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
1367 devices
601–624 of 1367
Cleared Jan 03, 1989
HEARING AID, UNITRON BTE MODEL UM60-AGC0
K884288
Unitron Industries, Inc.
Ear, Nose, Throat · 83d
Cleared Dec 19, 1988
HEARING AID WIDEX BTE
K884113
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 81d
Cleared Sep 22, 1988
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
K882678
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared Sep 01, 1988
HEARING AID, UNITRON MODEL VISTA 1000
K883513
Unitron Industries, Inc.
Ear, Nose, Throat · 15d
Cleared Aug 30, 1988
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 63d
Cleared Aug 09, 1988
HEARING AID, UNITRON MODEL UI5
K882375
Unitron Industries, Inc.
Ear, Nose, Throat · 62d
Cleared Jul 15, 1988
MODEL P20/P21 IN-THE-EAR HEARING AID
K882692
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Jun 07, 1988
DAHLBERG MODEL GP BODY AID
K881417
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 01, 1988
DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID
K881612
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 50d
Cleared May 18, 1988
IMPULSE TVC (RICHARDS, OMNI, MARCON)
K881143
Richards Medical Co., Inc.
Ear, Nose, Throat · 62d
Cleared Apr 11, 1988
STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
K880969
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Mar 18, 1988
CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
K880333
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 18, 1988
CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7
K880334
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 18, 1988
INTRA II SECRET EAR HEARING AIDS ISE
K880335
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 14, 1988
WIDEX HEARING AID MODEL C1
K880273
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 52d
Cleared Mar 09, 1988
MEMORYMATE HEARING AID MODEL 8200
K880082
3M Company
Ear, Nose, Throat · 57d
Cleared Feb 26, 1988
ADDVANTAGE:TVC MARCON
K880284
Richards Medical Co., Inc.
Ear, Nose, Throat · 32d
Cleared Feb 23, 1988
RIONET HEARING AID HB-75
K874510
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 113d
Cleared Feb 23, 1988
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP
K880285
Richards Medical Co., Inc.
Ear, Nose, Throat · 29d
Cleared Feb 23, 1988
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
K880286
Richards Medical Co., Inc.
Ear, Nose, Throat · 29d
Cleared Feb 23, 1988
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
K880465
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Feb 23, 1988
SERIES S415/S425 - BEHIND-THE-EAR HEARING AID
K880466
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Feb 22, 1988
AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID
K874831
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Feb 17, 1988
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID
K874830
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 85d