KHL · Class II · 21 CFR 874.3330

FDA Product Code KHL: Hearing Aid, Master

Leading manufacturers include Starkey Laboratories, Inc., Craigwell Electronics, Ltd. and Voroba Technologies Assoc..

7
Total
7
Cleared
91d
Avg days
1979
Since

FDA 510(k) Cleared Hearing Aid, Master Devices (Product Code KHL)

7 devices
1–7 of 7
Cleared Jan 08, 1997
LORI HEARING AID SIMULATOR
K964080
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 89d
Cleared Oct 23, 1991
PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
K911726
Bausch & Lomb, Inc.
Ear, Nose, Throat · 195d
Cleared Sep 21, 1989
RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE
K894019
Resound Corp.
Ear, Nose, Throat · 107d
Cleared May 02, 1986
VOROBA PROGRAMMABLE AUDITORY COMPARATOR
K860171
Voroba Technologies Assoc.
Ear, Nose, Throat · 105d
Cleared Jan 16, 1986
CRAIGWELL MASTER HEARING AID MHA
K854126
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Apr 03, 1979
MODEL FS1
K790481
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d

About Product Code KHL - Regulatory Context