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 Apr 24, 2001
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 158d
Cleared Dec 12, 1997
RESOUND STEALTH CIC
K974081
Resound Corp.
Ear, Nose, Throat · 44d
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 Sep 23, 1997
Z DEQ-II
K973266
Electone, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 05, 1997
PRISMA
K972998
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 15, 1997
AIR CONDUCTION HAEARING AIDS
K971852
Beltone Electronics Corp.
Ear, Nose, Throat · 87d
Cleared Aug 15, 1997
PHONAK NOVO FORTE E3
K972106
Phonak, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 01, 1997
PHONAK EPICA
K972105
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 30, 1997
PHONAK MICROZOOM P 2
K972097
Phonak, Inc.
Ear, Nose, Throat · 56d
Cleared Jul 23, 1997
MIRACLE-EAR DIGITAL BTE
K972344
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
DAHLBERG/MIRACLE-EAR
K972345
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
MIRACLE-EAR ITE DIGITAL
K972346
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 03, 1997
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K971605
Resound Corp.
Ear, Nose, Throat · 63d
Cleared Jun 06, 1997
WIDEX SENSO DIGITAL (MINI CANAL)
K971535
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d
Cleared Jun 06, 1997
RIONET HB-79P
K971693
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 30d
Cleared May 08, 1997
UNITRON MODEL SOUND F/X CIC
K970692
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared May 02, 1997
PRECISE IMPRESSION KIT
K970952
Starkey Laboratories, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 24, 1997
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K970519
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared Mar 31, 1997
AUDALLION II HEARING SYSTEM
K970215
Resound Corp.
Ear, Nose, Throat · 69d
Cleared Mar 31, 1997
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262
Miracle-Ear, Inc.
Ear, Nose, Throat · 67d

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.