Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Recruiting now · Not applicable
Conditions studied: Hearing Loss, Unilateral, Deafness, Unilateral
In brief
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.
Key facts
- Study ID
- NCT05318417
- Run by
- Cochlear
- People needed
- 60
- Starts
- 2022-08-19
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-09-02
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Virginia Mason Medical Center — Seattle, Washington, United States (enrolling)
- Rocky Mountain Ear Center — Englewood, Colorado, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- New York Eye and Ear Infirmary — New York, New York, United States (enrolling)
- University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery — Dallas, Texas, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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