Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorCochlear

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

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Cochlear

Lead sponsor

NAMSA

Collaborator