INTRICON CORPORATION

Address:1260 Red Fox Rd,ARDEN HILLS,MN,55112,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) (6) Hearing Aid, Air Conduction (ESD) (4)

Premarket Exempt

Yes

Clear

Hearing Help Express - 00858177007564 Catalog Number : 93336-010

Device Description : Sentibo OTC BTE Wireless Hearing Aid, Left, Beige

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hearing Help Express - 00858177007571 Catalog Number : 93336-011

Device Description : Sentibo OTC BTE Wireless Hearing Aid, Right, Beige

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Intricon - 00858177007588 Catalog Number : 93336-004

Device Description : BTE Wireless Directional Hearing Aid, Light Gray

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Lexie Hearing - 00858177007595 Catalog Number : 93237-004

Device Description : Hearing Aid Accessory

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

AudiconX - 00858177007601 Catalog Number : 93447-000

Device Description : BTE Hearing Aid, Beige

Device Class : 1

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

AudiconX - 00858177007618 Catalog Number : 93447-001

Device Description : BTE Hearing Aid, Light Gray

Device Class : 1

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Nano Ultra - 00858177007625 Catalog Number : 93447-002

Device Description : BTE Hearing Aid, Beige

Device Class : 1

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Nano Ultra - 00858177007632 Catalog Number : 93447-003

Device Description : BTE Hearing Aid, Light Gray

Device Class : 1

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Intricon - 00858177007649 Catalog Number : 93336-012

Device Description : BTE Wireless Directional Hearing Aid

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Signison - 00858177007656 Catalog Number : 93232-011

Device Description : BTE Wireless Hearing Aid, Grey

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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