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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Active Implantable Bone Conduction Hearing System
510(k) Number K240155
Device Name Cochlear Osia System
Applicant
Cochlear Americas
10350 Park Meadows Dr
Lone Tree,  CO  80124
Applicant Contact Whitney Alexander
Correspondent
Cochlear Americas
10350 Park Meadows Dr
Lone Tree,  CO  80124
Correspondent Contact Whitney Alexander
Regulation Number874.3340
Classification Product Code
PFO  
Date Received01/19/2024
Decision Date 04/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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