FDA-approved cochlear implant family, newest implant series CI1000 approved July 2025. Thinly sourced from the FDA supplement record and a Cochlear announcement; electrode specifications are not yet on the sheet.
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.
Cochlear Nucleus implant system
The Nucleus system is Cochlear’s implant family under PMA P840024. The newest approval read is supplement S096 (decision July 3, 2025), which adds the CI1000 Series implants. This is a thin sheet: electrode and clinical specifications were not found in the sources read and stay Unreported. MED-EL and Advanced Bionics are separate families.
Identity
Field
Value and source scope
Device
Cochlear Nucleus Cochlear Implant System: CI1000 Series implants, Nucleus 8 and Kanso 3 sound processors, surgical processor, Nucleus Smart App and Custom Sound Pro software [1]
Manufacturer
Cochlear Limited (Cochlear Americas) [1][2]
Interface class
Cochlear implant with an electrode array and an external sound processor [1]
PMA P840024/S096 decision July 3, 2025: new CI1000 Series implants, updated Nucleus 8 processor, two new Kanso 3 processors, a new surgical processor and updated software. Nucleus 8 sound processor FDA approval announced November 1, 2022 [1][2]
Function
Cochlear implant for severe to profound sensorineural hearing loss, per Cochlear’s description [2]
Target tissue
Cochlea [2]
Geometry and architecture
Field
Value and source scope
Interface type
Unreported
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
Nucleus 8 processor streams audio directly and is ready for Bluetooth LE Audio; Nucleus Smart App allows setting changes and remote care and firmware updates [2]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Unreported
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Unreported
Surgical complexity
Unreported
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
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Unreported in the supplement record read; Cochlear describes cochlear implants as treatment for severe to profound sensorineural hearing loss [2]
Trials and registries
Unreported
Primary outcomes
Unreported
Key limitations
This sheet rests on an FDA supplement record and a company announcement. Electrode count, array geometry, stimulation and clinical outcomes for the CI1000 Series were not located in sources read here [1][2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Cochlear states the Nucleus 8 is the smallest and lightest behind-the-ear processor in the industry (manufacturer claim) [2]
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
S096 covers CI1000 Series implants, the Nucleus 8 and Kanso 3 processors and a surgical processor. Earlier implant series (CI24RE, CI500, CI600) are named in the record but not described here.