Product Code: ETY FDA class 2 21 CFR 874.1090

Tester, Auditory Impedance

Ear, Nose, Throat

The auditory impedance tester is a diagnostic device that measures the acoustic impedance or admittance of the middle ear system to assess tympanic membrane mobility and middle ear function, used in the diagnosis of conditions such as otitis media and ossicular chain disorders. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is ETY, regulated under 21 CFR 874.1090 in the Ear, Nose, Throat specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ETY
Device Class: FDA class 2
Regulation Number: 874.1090
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 70 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K183201	Hearing Healthcare Pro	Mar 06, 2019	Substantially Equivalent	Db Diagnostic Systems, Inc.
K171038	Hearing Healthcare Pro	Aug 02, 2017	Substantially Equivalent	Db Diagnostic Systems, Inc.
K162210	touchTymp	Nov 16, 2016	Substantially Equivalent	Maico Diagnostics GmbH
K161707	Madsen Zodiac	Sep 01, 2016	Substantially Equivalent	Gn Otometrics
K151616	AT235	Jul 15, 2015	Substantially Equivalent	Interacoustics A/S
K151509	GSI TympStar Pro Middle Ear Analyzer	Jun 25, 2015	Substantially Equivalent	Diagnostic Group, Dba Grason-Stadler
K133013	INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE	Jan 24, 2014	Substantially Equivalent	Inventis S.R.L.
K121847	TITAN	Nov 29, 2012	Substantially Equivalent	Interacoustics A/S
K083861	TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE	Apr 09, 2009	Substantially Equivalent	Interacoustics AS
K081841	AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER	Jul 16, 2008	Substantially Equivalent	Amplivox, Ltd.
K070312	EARCHECK ACOUSTIC REFLECTOMETER	Mar 02, 2007	Substantially Equivalent	Innovia Medical, LLC
K033645	OTOFLEX 100 TYE 1012	Mar 31, 2004	Substantially Equivalent	Gn Otometrics A/S
K031978	AMPLAID A756 SCREENING ADMITTANCE METER	Jul 21, 2003	Substantially Equivalent	Amplaid
K022728	AUDIOTRAVELLER, MODEL AA222	Oct 11, 2002	Substantially Equivalent	Interacoustics A/S, Assens
K000097	GSI 2000 MIDDLE EAR ANALYZER	Apr 12, 2000	Substantially Equivalent	Grason-Stadler, Inc.
K994254	INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER	Mar 14, 2000	Substantially Equivalent	International Distributors of Electronics For Medi
K991562	PASCAL MEDICAL AB MENIETT 20	Dec 28, 1999	Substantially Equivalent	Pascal Medical AB
K992370	AMPLAID A724 AND A728	Sep 20, 1999	Substantially Equivalent	Amplifon S.P.A.
K990652	INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER	May 17, 1999	Substantially Equivalent	Idem (Int'L Dist. of Electronics For Medicine)
K990585	INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER	May 17, 1999	Substantially Equivalent	Idem (Int'L Dist. of Electronics For Medicine)
K983832	INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER	Jan 25, 1999	Substantially Equivalent	Idem (Int'L Dist. of Electronics For Medicine)
K983051	AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER	Nov 18, 1998	Substantially Equivalent	American Electromedics Corp.
K983049	AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER	Nov 18, 1998	Substantially Equivalent	American Electromedics Corp.
K983046	AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER	Nov 17, 1998	Substantially Equivalent	American Electromedics Corp.
K974235	AMPLAID AM50	Feb 10, 1998	Substantially Equivalent	Amplifon S.P.A.
K971859	EARCHECK	Aug 18, 1997	Substantially Equivalent	Mdi Instruments, Inc.
K970685	EARCHECK PRO	May 28, 1997	Substantially Equivalent	Mdi Instruments, Inc.
K955289	RACE CAR TYMPANOMETER	Dec 08, 1995	Substantially Equivalent	American Electromedics Corp.
K953161	MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION	Jul 24, 1995	Substantially Equivalent	Maico Hearing Instruments, Inc.
K942008	INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER	Aug 24, 1994	Substantially Equivalent	Precision Acoustics Ind., Inc.
K942007	INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26	Aug 24, 1994	Substantially Equivalent	Precision Acoustics Ind., Inc.
