FDA.reportPublic FDA data

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 usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).
GUDID devices
84
Last updated
2023-10-18 08:26:44

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05708296305285GN ReSoundGn Hearing A/S228513002023-10-10
05708296305308GN HearingGn Hearing A/S228515002023-10-10
05708296305315GN ReSoundGn Hearing A/S228516002023-10-10
05708296305346GN ReSoundGn Hearing A/S228519002023-10-10
05708296305360BeltoneGn Hearing A/S228521002023-10-10
05708296305377GN HearingGn Hearing A/S228522002023-10-10
05708296305391GN HearingGn Hearing A/S228524002023-10-10
05708296305438GN ReSoundGn Hearing A/S228528002023-10-10
05708296305452BeltoneGn Hearing A/S228530002023-10-10
05708296305476GN HearingGn Hearing A/S228532002023-10-10
07613389662481Unitron BrandSonova AG058-5237-0552023-09-19
05714880199420SonyWs Audiology Usa, Inc.Sony | Hearing Control WA2023-08-31
05712149027255PontoOticon Medical AB2569502023-08-21
05712149027262PontoOticon Medical AB2544342023-08-21
05712149027279Ponto Oticon Medical AB2544362023-08-21
05714464122509BernafonSbo Hearing A/S2628722023-08-07
05714464122516BernafonSbo Hearing A/S2628732023-08-07
05714464122523PhilipsSbo Hearing A/S2628742023-08-07
05714464122530PhilipsSbo Hearing A/S2628752023-08-07
05714464122547SonicSbo Hearing A/S2628762023-08-07
05714464122554OticonSbo Hearing A/S2628772023-08-07
05714464122561OticonSbo Hearing A/S2628782023-08-07
05714464122615OticonSbo Hearing A/S2628832023-08-07
09321502002448CLINICAL PROGRAMMING SYSTEMCOCHLEAR LIMITEDZ431022014-09-24
09321502011624CUSTOM SND SUITE 1.3 SERV RELEASE 1COCHLEAR LIMITEDZ611552014-09-24
09321502011921CUSTOM SOUND SUITE 2.0 SR1 FRENCHCOCHLEAR LIMITEDZ1949522014-09-24
09321502018906CUSTOM SOUND SUITE 3.0 US ENGLISHCOCHLEAR LIMITEDZ2201292014-09-24
09321502018913CUSTOM SOUND SUITE 2.0 SR2 US ENGLISHCOCHLEAR LIMITEDZ2294562014-09-24
09321502019873CUSTOM SOUND SUITE 3.1 ENGLISH (US)COCHLEAR LIMITEDZ2489402014-09-24
09321502020480CUSTOM SOUND SUITE 3.2 ENGLISH (US)COCHLEAR LIMITEDZ2749232014-09-24
09321502029445CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 ROW-CANADACOCHLEAR LIMITEDZ5321572014-09-24
09321502029452CUSTOM SOUND SUITE 4.1 SP3 (US) - CDCOCHLEAR LIMITEDZ5403692014-09-24
09321502029469CUSTOM SOUND SUITE 4.1 SOFTWARE - CAMCOCHLEAR LIMITEDZ4941792014-09-24
09321502029506CUSTOM SOUND SUITE 3.0 FRENCH (US)COCHLEAR LIMITEDZ2399302014-09-24
09321502029513CUSTOM SOUND SUITE 3.0 SPANISH (US)COCHLEAR LIMITEDZ2399322014-09-24
09321502029520CUSTOM SOUND SUITE 3.1 SPANISH (US)COCHLEAR LIMITEDZ2489452014-09-24
09321502029537CUSTOM SOUND SUITE 3.0 DAL SR US ENGLISHCOCHLEAR LIMITEDZ2525712014-09-24
09321502029551CUSTOM SOUND SUITE 3.2 FRENCH (US)COCHLEAR LIMITEDZ3013442014-09-24
09321502029568CUSTOM SOUND SUITE 3.2 SPANISH (US)COCHLEAR LIMITEDZ3013472014-09-24
09321502029599CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISHCOCHLEAR LIMITEDZ3612402014-09-24
09321502029605CSS4.0 SERVICE PACK 1 - ENG - CAMCOCHLEAR LIMITEDZ4750972014-09-24
09321502029612CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 CAMCOCHLEAR LIMITEDZ5321602014-09-24
09321502032230CUSTOM SOUND SUITE 4.2 CanadaCOCHLEAR LIMITEDZ5383002016-09-23
09321502032247CUSTOM SOUND SUITE 4.2 CAMCOCHLEAR LIMITEDZ5383012016-09-23
09321502033374Custom Sound Suite 4.4 DownloadCOCHLEAR LIMITEDP7053922016-10-05
07613389610918Unitron BrandSonova AG088-50162023-07-18
07613389610925Unitron BrandSonova AG088-50172023-07-18
07613389662467Unitron BrandSonova AG058-5178-0552023-07-18
07613389662474Unitron BrandSonova AG058-5180-0552023-07-18
07613389662498Unitron BrandSonova AG058-5262-0552023-07-18
07613389662504Unitron BrandSonova AG058-5267-0552023-07-18
07613389675320Easy Line Remote 6Sonova AG6.52023-06-20
05708296260874GN ReSoundGn Hearing A/S222269002023-04-28
07613389595321Phonak BrandSonova AG088-0022-000642023-04-25
07613389595338Sonova Brand (multiple brand)Sonova AG088-0023-000642023-04-25
07613389629330Phonak BrandSonova AG058-0125-0902023-04-25
07613389669039Phonak BrandSonova AG058-03202023-04-25
07613389669923Phonak BrandSonova AG088-0022-000652023-04-25
07613389670493Phonak BrandSonova AG088-0022-000662023-04-25
07613389670509Phonak BrandSonova AG088-0023-000672023-04-25
07613389675313Phonak BrandSonova AG058-03212023-04-25
07613389678277Phonak BrandSonova AG088-0017-000122023-04-25
07613389678284Phonak BrandSonova AG088-0023-000662023-04-25
07613389594607Phonak BrandSonova AG088-0022-000632023-03-08
05708296260805GN ReSoundGn Hearing A/S222262002023-02-24
05708296260812BeltoneGn Hearing A/S222263002023-02-24
05708296260829GN HearingGn Hearing A/S222264002023-02-24
05708296260867GN HearingGn Hearing A/S222268002023-02-24
05708296260904GN ReSoundGn Hearing A/S222272002023-02-24
05708296260928BeltoneGn Hearing A/S222274002023-02-24
05708296260942GN HearingGn Hearing A/S222276002023-02-24
05708296260973GN HearingGn Hearing A/S222279002023-02-24
05708296261000GN ReSoundGn Hearing A/S222311002023-02-24
07613389557930All-Day Clear 1.0 appSonova AG088-50152023-02-16
07613389638875CD TrueFit Software v5.3Sonova AG058-5178-0532023-02-15
07613389644579TrueFit Software v5.4Sonova AG058-5178-0542023-02-15
05714464095629PhilipsSbo Hearing A/S2532192023-02-10
05714464095636SonicSbo Hearing A/S2532202023-02-10
05714464095643NeutralSbo Hearing A/S2532212023-02-10
05714464095650BernafonSbo Hearing A/S2532222023-02-10