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Naida CI Q70B CI-5245-170

by Advanced Bionics 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840094475816 UDI-DI Date21 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

17 recalls · 3 ongoing · FDA

    • Ongoing Z-2283-2026 FDA Class II initiated 30 Apr 2026

    Due to incorrect shelf-life expiration date.

    • Ongoing Z-1950-2026 FDA Class II initiated 23 Mar 2026

    The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.

    • Ongoing Z-1813-2025 FDA Class II initiated 5 Mar 2025

    Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

  • 2 recalls, same reason

    • Terminated Z-2033-2020 FDA Class II initiated 17 Feb 2020
    • Terminated Z-2032-2020 FDA Class II initiated 17 Feb 2020

    hearing performance degradation due to body-fluid entering the device.

    • Terminated Z-1441-2020 FDA Class III initiated 4 Apr 2019

    The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.

    • Terminated Z-1259-2020 FDA Class III initiated 18 Mar 2019

    Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.

  • 3 recalls, same reason

    • Terminated Z-1085-2019 FDA Class II initiated 6 Feb 2019
    • Terminated Z-1084-2019 FDA Class II initiated 6 Feb 2019
    • Terminated Z-1083-2019 FDA Class II initiated 6 Feb 2019

    The sound processors were loaded with the incorrect firmware.

    • Terminated Z-2039-2009 FDA Unclassified (pre-2012) initiated 10 Jun 2009

    The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas

  • 2 recalls, same reason

    • Terminated Z-0957-2009 FDA Unclassified (pre-2012) initiated 24 Jul 2008
    • Terminated Z-0958-2009 FDA Unclassified (pre-2012) initiated 24 Jul 2008

    Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can

  • 2 recalls, same reason

    • Terminated Z-0956-2009 FDA Unclassified (pre-2012) initiated 24 Jul 2008
    • Terminated Z-0959-2009 FDA Unclassified (pre-2012) initiated 24 Jul 2008

    Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann

  • 2 recalls, same reason

    • Terminated Z-0759-06 FDA Unclassified (pre-2012) initiated 8 Mar 2006
    • Terminated Z-0758-06 FDA Unclassified (pre-2012) initiated 8 Mar 2006

    Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Naida CI Q70B
Generic Name
Cochlear implant/auditory brainstem implant sound processor
Model / Reference
CI-5245-170
Primary DI / UDI-DI
00840094475816
PMA Number
FDA Product Code
MCM
GMDN Term
Cochlear implant/auditory brainstem implant sound processor
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (P960058)

Show all (12)

Other devices from Advanced Bionics

See all devices from Advanced Bionics →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Expiration Date: No