Organization (Industry)
Advanced Bionics AG
ClinicalTrials.gov lists Advanced Bionics AG as lead sponsor of 24 trials.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.8 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Advanced Bionics AG: 24 lead-sponsored trials and 2 legal-entity registrations. Part of Sonova AG.
Disease areas (10)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Hearing Loss | 25 |
| Hearing Loss, Sensorineural | 11 |
| Deafness | 3 |
| Hearing Loss, Bilateral | 3 |
| Hearing Loss, Unilateral | 1 |
Showing 5 of 10 disease areas.
Trials by start year as sponsor or collaborator (17)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2025 | 3 |
| 2024 | 4 |
| 2023 | 1 |
| 2021 | 2 |
| 2020 | 4 |
| 2019 | 5 |
| 2018 | 1 |
| 2017 | 2 |
| 2016 | 1 |
Showing 10 of 17 years.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 86% hit target (n=7) | 29% on time (n=7) |
Journals published in (23)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Ear and hearing | 7 |
| Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology | 7 |
| Hearing research | 4 |
| Journal of the American Academy of Audiology | 3 |
| American journal of audiology | 2 |
Showing 5 of 23 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 754 | 86 | 2025-12-23 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 8 |
FDA recalls (14)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A | Class II | 2026-04-30 |
| Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable | Class II | 2026-03-23 |
| Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 | Class II | 2025-11-27 |
| HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Class II | 2025-03-05 |
| AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant. | Class III | 2020-09-26 |
Showing 5 of 14 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 2 | 2009-12-14 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Advanced Bionics LLC | Valencia, US | FDA |
Organization relationships (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| Ohio State University | Co sponsors trial with | 1 |
Latest dated events (811)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-08-24 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-04-30 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03-23 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-23 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-12-16 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 811 events.
Biomarker capability evidence (14)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| LDLRAP1 | Trial sponsor | Named in trial inclusion criteria |
| SLC8A1 | Trial collaborator | Named in trial inclusion criteria |
| SLC8A1 | Trial sponsor | Named in trial inclusion criteria |
| SLC8A1 | Trial sponsor | Named in trial inclusion criteria |
| SLC8A1 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 14 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.