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Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users

Study acronym: PACIFIC
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 2026 to Feb 2027
    • Start date: Sep 1, 2024 to Sep 1, 2025
    • Study completion date: Feb 2028 to Feb 2029
    v6
  2. Primary completion date: Feb 2025 to Feb 2026
    • Start date: Sep 1, 2023 to Sep 1, 2024
    • Study completion date: Feb 2027 to Feb 2028
    v5
  3. Start date: Nov 1, 2022 to Sep 1, 2023v4
  4. Start date: Aug 1, 2022 to Nov 1, 2022v3
  5. Start date: Feb 19, 2022 to Aug 1, 2022v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). To help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2). The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.
Trial Details
NCT Number NCT05154188
Lead Sponsor Oticon Medical
Conditions
(from sponsor)		 Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
Related terms Hearing Loss, Sensorineural
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov