Chrysalis Intelligence · Sponsors · Cochlear Americas

Cochlear Americas

Lone Tree, CO, US · 6 510(k) clearances · 100 PMAs

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Total clearances
6
2021-02-23 → 2026-07-10
Last 12 months
1
Product codes
3
Most recent
2026-07-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PFO Active Implantable Bone Conduction Hearing System Class II Ear, Nose, Throat 3 2026-07-10
LXB — — — 2 2021-09-29
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 1 2023-08-24
Class III

PMA approvals (100)

Total PMA records
100
Originals + supplements
Distinct product codes
3
First decision
2020-02-14
Most recent
2026-04-30
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-04-30 P970051-S242 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2026-04-30 P130016-S060 Cochlear Hybrid Implant System 30-Day Notice PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2026-04-30 P000015-S056 Cochlear Auditory Brainstem Implant System 30-Day Notice MHE Implant, Auditory Brainstem Unknown
2025-12-19 P970051-S240 NUCLEUS 24 COCHLEAR IMPLANT SYSTEM 30-Day Notice MCM Implant, Cochlear Unknown
2025-10-16 P970051-S236 Nucleus® 24 Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2025-10-16 P130016-S058 Nucleus® Hybrid™ L24 Cochlear Implant System Real-Time Process PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2025-09-26 P970051-S238 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2025-09-02 P970051-S237 Cochlear™ Nucleus® System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2025-08-06 P970051-S235 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2025-07-24 P970051-S234 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2025-07-03 P970051-S225 Nucleus® 24 Cochlear Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
2025-07-03 P890027-S064 Nucleus® 22 Cochlear Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
2025-07-03 P840024-S096 Nucleus® 22 Cochlear Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
2025-07-03 P130016-S056 Nucleus® Hybrid™ L24 Cochlear Implant System Normal 180 Day Track PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2025-07-03 P000015-S053 Nucleus® 24 Auditory Brainstem Implant System Normal 180 Day Track MHE Implant, Auditory Brainstem Unknown
2025-02-28 P970051-S233 Nucleus 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2024-11-15 P970051-S231 Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant 30-Day Notice MCM Implant, Cochlear Unknown
2024-11-13 P970051-S232 Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant 30-Day Notice MCM Implant, Cochlear Unknown
2024-10-25 P970051-S230 Cochlear™ Slimline™ Coil, Cochlear™ Slimline™ Coil (5(I)), Nucleus® 7 Aqua+ Coil (5(I)), Nucleus 7 Aqua+ Coil 30-Day Notice MCM Implant, Cochlear Unknown
2024-10-25 P970051-S229 Nucleus 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2024-08-01 P970051-S228 Cochlear™ Nucleus® CI632 cochlear implant with Slim Modiolar electrode, Cochlear™ Nucleus® CI532 cochlear implant with S 30-Day Notice MCM Implant, Cochlear Unknown
2024-06-17 P970051-S227 Cochlear™ Nucleus® CI522 cochlear implant with Slim Straight electrode, Cochlear™ Nucleus® CI532 cochlear implant with S 30-Day Notice MCM Implant, Cochlear Unknown
2024-05-31 P970051-S226 Nucleus® 24 Cochlear Implant System Special (Immediate Track) MCM Implant, Cochlear Unknown
2024-05-31 P890027-S065 Nucleus® 22 Cochlear Implant System Special (Immediate Track) MCM Implant, Cochlear Unknown
2024-05-31 P840024-S097 Nucleus® 22 Cochlear Implant System Special (Immediate Track) MCM Implant, Cochlear Unknown
2024-05-31 P130016-S057 Nucleus® Hybrid™ L24 Cochlear Implant System Special (Immediate Track) PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2024-05-31 P000015-S054 Nucleus® 24 Auditory Brainstem Implant System Special (Immediate Track) MHE Implant, Auditory Brainstem Unknown
2024-05-08 P970051-S220 Nucleus 24 Cochlear Implant System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2023-12-13 P970051-S224 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2023-12-13 P130016-S055 Nucleus® Hybrid Cochlear Implant 30-Day Notice PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2023-12-13 P000015-S052 Nucleus® Auditory Brainstem Implant 30-Day Notice MHE Implant, Auditory Brainstem Unknown
