EWOClass II

Audiometer

21 CFR 874.1050 / Ear, Nose, Throat

EWO is the FDA product code for Audiometer, a class II device type, regulated under 21 CFR 874.1050. As of 2026-09-10, FDA records hold 235 510(k) clearances under this code, the most recent dated 2024-06-21, and 5 recalls.

Classification record

Product code: EWO
Device name: Audiometer
Regulation: 21 CFR 874.1050
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 235
Ingested recalls: 5

Clearances, product code EWO

By decision year

235 clearances under product code EWO with a decision year between 1976 and 2024, 1998 the highest year at 20.

Show the numbers

510(k) clearances under FDA product code EWO by decision year
Year	Clearances
1976	1
1977	6
1978	7
1979	6
1980	6
1981	4
1982	3
1983	3
1984	5
1985	5
1986	7
1987	2
1988	5
1989	12
1990	12
1991	9
1992	6
1993	12
1994	16
1995	11
1996	4
1997	11
1998	20
1999	4
2000	4
2001	6
2002	1
2003	7
2005	2
2006	5
2007	5
2008	1
2009	2
2010	2
2011	3
2012	4
2013	2
2014	1
2015	4
2017	2
2018	2
2019	1
2022	1
2023	1
2024	2

Applicants with the most clearances

Product code EWO

Applicants holding the most 510(k) clearances under product code EWO
Applicant	Clearances
Maico Hearing Instruments, Inc.	20
Grason-Stadler, Inc.	12
Bio-Logic Systems Corp.	9
Etymotic Research, Inc.	8
Otodynamics, Ltd.	8
Interacoustics a/S	7
Tracor Instruments, Inc.	7
American Electromedics Corp.	6
Micro Audiometrics Corporation	6
Beltone Electronics Corp.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order