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Baha SoundArc Extra Large P807178

by Cochlear

Ref P807178

Baha SoundArc Extra Large P807178 is a device classified as Class I in the EU and Class II in the US made by Cochlear, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 9321502BSoundArcV3), cleared under FDA 510(k) K171088 on 7 Jun 2017 and listed in FDA GUDID since 28 Jun 2017 (UDI-DI 09321502040891), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171088

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9321502BSoundArcV3 Basic UDI-DI 09321502040891UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09321502040891 UDI-DI Date28 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK171088 Date7 Jun 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9321502BSoundArcV3 registered 8 Sep 2026 Active
  • FDA 510(k) K171088 decided 7 Jun 2017 Active
  • FDA GUDID UDI-DI 09321502040891 listed 28 Jun 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171088
  2. Listed FDA GUDID 09321502040891
  3. Registered EUDAMED 9321502BSoundArcV3

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  • Withdrawn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® SoundArc™ Extra Large EUDAMED
Baha SoundArc Extra Large GUDID
Generic name
Bone-conduction hearing implant system sound processor/vibrator
Device name
Baha SoundArc
Model / Ref / Catalog
P807178
Primary DI / UDI-DI
09321502040891
Basic UDI-DI
9321502BSoundArcV3
510(k) Number
FDA product code
LXB
EMDN code
Y214599 Hearing aids - other
GMDN term
Bone-conduction hearing implant system sound processor/vibrator
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.3302
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Bone-conduction hearing implant system sound processor/vibrator

Cleared under the same submission (K171088)

and 8 more cleared under K171088

Similar devices in this category

Other devices filed under HEARING AIDS - OTHER.

Other devices from Cochlear

See all devices from Cochlear →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)