FDA Product Code
FDA Product Code ESD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3300
510(k) Clearances — 1,367 records · page 1 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | 2024-04-11 | Traditional | PDF ↗ |
| K130790 | LYRIC2 | Phonak, LLC | 2013-06-27 | Traditional | PDF ↗ |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | 2008-05-08 | Traditional | PDF ↗ |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | 2002-11-19 | Traditional | PDF ↗ |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-04-24 | Traditional | PDF ↗ |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | 1999-03-12 | Traditional | PDF ↗ |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | 1998-03-06 | Traditional | PDF ↗ |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | 1998-01-20 | Traditional | PDF ↗ |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | 1998-01-12 | Traditional | PDF ↗ |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | 1997-12-15 | Traditional | PDF ↗ |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | 1997-12-15 | Traditional | PDF ↗ |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | 1997-12-15 | Traditional | PDF ↗ |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | 1997-12-12 | Traditional | PDF ↗ |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Resound Corp. | 1997-12-12 | Traditional | PDF ↗ |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | 1997-12-12 | Traditional | PDF ↗ |
| K974081 | RESOUND STEALTH CIC | Resound Corp. | 1997-12-12 | Traditional | PDF ↗ |
| K974129 | HI-69E, HI-69N, HI-69P | Rockwin Corp. | 1997-12-12 | Traditional | PDF ↗ |
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | 1997-12-12 | Traditional | PDF ↗ |
| K973927 | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | Hyunjae Corp. | 1997-12-11 | Traditional | PDF ↗ |
| K973861 | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 | Magnatone Hearing Aid Corp. | 1997-11-19 | Traditional | PDF ↗ |
| K973972 | PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) | Perfect Ear | 1997-11-04 | Traditional | PDF ↗ |
| K973886 | OTICON DIGISOUND COMPACT | Oticon, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K973885 | OTICON DIGISOUND ITE | Oticon, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K973665 | MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER | Magnatone Hearing Aid Corp. | 1997-11-04 | Traditional | PDF ↗ |
| K973846 | AIR CONDUCTION HEARING AID | Baron Trading, Inc. | 1997-10-29 | Traditional | PDF ↗ |
| K973948 | DUALINE 100 BTE | Bernafon-Maico, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K973579 | AM SERIES HEARING AID | A & M Hearing, Ltd. | 1997-10-28 | Traditional | PDF ↗ |
| K973043 | MODEL C-1 HEARING AID | Better Hearing, Inc. | 1997-10-27 | Traditional | PDF ↗ |
| K972818 | D72 DIGITAL | Philips Hearing Instruments Co. | 1997-10-17 | Traditional | PDF ↗ |
| K973376 | LORI/LORI, LORI-S (LORI STOCK AID) | Lori Medical Laboratories, Inc. | 1997-10-14 | Traditional | PDF ↗ |
| K973266 | Z DEQ-II | Electone, Inc. | 1997-09-23 | Traditional | PDF ↗ |
| K972776 | DRY & STORE | Ear Technology Corp. | 1997-09-08 | Traditional | PDF ↗ |
| K972998 | PRISMA | Siemens Hearing Instruments, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K972039 | NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) | Nu-Sound | 1997-08-25 | Traditional | PDF ↗ |
| K971845 | HEARTLAND TECHNOLOGIES, ITE, ITC, CIC | Sound Hearing Instruments, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K972106 | PHONAK NOVO FORTE E3 | Phonak, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K972058 | LORIPRO, LORIPRO II | Lori Medical Laboratories, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K971852 | AIR CONDUCTION HAEARING AIDS | Beltone Electronics Corp. | 1997-08-15 | Traditional | PDF ↗ |
| K971807 | IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL | Hear-Right, Inc. | 1997-08-07 | Traditional | PDF ↗ |
| K972755 | V-12 LONG LIFE 675 HEARING AID | Vista Labs | 1997-08-05 | Traditional | PDF ↗ |
| K972105 | PHONAK EPICA | Phonak, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K972550 | AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC | Trutone | 1997-07-31 | Traditional | PDF ↗ |
| K972097 | PHONAK MICROZOOM P 2 | Phonak, Inc. | 1997-07-30 | Traditional | PDF ↗ |
| K972552 | AUDIFON H20 PC/AUDIFON H32 PP | Trutone | 1997-07-30 | Traditional | PDF ↗ |
| K972373 | OVATION HDP | Orsonique, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K972345 | DAHLBERG/MIRACLE-EAR | Miracle-Ear, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K972542 | JAZZ PP AGC-O, JAZZ PP | Trutone | 1997-07-23 | Traditional | PDF ↗ |
| K972543 | TWIST PPAGC-1, TWIST PP | Trutone | 1997-07-23 | Traditional | PDF ↗ |
| K971298 | BETTER HEARING, INC. MODEL L-1 HEARING AID | Better Hearing, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K972344 | MIRACLE-EAR DIGITAL BTE | Miracle-Ear, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K972431 | MERIDIAN DSP | Micro-Ear Technology, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K972346 | MIRACLE-EAR ITE DIGITAL | Miracle-Ear, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971699 | ARGOSY DYNAMEQ | Argosy Electronics | 1997-07-03 | Traditional | PDF ↗ |
