HEARING LAB TECHNOLOGY, LLC

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) (9) Hearing aid, air conduction (ESD) (1)

Premarket Exempt

Yes

Clear

Liberty® - 00810068830026 Catalog Number : HLT-LBTYCLEAR-A-GR-M

Device Description : A-24 ch Rechargeable WL Grey - Monaural

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830187 Catalog Number : HLT-ESSENTIAL-BG

Device Description : Essential HA Package - Beige

Device Class : 1

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830194 Catalog Number : HLT-PRO-I-BG

Device Description : Pro HA MFI Package - Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830200 Catalog Number : HLT-PRO-I-BK

Device Description : Pro HA MFI Package - Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830217 Catalog Number : HLT-PRO-I-GR

Device Description : Pro HA MFI Package - Grey

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830224 Catalog Number : HLT-PRO-A-BG

Device Description : Pro HA Android Package - Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830231 Catalog Number : HLT-PRO-A-BK

Device Description : Pro HA Android Package - Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830248 Catalog Number : HLT-PRO-A-GR

Device Description : Pro HA Android Package - Grey

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830255 Catalog Number : HLT-ELITE-I-BG

Device Description : Elite HA MFI Package - Beige

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

America Hears® - 00810068830262 Catalog Number : HLT-ELITE-I-BK

Device Description : Elite HA MFI Package - Black

Device Class : 2

Duns Number: 827693503

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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