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Combi 40+ Cochlear Implant System

by Med-El Corp.

PMA P000025

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P000025↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP000025 Date20 Aug 2001ApprovedStatusActive

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2356-2024 FDA Class II initiated 18 Apr 2024

    A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

  • 3 recalls, same reason

    • Terminated Z-2138-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025
    • Terminated Z-2136-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025
    • Terminated Z-2137-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025

    Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Implant, cochlear
PMA Number
FDA Product Code
MCM
Device Class
Class III
Advisory Committee
Ear, Nose, Throat
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Combi 40+ Cochlear Implant System is a cochlear implant designed to provide the opportunity to detect and recognize auditory information. It functions through the electrical stimulation of the auditory nerve for individuals with severe to profoundly sensorineural hearing impairment who obtain little or no benefit from conventional acoustic amplification.

This device is indicated for adults with bilateral hearing impairment and children aged 18 months to 17 years with profound bilateral sensorineural hearing loss. The system has received FDA PMA authorization for use in patients who meet specific audiometric thresholds and demonstrate limited benefit from appropriately fitted binaural hearing aids.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Who is the Combi 40+ Cochlear Implant System intended for?

    The system is intended for adults and children aged 18 months and older who have severe to profound sensorineural hearing loss and receive little or no benefit from conventional hearing aids.

  • How does the Combi 40+ work?

    The device works by providing the user with the ability to detect and recognize auditory information through the electrical stimulation of the auditory nerve.

  • Is the Combi 40+ FDA authorized?

    Yes, the Combi 40+ Cochlear Implant System has received FDA PMA authorization for the treatment of severe to profound sensorineural hearing impairment.