2023-11-29 P970051-S223 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2023-11-17 P130016-S052 Nucleus Hybrid L24 Cochlear Implant System Normal 180 Day Track No User Fee PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2023-10-25 P970051-S222 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2023-10-25 P130016-S054 Nucleus® Hybrid™ L24 Cochlear Implant System 30-Day Notice PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2023-10-25 P000015-S051 Nucleus® 24 Auditory Brainstem Implant System 30-Day Notice MHE Implant, Auditory Brainstem Unknown
2023-10-13 P970051-S221 Nucleus® 24 Cochlear Implant System Special (Immediate Track) MCM Implant, Cochlear Unknown
2023-10-13 P890027-S063 Nucleus® 22 Cochlear Implant System Special (Immediate Track) MCM Implant, Cochlear Unknown
2023-10-13 P840024-S095 Nucleus® 22 Cochlear Implant System Special (Immediate Track) MCM Implant, Cochlear Unknown
2023-10-13 P130016-S053 Nucleus® Hybrid™ L24 Cochlear Implant System Special (Immediate Track) PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2023-10-13 P000015-S050 Nucleus® 24 Auditory Brainstem Implant System Special (Immediate Track) MHE Implant, Auditory Brainstem Unknown
2023-07-14 P970051-S219 Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I 30-Day Notice MCM Implant, Cochlear Unknown
2023-06-08 P970051-S218 Nucleus 24 Cochlear Implant System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2023-04-24 P970051-S217 Nucleus 24 Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2023-04-24 P000015-S049 Nucleus 24 Auditory Brainstem Implant System Real-Time Process MHE Implant, Auditory Brainstem Unknown
2022-12-15 P970051-S216 Nucleus 24 Cochlear Implant System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2022-12-06 P970051-S215 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2022-12-06 P970051-S214 Nucleus 24 Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2022-12-06 P890027-S061 Nucleus 22 Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2022-12-06 P840024-S093 Nucleus 22 Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2022-12-06 P130016-S051 Nucleus Hybrid L24 Cochlear Implant System Real-Time Process PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2022-12-06 P000015-S048 Nucleus 24 Auditory Brainstem Implant System Real-Time Process MHE Implant, Auditory Brainstem Unknown
2022-10-31 P970051-S211 Nucleus Cochlear Implant Systems Normal 180 Day Track MCM Implant, Cochlear Unknown
2022-10-31 P890027-S062 Nucleus Cochlear Implant Systems Normal 180 Day Track MCM Implant, Cochlear Unknown
2022-10-31 P840024-S094 Nucleus Cochlear Implant Systems Normal 180 Day Track MCM Implant, Cochlear Unknown
2022-10-31 P130016-S048 Nucleus Hybrid Cochlear Implant Normal 180 Day Track PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2022-10-31 P000015-S047 Nucleus Auditory Brainstem Implant Normal 180 Day Track MHE Implant, Auditory Brainstem Unknown
2022-09-26 P970051-S212 Nucleus® 24 Cochlear™ Implant System Real-Time Process MCM Implant, Cochlear Unknown
2022-08-09 P970051-S213 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2022-08-09 P130016-S050 Nucleus® Hybrid™ L24 Cochlear Implant System 30-Day Notice PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2022-06-16 P130016-S049 Nucleus Hybrid L24 Implant System Normal 180 Day Track No User Fee PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2022-04-29 P970051-S208 Nucleus® 24 Cochlear™ Implant System Real-Time Process MCM Implant, Cochlear Unknown
2022-04-29 P130016-S046 Nucleus® Hybrid™ Implant System Real-Time Process PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2022-03-11 P970051-S210 Nucleus 24 Cochlear Implant System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2022-03-03 P970051-S209 Nucleus® 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2022-03-03 P130016-S047 Nucleus® Hybrid™ L24 Cochlear Implant System 30-Day Notice PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2022-01-10 P970051-S205 Nucleus 24 Cochlear Implant System Panel Track MCM Implant, Cochlear Unknown
2021-12-07 P970051-S206 Nucleus® 24 Cochlear Implant System 135 Review Track For 30-Day Notice MCM Implant, Cochlear Unknown
