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FDA 510(k)

Cochlear Osia System

K-Number: K240155 · 2024-04-18

ApplicantCochlear Americas
Decision Date2024-04-18
Product CodePFO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Cochlear Osia System is a medical device manufactured by Cochlear Americas. It received FDA 510(k) clearance on 2024-04-18 under approval number K240155. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cochlear Osia System?

Cochlear Osia System is a medical device that received FDA 510(k) clearance on 2024-04-18. It is manufactured by Cochlear Americas. The 510(k) number is K240155.

When was Cochlear Osia System approved by the FDA?

Cochlear Osia System received FDA 510(k) clearance on 2024-04-18, under approval number K240155.

What company makes Cochlear Osia System?

Cochlear Osia System is manufactured by Cochlear Americas.

What is the FDA product code for Cochlear Osia System?

The FDA product code for Cochlear Osia System is PFO.

Related Clinical Trials

NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED NCT05110183 Opto-electrical Cochlear Implants ENROLLING_BY_INVITATION NCT07139327 A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults ACTIVE_NOT_RECRUITING NCT07557771 Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function. RECRUITING

Other Devices by Cochlear Americas

K161123Baha 5 Power Sound Processor K153245Baha 5 Super Power Sound Processor K171088Cochlear Baha SoundArc K182116BA310 Abutment, BIA310 Implant/Abutment K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

View all 16 devices →

Related Devices (Code: PFO)

DEN170009BonebridgeMed-El Elektromedizinische Geraete GmbH K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsCochlear Americas K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)Med-El Elektromedizinische Geraete GmbH K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsCochlear Americas K183373BonebridgeMed-El Elektromedizinische Geraete GmbH K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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