Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3310](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3310) → ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems # ETW · Calibrator, Hearing Aid / Earphone And Analysis Systems _Ear, Nose, Throat · 21 CFR 874.3310 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW ## Overview - **Product Code:** ETW - **Device Name:** Calibrator, Hearing Aid / Earphone And Analysis Systems - **Regulation:** [21 CFR 874.3310](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3310) - **Device Class:** 2 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## Identification A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. ## Recent Cleared Devices (20 of 46) Showing 20 most recent of 46 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K122028](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K122028.md) | AURICAL HIT | Gn Otometrics | Oct 23, 2012 | SESE | | [K113831](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K113831.md) | PRIMUS HEARING INSTRUMENT TEST UNIT | Auditdata A/S | Apr 19, 2012 | SESE | | [K110286](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K110286.md) | GN OTOMETRICS TYPE 1053 FREEFIT | Gn Otometrics A/S | Apr 28, 2011 | SESE | | [K093006](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K093006.md) | FONIX ,MODEL 8000 | Frye Electronics, Inc. | Dec 30, 2009 | SESE | | [K071462](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K071462.md) | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | Siemens Hearing Instruments, Inc. | Jun 5, 2007 | SESE | | [K061104](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K061104.md) | SPEECHLINK 100 TYPE 1053 | Gn Otometrics A/S | May 3, 2006 | SESE | | [K050496](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K050496.md) | REM440 | Interacoustics A/S, Assens | Apr 29, 2005 | SESE | | [K041853](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K041853.md) | OTOGRAM | Tympany, Inc. | Sep 3, 2004 | SESE | | [K022510](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K022510.md) | FONIX, MODEL 7000 | Frye Electronics, Inc. | Aug 27, 2002 | SESE | | [K012306](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K012306.md) | AUDIOSCAN VERIFIT, MODEL VF-1 | Etymonic Design, Inc. | Sep 21, 2001 | SESE | | [K980377](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K980377.md) | FONIX FP35 HEARING AID ANALYZER | Frye Electronics, Inc. | Mar 18, 1998 | SESE | | [K970324](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K970324.md) | GSI SA60 DPOAE SYSTEM | Grason-Stadler, Inc. | Jun 6, 1997 | SESE | | [K960229](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K960229.md) | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM | Resound Corp. | Mar 7, 1996 | SESE | | [K952098](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K952098.md) | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE | Siemens Hearing Instruments, Inc. | May 25, 1995 | SESE | | [K943460](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K943460.md) | PORTAREM 2000 | Starkey Laboratories, Inc. | Oct 21, 1994 | SESE | | [K943459](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K943459.md) | DESKREM-1000 | Starkey Laboratories, Inc. | Oct 21, 1994 | SESE | | [K943607](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K943607.md) | INTERACOUSTICS HEARING AID ANALYZER MS 40 | Precision Acoustics Ind., Inc. | Sep 23, 1994 | SESE | | [K941848](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K941848.md) | INTERACOUSTICS. HEARING AID ANALYZER | Precision Acoustics Ind., Inc. | May 23, 1994 | SESE | | [K934342](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K934342.md) | GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM | Glaser Instruments AG | Jan 21, 1994 | SESE | | [K935400](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K935400.md) | FONIX 3500 HEARING AID ANALYZER | Frye Electronics, Inc. | Jan 14, 1994 | SESE | ## Top Applicants - Frye Electronics, Inc. — 9 clearances - Starkey Laboratories, Inc. — 4 clearances - Madsen Electronics (Canada) , Ltd. — 4 clearances - Rastronics USA, Inc. — 3 clearances - Siemens Hearing Instruments, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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