FDA.reportPublic FDA data

Measure by Otometrics - HIT

Primary DI
05711781004372
Brand
Measure by Otometrics - HIT
Company
Auditdata A/S
Model
US/CA AUD HIT Pro Package
Catalog number
100.451
Device description
2000 Primus HIT Pro
Published
2025-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETWCalibrator, Hearing Aid / Earphone And Analysis SystemsEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711781004372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711781004372057117810043725711781004372

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid tester, electricalAn assembly of electronic reference devices intended to be used by a healthcare provider in a clinical setting to verify the performance of and/or calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, microphone, oscillators, frequency counters, microphone amplifiers, distortion analyser, chart recorder, and a hearing aid test box; some types may include a probe microphone used for real-ear measurement (REM). It does not measure hearing acuity [i.e., it is not an audiometer].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
310385849
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057117810041053000 Real EarCA1 Audiometric Headphone100.0642026-01-23
057117810041363000 Real EarIN1 Insert Earphone100.0672026-01-23
057117810041433000 Real EarBC1 Bone Conductor100.0602026-01-23
057117810041503000 Real EarCA1 HF Audiometric Headphone100.0652026-01-23
057117810041673000 Real EarSA1 HBA Headphone100.0632026-01-23
057117810041743000 Real EarSA1 RE-7 Headphone100.0682026-01-23
05711781004204Measure by OtometricsAUD Base Package100.4212025-11-14
05711781004211Measure by OtometricsAUD-HF & REM & Speech Mapping Package100.4222025-11-14
05711781004228Measure by OtometricsAUD-HF & Wireless REM & Speech Mapping Package100.4232025-11-14
05711781004235Measure by OtometricsAUD & REM & Speech Mapping Package100.4242025-11-14
05711781004242Measure by OtometricsAUD & Wireless REM & Speech Mapping Package100.4252025-11-14
05711781004259Measure by OtometricsUS/CA AUD & REM & Speech Mapping (ANSI) Package100.4262025-11-14
05711781004266Measure by OtometricsUS/CA AUD & Wireless REM & Speech Mapping (ANSI) P100.4272025-11-14
05711781004280Measure by OtometricsUS/CA AUD Base (ANSI) Package100.4282025-11-14
05711781004297Measure by Otometrics - HITHIT Pro Package100.4502025-11-14
00571178100316Unity 4Unity 4 INSITU Package210311812024-08-21
05711781004006Unity 3Unity 3 HIT UNIT US package 210447342024-10-21
05711781002743MeasureMeasure Software (USB stick) 100.115 2024-09-17
05711781003818Unity 4 / MeasureUNITY 4 PROBE MIC US PACKAGE210311792024-09-17
05711781002729Unity 4 / MeasureTalk Back Client Microphone (2000-1)100.1132024-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711781004297Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004006Unity 3Auditdata A/SETW2024-10-21
05711117244335Sanibel Supply A/SInteracoustics A/SETW2024-10-07
05711117228458Sanibel Supply A/SInteracoustics A/SETW2024-10-07
00810044583182MedRxMEDRX, INC.ETW2024-05-07
EADF03410600217207189audifonaudifon GmbH & Co. KGETW2023-03-31
05711117121742Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117094206Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117226478Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117227550Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227574Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227581Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228557Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228564Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228571Sanibel Supply A/SInteracoustics A/SETW2022-11-29
EADF034106002172068681audifonaudifon GmbH & Co. KGETW2022-10-21
05713315009037NatusNatus Medical Denmark ApSETW2021-04-12
05713315009044NatusNatus Medical Denmark ApSETW2021-04-12
05713315009051NatusNatus Medical Denmark ApSETW2021-04-12
05713315008689NatusNatus Medical Denmark ApSETW2021-01-04
B161RE3670Audioscan Probe TubeEtymonic Design IncorporatedETW2020-01-15
05711117198218InteracousticsInteracoustics A/SETW2019-11-26
B161VA3000Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
B161VA3003Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
05713315005848GN Otometrics A/SNatus Medical Denmark ApSETW2019-04-24
05713315008184GN Otometrics A/SNatus Medical Denmark ApSETW2019-03-18
05713315005701GN Otometrics A/SNatus Medical Denmark ApSETW2018-11-06
05713315003301GN Otometrics A/SNatus Medical Denmark ApSETW2018-07-31
08054187380730DRUMINVENTIS SRLETW2017-08-24
08054187380617TRUMPETINVENTIS SRLETW2016-11-23