Maico Hearing Instruments, Inc.

Mchenry, IL, US

Maico Hearing Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 58 510(k) clearances between 1977-02-28 and 1996-03-07, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 58
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

Showing 50 of 58

FDA records hold 58 510(k) clearances for Maico Hearing Instruments, Inc. between 1977 and 1996. The busiest year on record is 1977, with 11. The most recent is 1996, with 1.

Clearances by year, as a table

510(k) clearance decisions for Maico Hearing Instruments, Inc., by decision year
Year	Clearances
1977	11
1978	4
1979	2
1980	1
1981	2
1982	1
1983	2
1984	4
1985	1
1986	4
1987	1
1988	4
1989	2
1990	2
1991	2
1992	1
1993	8
1994	1
1995	4
1996	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K960031	AUDIOFLEX 120	ESD	Substantially Equivalent	1996-03-07
K954054	MAICO PRODIGY CIC SERIES	ESD	Substantially Equivalent	1995-09-28
K953161	MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION	ETY	Substantially Equivalent	1995-07-24
K950637	MAICO IN-THE-EAR MODEL RD-312 CIC	ESD	Substantially Equivalent	1995-03-21
K946253	MAICO IN-THE-EAR MODEL RD 201	ESD	Substantially Equivalent	1995-01-30
K931322	KS 5 - CLINICAL AUDIOMETER	EWO	Substantially Equivalent	1994-08-19
K933291	MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID	ESD	Substantially Equivalent	1993-08-23
K930112	MAICO MA790 AUDIOMETER	EWO	Substantially Equivalent	1993-08-05
K926439	MA25 - PORTABLE AUDIOMETER, MODIFICATION	EWO	Substantially Equivalent	1993-08-05
K931161	SERIES STAR 22 - BEHIND THE EAR HEARING AID	ESD	Substantially Equivalent	1993-06-01
K931160	SERIES STAR 66 BEKHIND THE EAR HEARING AID	ESD	Substantially Equivalent	1993-06-01
K931041	STAR 42 PP-SP, STAR 42 PP-SL (T100)	ESD	Substantially Equivalent	1993-06-01
K931040	MT 80 SP	ESD	Substantially Equivalent	1993-06-01
K931035	MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID	ESD	Substantially Equivalent	1993-06-01
K922746	ST 20 PORTABLE AUDIOMETER	EWO	Substantially Equivalent	1992-11-05
K911368	MAICO MA800 AUDIOMETER	EWO	Substantially Equivalent	1991-06-26
K905704	MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER	ETY	Substantially Equivalent	1991-04-30
K903583	SERIES MCAXX (MODEL 851) ITE HEARING AID	ESD	Substantially Equivalent	1990-10-09
K895310	AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7	EWO	Substantially Equivalent	1990-01-23
K890993	AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID	EWO	Substantially Equivalent	1989-10-12
K890842	2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY	EWO	Substantially Equivalent	1989-06-07
K882691	MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX	ESD	Substantially Equivalent	1988-08-30
K882692	MODEL P20/P21 IN-THE-EAR HEARING AID	ESD	Substantially Equivalent	1988-07-15
K880466	SERIES S415/S425 - BEHIND-THE-EAR HEARING AID	ESD	Substantially Equivalent	1988-02-23
K880465	SERIES S515/S525 BEHIND-THE-EAR HEARING AID	ESD	Substantially Equivalent	1988-02-23
K873468	CUSTOM IN-THE-EAR HEARING AID SERIES MCA20	ESD	Substantially Equivalent	1987-09-29
K862770	AUDIOMETER/MASTER HEARING AID MF6	EWO	Substantially Equivalent	1986-08-15
K862769	FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR	LRB	Substantially Equivalent	1986-08-13
K862768	FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10	LRB	Substantially Equivalent	1986-08-13
K861597	BEHING-THE-EAR HEARING AID SERIES SP	ESD	Substantially Equivalent	1986-06-02
K853919	MA25 PORTABLE AUDIOMETER	EWO	Substantially Equivalent	1985-12-18
K841568	IMPEDANCE/PURE TONE AUDIOMETER MA620	ETY	Substantially Equivalent	1984-07-18
K841567	AUDIOMETER MA728	EWO	Substantially Equivalent	1984-06-27
K840298	MCA IN THE EAR CUSTOM HEARING AID	ESD	Substantially Equivalent	1984-04-17
K840825	SERIES MR IN-THE-EAR CUSTOM HEARING AID	ESD	Substantially Equivalent	1984-03-30
K831754	MA 610-IMPEDANCE AUDIOMETER	ETY	Substantially Equivalent	1983-07-07
K831755	MA600-IMPEDANCE AUDIOMETER	ETY	Substantially Equivalent	1983-07-06
K821760	SERIES M PUSH-PULL INPUT COMPRESSION	ESD	Substantially Equivalent	1982-06-25
K811727	PORTABLE AUDIOMETERS	EWO	Substantially Equivalent	1981-07-15
K811344	BEHIND-THE-EAR HEARING AID	ESD	Substantially Equivalent	1981-06-16
K801062	BEHIND-THE-EAR HEARING AID SERIES G	ESD	Substantially Equivalent	1980-06-04
K792198	SERIES S (BEHIND-THE-EAR-HEARING AID)	ESD	Substantially Equivalent	1979-11-27
K791170	MIS AURAL ACOUSTIC SCREENER	EWO	Unknown	1979-06-25
K780382	AUDIOMETER, PORTABLE, AIR CONDUCTION	EWO	Substantially Equivalent	1978-03-14
K780270	COMPUTER AUDIOMETER - MA26	EWO	Substantially Equivalent	1978-02-27
K780269	COMPUTER AUDIOMETER - MA25	EWO	Substantially Equivalent	1978-02-27
K780067	HEARING AID, BEHIND-THE-EAR	ESD	Substantially Equivalent	1978-01-20
K772201	HEARING AID, BODY TYPE, MODEL H	ESD	Substantially Equivalent	1977-12-20
K770960	HEARING AID, SERIES R	ESD	Substantially Equivalent	1977-06-14
K770885	HEARING AID, SERIES K-BEHIND-THE-EAR	ESD	Substantially Equivalent	1977-05-25

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain