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

Study acronym: PAS-SSD
StatusActive, Not Recruiting
PhaseNot applicable
SponsorCochlear
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Study sites: 8 to 6
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. 3 versions Re-verified since Apr 2, 2024, no change to tracked fieldsv11-v13
  3. Site details revised at 1 of 8 sitesv10
  4. Site details revised at 1 of 8 sitesv9
  5. Site contacts updated at 1 of 8 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 2 of 8 sitesv7
  2. Site details revised at 1 of 8 sitesv6
  3. Site details revised at 2 of 8 sitesv5
  4. Primary completion date: Aug 2027 to May 2027
    • Study completion date: Aug 2027 to Jun 2027
    • Start date changed from estimate of Aug 2022 to Aug 19, 2022
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 7 to 8
    v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cochlear
28 trials monitored
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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 Details
NCT Number NCT05318417
Lead Sponsor Cochlear
Collaborators: NAMSA
Conditions
(from sponsor)		 Hearing Loss, Unilateral, Deafness, Unilateral
Related terms Hearing Loss, Unilateral
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov