Skip to content

Baha 92833

by Cochlear Bone Anchored Solutions AB

Baha 92833 is a Class II device made by Cochlear Bone Anchored Solutions AB, cleared under FDA 510(k) K110996 on 10 May 2011 and listed in FDA GUDID since 3 Jul 2017 (UDI-DI 09321502021326), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K110996

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09321502021326 UDI-DI Date3 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK110996 Date10 May 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110996 decided 10 May 2011 Active
  • FDA GUDID UDI-DI 09321502021326 listed 3 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110996
  2. Listed FDA GUDID 09321502021326

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Baha
Generic name
Bone-conduction hearing implant system sound processor/vibrator
Model / Ref / Catalog
92833
Primary DI / UDI-DI
09321502021326
510(k) Number
FDA product code
LXB
GMDN term
Bone-conduction hearing implant system sound processor/vibrator
Device class
Class II
Regulation number
874.3302
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Bone-conduction hearing implant system sound processor/vibrator.

Other devices from Cochlear Bone Anchored Solutions AB

See all devices from Cochlear Bone Anchored Solutions AB →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)