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Details checkedStrong evidenceCheckedregulatory

Cochlear Osia System

Also known as: Osia, Osia 2 System, Osia OSI200, Osia OSI300

Cochlear

Primary source
Company
Cochlear
Program Type
Device
Modality
Cochlear/Auditory Implant
Stage
Marketed
Status
Marketed
Target Gene
—
Route / Mode
Implantable bone-conduction system with external sound processor
Confidence
96%
Status Confidence
Status confirmed
Evidence Strength
Strong evidence
Last Reviewed
2026-05-31
Geography
United States, Europe, Global
Population
pediatric, adult, unilateral, bilateral
Trial IDs
0
Mechanism

An active implantable bone-conduction system using piezoelectric stimulation to bypass dysfunctional outer and middle ear structures and send sound directly to the cochlea.

Indications
Hearing LossConductive Hearing LossMixed Hearing LossSensorineural Hearing Loss
Notes

One of the most important active bone-conduction implant franchises; OSI300 shows ongoing platform refresh beyond the original Osia 2 configuration.

Evidence & Sources
3 structured sources
company
Supports: canonicalName, aliases, company, modality, mechanism, indications, populationTags, route
Open
regulatory
Supports: aliases, stage, status, geography, notes
IDs: K231204
Open
company
Supports: keyEvents, notes, geography
Open
Key Events
2019-12-11
FDA clearance announced for the Osia system
2024-01-31
FDA 510(k) entry documented the Osia OSI300 configuration
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