HiRes Ultra 3D Cochlear Implant by Advanced Bionics (Sonova): status and timeline

Milestones

Next · Reimbursement expansion for SSD/AHL

HiRes Ultra introducedSep 2016Complete.
HiRes Ultra 3D FDA approvalAug 2018Complete.
FDA expanded indications for SSD/AHL22 Jul 2026Complete.

Most important, last 3 months

Advanced Bionics achieves FDA approval for cochlear implants in single-sided deafness and asymmetric hearing loss28 Jul 2026

Upcoming

2027Reimbursement expansion for SSD/AHL (next)
2027Next-gen processor with wireless

Current obstacles

New indication protocolsSSD and AHL are newly approved. Clinicians still developing selection and implantation practices.
Surgical expertise requiredRequires specialized otologic surgeons. Variation in expertise and access affects outcomes.

Physics limits

Frequency resolutionStimulation map along cochlea is coarser than natural hearing, especially at high frequencies.
Music and tone perceptionSpeech perception is excellent; music and tonal language perception remain challenging.

How it works

4 parts

Microphone

Sound capture

External processor with microphone captures sound; converts to digital signals.

Processing

Signal conversion

Algorithms process signals to extract speech and cues; encode for electrical stimulation.

Electrode array

Precise neural stimulation

Closely-spaced electrodes stimulate cochlear nerve regions with fine spatial resolution.

Hearing perception

Auditory processing

Cochlear nerve transmits signals to brain; auditory cortex interprets as sound and speech.

Spec sheet

Spec	HiRes Ultra 3D Cochlear Implant
Estimated U.S. SSD adults	271,000-345,000^E (estimated)
Electrode resolution	High-density 3D design^R (reported)

^R reported by the company · ^E our estimate

Update log

1 update

Tue 28 Jul

Major: Advanced Bionics achieves FDA approval for cochlear implants in single-sided deafness and asymmetric hearing lossPressRegulatory

About Advanced Bionics (Sonova)

The team behind HiRes Ultra 3D Cochlear Implant

Advanced Bionics (Sonova)

Cochlear implant, HiRes Ultra 3D, Marvel

Advanced Bionics is a leading cochlear implant manufacturer (Sonova subsidiary since 2009). HiRes Ultra 3D and Marvel systems gained FDA approval for single-sided deafness in July 2026.

Advanced Bionics is one of three major global CI manufacturers with HiRes Ultra 3D and Marvel systems.
FDA approval for single-sided deafness (July 2026) expands addressable market to 271,000-345,000 U.S. adults.
Sonova subsidiary since 2009; integrates with Phonak hearing aids for comprehensive hearing solutions.

advancedbionics.com (opens advancedbionics.com)Company profile →

Founded: 199333 yrs
Headquarters: United States
Status: Private
Valuation: private
Works in: NeurotechCochlear implants
Coverage: 2 programs · 1 updatelatest 28 Jul 2026checked 11 Oct
Partners: Sonova (opens sonova.com)Phonak (opens phonak.com)

Spec

HiRes Ultra 3D Cochlear Implant

Estimated U.S. SSD adults

271,000-345,000^E (estimated)

Electrode resolution

High-density 3D design^R (reported)