ETWClass II

Calibrator, Hearing Aid / Earphone And Analysis Systems

21 CFR 874.3310 / Ear, Nose, Throat

ETW is the FDA product code for Calibrator, Hearing Aid / Earphone And Analysis Systems, a class II device type, regulated under 21 CFR 874.3310. As of 2026-09-10, FDA records hold 46 510(k) clearances under this code, the most recent dated 2012-10-23, and no recalls.

Classification record

Product code: ETW
Device name: Calibrator, Hearing Aid / Earphone And Analysis Systems
Regulation: 21 CFR 874.3310
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: 46
Ingested recalls: 0

Clearances, product code ETW

By decision year

46 clearances under product code ETW with a decision year between 1980 and 2012, 1986 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code ETW by decision year
Year	Clearances
1980	1
1982	1
1984	1
1985	2
1986	8
1987	4
1989	3
1990	6
1994	6
1995	1
1996	1
1997	1
1998	1
2001	1
2002	1
2004	1
2005	1
2006	1
2007	1
2009	1
2011	1
2012	2

Applicants with the most clearances

Product code ETW

Applicants holding the most 510(k) clearances under product code ETW
Applicant	Clearances
Frye Electronics, Inc.	9
Madsen Electronics (Canada), Ltd.	4
Starkey Laboratories, Inc.	4
Natus Medical Denmark ApS	3
Rastronics USA, Inc.	3
Etymonic Design, Inc.	2
Phonic Ear, Inc.	2
Precision Acoustics Ind., Inc.	2
Siemens Hearing Instruments, Inc.	2
A/S Bruel & Kjaer	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order