60 Participants Needed

Cochlear Implant for Single-Sided Deafness

(PAS-SSD Trial)

Recruiting at 5 trial locations
KH
JC
LL
Overseen ByLaura Lambrecht
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Cochlear
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.46789

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.1241011

Research Team

JC

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.
See 7 more

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
See 10 more

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
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Children and adults with unilateral hearing loss/single-sided deafnessExperimental Treatment1 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

Find a Clinic Near You

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 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.
Cochlear implantation in recipients with single-sided deafness: Audiological performance.Hoth, S., Rösli-Khabas, M., Herisanu, I., et al.[2022]
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.
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.
Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Ménière's disease.Hansen, MR., Gantz, BJ., Dunn, C.[2022]

References

Cochlear implantation in recipients with single-sided deafness: Audiological performance. [2022]
Cochlear implantation in single-sided deafness: a single-center experience of 138 cases. [2023]
Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Ménière's disease. [2022]
Pediatric outcomes with the nucleus 24 contour: North American clinical trial. [2019]
(Even Off-Label) Cochlear Implantation in Single-Sided Deafness and Asymmetric Hearing Loss Results in Measurable Objective and Subjective Benefit. [2022]
Nucleus N5 CI500 series implant recall: hard failure rate at a major Cochlear implantation center. [2013]
Outcomes for a clinically representative cohort of hearing-impaired adults using the Nucleus® CI532 cochlear implant. [2021]
Medical and surgical complications in pediatric cochlear implantation. [2022]
The Nucleus 22-channel cochlear implant system. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Cochlear Implantation in Children with Single-Sided Deafness. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Prospective Multicentric Follow-up Study of Cochlear Implantation in Adults With Single-Sided Deafness: Tinnitus and Audiological Outcomes. [2023]