About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- The Cochlear™ Nucleus® Cochlear Implant (CI) System
Treatment groups
Sponsors and collaborators
Cochlear
Lead sponsor
NAMSA
Collaborator