Atlas FDA

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

FDA 510(k) clearance K260902 · decided 2026-07-10

Clearance details

K-number
K260902
Device name
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
Applicant
Cochlear Americas
Decision
Substantially Equivalent
Date received
2026-03-18
Decision date
2026-07-10
Days to decision
114 days
Clearance type
Traditional
Product code
PFO
Device class
2
Regulation number
874.3340
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Lone Tree, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (K240614)Oticon Medical AB2024-07-10
Cochlear Osia System (K240155)Cochlear Americas2024-04-18
Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App (K231204)Cochlear2023-08-18
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit (K220922)Cochlear Americas2022-07-27
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) (K201983)Med-El Elektromedizinische Geraete GmbH2020-10-09
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote (K200504)Med-El Elektromedizinische Geraete GmbH2020-07-29
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (K191921)Cochlear Americas2019-11-15
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (K191457)Med-El Elektromedizinische Geraete GmbH2019-09-18
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments (K190589)Cochlear Americas2019-07-03
Bonebridge (K183373)Med-El Elektromedizinische Geraete GmbH2019-03-07
Bonebridge (DEN170009)Med-El Elektromedizinische Geraete GmbH2018-07-20

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Cochlear Hybrid Implant System (P130016/S060)Cochlear Americas2026-04-30
Nucleus® 24 Cochlear Implant System (P970051/S242)Cochlear Americas2026-04-30
Cochlear Auditory Brainstem Implant System (P000015/S056)Cochlear Americas2026-04-30
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240)Cochlear Americas2025-12-19
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S058)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S236)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S238)Cochlear Americas2025-09-26
Cochlear™ Nucleus® System (P970051/S237)Cochlear Americas2025-09-02