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
577–600 of 1367
Cleared Jan 22, 1990
DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID
K896159
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 16, 1990
MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
K896057
Rexton, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 10, 1990
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
K896056
Rexton, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 24, 1989
3M INSTANT FIT CUSTOM EARMOLD
K895134
3M Company
Ear, Nose, Throat · 69d
Cleared Oct 11, 1989
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
K895140
Oticon Corp.
Ear, Nose, Throat · 56d
Cleared Aug 15, 1989
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
K893528
Oticon Corp.
Ear, Nose, Throat · 99d
Cleared Aug 08, 1989
ASTRO BEHIND-THE-EAR HEARING AID
K892898
Rexton, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 04, 1989
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K893432
Electone, Inc.
Ear, Nose, Throat · 94d
Cleared Aug 04, 1989
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927
Resound Corp.
Ear, Nose, Throat · 65d
Cleared Aug 03, 1989
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
K892338
Qualitone
Ear, Nose, Throat · 120d
Cleared Jun 14, 1989
PERSONAL AMPLIFIER MODEL ULTRA HELIX
K893433
Electone, Inc.
Ear, Nose, Throat · 43d
Cleared May 19, 1989
REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
K892333
Rexton, Inc.
Ear, Nose, Throat · 44d
Cleared May 19, 1989
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
K892336
Qualitone
Ear, Nose, Throat · 44d
Cleared May 10, 1989
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
K892337
Qualitone
Ear, Nose, Throat · 35d
Cleared Mar 31, 1989
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
K891251
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 29, 1989
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
K891011
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
K891248
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 303 ASP
K891249
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
K891250
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 17, 1989
CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A
K890703
Oticon Corp.
Ear, Nose, Throat · 35d
Cleared Mar 09, 1989
BTE HEARING AID OTICON MODEL: E42P
K890704
Oticon Corp.
Ear, Nose, Throat · 27d
Cleared Mar 01, 1989
WIDEX BTE HEARING AID MODEL Q8
K885128
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 79d
Cleared Feb 22, 1989
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
K884871
Resound Corp.
Ear, Nose, Throat · 93d
Cleared Jan 18, 1989
BTE HEARING AID SIEMENS MODEL 284PP-ASP
K884583
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 77d