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SoundBite G3

by Sonitus Medical?Shanghai?Co., ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06972667660313 UDI-DI Date1 Apr 2021ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1182-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1180-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1179-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1183-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1181-2012 FDA Not yet classified initiated 2 Feb 2012

    Sonitas received reports of stress cracking on the SoundBite Microphone Tube.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SoundBite
Generic Name
Bone-conduction hearing aid, tooth-worn
Model / Reference
G3
Primary DI / UDI-DI
06972667660313
510(k) Number
FDA Product Code
LXB
GMDN Term
Bone-conduction hearing aid, tooth-worn
Device Class
Class II
Regulation Number
874.3302
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Bone-conduction hearing aid, tooth-worn

Properties

  • Manufacturing Date

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No