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 with wireless technology (OSM) (10)

Premarket Exempt

Yes

Clear

America Hears® - 00810068830590 Catalog Number : HLT-A32WL-PW

Device Description : A32 Hearing aid White

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830606 Catalog Number : HLT-A16WL-BG

Device Description : A16 Hearing aid Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830613 Catalog Number : HLT-A16WL-GR

Device Description : A16 Hearing aid Gray

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830620 Catalog Number : HLT-A16WL-BK

Device Description : A16 Hearing aid Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830637 Catalog Number : HLT-U16WL-RCG-BG

Device Description : U16 Rechargeable Hearing Aid Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830644 Catalog Number : HLT-U16WL-RCG-GR

Device Description : U16 Rechargeable Hearing Aid Gray

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830651 Catalog Number : HLT-U64WL-GR

Device Description : U64 Hearing aid Gray

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830668 Catalog Number : HLT-U64WL-BK

Device Description : U64 Hearing aid Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830675 Catalog Number : HLT-U64WL-BR

Device Description : U64 Hearing aid Brown

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830682 Catalog Number : HLT-U64WL-PW

Device Description : U64 Hearing aid White

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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