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
793–816 of 1367
Cleared Feb 01, 1983
PHONIC EAR
K830098
Phonic Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 21, 1983
RIONET HEARING AID HB-32P
K823803
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jan 21, 1983
RIONET HEARING AID HB-69CI
K823847
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 07, 1983
101M IN-THE-EAR
K823073
Danavox, Inc.
Ear, Nose, Throat · 80d
Cleared Dec 28, 1982
HEARING AID UNITRON #UE4-H
K823669
Unitron Industries, Inc.
Ear, Nose, Throat · 21d
Cleared Dec 15, 1982
BEHIND-THE-EAR HEARING AID #8003
K823531
Danavox, Inc.
Ear, Nose, Throat · 16d
Cleared Dec 03, 1982
HEARING AID #G6H & G6T
K823431
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
MODELS G6H, G6T, G1H & G1T
K823460
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Nov 29, 1982
HEARING AID UE-10-H
K823366
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 22, 1982
HEARING AID UE-10
K823365
Unitron Industries, Inc.
Ear, Nose, Throat · 12d
Cleared Oct 13, 1982
HEARING AID, UNITRON MODEL UE7
K822805
Unitron Industries, Inc.
Ear, Nose, Throat · 26d
Cleared Oct 04, 1982
PHONIC EAR-PE 845-PPC
K822779
Phonic Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Sep 14, 1982
BEHIND-THE-EAR MODEL 115PPPCW
K822619
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 14, 1982
BEHIND-THE-EAR MODEL 115 V AGC O W
K822655
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 07, 1982
HEARING AID, UNITRON UE3-D/DN
K822506
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Aug 19, 1982
EARETTE HEARING AID OPTICON MODEL E28P
K821987
Oticon Corp.
Ear, Nose, Throat · 43d
Cleared Aug 19, 1982
BEHIND-THE-EAR MODEL SERIES 123
K822387
Danavox, Inc.
Ear, Nose, Throat · 10d
Cleared Aug 11, 1982
ENT RETRACTORS
K822163
Kelleher Corp.
Ear, Nose, Throat · 19d
Cleared Jul 14, 1982
HEARING AID, UNITRON MODELS UE3/3-N
K821899
Unitron Industries, Inc.
Ear, Nose, Throat · 16d
Cleared Jul 14, 1982
HEARING AID, UNITRON MODEL UE5
K821900
Unitron Industries, Inc.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
SERIES M PUSH-PULL INPUT COMPRESSION
K821760
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 10d
Cleared Jun 14, 1982
MODEL AH BEHING-THE-EAR-HEARING AID
K821550
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 20d
Cleared Jun 07, 1982
OTICON
K821325
Oticon Corp.
Ear, Nose, Throat · 34d
Cleared May 13, 1982
MODEL 28C HEAPING AID
K821132
Telex Communications, Inc.
Ear, Nose, Throat · 23d