Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ESD — Predicate Candidate Screening
1,367 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
104 days90th percentile
1,367clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | 2024-04-11 | 202 | 0 |
| K130790 | LYRIC2 | Phonak, LLC | 2013-06-27 | 97 | 0 |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | 2008-05-08 | 17 | 1 |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | 2002-11-19 | 166 | 0 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-04-24 | 158 | 0 |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WI | Sonic Innovations, Inc. | 1999-03-12 | 81 | 0 |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | 1998-03-06 | 77 | 0 |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | 1998-01-20 | 69 | 0 |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | 1998-01-12 | 90 | 0 |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | 1997-12-15 | 48 | 0 |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | 1997-12-15 | 41 | 0 |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | 1997-12-15 | 35 | 0 |
| K974081 | RESOUND STEALTH CIC | Resound Corp. | 1997-12-12 | 44 | 0 |
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | 1997-12-12 | 24 | 0 |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | 1997-12-12 | 24 | 0 |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | 1997-12-12 | 24 | 0 |
| K974129 | HI-69E, HI-69N, HI-69P | Rockwin Corp. | 1997-12-12 | 39 | 0 |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMME | Resound Corp. | 1997-12-12 | 29 | 0 |
| K973927 | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | Hyunjae Corp. | 1997-12-11 | 57 | 0 |
| K973861 | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 5 | Magnatone Hearing Aid Corp. | 1997-11-19 | 41 | 0 |
| K973972 | PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C | Perfect Ear | 1997-11-04 | 15 | 0 |
| K973665 | MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ | Magnatone Hearing Aid Corp. | 1997-11-04 | 40 | 0 |
| K973886 | OTICON DIGISOUND COMPACT | Oticon, Inc. | 1997-11-04 | 21 | 0 |
| K973885 | OTICON DIGISOUND ITE | Oticon, Inc. | 1997-11-04 | 21 | 0 |
| K973846 | AIR CONDUCTION HEARING AID | Baron Trading, Inc. | 1997-10-29 | 21 | 0 |
| K973948 | DUALINE 100 BTE | Bernafon-Maico, Inc. | 1997-10-28 | 12 | 0 |
| K973579 | AM SERIES HEARING AID | A & M Hearing, Ltd. | 1997-10-28 | 39 | 0 |
| K973043 | MODEL C-1 HEARING AID | Better Hearing, Inc. | 1997-10-27 | 73 | 0 |
| K972818 | D72 DIGITAL | Philips Hearing Instruments Co. | 1997-10-17 | 80 | 0 |
| K973376 | LORI/LORI, LORI-S (LORI STOCK AID) | Lori Medical Laboratories, Inc. | 1997-10-14 | 36 | 0 |
| K973266 | Z DEQ-II | Electone, Inc. | 1997-09-23 | 25 | 0 |
| K972776 | DRY & STORE | Ear Technology Corp. | 1997-09-08 | 45 | 0 |
| K972998 | PRISMA | Siemens Hearing Instruments, Inc. | 1997-09-05 | 24 | 0 |
| K972039 | NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) | Nu-Sound | 1997-08-25 | 84 | 0 |
| K971845 | HEARTLAND TECHNOLOGIES, ITE, ITC, CIC | Sound Hearing Instruments, Inc. | 1997-08-15 | 88 | 0 |
| K971852 | AIR CONDUCTION HAEARING AIDS | Beltone Electronics Corp. | 1997-08-15 | 87 | 0 |
| K972058 | LORIPRO, LORIPRO II | Lori Medical Laboratories, Inc. | 1997-08-15 | 74 | 0 |
| K972106 | PHONAK NOVO FORTE E3 | Phonak, Inc. | 1997-08-15 | 71 | 0 |
| K971807 | IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL | Hear-Right, Inc. | 1997-08-07 | 84 | 0 |
| K972755 | V-12 LONG LIFE 675 HEARING AID | Vista Labs | 1997-08-05 | 14 | 0 |
| K972105 | PHONAK EPICA | Phonak, Inc. | 1997-08-01 | 57 | 0 |
| K972550 | AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC | Trutone | 1997-07-31 | 31 | 0 |
| K972097 | PHONAK MICROZOOM P 2 | Phonak, Inc. | 1997-07-30 | 56 | 0 |
| K972552 | AUDIFON H20 PC/AUDIFON H32 PP | Trutone | 1997-07-30 | 30 | 0 |
| K972373 | OVATION HDP | Orsonique, Inc. | 1997-07-29 | 34 | 0 |
| K972344 | MIRACLE-EAR DIGITAL BTE | Miracle-Ear, Inc. | 1997-07-23 | 29 | 0 |
| K971298 | BETTER HEARING, INC. MODEL L-1 HEARING AID | Better Hearing, Inc. | 1997-07-23 | 107 | 0 |
| K972346 | MIRACLE-EAR ITE DIGITAL | Miracle-Ear, Inc. | 1997-07-23 | 29 | 0 |
| K972542 | JAZZ PP AGC-O, JAZZ PP | Trutone | 1997-07-23 | 14 | 0 |
| K972543 | TWIST PPAGC-1, TWIST PP | Trutone | 1997-07-23 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda