Hearing assist
Meta Platform Technologies, LLC · K254044
FDA-authorized Predetermined Change Control Plan
- Company
- Meta Platform Technologies, LLC
- 510(k)/De Novo #
- K254044
- Decision date
- 2026-07-13
- Panel
- Ear, Nose, Throat
- Pathway
- 510(k)
- Category
- AI/SaMD
- PCCP type
- Compatibility expansion
- Monitoring commitment
- Not stated
What this PCCP covers. Permits compatibility expansion to additional hardware
Other Ear, Nose, Throat PCCPs
Want the monitoring teardown?
We read the PCCP for Hearing assist, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.