Product code ETW
- Device name
- Calibrator, Hearing Aid / Earphone And Analysis Systems
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3310
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122028 | AURICAL HIT | Gn Otometrics | 2012-10-23 |
| K113831 | PRIMUS HEARING INSTRUMENT TEST UNIT | Auditdata A/S | 2012-04-19 |
| K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | Gn Otometrics A/S | 2011-04-28 |
| K093006 | FONIX ,MODEL 8000 | Frye Electronics, Inc. | 2009-12-30 |
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | Siemens Hearing Instruments, Inc. | 2007-06-05 |
| K061104 | SPEECHLINK 100 TYPE 1053 | Gn Otometrics A/S | 2006-05-03 |
| K050496 | REM440 | Interacoustics A/S, Assens | 2005-04-29 |
| K041853 | OTOGRAM | Tympany, Inc. | 2004-09-03 |
| K022510 | FONIX, MODEL 7000 | Frye Electronics, Inc. | 2002-08-27 |
| K012306 | AUDIOSCAN VERIFIT, MODEL VF-1 | Etymonic Design, Inc. | 2001-09-21 |
| K980377 | FONIX FP35 HEARING AID ANALYZER | Frye Electronics, Inc. | 1998-03-18 |
| K970324 | GSI SA60 DPOAE SYSTEM | Grason-Stadler, Inc. | 1997-06-06 |
| K960229 | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM | Resound Corp. | 1996-03-07 |
| K952098 | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE | Siemens Hearing Instruments, Inc. | 1995-05-25 |
| K943460 | PORTAREM 2000 | Starkey Laboratories, Inc. | 1994-10-21 |
| K943459 | DESKREM-1000 | Starkey Laboratories, Inc. | 1994-10-21 |
| K943607 | INTERACOUSTICS HEARING AID ANALYZER MS 40 | Precision Acoustics Ind., Inc. | 1994-09-23 |
| K941848 | INTERACOUSTICS. HEARING AID ANALYZER | Precision Acoustics Ind., Inc. | 1994-05-23 |
| K934342 | GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM | Glaser Instruments AG | 1994-01-21 |
| K935400 | FONIX 3500 HEARING AID ANALYZER | Frye Electronics, Inc. | 1994-01-14 |
| K902244 | RASTRONICS CCI 8 | Rastronics USA, Inc. | 1990-10-05 |
| K902252 | RASTRONICS CCI 10/3 HEARING AID ANALYSIS | Rastronics USA, Inc. | 1990-09-12 |
| K896996 | CAS (COMPUTERIZED ANALYZER SYSTEM) | Gn Danavox, Inc. | 1990-08-09 |
| K896477 | NICOLET REAL EAR ANALYZER | Nicolet Instrument Corp. | 1990-02-08 |
| K895383 | TYPE FP40 DIGITAL HEARING AID ANALYZER | Frye Electronics, Inc. | 1990-01-22 |
| K896301 | MODEL 340 PROBE MIC SYSTEM | Virtual Corp. | 1990-01-16 |
| K884046 | AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 | Etymonic Design, Inc. | 1989-02-13 |
| K884371 | MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM | Madsen Electronics (Canada) , Ltd. | 1989-02-13 |
| K884372 | MADSEN IGO1500 INSERTION GAIN OPTIMIZER | Madsen Electronics (Canada) , Ltd. | 1989-02-13 |
| K872633 | MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM | Hearing Health Care Program | 1987-09-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05711781004372 | Measure by Otometrics - HIT | Auditdata A/S | 2025-11-14 |
| 05711781004297 | Measure by Otometrics - HIT | Auditdata A/S | 2025-11-14 |
| 05711781004006 | Unity 3 | Auditdata A/S | 2024-10-21 |
| 05711117228458 | Sanibel Supply A/S | Interacoustics A/S | 2024-10-07 |
| 05711117244335 | Sanibel Supply A/S | Interacoustics A/S | 2024-10-07 |
| 00810044583182 | MedRx | MEDRX, INC. | 2024-05-07 |
| EADF03410600217207189 | audifon | audifon GmbH & Co. KG | 2023-03-31 |
| 05711117094206 | Sanibel Supply A/S | Interacoustics A/S | 2022-12-29 |
| 05711117121742 | Sanibel Supply A/S | Interacoustics A/S | 2022-12-29 |
| 05711117226478 | Sanibel Supply A/S | Interacoustics A/S | 2022-12-29 |
| 05711117227574 | Sanibel Supply A/S | Interacoustics A/S | 2022-11-29 |
| 05711117227581 | Sanibel Supply A/S | Interacoustics A/S | 2022-11-29 |
| 05711117227550 | Sanibel Supply A/S | Interacoustics A/S | 2022-11-29 |
| 05711117228557 | Sanibel Supply A/S | Interacoustics A/S | 2022-11-29 |
| 05711117228564 | Sanibel Supply A/S | Interacoustics A/S | 2022-11-29 |
| 05711117228571 | Sanibel Supply A/S | Interacoustics A/S | 2022-11-29 |
| EADF034106002172068681 | audifon | audifon GmbH & Co. KG | 2022-10-21 |
| 05713315009051 | Natus | Natus Medical Denmark ApS | 2021-04-12 |
| 05713315009037 | Natus | Natus Medical Denmark ApS | 2021-04-12 |
| 05713315009044 | Natus | Natus Medical Denmark ApS | 2021-04-12 |
| 05711117198218 | Interacoustics | Interacoustics A/S | 2019-11-26 |
| B161VA3000 | Verifit Skull Simulator | Etymonic Design Incorporated | 2019-05-02 |
| 08054187380624 | TRUMPET | INVENTIS SRL | 2016-11-23 |
| 08054187380617 | TRUMPET | INVENTIS SRL | 2016-11-23 |
| B161RM500SL0 | Audioscan | Etymonic Design Incorporated | 2016-09-23 |
| B161AXIOM0 | Audioscan | Etymonic Design Incorporated | 2016-09-23 |
| 05713315000874 | GN Otometrics A/S | Natus Medical Denmark ApS | 2016-09-19 |
| 08054187380570 | TRUMPET | INVENTIS SRL | 2016-09-17 |
| 08054187380556 | TRUMPET | INVENTIS SRL | 2016-09-17 |
| FONIXFP35 | Fonix | FRYE ELECTRONICS, INC. | 2016-08-22 |