Nucleus CI624 (Profile Plus)

Cochlear Ltd

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

Regulatory Info

No 510(k) clearance data available for this device.

✅No Recalls Found

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Cochlear Implants

Body Region

Head/Ear

Model

CI624

MRI Scan Parameters

Max Field Strength3.0T

MRI Conditions

MR Conditional at 1.5T and 3.0T. "Profile Plus" model — features a specialized internal magnet that rotates within its housing to align with the MRI field.

Clinical Warnings

No tight compression bandage or head wrap required for 1.5T/3.0T scans (rotating magnet eliminates that need).

Post-MRI Notes

Verify implant function and mapping post-MRI.

Tracked Settings

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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.