Medical Device Manufacturer · US , Mchenry , IL

Maico Hearing Instruments, Inc.

58 submissions · 57 cleared · Since 1977
58
Total
57
Cleared
0
Denied

Maico Hearing Instruments, Inc. — FDA 510(k) Submissions

Maico Hearing Instruments, Inc. has submitted 58 FDA 510(k) premarket notifications since 1977, of which 57 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Audiometer, Tester, Auditory Impedance, Face Plate Hearing Aid . Use the specialty filter in the sidebar to narrow results.

58 devices
1–25 of 58
AUDIOFLEX 120
K960031 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1996 65d
MAICO PRODIGY CIC SERIES
K954054 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1995 30d
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
K953161 · ETY Tester, Auditory Impedance · Ear, Nose, Throat
Jul 1995 17d
MAICO IN-THE-EAR MODEL RD-312 CIC
K950637 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 36d
MAICO IN-THE-EAR MODEL RD 201
K946253 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1995 38d
KS 5 - CLINICAL AUDIOMETER
K931322 · EWO Audiometer · Ear, Nose, Throat
Aug 1994 521d
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
K933291 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1993 48d
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · EWO Audiometer · Ear, Nose, Throat
Aug 1993 225d
MAICO MA790 AUDIOMETER
K930112 · EWO Audiometer · Ear, Nose, Throat
Aug 1993 206d
MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID
K931035 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1993 92d
MT 80 SP
K931040 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1993 92d
STAR 42 PP-SP, STAR 42 PP-SL (T100)
K931041 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1993 92d
SERIES STAR 66 BEKHIND THE EAR HEARING AID
K931160 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1993 85d
SERIES STAR 22 - BEHIND THE EAR HEARING AID
K931161 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1993 85d
ST 20 PORTABLE AUDIOMETER
K922746 · EWO Audiometer · Ear, Nose, Throat
Nov 1992 150d
MAICO MA800 AUDIOMETER
K911368 · EWO Audiometer · Ear, Nose, Throat
Jun 1991 90d
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · ETY Tester, Auditory Impedance · Ear, Nose, Throat
Apr 1991 130d
SERIES MCAXX (MODEL 851) ITE HEARING AID
K903583 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1990 62d
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · EWO Audiometer · Ear, Nose, Throat
Jan 1990 147d
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · EWO Audiometer · Ear, Nose, Throat
Oct 1989 227d
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · EWO Audiometer · Ear, Nose, Throat
Jun 1989 106d
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1988 63d
MODEL P20/P21 IN-THE-EAR HEARING AID
K882692 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1988 17d
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
K880465 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1988 20d
SERIES S415/S425 - BEHIND-THE-EAR HEARING AID
K880466 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1988 20d
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