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General regulatory information only. This page is not medical advice and does not describe surgery, candidacy or fitting.
Short answer
Osia is a brand name. The device category behind it is an active implantable bone conduction hearing system, which the US FDA regulates under 21 CFR 874.3340 as a Class II prescription device with product code PFO. The regulation defines three parts: an implanted transducer, implanted electronics and an audio processor. Its 510(k) record, K231204, lists a Cochlear Osia system cleared on 2023-08-18.
Definition and scope
21 CFR 874.3340(a) identifies an active implantable bone conduction hearing system as a prescription device consisting of an implanted transducer, implanted electronics components and an audio processor. It is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. The FDA classification database lists the same device name, medical specialty Ear, Nose, Throat, device class 2 and an implant flag of Y for product code PFO.
The regulation was published at 83 FR 54009 on 2018-10-26. Its text does not use the word “percutaneous”, so this page makes no statement about devices outside what the section itself describes. For the clinical specialty that treats hearing and ear disorders, see what otolaryngology is.
What the regulation says the system consists of
- Implanted transducer: named first in the definition and implanted.
- Implanted electronics components: named separately from the transducer and also implanted.
- Audio processor: the third named part, listed after the two implanted parts.
The three-part wording is the regulator’s definition, so it is the reference point when a brand name, a model number or a marketing term is used for any one of these parts.
Special controls and required labeling
Class II (special controls) means a manufacturer must meet the specific controls in 874.3340(b). The table restates them in plain language; every row comes directly from that paragraph.
| Area | What 874.3340(b) requires |
|---|---|
| Clinical performance testing | Characterize adverse events seen during implantation and clinical use, and show the device performs as intended under anticipated conditions of use. |
| Force output | Performance data must validate force output in a clinically relevant model. |
| Impact | Impact testing in a clinically relevant anatomic model. |
| Mechanical integrity and reliability | Mechanical integrity testing, and reliability testing consistent with expected device life. |
| Biocompatibility | Patient-contacting components must be shown to be biocompatible. |
| Sterility and shelf life | Data must show sterility of patient-contacting components and support the shelf life (continued sterility, package integrity and device function). |
| Wireless, EMC, electrical safety | Data must demonstrate wireless compatibility, electromagnetic compatibility and electrical safety. |
| Software | Software verification, validation and hazard analysis. |
The same paragraph lists six required labeling items: a summary of clinical testing including device-related complications and adverse events; instructions for use; a surgical guide for implantation that includes instructions for imaging to assess bone dimensions; a shelf life for components provided sterile; a patient identification card; and a patient user manual.
How to look up a cleared system
Three identifiers connect a brand to the regulation, and all three are public in FDA databases.
- Product code: PFO, whose classification record names 21 CFR 874.3340.
- Regulation number: 874.3340, the section quoted above.
- 510(k) number: for example K231204. Its record shows applicant Cochlear, product code PFO, regulation number 874.3340, decision date 08/18/2023 and review panel Ear Nose and Throat. The device names in the clearance include the Osia System, an implant, a magnet cassette, a sound processor, fitting software and a smartphone app.
That list of cleared device names shows that a single clearance can cover implanted parts, an external processor and software together. For how 510(k) clearance and classification work in general, see the guides on FDA 510(k) premarket notification and FDA device classification, 510(k) and PMA.
Where it matters for labs, clinics and supply records
The labeling items in 874.3340(b)(8) are the documents the regulation expects to accompany this type of system: instructions for use, a surgical guide with imaging instructions, a patient identification card and a patient user manual, plus a stated shelf life for sterile components. A clinic or supply file that refers to the system by brand name can be matched to these identifiers (product code, regulation number, 510(k) number). For device identification on labels, see UDI for medical devices. For a supply-list example from the hearing field, see the audiology clinic supply checklist.
Common misunderstandings
A brand name is the regulatory category
It is not. The regulation and product code describe a category; Osia appears in the 510(k) record as a device name within it.
A bone conduction implant is a cochlear implant
The regulation describes conveying signals to the cochlea via mechanical vibrations on the skull bone, not electrical stimulation. For the general comparison between hearing aids and cochlear implants, see hearing aid vs cochlear implant. The middle-ear prosthesis in TORP is a different device again.
Clearance equals suitability for any person
The regulation sets requirements for the device and its labeling. Whether a given system suits a given person is a clinical decision for a qualified clinician and is outside this page.
FAQ
Is Osia a type of device or a brand?
A brand. The FDA category is an active implantable bone conduction hearing system (21 CFR 874.3340, product code PFO), and the Osia System appears as a device name in 510(k) record K231204.
What parts does the FDA definition list?
Three: an implanted transducer, implanted electronics components and an audio processor.
What FDA class is this device type?
Class II (special controls), as a prescription device.
How do I find the FDA record for a specific system?
Search the FDA 510(k) database by 510(k) number, or use product code PFO and regulation number 874.3340 to list related records.
Does the regulation cover percutaneous bone conduction systems?
The text of 874.3340 does not use the word “percutaneous”, so this page makes no statement on them.
Sources
- 21 CFR 874.3340, Active implantable bone conduction hearing system, eCFR: ecfr.gov. Checked 2026-10-30.
- FDA 510(k) database, K231204: accessdata.fda.gov. Checked 2026-10-30.
- FDA device classification, product code PFO, via openFDA: api.fda.gov. Checked 2026-10-30.
