ETW · Calibrator, Hearing Aid / Earphone And Analysis Systems
Ear, Nose, Throat · 21 CFR 874.3310 · Class 2
Overview
| Product Code | ETW |
|---|---|
| Device Name | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Regulation | 21 CFR 874.3310 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
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 | AURICAL HIT | Gn Otometrics | Oct 23, 2012 | SESE |
| K113831 | PRIMUS HEARING INSTRUMENT TEST UNIT | Auditdata A/S | Apr 19, 2012 | SESE |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | Gn Otometrics A/S | Apr 28, 2011 | SESE |
| K093006 | FONIX ,MODEL 8000 | Frye Electronics, Inc. | Dec 30, 2009 | SESE |
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | Siemens Hearing Instruments, Inc. | Jun 5, 2007 | SESE |
| K061104 | SPEECHLINK 100 TYPE 1053 | Gn Otometrics A/S | May 3, 2006 | SESE |
| K050496 | REM440 | Interacoustics A/S, Assens | Apr 29, 2005 | SESE |
| K041853 | OTOGRAM | Tympany, Inc. | Sep 3, 2004 | SESE |
| K022510 | FONIX, MODEL 7000 | Frye Electronics, Inc. | Aug 27, 2002 | SESE |
| K012306 | AUDIOSCAN VERIFIT, MODEL VF-1 | Etymonic Design, Inc. | Sep 21, 2001 | SESE |
| K980377 | FONIX FP35 HEARING AID ANALYZER | Frye Electronics, Inc. | Mar 18, 1998 | SESE |
| K970324 | GSI SA60 DPOAE SYSTEM | Grason-Stadler, Inc. | Jun 6, 1997 | SESE |
| K960229 | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM | Resound Corp. | Mar 7, 1996 | SESE |
| K952098 | 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 | PORTAREM 2000 | Starkey Laboratories, Inc. | Oct 21, 1994 | SESE |
| K943459 | DESKREM-1000 | Starkey Laboratories, Inc. | Oct 21, 1994 | SESE |
| K943607 | INTERACOUSTICS HEARING AID ANALYZER MS 40 | Precision Acoustics Ind., Inc. | Sep 23, 1994 | SESE |
| K941848 | INTERACOUSTICS. HEARING AID ANALYZER | Precision Acoustics Ind., Inc. | May 23, 1994 | SESE |
| K934342 | GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM | Glaser Instruments AG | Jan 21, 1994 | SESE |
| K935400 | 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
