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) (9) Hearing Aid, Air Conduction (ESD) (1)

Premarket Exempt

Yes

Clear

Intricon - 00858177007274 Catalog Number : 93337-000, 001, 002, 003, 004

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

Intricon - 00858177007281 Catalog Number : 93338-000, 001, 002, 003, 004

Device Description : BTE Wireless Omni Hearing Aid

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Intricon - 00858177007298 Catalog Number : 93339-000, 001, 002, 003, 004

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

Intricon - 00858177007304 Catalog Number : 93384-000

Device Description : Companion Microphone

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Hearing Help Express - 00858177007311 Catalog Number : 93384-001

Device Description : Companion Microphone

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Intricon - 00858177007328 Catalog Number : 93336-000

Device Description : BTE Wireless Directional Hearing Aid, Silver

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hearing Help Express - 00858177007335 Catalog Number : 23354

Device Description : Android App

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

hearX - 00858177007342 Catalog Number : 93336-005

Device Description : Behind-the-Ear Wireless Hearing Aid, Lumen 155i, Silver

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hearing Help Express - 00858177007359 Catalog Number : 93423-000

Device Description : Lumen 155i Behind-the-Ear Air-Conduction Hearing Aid.

Device Class : 1

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

hearX - 00858177007458 Catalog Number : Lexie IOS App

Device Description : IOS Hearing Aid Programming App

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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