K930165	AE-207D TYMPANOMETER	Apr 23, 1993	Substantially Equivalent	Amrex Electronics, Inc.
K930164	THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S	Apr 23, 1993	Substantially Equivalent	American Electromedics Corp.
K923072	HANDTYMP	Mar 18, 1993	Substantially Equivalent	Life-Tech Intl., Inc.
K923073	AUTOMATIC TYMPANOMETER	Feb 19, 1993	Substantially Equivalent	Life-Tech Intl., Inc.
K925585	GSI 38 AUTO TYMP	Feb 02, 1993	Substantially Equivalent	Lucas Grason-Stadler, Inc.
K924934	AUTOMATIC IMPEDANCE METER AE-205	Jan 21, 1993	Substantially Equivalent	American Electromedics Corp.
K924933	AE-206 TYMPNOMWRWE(R) AUDIOMETER	Jan 21, 1993	Substantially Equivalent	American Electromedics Corp.
K910247	ZODIAC 901 MIDDLE-EAR ANALYZER	Jun 19, 1991	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K905704	MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER	Apr 30, 1991	Substantially Equivalent	Maico Hearing Instruments, Inc.
K911095	GSI 37 AUTO TYMP	Mar 29, 1991	Substantially Equivalent	Lucas Grason-Stadler, Inc.
K905213	MIDDLE EAR ANALYZER, MODEL AE-803	Feb 20, 1991	Substantially Equivalent	American Electromedics Corp.
K905212	IMMITTANCE METER, MODEL AE-105D/S	Feb 19, 1991	Substantially Equivalent	American Electromedics Corp.
K903066	AMPLAID 770 ADMITTANCE METER	Oct 24, 1990	Substantially Equivalent	Amplus Corp.
K894260	AE-105D DIAGNOSTIC TYMPANOMETER	Jan 23, 1990	Substantially Equivalent	American Electromedics Corp.
K895443	MODEL 210 IMPEDANCE SYSTEM	Jan 16, 1990	Substantially Equivalent	Virtual Corp.
K895783	IMPEDANCE ANALYZER MODELS MD-2, MD-P	Dec 05, 1989	Substantially Equivalent	Singer Medical Products, Inc.
K890864	HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.	Jun 21, 1989	Substantially Equivalent	Rastronics USA, Inc.
K883293	STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT	Jun 09, 1989	Substantially Equivalent	Storz Instrument Co.
K883728	AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER	Jan 03, 1989	Substantially Equivalent	American Electromedics Corp.
K874354	AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020	Jan 27, 1988	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K871652	NEUROCOM PRESSURE TEST SYSTEM	Jul 16, 1987	Substantially Equivalent	Neurocom International, Inc.
K863353	MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)	Nov 03, 1986	Substantially Equivalent	Grason-Stadler, Inc.
K861516	WELCH ALLYN TYMPANOMETER	Jun 10, 1986	Substantially Equivalent	Welch Allyn, Inc.
K860262	TA-6C - PART NUMBER SLZ 7520	Apr 23, 1986	Substantially Equivalent	Teledyne Avionics Div. of Teledyne
K854043	AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B	Dec 31, 1985	Substantially Equivalent	Teledyne Avionics Div. of Teledyne
K853863	MODEL 310 IMPEDANCE SYSTEM	Dec 18, 1985	Substantially Equivalent	Virtual Corp.
K845049	Z0174, IMPEDANCE AUDIOMETER	May 21, 1985	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K850461	AUTOMATIC IMPEDANCE METER TA-7A	Mar 25, 1985	Substantially Equivalent	Teledyne Avionics Div. of Teledyne
K850007	ACOUSTIC OTOCOPE RECORDER	Mar 01, 1985	Substantially Equivalent	Endeco Medical, Inc.
K841568	IMPEDANCE/PURE TONE AUDIOMETER MA620	Jul 18, 1984	Substantially Equivalent	Maico Hearing Instruments, Inc.
K833045	CLINICAL TYMPANOMETER	Dec 08, 1983	Substantially Equivalent	American Electromedics Corp.
K831754	MA 610-IMPEDANCE AUDIOMETER	Jul 07, 1983	Substantially Equivalent	Maico Hearing Instruments, Inc.
K831755	MA600-IMPEDANCE AUDIOMETER	Jul 06, 1983	Substantially Equivalent	Maico Hearing Instruments, Inc.
K830139	ENDECO ACOUSTIC OTOSCOPE	Mar 09, 1983	Substantially Equivalent	Endeco Medical, Inc.
K823227	IMPEDANCE METER ON-1	Nov 22, 1982	Substantially Equivalent	Kells Medical, Inc.
K822566	AURAL REFLEX INDICATOR	Sep 14, 1982	Substantially Equivalent	Kelleher Corp.
K811509	AUTO-TYMPANIGRAPH (TA-5A)	Jun 16, 1981	Substantially Equivalent	Teledyne Avionics Div. of Teledyne
K802097	SELF-RECORDING ADMITTANCE METER 709	Oct 10, 1980	Substantially Equivalent	Amplaid USA, Inc.
K801293	ACOUSTIC IMPEDANCE METER, MODEL TA-4D	Jun 17, 1980	Substantially Equivalent	Teledyne Avionics Div. of Teledyne