ETYClass II

Tester, Auditory Impedance

21 CFR 874.1090 / Ear, Nose, Throat

ETY is the FDA product code for Tester, Auditory Impedance, a class II device type, regulated under 21 CFR 874.1090. As of 2026-09-10, FDA records hold 70 510(k) clearances under this code, the most recent dated 2019-03-06, and one recall.

Classification record

Product code: ETY
Device name: Tester, Auditory Impedance
Regulation: 21 CFR 874.1090
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 70
Ingested recalls: 1

Clearances, product code ETY

By decision year

70 clearances under product code ETY with a decision year between 1980 and 2019, 1993 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code ETY by decision year
Year	Clearances
1980	2
1981	1
1982	2
1983	4
1984	1
1985	5
1986	3
1987	1
1988	1
1989	4
1990	3
1991	5
1993	7
1994	2
1995	2
1997	2
1998	4
1999	5
2000	2
2002	1
2003	1
2004	1
2007	1
2008	1
2009	1
2012	1
2014	1
2015	2
2016	2
2017	1
2019	1

Applicants with the most clearances

Product code ETY

Applicants holding the most 510(k) clearances under product code ETY
Applicant	Clearances
American Electromedics Corp.	12
Maico Hearing Instruments, Inc.	5
Teledyne Avionics Div. of Teledyne	5
Idem (Int'L Dist. of Electronics for Medicine)	3
Interacoustics a/S	3
Madsen Electronics (Canada), Ltd.	3
Amplifon	2
Db Diagnostic Systems, Inc.	2
Endeco Medical, Inc.	2
Natus Medical Denmark ApS	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order