Cochlear Implant for Single-Sided Deafness

(PAS-SSD Trial)

Recruiting at 5 trial locations

Overseen By PRS Specialist

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Cochlear anomalies, Previous implantation, Pregnancy, 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: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Cochlear™ Nucleus® Cochlear Implant (CI) System to evaluate its effectiveness and safety for individuals with hearing loss in one ear. The goal is to assist those with severe hearing loss on one side and normal hearing on the other, as this condition can complicate everyday listening and communication. Ideal participants are individuals at least five years old who have not benefited from other hearing devices. As an unphased trial, this study allows participants to contribute to innovative research that could enhance hearing solutions for many.

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 prior data suggests that the Cochlear™ Nucleus® Cochlear Implant (CI) System is safe for individuals with single-sided deafness?

Research shows that the Cochlear™ Nucleus® Cochlear Implant System is generally safe for both adults and children. Studies have found that this implant helps individuals with hearing loss in one ear to hear better. The FDA has approved the device for certain types of hearing loss, indicating it is usually well-tolerated.

While some users have reported issues, these are uncommon. Concerns may include minor surgical complications, typical of any medical procedure. The Cochlear Nucleus Implant has been successfully used in many patients, providing a reliable way to improve hearing in those with hearing loss in one ear. It is important to consult a doctor to determine if this is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cochlear™ Nucleus® Cochlear Implant (CI) System is unique because it offers a new approach for individuals with single-sided deafness, a condition where traditional hearing aids or sound therapy might not be as effective. Unlike conventional treatments that amplify sound, the cochlear implant directly stimulates the auditory nerve, potentially providing a clearer and more natural hearing experience. Researchers are excited about this treatment because it opens up the possibility of restoring directional hearing and improving sound localization, which can significantly enhance the quality of life for those affected by unilateral hearing loss.

What evidence suggests that the Cochlear™ Nucleus® Cochlear Implant (CI) System is effective for single-sided deafness?

Research shows that cochlear implants can help people with hearing loss in one ear. In this trial, participants will receive the Cochlear™ Nucleus® Cochlear Implant. Clinical studies found that 82% of patients with this implant experienced a noticeable improvement in hearing. This implant enhances speech understanding and allows users to hear sounds from all directions. It sends sound signals directly to the brain, bypassing the damaged parts of the ear. Approved for use in individuals aged 5 and older, this system confirms its effectiveness and safety for this age group. ^{1 2 3 4 5}

Who Is on the Research Team?

Jillian Crosson

Principal Investigator

Cochlear

Are You a Good Fit for This Trial?

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

My child is between 5 years and 17 years, 11 months old.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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

The Cochlear™ Nucleus® Cochlear Implant (CI) System is already approved in United States, European Union for the following indications:

Approved in United States as Cochlear Nucleus CI624 for:

• Bilateral sensorineural hearing loss
• Single-sided deafness
• Unilateral hearing loss

Approved in European Union as Cochlear Nucleus 24 for:

• Severe to profound sensorineural hearing loss
• Bilateral sensorineural hearing loss
• Single-sided deafness

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+

Published Research Related to This Trial

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]

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]

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]

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]

Cochlear implantation (CI) significantly improved tinnitus symptoms in 92% of the 26 adults with single-sided deafness and incapacitating tinnitus after one year of standard stimulation, with many reporting over 40% improvement.

The initial month of white noise stimulation before standard CI use led to a notable reduction in tinnitus handicap scores, indicating that CI can effectively reduce the impact of tinnitus and improve hearing abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Multicentric Follow-up Study of Cochlear Implantation in Adults With Single-Sided Deafness: Tinnitus and Audiological Outcomes. Poncet-Wallet, C., Mamelle, E., Godey, B., 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]

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]

The Nucleus 24 Contour cochlear implant, tested in 256 children, shows significant improvement in speech perception post-implantation compared to preoperative levels with hearing aids.

The device is effective for children as young as 12 months with severe to profound hearing loss, and those with some pre-surgery speech perception performed even better after receiving the implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric outcomes with the nucleus 24 contour: North American clinical trial. Staller, S., Parkinson, A., Arcaroli, J., et al.[2019]

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]

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]

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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P970051S205C.pdf

Cochlear™ Nucleus® CI624 cochlear implant Clinical studies were performed to test whether the Cochlear Nucleus cochlear implant system was safe and effective for use. Participants who were part of the ...

2. cochlear.com cochlear.com/us/en/professionals/products-and-candidacy/nucleus/implant/nucleus-profile-plus

Cochlear Nucleus Profile Plus series implant At only 3.9mm, Profile Plus provides a thin design along with a flexible coil to fit the natural shape of the head resulting in a better cosmetic outcome.3 ...

3. fda.gov fda.gov/medical-devices/recently-approved-devices/nucleus-24-cochlear-implant-system-p970051s205

Nucleus 24 Cochlear Implant System – P970051/S205 The Nucleus 24 Cochlear Implant System provides access to sound for people ages 5 plus with single-sided deafness/unilateral hearing loss.

4. assets.cochlear.com assets.cochlear.com/api/public/content/FUN3844-Slim-20-CI624-Spec-Sheet.pdf

Cochlear™ Nucleus® Profile™ Plus with Slim 20 ... Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about ...

5. aetna.com aetna.com/cpb/medical/data/1_99/0013.html

Cochlear Implants and Auditory Brainstem Implants Hearing aids and standard cochlear implants are not effective in these patients. In clinical studies submitted to the FDA, 82 % of the 90 patients implanted ...