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® - 00810068830279 Catalog Number : HLT-ELITE-I-GR

Device Description : Elite HA MFI Package - Grey

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830286 Catalog Number : HLT-ELITE-A-BG

Device Description : Elite HA Android Package - Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830293 Catalog Number : HLT-ELITE-A-BK

Device Description : Elite HA Android Package - Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830309 Catalog Number : HLT-ELITE-A-GR

Device Description : Elite HA Android Package - Grey

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830316 Catalog Number : HLT-RCGPRO-I-BG

Device Description : Pro Rechargeable HA MFI Package - Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830323 Catalog Number : HLT-RCGPRO-I-BK

Device Description : Pro Rechargeable HA MFI Package - Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830330 Catalog Number : HLT-RCGPRO-I-GR

Device Description : Pro Rechargeable HA MFI Package - Grey

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830347 Catalog Number : HLT-RCGPRO-A-BG

Device Description : Pro Rechargeable HA Android Package - Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830354 Catalog Number : HLT-RCGPRO-A-BK

Device Description : Pro Rechargeable HA Android Package - Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830361 Catalog Number : HLT-RCGPRO-A-GR

Device Description : Pro Rechargeable HA Android Package - Grey

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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