ESD · Class I · 21 CFR 874.3300

FDA Product Code ESD: Hearing Aid, Air-conduction, Prescription

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.

Leading manufacturers include Unitron Industries, Inc., Miracle-Ear, Inc. and Electone, Inc..

1367
Total
1367
Cleared
56d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Hearing Aid, Air-conduction, Prescription Devices (Product Code ESD)

1367 devices
1–24 of 1367
Cleared Apr 11, 2024
Lyric4 Hearing Aid
K232999
Sonova AG
Ear, Nose, Throat · 202d
Cleared Jun 27, 2013
LYRIC2
K130790
Phonak, LLC
Ear, Nose, Throat · 97d
Cleared May 08, 2008
LYRIC HEARING AID
K081136
Insound Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Apr 24, 2001
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 158d
Cleared Mar 12, 1999
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
K984518
Sonic Innovations, Inc.
Ear, Nose, Throat · 81d
Cleared Mar 06, 1998
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
K974751
General Hearing Instruments, Inc.
Ear, Nose, Throat · 77d
Cleared Jan 20, 1998
ARGOSY PROGRAMMABLE ONQUE
K974242
Argosy Electronics
Ear, Nose, Throat · 69d
Cleared Jan 12, 1998
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
K973880
Sonix Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Dec 15, 1997
OPUS 2 - CANAL SERIES (ITC)
K974069
Bernafon-Maico, Inc.
Ear, Nose, Throat · 48d
Cleared Dec 15, 1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
K974152
Bernafon-Maico, Inc.
Ear, Nose, Throat · 41d
Cleared Dec 15, 1997
OPUS 2 - FULL CONCHA SERIES - ITE
K974211
Bernafon-Maico, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 12, 1997
RESOUND STEALTH CIC
K974081
Resound Corp.
Ear, Nose, Throat · 44d
Cleared Dec 12, 1997
HI-69E, HI-69N, HI-69P
K974129
Rockwin Corp.
Ear, Nose, Throat · 39d
Cleared Dec 12, 1997
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
K974257
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Dec 12, 1997
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
K974338
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XD PROGRAMMABLE
K974339
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
K974340
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 11, 1997
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
K973927
Hyunjae Corp.
Ear, Nose, Throat · 57d
Cleared Nov 19, 1997
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
K973861
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 41d
Cleared Nov 04, 1997
MAGNATONE / STERLING/ ST
K973665
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 40d
Cleared Nov 04, 1997
OTICON DIGISOUND ITE
K973885
Oticon, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 04, 1997
OTICON DIGISOUND COMPACT
K973886
Oticon, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 04, 1997
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
K973972
Perfect Ear
Ear, Nose, Throat · 15d
Cleared Oct 29, 1997
AIR CONDUCTION HEARING AID
K973846
Baron Trading, Inc.
Ear, Nose, Throat · 21d

About Product Code ESD - Regulatory Context

510(k) Submission Activity

1367 total 510(k) submissions under product code ESD since 1976, with 1367 receiving FDA clearance (average review time: 56 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.