FDA.reportPublic FDA data

1053 Aurical Freefit

Primary DI
05713315012433
Brand
1053 Aurical Freefit
Company
Natus Medical Denmark ApS
Model
9-62-49110
Catalog number
9-62-49110
Device description
1053 FreeFit Module (CN only)
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
05713315012433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315012433057133150124335713315012433

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].

Regulatory Flags#

DUNS number
306633756
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057133150123581082 Aurical HIT9-04-151019-04-151012026-10-28
057133150123651053 Aurical Freefit9-62-491009-62-491002026-10-28
05713315012389GN Otometrics A/S1053 PMM, RECD Probe, Long (2pcs)9-69-392102026-10-28
057133150123961053 Aurical Freefit9-04-118089-04-118082026-10-28
057133150124021053 Aurical FreeFit9-62-453009-62-453002026-10-28
057133150124261053 AUrical Freefit9-04-118209-04-118202026-10-28
057133150124401081 Aurical Aud9-04-145309-04-145302026-10-28
05713315012532GN Otometrics A/S1053 PMM RECD Probe, Long9-69-392062026-10-28
05713315010996AccuScreen Earcouplers0465850465852026-10-14
05713315011009AccuScreen Earcouplers0462000462002026-10-14
05713315012297Disposable Snap Electrodes (25 x 3 pack)0521630521632026-10-14
05713315012303Disposable Snap Electrodes (3 pack)0521650521652026-10-14
05713315000331GN Otometrics A/SHearing Instrument Programmer8-04-148002016-09-17
05713315012341Aurical Otocam 300-III10768-04-132602026-07-20
05713315006890Madsen Accsucreen8-04-139778-04-139772026-07-08
05713315006906Madsen Accuscreen8-04-139788-04-139782026-07-08
05713315008610Natus8-31-2008-31-2002020-12-16
05713315008627Natus8-31-190028-31-190022020-12-16
05713315000713GN Otometrics A/SPatient Responder (Red)8-31-1902016-09-19
057133150000581052 OTOsuite8-49-758008-49-758002026-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
057133150123581082 Aurical HITNatus Medical Denmark ApSETW2026-10-28
057133150123651053 Aurical FreefitNatus Medical Denmark ApSETW2026-10-28
05713315012389GN Otometrics A/SNatus Medical Denmark ApSETW2026-10-28
057133150123961053 Aurical FreefitNatus Medical Denmark ApSETW2026-10-28
057133150124021053 Aurical FreeFitNatus Medical Denmark ApSETW2026-10-28
057133150124261053 AUrical FreefitNatus Medical Denmark ApSETW2026-10-28
05713315012532GN Otometrics A/SNatus Medical Denmark ApSETW2026-10-28
05711781004297Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004372Measure 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