Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Hearing Aid, Bone Conduction
510(k) Number K254296
Device Name Ossiclear (Ossiclear System)
Applicant
Sounduct
2, Rue Marie Hamm
Strasbourg,  FR 67000
Applicant Contact Camille Bonnassieux
Correspondent
Sounduct
2, Rue Marie Hamm
Strasbourg,  FR 67000
Correspondent Contact Camille Bonnassieux
Regulation Number874.3302
Classification Product Code
LXB  
Date Received12/31/2025
Decision Date 07/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-