FDA.reportPublic FDA data

Audiometric/hearing aid tester

Definition
An electroacoustic device intended to be used for the evaluation of hearing loss (audiometer function), the evaluation of hearing aids while worn to assure optimal amplification (real-ear measurement), and/or for other hearing aid analysis (functions as the hearing aid analyser to check its proper function when this is being fitted to the patient). It typically consists of a test box and a control unit that connect to a computer that runs application software to provide results and graphics (which may be stored in a database). The control unit may also be connected to other manufacturer's test boxes, or run as an audiometer or real-ear-measurement instrument without the test box.
GUDID devices
138
Last updated
2022-12-09 01:59:59

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05711117228557Sanibel Supply A/SInteracoustics A/SSanibel REM Probe Tubes, type A2022-11-29
05711117228564Sanibel Supply A/SInteracoustics A/SSanibel REM Probe Tubes, type C2022-11-29
05711117228571Sanibel Supply A/SInteracoustics A/SSanibel REM Probe Tubes, type D2022-11-29
00860002174006Healing Healthcare ProDB DIAGNOSTIC SYSTEMS, INC.Revision 22019-07-29
00864994000305Precision Probe TubesPRECISION CAST PLASTIC PARTS, INC.U76MBY-362019-08-06
00864994000312Precision Probe TubesPRECISION CAST PLASTIC PARTS, INC.U76MBY-1202019-08-06
00864994000329Precision Probe TubesPRECISION CAST PLASTIC PARTS, INC.76109MBB-1202019-08-06
00864994000336Precision Probe TubesPRECISION CAST PLASTIC PARTS, INC.76109MBB-402019-08-06
00864994000343Precision Probe TubesPRECISION CAST PLASTIC PARTS, INC.U76MBY-402019-08-06
00864994000350Precision Probe TubesPRECISION CAST PLASTIC PARTS, INC.81078MBG-402019-08-06
00864994000367Precision Probe TubesPRECISION CAST PLASTIC PARTS, INC.81078MBG-362019-08-06
00810044580037MedRxMEDRX, INC.Avant REM Speech+2016-09-24
00810044580075MedRxMEDRX, INC.Avant REMsp2016-09-24
05711781000091REAL-EARWs Audiology Usa, Inc.REAL-EAR CLIENT RESPONSE2020-01-22
05711781000176REAL-EARWs Audiology Usa, Inc.REAL-EAR SOUNDBOOTH CABLE SET2020-01-22
05711781000183REAL-EARWs Audiology Usa, Inc.REAL-EAR EAR HANGER2020-01-22
05711781000206REAL-EARWs Audiology Usa, Inc.REAL-EAR DC ADAPTOR (AUD/REM)2020-01-22
05711781000213REAL-EARWs Audiology Usa, Inc.REAL-EAR USB CABLE FOR PC2020-01-22
05711781000244REAL-EARWs Audiology Usa, Inc.REAL-EAR MICROPHONE2020-01-22
05711781000251REAL-EARWs Audiology Usa, Inc.REAL-EAR FREE FIELD SPEAKER2020-01-22
05711781000275REAL-EARWs Audiology Usa, Inc.REAL-EAR USB ISOLATION CORD2020-01-22
05711781000312REAL-EARWs Audiology Usa, Inc.REAL-EAR INSERT TUBE W NIPPLES2020-01-22
05711781000336REAL-EARWs Audiology Usa, Inc.REAL-EAR PROBE TUBE GUIDE2020-01-22
05711781000343REAL-EARWs Audiology Usa, Inc.REAL-EAR PROBE TUBE2020-01-22
05711781000367REAL-EARWs Audiology Usa, Inc.REAL-EAR COUPLER MICROPHONE2020-01-22
05711781000381REAL-EARWs Audiology Usa, Inc.REAL-EAR BATTERY PILLS (5 SIZES)2020-01-22
05711781000411REAL-EARWs Audiology Usa, Inc.REAL-EAR ITE COUPLER ATTACHMENT2020-01-22
05711781000428REAL-EARWs Audiology Usa, Inc.REAL-EAR BTE COUPLER ATTACHMENT2020-01-22
05711781000435REAL-EARWs Audiology Usa, Inc.REAL-EAR BODY COUPLER ATTACHMEN2020-01-22
05711781000442REAL-EARWs Audiology Usa, Inc.REAL-EAR HI-PRO EXTENSION CABLE2020-01-22
05711781000459REAL-EARWs Audiology Usa, Inc.REAL-EAR 2CC COUPLER2020-01-22
05711781000473REAL-EARWs Audiology Usa, Inc.REAL-EAR BTE FOAM2020-01-22
