Synchrony 2 Cochlear Implant

MED-EL

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.

⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

4/17/2024 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

4/17/2024 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

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

⚠️2 Active Recalls

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

Category

Cochlear

Body Region

Head/Ear

Model

Synchrony 2

MRI Scan Parameters

Max Field Strength3.0T

MRI Conditions

MR Conditional at 1.5T and 3.0T. Magnet removal is NOT required. No head bandage or splint required.

Clinical Warnings

Most MRI-compatible cochlear implant. Remove external audio processor before scan.

Post-MRI Notes

Verify implant function and audio processor settings 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.