HEARING LAB TECHNOLOGY, LLC

Address:14301 FAA Blvd,Fort Worth,TX,76155,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hearing aid, air conduction (ESD) (6) Hearing aid, air conduction with wireless technology (OSM) (4)

Premarket Exempt

Yes

Clear

America Hears® - 00810068830385 Catalog Number : HLT-CUS-FS-ELITE

Device Description : Custom Elite Full Shell HA Package

Device Class : 1

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830392 Catalog Number : HLT-CUS-HS-ELITE

Device Description : Custom Elite Half Shell HA Package

Device Class : 1

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830408 Catalog Number : HLT-CUS-CA-ELITE

Device Description : Custom Elite Canal HA Package

Device Class : 1

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830415 Catalog Number : HLT-CUS-MC-ELITE

Device Description : Custom Elite Micro Canal HA Package

Device Class : 1

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830422 Catalog Number : HLT-CUS-CIC-ELITE

Device Description : Custom Elite CIC HA Package

Device Class : 1

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

Liberty® - 00810068830446 Catalog Number : HLT-FIO

Device Description : Fio

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830453 Catalog Number : HLT-U128WLA-BG

Device Description : A128 Hearing Aid Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830460 Catalog Number : HLT-U96WLA-GR

Device Description : A96 Hearing aid Gray

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830477 Catalog Number : HLT-U96WLA-BK

Device Description : A96 Hearing aid Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830484 Catalog Number : HLT-U96WLA-BR

Device Description : A96 Hearing aid Brown

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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