FDA-approved cochlear implant family with SYNCHRONY 2 as the current implant, indications expanded in October 2024. Values come from the FDA summary of safety and effectiveness; electrode specs are not on this sheet yet.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
MED-EL cochlear implant system
The MED-EL Cochlear Implant System is an FDA-approved cochlear implant family. This sheet uses the FDA summary for supplement S129 (approved October 3, 2024) and MED-EL’s SYNCHRONY 2 page. It is thin on hardware: electrode geometry and implant dimensions are Unreported.
Identity
Field
Value and source scope
Device
MED-EL Cochlear Implant System: implants (stimulator, coil with magnet, active electrode, reference electrode and ECAP reference electrode) including SYNCHRONY 2 (PIN) Mi1250, with SONNET 2 and RONDO 3 processors and MAESTRO fitting software [1][2]
Manufacturer
MED-EL Elektromedizinische Geraete GmbH, Innsbruck, Austria (MED-EL Corp.) [1]
Interface class
Cochlear implant with an electrode array and external audio processor [1]
Origin
Commercial FDA-approved device; PMA P000025, original approval August 20, 2001 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
P000025/S129 panel-track supplement approved October 3, 2024, expanding indications to adults with bilateral moderate to profound sensorineural hearing loss; SYNCHRONY 2 approved under S110 (decision 06/04/2019) [1][3]
Function
Evokes auditory sensations by electrical stimulation of the auditory pathways [1]
Target tissue
Cochlea and auditory nerve [1]
Geometry and architecture
Field
Value and source scope
Interface type
A variant of an active electrode array in the cochlea; the SSED notes hearing preservation claims for the FLEX electrode series [1]
Array layout
Unreported
Electrode count
Unreported
Pitch
Unreported
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Unreported
Anchoring and fixation
Unreported
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Unreported
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Unreported
Data path
Audio processor sends a coded signal over an RF inductive link through an external coil held by the implant magnet [1]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Unreported
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
MED-EL states SYNCHRONY 2 allows MRI up to 3.0 T without magnet removal surgery (manufacturer claim) [2]
Surgical complexity
Implant stimulator housing recessed in the skull; PIN variants named in the product list [1]
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
IDE G170111: 44 participants in the database through March 27, 2023; enrolled April 26, 2018 to March 27, 2023 [1]
Preclinical cohort
Unreported
Follow-up duration
6 months after activation for the primary endpoints [1]
Indications
Adults 18 and older with bilateral moderate to profound sensorineural hearing loss and limited benefit from appropriately fit hearing aids (CNC 50% or less in the implant ear) [1]
Trials and registries
IDE G170111, multicenter, prospective, open-label, single-arm, US and Canada [1]
Single-arm study of 44 participants. Electrode contact counts, lengths and implant dimensions are not in the SSED text read, so they read Unreported. Many models and processors are covered by one PMA; this sheet follows the SYNCHRONY 2 family [1]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
SYNCHRONY 2 (Mi1250) is the newest implant in the S129 component list alongside SONATA 2, SYNCHRONY ST, SYNCHRONY, CONCERTO 2 and SONATATI100. Processors SONNET 2 and RONDO 3 are the newest listed.