Product Code: ETW FDA class 2 21 CFR 874.3310

Calibrator, Hearing Aid / Earphone And Analysis Systems

Ear, Nose, Throat

The hearing aid and earphone calibrator and analysis system is a device used to verify and adjust the acoustic output of hearing aids and audiometric earphones against standardized reference values, ensuring accurate device performance. It is classified as FDA Class 2, representing moderate risk, and is subject to special controls. The product code is ETW, regulated under 21 CFR 874.3310 in the Ear, Nose, Throat specialty. No special implant or life-sustaining flags apply.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: ETW
Device Class: FDA class 2
Regulation Number: 874.3310
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K122028	AURICAL HIT	Oct 23, 2012	Substantially Equivalent	Gn Otometrics
K113831	PRIMUS HEARING INSTRUMENT TEST UNIT	Apr 19, 2012	Substantially Equivalent	Auditdata A/S
K110286	GN OTOMETRICS TYPE 1053 FREEFIT	Apr 28, 2011	Substantially Equivalent	Gn Otometrics A/S
K093006	FONIX ,MODEL 8000	Dec 30, 2009	Substantially Equivalent	Frye Electronics, Inc.
K071462	UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)	Jun 05, 2007	Substantially Equivalent	Siemens Hearing Instruments, Inc.
K061104	SPEECHLINK 100 TYPE 1053	May 03, 2006	Substantially Equivalent	Gn Otometrics A/S
K050496	REM440	Apr 29, 2005	Substantially Equivalent	Interacoustics A/S, Assens
K041853	OTOGRAM	Sep 03, 2004	Substantially Equivalent	Tympany, Inc.
K022510	FONIX, MODEL 7000	Aug 27, 2002	Substantially Equivalent	Frye Electronics, Inc.
K012306	AUDIOSCAN VERIFIT, MODEL VF-1	Sep 21, 2001	Substantially Equivalent	Etymonic Design, Inc.
K980377	FONIX FP35 HEARING AID ANALYZER	Mar 18, 1998	Substantially Equivalent	Frye Electronics, Inc.
K970324	GSI SA60 DPOAE SYSTEM	Jun 06, 1997	Substantially Equivalent	Grason-Stadler, Inc.
K960229	RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM	Mar 07, 1996	Substantially Equivalent	Resound Corp.
K952098	SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE	May 25, 1995	Substantially Equivalent	Siemens Hearing Instruments, Inc.
K943460	PORTAREM 2000	Oct 21, 1994	Substantially Equivalent	Starkey Laboratories, Inc.
K943459	DESKREM-1000	Oct 21, 1994	Substantially Equivalent	Starkey Laboratories, Inc.
K943607	INTERACOUSTICS HEARING AID ANALYZER MS 40	Sep 23, 1994	Substantially Equivalent	Precision Acoustics Ind., Inc.
K941848	INTERACOUSTICS. HEARING AID ANALYZER	May 23, 1994	Substantially Equivalent	Precision Acoustics Ind., Inc.
K934342	GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM	Jan 21, 1994	Substantially Equivalent	Glaser Instruments AG
K935400	FONIX 3500 HEARING AID ANALYZER	Jan 14, 1994	Substantially Equivalent	Frye Electronics, Inc.
K902244	RASTRONICS CCI 8	Oct 05, 1990	Substantially Equivalent	Rastronics USA, Inc.
K902252	RASTRONICS CCI 10/3 HEARING AID ANALYSIS	Sep 12, 1990	Substantially Equivalent	Rastronics USA, Inc.
K896996	CAS (COMPUTERIZED ANALYZER SYSTEM)	Aug 09, 1990	Substantially Equivalent	Gn Danavox, Inc.
K896477	NICOLET REAL EAR ANALYZER	Feb 08, 1990	Substantially Equivalent	Nicolet Instrument Corp.
K895383	TYPE FP40 DIGITAL HEARING AID ANALYZER	Jan 22, 1990	Substantially Equivalent	Frye Electronics, Inc.
K896301	MODEL 340 PROBE MIC SYSTEM	Jan 16, 1990	Substantially Equivalent	Virtual Corp.
K884372	MADSEN IGO1500 INSERTION GAIN OPTIMIZER	Feb 13, 1989	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K884371	MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM	Feb 13, 1989	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K884046	AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500	Feb 13, 1989	Substantially Equivalent	Etymonic Design, Inc.
K872633	MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM	Sep 16, 1987	Substantially Equivalent	Hearing Health Care Program
K872242	TYPE 6400 REAL EAR HEARING AID ANALYZER	Jul 10, 1987	Substantially Equivalent	Frye Electronics, Inc.
K870337	AUDIOMETER	Apr 16, 1987	Substantially Equivalent	Bio-Logic Systems Corp.
K870229	HEARING AID TEST SYSTEM MODEL HAT 1000	Mar 13, 1987	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K862026	HA-2000 REAL EAR SPECTROSCOPE	Aug 15, 1986	Substantially Equivalent	And/Or Corp.
K862162	PHONIC EAR, MODEL PE 1800	Jul 18, 1986	Substantially Equivalent	Phonic Ear, Inc.
K862086	IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823	Jul 16, 1986	Substantially Equivalent	A/S Bruel & Kjaer
K861857	PHONIC EAR	Jun 09, 1986	Substantially Equivalent	Phonic Ear, Inc.
K861571	TYPE 6500 HEARING AID ANALYZER	May 30, 1986	Substantially Equivalent	Frye Electronics, Inc.
K861113	ER-7C CLINICAL PROBE MICROPHONE	Apr 23, 1986	Substantially Equivalent	Etymotic Research
K854535	INSERTION GAIN OPTIMIZER IGO-1000	Feb 20, 1986	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K853271	HEARING AID ANALYSIS SYSTEM	Jan 16, 1986	Substantially Equivalent	Robert Bosch Corp.
K853320	FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10	Sep 27, 1985	Substantially Equivalent	Rastronics USA, Inc.
K850918	TYPE FP30 DIGITAL HEARING AID ANALYZER	May 29, 1985	Substantially Equivalent	Frye Electronics, Inc.
K844275	STARKET MODEL HMS	Dec 03, 1984	Substantially Equivalent	Starkey Laboratories, Inc.
K821908	STARKEY MODEL HAL-1	Aug 03, 1982	Substantially Equivalent	Starkey Laboratories, Inc.
K801905	FONIX TYPE 5100 HEARING AID ANALYZER	Aug 27, 1980	Substantially Equivalent	Frye Electronics, Inc.