Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Recruiting
N/A
Interventional Study
Hearing Loss, Unilateral
Deafness, Unilateral
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 5 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Cochlear · Industry
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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.
Trial Locations
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Eligibility 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 d…
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