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Cochlear Osia System

by Cochlear Americas

510(k) K240155

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240155 Date18 Apr 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PFO
Device class
Class II
Regulation
21 CFR Part 874.3340
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cochlear Osia System is an active implantable bone conduction hearing system. It is designed to deliver sound through bone conduction for individuals with hearing loss.

The system is supplied as an active implantable device and is supported by years of reliability data. It enables MRI at 1.5 and 3 Tesla and is authorized under FDA 510(k) clearance K240155. The device is classified as a Class II medical device under regulation number 874.3340.

Similar devices

Other devices filed under FDA product code PFO (Active Implantable Bone Conduction Hearing System).

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