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Baha Fitting Software 7 V 7.0

by Cochlear Bone Anchored Solutions AB

Ref P2121898

Baha Fitting Software 7 V 7.0 (P2121898) is a hearing aid wireless-fitting computer-aided set (EU MDR Class IIa; FDA Class II; FDA product code LXB, Hearing aid, bone conduction) made by Cochlear Bone Anchored Solutions AB, registered in EUDAMED on 30 Apr 2026 (Basic UDI-DI 9321502BFS7WN), cleared under FDA 510(k) K250215 on 29 May 2025 and listed in FDA GUDID since 5 Jun 2025 (UDI-DI 09321502075510), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250215

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9321502BFS7WN Basic UDI-DI 09321502075510UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09321502075510 UDI-DI Date5 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250215 Date29 May 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9321502BFS7WN registered 30 Apr 2026 Active
  • FDA 510(k) K250215 decided 29 May 2025 Active
  • FDA GUDID UDI-DI 09321502075510 listed 5 Jun 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250215
  2. Listed FDA GUDID 09321502075510
  3. Registered EUDAMED 9321502BFS7WN

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cochlear® Baha® Fitting Software 7 EUDAMED
Baha Fitting Software 7 GUDID
Generic name
Hearing aid wireless-fitting computer-aided set
Device name
Cochlear Baha Fitting Software 7
Model / Ref / Catalog
P2121898, V 7.0
Primary DI / UDI-DI
09321502075510
Basic UDI-DI
9321502BFS7WN
510(k) Number
FDA product code
LXB
EMDN code
Z12149082 Various ENT instruments - software accessories
GMDN term
Hearing aid wireless-fitting computer-aided set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.3302
Special device type
Software
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
P2121898
GUDID
V 7.0
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Hearing aid wireless-fitting computer-aided set

Cleared under the same submission (K250215)

and 8 more cleared under K250215

Similar devices in this category

Other devices filed under VARIOUS ENT INSTRUMENTS.

Other devices from Cochlear Bone Anchored Solutions AB

See all devices from Cochlear Bone Anchored Solutions AB →

Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)