Evaluating cochlear implants for unilateral hearing loss in children and adults
A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
This study is testing if cochlear implants can help children and adults with hearing loss in one ear hear better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 8 sites (Palo Alto, California and 7 other locations) |
| Trial ID | NCT05318417 on ClinicalTrials.gov |
What this trial studies
This investigation aims to assess the safety and effectiveness of cochlear implantation in individuals aged 5 years and older who suffer from unilateral hearing loss or single-sided deafness. Participants will receive the Cochlear™ Nucleus® Cochlear Implant System, and the study will evaluate its efficacy in improving hearing outcomes. The study includes both children and adults, ensuring a comprehensive understanding of the device's impact across different age groups. The goal is to support a change in the indication for use based on the findings.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 5 years and older with severe sensorineural hearing loss in one ear and normal hearing in the other.
Not a fit: Patients with ossification or abnormalities that prevent cochlear implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve hearing capabilities and quality of life for patients with unilateral hearing loss.
How similar studies have performed: Previous studies have shown promising results with cochlear implants for similar conditions, indicating a potential for success in this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Individuals 18 years or older (Group A) Ear to be Implanted: Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL • Children 5 years to 17 years, 11 months (Group B) Ear to be Implanted: Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL; Aided CNC score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL * Previous experience with a current conventional treatment option for unilateral \[SSD\] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required * English spoken as a primary language * Willing and able to provide written informed consent Exclusion Criteria: * Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array * Previous cochlear implantation * Hearing loss of neural or central origin, including auditory neuropathy * Duration of profound sensorineural HL \>10 years per self-report * Active / chronic middle-ear infection; conductive HL in either ear * Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator * Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator * Evidence of and/or suspected cognitive or developmental concern * 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 * Pregnant or breastfeeding women * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Where this trial is running
Palo Alto, California and 7 other locations
- Stanford University — Palo Alto, California, United States (Recruiting)
- Rocky Mountain Ear Center — Englewood, Colorado, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- New York Eye and Ear Infirmary — New York, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Withdrawn)
- University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery — Dallas, Texas, United States (Withdrawn)
- Virginia Mason Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: PRS Specialist
- Email: cltd-prs-admin@cochlear.com
- Phone: +612294286555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.