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Cochlear™ Headworn Adaptor P706992

by Cochlear

Ref P706992

Cochlear™ Headworn Adaptor P706992 is a Class III device made by Cochlear, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 9321502CP1000HAdaptorAA) with CE/MDR certificate G70 078611 0143 valid until 20 Jul 2027, approved under FDA PMA P970051 on 25 Jun 1998 and listed in FDA GUDID since 7 Jul 2017 (UDI-DI 09321502035187), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

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

CE MDR PMA

Valid until

20 Jul 2027

CE MDR certificate

FDA recalls

None ongoing

3 closed

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

PMA P970051

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 Number9321502CP1000HAdaptorAA Basic UDI-DI 09321502035187UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09321502035187 UDI-DI Date7 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP970051 Date25 Jun 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9321502CP1000HAdaptorAA registered 7 Oct 2026 Active· +1 more in the status table
  • FDA PMA P970051 decided 25 Jun 1998 Active
  • FDA GUDID UDI-DI 09321502035187 listed 7 Jul 2017 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 078611 0143 Expiring Supplemented Expires in 249 days

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    12 Dec 2025
    Expires
    20 Jul 2027
    Reason
    Other

Recalls

3 recalls · FDA

    • Terminated Z-2155-2015 FDA Class II initiated 5 Jun 2015

    Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

    • Terminated Z-0003-2012 FDA Unclassified (pre-2012) initiated 16 Sep 2011

    Cochlear implant may shut down and cease to function.

    • Terminated Z-0119-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2009

    Cochlear implant device component was mis-labeled.

Timeline

8 dated events

  1. Approved FDA PMA P970051
  2. Recall initiated FDA recalls Z-0119-2010
  3. Recall initiated FDA recalls Z-0003-2012
  4. Recall initiated FDA recalls Z-2155-2015
  5. Listed FDA GUDID 09321502035187
  6. Certificate issued EUDAMED G70 078611 0143
  7. Registered EUDAMED 9321502CP1000HAdaptorAA
  8. Certificate expires EUDAMED G70 078611 0143

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Cochlear® Headworn Adaptor (Right, 2 pcs) EUDAMED
Cochlear™ Headworn Adaptor GUDID
Generic name
Cochlear implant/auditory brainstem implant sound processor off-ear holder
Model / Ref / Catalog
P706992
Primary DI / UDI-DI
09321502035187
Basic UDI-DI
9321502CP1000HAdaptorAA
Unit of use DI
09321502042185
PMA number
FDA product code
MCM
EMDN code
J0380 Auditory active-implantable devices - accessories
GMDN term
Cochlear implant/auditory brainstem implant sound processor off-ear holder
Device class
Class III
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Cochlear implant/auditory brainstem implant sound processor off-ear holder

Cleared under the same submission (P970051)

and 8 more cleared under P970051

Similar devices in this category

Other devices filed under AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES.

Other devices from Cochlear

See all devices from Cochlear →

Properties

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