Hearing Aid, Air-Conduction, Prescription 510(k) Clearances
Product code ESD is the FDA classification for Hearing Aid, Air-Conduction, Prescription, a Class 1 device regulated under 21 CFR 874.3300, reviewed by the FDA Ear, Nose, Throat panel. FDA has cleared 1,367 510(k) submissions under this product code.
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
Every device cleared under product code ESD shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.
- Cleared devices
- 1,367
- Device class
- Class 1
- Regulation
- 874.3300
- Latest clearance
- 2024-04-11
Cleared devices under product code ESD
Showing the 50 most recent of 1,367 cleared devices. Clearances from 1997-07-23 to 2024-04-11.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | 2024-04-11 |
| K130790 | LYRIC2 | Phonak, LLC | 2013-06-27 |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | 2008-05-08 |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | 2002-11-19 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | 1999-03-12 |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | 1998-03-06 |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | 1998-01-20 |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | 1998-01-12 |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | 1997-12-15 |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Resound Corp. | 1997-12-12 |
| K974081 | RESOUND STEALTH CIC | Resound Corp. | 1997-12-12 |
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | 1997-12-12 |
| K974129 | HI-69E, HI-69N, HI-69P | Rockwin Corp. | 1997-12-12 |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | 1997-12-12 |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | 1997-12-12 |
| K973927 | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | Hyunjae Corp. | 1997-12-11 |
| 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 |
| K973885 | OTICON DIGISOUND ITE | Oticon, Inc. | 1997-11-04 |
| 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 |
| 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 |
| K973886 | OTICON DIGISOUND COMPACT | Oticon, Inc. | 1997-11-04 |
| K973846 | AIR CONDUCTION HEARING AID | Baron Trading, Inc. | 1997-10-29 |
| K973948 | DUALINE 100 BTE | Bernafon-Maico, Inc. | 1997-10-28 |
| K973579 | AM SERIES HEARING AID | A & M Hearing, Ltd. | 1997-10-28 |
| K973043 | MODEL C-1 HEARING AID | Better Hearing, Inc. | 1997-10-27 |
| K972818 | D72 DIGITAL | Philips Hearing Instruments Co. | 1997-10-17 |
| K973376 | LORI/LORI, LORI-S (LORI STOCK AID) | Lori Medical Laboratories, Inc. | 1997-10-14 |
| K973266 | Z DEQ-II | Electone, Inc. | 1997-09-23 |
| K972776 | DRY & STORE | Ear Technology Corp. | 1997-09-08 |
| K972998 | PRISMA | Siemens Hearing Instruments, Inc. | 1997-09-05 |
| K972039 | NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) | Nu-Sound | 1997-08-25 |
| K972106 | PHONAK NOVO FORTE E3 | Phonak, Inc. | 1997-08-15 |
| K972058 | LORIPRO, LORIPRO II | Lori Medical Laboratories, Inc. | 1997-08-15 |
| K971845 | HEARTLAND TECHNOLOGIES, ITE, ITC, CIC | Sound Hearing Instruments, Inc. | 1997-08-15 |
| K971852 | AIR CONDUCTION HAEARING AIDS | Beltone Electronics Corp. | 1997-08-15 |
| K971807 | IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL | Hear-Right, Inc. | 1997-08-07 |
| K972755 | V-12 LONG LIFE 675 HEARING AID | Vista Labs | 1997-08-05 |
| K972105 | PHONAK EPICA | Phonak, Inc. | 1997-08-01 |
| K972550 | AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC | Trutone | 1997-07-31 |
| K972097 | PHONAK MICROZOOM P 2 | Phonak, Inc. | 1997-07-30 |
| K972552 | AUDIFON H20 PC/AUDIFON H32 PP | Trutone | 1997-07-30 |
| K972373 | OVATION HDP | Orsonique, Inc. | 1997-07-29 |
| K972345 | DAHLBERG/MIRACLE-EAR | Miracle-Ear, Inc. | 1997-07-23 |
| K972431 | MERIDIAN DSP | Micro-Ear Technology, Inc. | 1997-07-23 |
| K971298 | BETTER HEARING, INC. MODEL L-1 HEARING AID | Better Hearing, Inc. | 1997-07-23 |
| K972543 | TWIST PPAGC-1, TWIST PP | Trutone | 1997-07-23 |
| K972344 | MIRACLE-EAR DIGITAL BTE | Miracle-Ear, Inc. | 1997-07-23 |
Filing a 510(k) for a Hearing Aid, Air-Conduction, Prescription of this type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.