| K971605 | RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | Resound Corp. | 1997-07-03 | Traditional | PDF ↗ |
| K971296 | TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 | National Hearing Aid Dist., Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K971031 | AUDALLION III HEARING SYSTEM | Gn Danavox, Inc. | 1997-06-17 | Traditional | PDF ↗ |
| K971032 | DANAVOX MODELS 163/162 BTE | Gn Danavox, Inc. | 1997-06-17 | Traditional | PDF ↗ |
| K971158 | DUALINE 400 CIC | Bernafon-Maico, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K971399 | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC | General Hearing Instruments, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K970939 | VISTA V-38 CIC | Vista Labs | 1997-06-06 | Traditional | PDF ↗ |
| K971299 | SCIENTIFIC PLASTICS MODEL SP | Scientific Plastics, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K971535 | WIDEX SENSO DIGITAL (MINI CANAL) | Widex Hearing Aid Co., Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K971693 | RIONET HB-79P | Authorized Hearing Systems, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K970880 | POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN | Micro-Ear Technology, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K971804 | PHILIPS S1694, S1695 | Philips Hearing Instruments Co. | 1997-06-06 | Traditional | PDF ↗ |
| K970828 | UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER | United Hearing Systems, Inc. | 1997-05-28 | Traditional | PDF ↗ |
| K970692 | UNITRON MODEL SOUND F/X CIC | Unitron Industries, Inc. | 1997-05-08 | Traditional | PDF ↗ |
| K970952 | PRECISE IMPRESSION KIT | Starkey Laboratories, Inc. | 1997-05-02 | Traditional | PDF ↗ |
| K970519 | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) | Unitron Industries, Inc. | 1997-04-24 | Traditional | PDF ↗ |
| K964898 | IN THE EAR HEARING AID | Keytone Hearing Laboratory | 1997-04-21 | Traditional | PDF ↗ |
| K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) | Miracle-Ear, Inc. | 1997-03-31 | Traditional | PDF ↗ |
| K970215 | AUDALLION II HEARING SYSTEM | Resound Corp. | 1997-03-31 | Traditional | PDF ↗ |
| K970537 | REXTON MODEL 48 AND 49PP | Rexton, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K970904 | WIDEX SENSO DIGITAL (CIC) | Widex Hearing Aid Co., Inc. | 1997-03-26 | Traditional | PDF ↗ |
| K965254 | WIDEX MODEL SENSO DIGITAL (C9) | Widex Hearing Aid Co., Inc. | 1997-03-12 | Traditional | PDF ↗ |
| K970430 | ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI | Midwest City Hearing Aid Center | 1997-03-11 | Traditional | PDF ↗ |
| K970057 | AHS OMEGA SP | Authorized Hearing Systems, Inc. | 1997-02-26 | Traditional | PDF ↗ |
| K964657 | SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF | Micro-Ear Technology, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K964245 | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS | Starkey Laboratories, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K964419 | MIRACLE - EAR (ITE/ITC/CIC) | Miracle-Ear, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K965049 | DAHLBERG (A-554) | Miracle-Ear, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K965057 | AUDIOTONE (A554H) | Miracle-Ear, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K965063 | AUDIOTONE (A-552) | Miracle-Ear, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K964680 | COMFORTAID HEARING AID | Ethical Hearing Instruments | 1997-01-24 | Traditional | PDF ↗ |
| K965088 | M11 SERIES: M11, M11M | Philips Hearing Instruments Co. | 1997-01-24 | Traditional | PDF ↗ |
| K965218 | SENSO DIGITAL (C18) | Widex Hearing Aid Co., Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K964639 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II | Telex Communications, Inc. | 1997-01-21 | Traditional | PDF ↗ |
| K964816 | AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR | Audina Hearing Instrument | 1997-01-17 | Traditional | PDF ↗ |
| K964669 | MIRACLE-EAR OR AUDIOTONE | Miracle-Ear, Inc. | 1996-12-26 | Traditional | PDF ↗ |
| K964794 | DAHLBERG K-AMP BTE | Miracle-Ear, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K964683 | DIGIFOCUS ITE | Oticon, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K964603 | ARTICULAR HEARING AIDS | Decibel Instruments, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K963877 | AHS OMEGA CONCEPT | Authorized Hearing Systems, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K963878 | AHS OMEGA HF | Authorized Hearing Systems, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K963958 | IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT | Beltone Electronics Corp. | 1996-12-05 | Traditional | PDF ↗ |
| K964035 | PHONAK MICROLINK, PERSONAL FM RECEIVER | Phonak, Inc. | 1996-12-04 | Traditional | PDF ↗ |
| K964530 | DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT | Miracle-Ear, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K964502 | UNITRON MODEL SOUND F/XP +4 | Unitron Industries, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K964504 | UNITRON MODEL ICON AOHPL +4 | Unitron Industries, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K964503 | UNITRON MODEL SOUND F/X +4 | Unitron Industries, Inc. | 1996-11-27 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.