitus and Audiological Outcomes. [2023]