FDA.report

Audiometric/hearing device software

Definition
A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).
GUDID devices
287
Last updated
2026-03-24 18:18:46

Related Product Codes

CodeDeviceSpecialtyClassDevices
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2232
MCMImplant, CochlearUnknown318
KLWMasker, TinnitusEar, Nose, Throat216
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat18
PFOActive Implantable Bone Conduction Hearing SystemEar, Nose, Throat26
LXBHearing Aid, Bone ConductionEar, Nose, Throat25
PLKTympanic Membrane Direct Contact Hearing AidEar, Nose, Throat21
QDDSelf-Fitting Air-Conduction Hearing Aid, PrescriptionEar, Nose, Throat21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
07613389879841myPhonak 7Sonova AG7.52026-03-16
07613389879858Easy Line Remote 7Sonova AG7.52026-03-16
07613389879865myPhonak 7Sonova AG7.62026-03-16
07613389879872Easy Line Remote 7Sonova AG7.62026-03-16
05708296390243GN HearingGn Hearing A/S237709002026-03-05
05708296390328GN HearingGn Hearing A/S237717002026-03-05
05708296390410GN HearingGn Hearing A/S237726002026-03-05
05714464175406NeutralSbo Hearing A/S2860652026-01-07
05714464175413BernafonSbo Hearing A/S2860662026-01-07
05714464175420PhilipsSbo Hearing A/S2860672026-01-07
05714464175437PhilipsSbo Hearing A/S2860682026-01-07
05714464175444OticonSbo Hearing A/S2860692026-01-07
05714464175468OticonSbo Hearing A/S2860712026-01-07
05714464175505AGXOSbo Hearing A/S2860752026-01-07
07613389837810TrueFit 5.9 USBSonova AGn/a2025-12-30
07613389837827Unitron TrueFit 5.9Sonova AGn/a2025-12-30
07613389837841Aura:fit AudioNova 5.9Sonova AGn/a2025-12-30
07613389837858Aura:fit Relate 5.9Sonova AGn/a2025-12-30
05708296418404GN HearingGn Hearing A/S238475002025-12-01
05708296418459GN HearingGn Hearing A/S238480002025-12-01
05708296418473GN HearingGn Hearing A/S238482002025-12-01
05708296418480GN HearingGn Hearing A/S238483002025-12-01
05708296418503GN HearingGn Hearing A/S238485002025-12-01
05708296418541GN HearingGn Hearing A/S238489002025-12-01
05708296418565GN HearingGn Hearing A/S238491002025-12-01
05708296418589GN HearingGn Hearing A/S238493002025-12-01
05708296399796GN HearingGn Hearing A/S238376002025-09-19
05708296399826GN HearingGn Hearing A/S238379002025-09-21
05708296399833GN HearingGn Hearing A/S238380002025-09-21
05708296399871GN HearingGn Hearing A/S238384002025-09-21
05708296399895GN HearingGn Hearing A/S238386002025-09-21
05708296399901GN HearingGn Hearing A/S238387002025-09-21
05708296399925GN HearingGn Hearing A/S238389002025-09-21
05708296399963GN HearingGn Hearing A/S238393002025-09-19
05708296399987GN HearingGn Hearing A/S238395002025-09-21
05708296400003GN HearingGn Hearing A/S238397002025-09-19
07613389637618myPhonak Junior 2.0Sonova AG2.02025-08-26
07613389836295DVD Phonak Target 11.1 DVDSonova AG11.1 DVD2025-08-25
07613389836301USB Phonak Target 11.1 USBSonova AG11.1 USB2025-08-25
07613389836318Phonak Target 11.1Sonova AG11.12025-08-25
05708296384983GN HearingGn Hearing A/S236704002025-08-06
05708296385010GN HearingGn Hearing A/S236707002025-08-06
05708296385027GN HearingGn Hearing A/S236708002025-08-06
05708296385065GN HearingGn Hearing A/S236712002025-08-06
05708296385089GN HearingGn Hearing A/S236714002025-08-06
05708296385096GN HearingGn Hearing A/S236715002025-08-06
05708296385119GN HearingGn Hearing A/S236717002025-08-06
05708296385157GN HearingGn Hearing A/S236721002025-08-06
05708296385164GN HearingGn Hearing A/S236722002025-08-06
05708296385171GN HearingGn Hearing A/S236723002025-08-06
05708296385195GN HearingGn Hearing A/S236725002025-08-06
09321502072359Custom Sound ProCOCHLEAR LIMITEDv7.1, US2025-07-07
05708296386048GN HearingGn Hearing A/S237212002025-06-09
05708296386055GN HearingGn Hearing A/S237213002025-06-09
05708296386093GN HearingGn Hearing A/S237217002025-06-09
05708296386116GN HearingGn Hearing A/S237219002025-06-09
05708296386123GN HearingGn Hearing A/S237220002025-06-09
05708296386147GN HearingGn Hearing A/S237222002025-06-09
05708296386185GN HearingGn Hearing A/S237226002025-06-09
05708296386208GN HearingGn Hearing A/S237228002025-06-09
05708296386222GN HearingGn Hearing A/S237230002025-06-09
09321502078955Baha Smart AppCochlear Bone Anchored Solutions ABV 1.22025-06-05
09321502078962Baha Smart AppCochlear Bone Anchored Solutions ABV 1.22025-06-05
07613389790337DVD Phonak Target 11.0 DVDSonova AG11.0 DVD2025-05-20
07613389790184Unitron TrueFit 5.8Sonova AGn/a2025-04-01
07613389790191Unitron TrueFit 5.8 USBSonova AGn/a2025-04-01
07613389790207Unitron TrueFit 5.8 DVDSonova AGn/a2025-04-01
07613389792317Aura:fit 5.8Sonova AGn/a2025-04-01
07613389792324Aura:fit AudioNova 5.8Sonova AGn/a2025-04-01
07613389792331Aura:fit Relate 5.8Sonova AGn/a2025-04-01
09008737983307MAESTRO 11Med-El Elektromedizinische Geräte Gesellschaft m.b.H.983302025-03-28
05708296368884GN HearingGn Hearing A/S235083002025-03-27
05708296368969GN HearingGn Hearing A/S235091002025-03-27
05708296384785GN HearingGn Hearing A/S236677002025-03-27
05708296384792GN HearingGn Hearing A/S236678002025-03-27
05708296384839GN HearingGn Hearing A/S236682002025-03-27
05708296384853GN HearingGn Hearing A/S236684002025-03-27
05708296384860GN HearingGn Hearing A/S236685002025-03-27
05708296384884GN HearingGn Hearing A/S236687002025-03-27
05708296384921GN HearingGn Hearing A/S236691002025-03-27