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
481–504 of 1367
Cleared May 17, 1991
REGAL, BEHIND-THE-EAR HEARING AID
K911707
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL E-50, IN-THE-EAR HEARING AID
K911708
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
STOCK CANAL, IN-THE-EAR HEARING AID
K911709
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 07, 1991
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
K911579
Starkey Laboratories, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 19, 1991
CUSTOM PERSONAL EAR - CPE
K911497
Qualitone
Ear, Nose, Throat · 18d
Cleared Apr 19, 1991
ADJUSTRETTE - DAO, MODIFICATION
K911498
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ELEGANCE - DEO, MODIFICATION
K911499
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ULTRA & ULTRA LITE II, MODIFICATION
K911504
Qualitone
Ear, Nose, Throat · 16d
Cleared Apr 17, 1991
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
K911210
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 17, 1991
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
K911211
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 15, 1991
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
K911209
Phonak, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 03, 1991
RESORBABLE BONE PLUG
K905740
Zimmer, Inc.
Ear, Nose, Throat · 100d
Cleared Apr 03, 1991
ELECTONE ITE MODEL PREMIER
K910097
Electone, Inc.
Ear, Nose, Throat · 84d
Cleared Mar 21, 1991
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
K910809
Miracle-Ear, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 21, 1991
DAHLBERG MODEL LT BTE HEARING AID
K910979
Miracle-Ear, Inc.
Ear, Nose, Throat · 14d
Cleared Mar 21, 1991
DAHLBERG MODEL LU BTE HEARING AID
K911063
Miracle-Ear, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 21, 1991
DAHLBERG MODEL LG BTE HEARING AID
K911064
Miracle-Ear, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 21, 1991
DAHLBERG MODEL LZ BTE HEARING AID
K911096
Miracle-Ear, Inc.
Ear, Nose, Throat · 9d
Cleared Mar 15, 1991
MATRICS
K904756
Kerr Corporation (Danbury)
Ear, Nose, Throat · 147d
Cleared Mar 13, 1991
3M MODEL 8240 ITE HEARING AID
K910690
3M Company
Ear, Nose, Throat · 22d
Cleared Mar 08, 1991
POST AURICULAR HEARING AID MODEL PICO SC-H
K910028
Phonak, Inc.
Ear, Nose, Throat · 63d
Cleared Feb 28, 1991
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
K910012
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Feb 28, 1991
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
K910018
Phonak, Inc.
Ear, Nose, Throat · 55d
Cleared Feb 28, 1991
PHILIPS MODEL S46-OL BTE HEARING AID
K910743
Philips Hearing Instruments Co.
Ear, Nose, Throat · 7d