Model note · Cochlear Implant

Advanced Bionics HiRes Ultra 3D cochlear implant

Name: Advanced Bionics HiRes Ultra 3D cochlear implant
Brand: Advanced Bionics HiRes Ultra 3D

HiRes Ultra 3D is Advanced Bionics' current cochlear implant, part of the HiResolution Bionic Ear System. It drives 16 electrode contacts with independent output circuits that allow current steering, and uses a magnet assembly of four bar magnets that rotate in three dimensions so the implant can stay in place during MRI without head bandaging. Two electrode arrays are offered: a precurved Mid-Scala and a straight SlimJ.

Start 7-day free trial Ask Essentia about the Cochlear Implant

The model

Maker, model and type.

Maker: Advanced Bionics (Sonova group)
Model: HiRes Ultra 3D cochlear implant with HiFocus Mid-Scala (CI-1601-04) or HiFocus SlimJ (CI-1601-05) electrode
Device type: Cochlear Implant
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Models	CI-1601-04 with HiFocus Mid-Scala electrode; CI-1601-05 with HiFocus SlimJ electrode	Source
Electrode contacts and spectral channels	16 independent contacts; current steering gives up to 120 stimulation sites (manufacturer claim)	Source
Electrode length and depth	Mid-Scala 18.5 mm, SlimJ 23 mm; target angular insertion about 420 degrees	Source
Apical tip size	0.26 x 0.55 mm, asymmetric	Source
Magnet design	Four bar magnets in a frame, free to rotate in three dimensions	Source
Impact resistance	Stated to exceed the 2.5 J industry standard (EN 45502-2-3)	Source
Maximum skin flap thickness	Up to 10 mm with full system function	Source
Shelf life	3 years approved	Source
FDA approval	PMA P960058 supplement S129, approved 28 August 2018, product code MCM	Source

Recalls

Known FDA recalls.

Z-2283-20262026-04-30
CI-1601-04 units labelled with an expiry beyond the approved 3 year shelf life.
FDA record
Z-2032-20202020-02-17
Hearing performance degradation from body fluid entering the device (Mid-Scala and SlimJ versions).
FDA record

Safety

Safety warnings from the record.

Do not implant unimplanted devices covered by the 2020 field action; they were to be returned. Source
MRI must follow AB's MRI guidelines for the implant; the manufacturer cites magnet dislocation studies at 1.5 T, and exact conditions should be checked in current labelling. Source

Sources

Where this note comes from.

Not covered: Most specs come from an AB marketing comparison flyer in Spanish, not an independent technical sheet; figures should be checked against AB's technical specifications and MRI guidelines. Implant dimensions, weight, stimulation rate and current limits were not found. No FDA SSED exists for the S129 supplement. Implants have no user error codes; processor messages were out of scope. MAUDE counts are not failure rates.

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