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

NCT05154188 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-03-28

No results posted yet for this study

Summary

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.

Conditions

  • Sensorineural Hearing Loss, Bilateral
  • Sensorineural Hearing Loss, Severe
  • Sensorineural Hearing Loss, Profound

Interventions

DEVICE

Neuro Cochlear Implant system

Patients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-02-28
Completion
2029-02-28
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154188 on ClinicalTrials.gov