FDA-approved cochlear implant with a 16-contact HiFocus electrode, specified from the manufacturer's surgeon manual and the FDA PMA record P960058. Clinical data not extracted 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.
Advanced Bionics HiRes Ultra 3D cochlear implant
The HiRes Ultra 3D is Advanced Bionics’ current FDA-approved cochlear implant, with a choice of SlimJ or Mid-Scala 16-contact electrodes. Hardware values come from the manufacturer’s surgeon manual, so they are manufacturer-stated. Clinical trial values are Unreported pending a deeper pass.
Identity
Field
Value and source scope
Device
Advanced Bionics HiRes Ultra 3D Cochlear Implant with HiFocus SlimJ or HiFocus Mid-Scala electrode, part of the HiResolution Bionic Ear System [1][2]
Manufacturer
Advanced Bionics, Valencia, California [2]
Interface class
Cochlear implant with a 16-contact electrode array and external processor [1]
Origin
Commercial FDA-approved device; PMA P960058 [2]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P960058; the latest supplement I read is S166, decision December 18, 2024 (30-day notice, manufacturing and surgical tool change). Original and Ultra 3D approval dates not extracted [2]
Function
Provides useful hearing to individuals with severe-to-profound hearing loss [3]
Target tissue
Cochlea [1]
Geometry and architecture
Field
Value and source scope
Interface type
HiFocus SlimJ (lateral wall) or HiFocus Mid-Scala electrode array [1]
Array layout
Unreported
Electrode count
16 platinum contacts [1]
Pitch
Contact spacing 1.3 mm (SlimJ) and 0.975 mm (Mid-Scala) [1]
Electrode lengths
Active length about 20 mm (SlimJ) and about 15 mm (Mid-Scala) [1]
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
Platinum contacts on platinum-iridium wires in a flexible silicone carrier; minimum exposed contact area 0.12 mm2 [1]
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Up to 83,000 pulses per second (software limited); 16 independent output circuits; up to 120 sites of stimulation (software limited); pulse amplitude 0-2040 uA; pulse width 10.78-229 us; monopolar configuration [1]
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
Hermetically sealed titanium case with removable magnet and telemetry coil in silicone; 25 mm wide at case, 28.5 mm at antenna, 56.2 mm long, 4.5 mm thick; 11 g; volume 4800 mm3 [1]
Data path
Bi-directional inductive telemetry; 90 kHz information update rate; neural response imaging and impedance diagnostics [1]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Unreported
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Magnet can be left in place for 1.5 T and 3.0 T MRI scans per the surgeon manual; see the MRI safety document [1]
Surgical complexity
Free-hand or stylet insertion; a maximum of 3 insertions for either electrode [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
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Unreported
Trials and registries
Unreported
Primary outcomes
Unreported
Key limitations
Source is the manufacturer’s surgeon manual and an FDA supplement record. Clinical trial data were not extracted here, so those cells read Unreported [1][2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
The surgeon manual covers the HiRes Ultra 3D with HiFocus SlimJ and Mid-Scala electrodes. The related HiRes Ultra implant is not described.