Model note · Cochlear Implant

MED-EL SYNCHRONY 2 cochlear implant

Name: MED-EL SYNCHRONY 2 cochlear implant
Brand: MED-EL SYNCHRONY 2

SYNCHRONY 2 (Mi1250) is MED-EL's titanium cased cochlear implant. It has 24 independent current sources driving 12 electrode channels, a self aligning, removable S-Vector magnet that allows MRI up to 3.0 T without magnet removal, and a family of soft lateral wall electrodes chosen to match cochlear length. A built in diagnostic toolkit supports impedance and field telemetry and several evoked response measurements.

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The model

Maker, model and type.

Maker: MED-EL Elektromedizinische Geraete GmbH
Model: SYNCHRONY 2 cochlear implant (Mi1250), with FLEX, FORM or CLASSIC electrode arrays
Device type: Cochlear Implant
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Stimulation channels and sources	12 electrode channels, sequential or parallel stimulation on 2 to 12 channels, 24 independent current sources	Source
Stimulation rate	Up to 50,704 pulses per second	Source
Pulse phase duration and current	2.1 to 425.0 microseconds per phase; 0 to 1200 microamps per phase (nominal)	Source
Pulse shapes	Biphasic, symmetric triphasic and triphasic precision pulses	Source
Size and weight	Stimulator 18.8 x 24 x 4.5 mm; coil 29.0 mm diameter, 3.3 mm thick; 7.7 g	Source
Housing	Hermetically sealed titanium, impact resistance 2.5 J or more; PIN variant with fixation pins	Source
MRI	MR Conditional at 0.2, 1.0, 1.5 and 3.0 T with no magnet removal, under the Medical Procedures Manual conditions	Source
Electrode examples	FLEX series 19 contacts (FLEX28 23.1 mm, FLEXSOFT 26.4 mm, FLEX34 28.6 mm); FORM and CLASSIC series 24 contacts	Source
Diagnostics	Status telemetry, impedance and field telemetry (IFT), ART, EABR, ESRT and EAEP measurements	Source
FDA approval	PMA P000025 (MED-EL cochlear implant system), product code MCM	Source

Recalls

Known FDA recalls.

Z-2356-20242024-04-18
Small number of Mi1250 S-Vector devices at higher risk of an internal substrate crack (7 US devices).
FDA record

Safety

Safety warnings from the record.

MRI is conditional, not unrestricted; the magnet may still be removed for diagnostic reasons such as reducing image artefact. Source
Affected 2024 recall devices were to be returned to MED-EL and not implanted. Source

Sources

Where this note comes from.

Not covered: MAUDE was not used because the brand name SYNCHRONY also matches an older St. Jude pacemaker, so counts could not be separated cleanly. Full MRI conditions are in the Medical Procedures Manual, which was not read. Implants have no user error codes; audio processor messages were out of scope. The 2018 helium leak recall covers earlier implant models and is listed only as background.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

Cochlear Implant