2021-12-07 P000015-S046 Nucleus® Auditory Brainstem Implant System 135 Review Track For 30-Day Notice MHE Implant, Auditory Brainstem Unknown
2021-10-08 P970051-S207 Nucleus 24 Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2021-06-09 P970051-S190 Nucleus 24 Cochlear Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
2021-06-09 P890027-S060 Nucleus 22 Cochlear Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
2021-06-09 P840024-S091 Nucleus 22 Cochlear Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
2021-06-09 P130016-S040 Nucleus Hybrid Implant System Normal 180 Day Track PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2021-06-09 P000015-S040 Nucleus ABI541 Auditory Brainstem Implant System Normal 180 Day Track MHE Implant, Auditory Brainstem Unknown
2021-04-21 P970051-S203 Nucleus Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2021-03-26 P970051-S204 Nucleus 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2020-12-30 P970051-S200 24 Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2020-12-30 P130016-S044 Hybrid Implant System Real-Time Process PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2020-12-30 P000015-S044 Nucleus Auditory Brainstem Implant System Real-Time Process MHE Implant, Auditory Brainstem Unknown
2020-12-16 P970051-S202 Nucleus 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2020-12-08 P970051-S201 Nucleus 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2020-12-08 P130016-S045 Nucleus Hybrid L24 Cochlear Implant System 30-Day Notice PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2020-12-08 P000015-S045 Nucleus Auditory Brainstem Implant System 30-Day Notice MHE Implant, Auditory Brainstem Unknown
2020-08-31 P970051-S197 Nucleus Cochlear Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
2020-08-13 P970051-S199 Nucleus 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2020-08-13 P000015-S043 Nucleus Auditory Brainstem Implant System 30-Day Notice MHE Implant, Auditory Brainstem Unknown
2020-07-28 P130016-S042 Nucleus Hybrid L24 Implant System Normal 180 Day Track No User Fee PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2020-07-02 P970051-S193 Nucleus 24 Cochlear Implant Systems Normal 180 Day Track MCM Implant, Cochlear Unknown
2020-07-02 P840024-S092 Nucleus 22 Cochlear Implant Systems Normal 180 Day Track MCM Implant, Cochlear Unknown
2020-07-02 P130016-S041 Nucleus Hybrid Cochlear Implant Normal 180 Day Track PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2020-07-02 P000015-S041 Nucleus Auditory Brainstem Implant Normal 180 Day Track MHE Implant, Auditory Brainstem Unknown
2020-05-15 P970051-S198 Nucleus 24 Cochlear Implant System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2020-04-02 P970051-S188 Nucleus 24 Cochlear Implant Normal 180 Day Track MCM Implant, Cochlear Unknown
2020-04-02 P130016-S039 Nucleus Hybrid Cochlear Implant Normal 180 Day Track PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2020-03-18 P970051-S196 Nucleus 24 Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2020-03-17 P970051-S172 NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Panel Track MCM Implant, Cochlear Unknown
2020-02-21 P970051-S195 Nucleus Cochlear Implant System (C124RE and C1500) Special (Immediate Track) MCM Implant, Cochlear Unknown
2020-02-21 P130016-S043 Nucleus Hybrid L24 Cochlear Implant System Special (Immediate Track) PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown
2020-02-14 P970051-S191 Nucleus CI624 Implant System Normal 180 Day Track MCM Implant, Cochlear Unknown
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-07-10 K260902 Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System PFO Class II Ear, Nose, Throat
2024-04-18 K240155 Cochlear Osia System PFO Class II Ear, Nose, Throat
2023-08-24 K231604 Instrument Case KCT Class II General Hospital
2022-07-27 K220922 Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit PFO Class II Ear, Nose, Throat
2021-09-29 K212136 Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App LXB — —
2021-02-23 K202048 Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App LXB — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence