Product code ESD: 510(k) clearances and predicates
Product code ESD covers Lyric4 Hearing Aid. FDA lists 1367 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
1367 clearances on file under product code ESD. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 1 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest ESD clearances in the FDA index, with applicant and decision date:
- K232999, Lyric4 Hearing Aid, applicant Sonova AG, decided 2024-04-11. FDA record
- K130790, LYRIC2, applicant Phonak, LLC, decided 2013-06-27. FDA record
- K081136, LYRIC HEARING AID, applicant Insound Medical, Inc., decided 2008-05-08. FDA record
- K021867, INSOUND XT SERIES HEARING AID, applicant Insound Medical, Inc., decided 2002-11-19. FDA record
- K003558, TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION), applicant Siemens Hearing Instruments, Inc., decided 2001-04-24. FDA record
- K984518, SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL, applicant Sonic Innovations, Inc., decided 1999-03-12. FDA record
- K974751, TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC, applicant General Hearing Instruments, Inc., decided 1998-03-06. FDA record
- K974242, ARGOSY PROGRAMMABLE ONQUE, applicant Argosy Electronics, decided 1998-01-20. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include LYRIC2, LYRIC HEARING AID. Watch new ESD clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code ESD?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent ESD clearances include Lyric4 Hearing Aid.
How many 510(k) clearances use product code ESD?
1367 at the time this page was generated, from openFDA records.
How do I find a predicate device under ESD?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new ESD clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.