05711781000541REAL-EARWs Audiology Usa, Inc.REAL-EAR PROBE (REFURBISHED)2020-01-22
05711781000671REAL-EARWs Audiology Usa, Inc.REAL-EAR BATTERY PILL 5A2020-01-22
05711781000688REAL-EARWs Audiology Usa, Inc.REAL-EAR BATTERY PILL 10A2020-01-22
05711781000695REAL-EARWs Audiology Usa, Inc.REAL-EAR BATTERY PILL 312A2020-01-22
05711781000701REAL-EARWs Audiology Usa, Inc.REAL-EAR BATTERY PILL 13A2020-01-22
05711781000718REAL-EARWs Audiology Usa, Inc.REAL-EAR BATTERY PILL 675A2020-01-22
05711781000794REAL-EARWs Audiology Usa, Inc.REAL-EAR HIT RUBBER FEET 4 PCE2020-01-22
B161RE3670Audioscan Probe TubeEtymonic Design IncorporatedRE3672020-01-15
57117810000071SiemensWs Audiology Usa, Inc.UNITY 3 HDA200 HEADSET2016-05-08
57117810000101SiemensWs Audiology Usa, Inc.UNITY 3 DD45 (REFURBISHED)2016-05-08
57117810000125SiemensWs Audiology Usa, Inc.UNITY 3 ER 3A (REFURBISHED)2016-05-08
57117810000736SiemensWs Audiology Usa, Inc.UNITY 3 STANDARD PACKAGE2016-05-07
57117810000743SiemensWs Audiology Usa, Inc.UNITY 3 WITH INSERTS2016-05-07
57117810000750SiemensWs Audiology Usa, Inc.UNITY 3 STANDARD WITH INSERTS2016-05-07
57117810000767SiemensWs Audiology Usa, Inc.UNITY 3 CLINICAL2016-05-07
57117810000774SiemensWs Audiology Usa, Inc.UNITY 3 HIGH FREQUENCY2016-05-07
57117810000781SiemensWs Audiology Usa, Inc.UNITY 3 REAL EAR FULL PACKAGE2016-05-07
57117810000804SiemensWs Audiology Usa, Inc.UNITY 3 HDA300 HEADSET2016-05-08
57117810001054Primus By AuditdataAuditdata A/S2000 Primus Fitting Unit Pro2016-06-09
B161AXIOM3AudioscanEtymonic Design IncorporatedAxiom2016-09-23
B161RM500SL3AudioscanEtymonic Design IncorporatedRM500SL2016-09-23
B161VERIFITVF20AudioscanEtymonic Design IncorporatedVerifit VF-22016-09-23
04056839030035SiemensWs Audiology Usa, Inc.UNITY 3 B71 (REFURBISHED)2016-05-08
04056839030042SiemensWs Audiology Usa, Inc.UNITY 3 COUPLER (REFURBISHED)2016-05-08
04056839030059SiemensWs Audiology Usa, Inc.UNITY 3 REF MIC (REFURBISHED)2016-05-08
04650075330036Neuro-AudioNEUROSOFT, OOONeuro-Audio2016-09-22
05711781000003SiemensSIVANTOS, INC.UNITY 3 INSERTS2016-05-07
05711781000004SiemensSIVANTOS, INC.UNITY 3 REM PROBE ASSEMBLY2016-05-07
05711781000008SiemensWs Audiology Usa, Inc.UNITY 3 B71 BONE CONDUCTOR2016-05-07
05711781000009SiemensSIVANTOS, INC.UNITY 3 CLIENT RESPONSE2016-05-07
05711781000010SiemensSIVANTOS, INC.UNITY 3 DD452016-05-07
05711781000012SiemensSIVANTOS, INC.UNITY 3 3A INSERTS2016-05-07
05711781000017SiemensSIVANTOS, INC.UNITY 3 SOUNDBOOTH CABLE SET2016-05-07
05711781000018SiemensSIVANTOS, INC.UNITY 3 EAR HANGER2016-05-07
05711781000020SiemensSIVANTOS, INC.UNITY 3 DC ADAPTOR (AUD/REM)2016-05-07
05711781000021SiemensSIVANTOS, INC.UNITY 3 USB CABLE FOR PC2016-05-07
05711781000024SiemensSIVANTOS, INC.UNITY 3 MICROPHONE2016-05-07
05711781000025SiemensSIVANTOS, INC.UNITY 3 FREE FIELD SPEAKER2016-05-07
05711781000027SiemensSIVANTOS, INC.UNITY 3 USB ISOLATION CORD2016-05-07
05711781000031SiemensSIVANTOS, INC.UNITY 3 INSERT TUBE W NIPPLES2016-05-07
05711781000033SiemensSIVANTOS, INC.UNITY 3 PROBE TUBE GUIDE2016-05-07
05711781000034SiemensSIVANTOS, INC.UNITY 3 PROBE TUBE2016-05-07
05711781000036SiemensSIVANTOS, INC.UNITY 3 COUPLER MICROPHONE2016-05-07
05711781000037SiemensSIVANTOS, INC.UNITY 3 REFERENCE MICROPHONE2016-05-07
05711781000038SiemensSIVANTOS, INC.UNITY 3 BATTERY PILLS (5 SIZES)2016-05-07
05711781000039SiemensWs Audiology Usa, Inc.UNITY 3 BTE TUBE2016-05-07
05711781000041SiemensSIVANTOS, INC.UNITY 3 ITE COUPLER ATTACHMENT2016-05-07
05711781000042SiemensSIVANTOS, INC.UNITY 3 BTE COUPLER ATTACHMENT2016-05-07