Soundwave Hearing, LLC

Address:619 Enterprise Dr Ste 205,Oak Brook,IL,60523,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)

Premarket Exempt

Yes

Clear

Soundwave Hearing - 00850016231321 Catalog Number :

Device Description : POWER-SMALL/991014-SWH; 10-pc blister pack of replacement ear domes for RIC

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Soundwave Hearing - 00850016231338 Catalog Number :

Device Description : POWER-MEDIUM/991015-SWH; 10-pc blister pack of replacement ear domes for RIC

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Soundwave Hearing - 00850016231345 Catalog Number :

Device Description : POWER-LARGE/991016-SWH; 10-pc blister pack of replacement ear domes for RIC

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Soundwave Hearing - 00850016231352 Catalog Number :

Device Description : 991019-SWH; retention lock for RIC

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

otoTune™ app - 00850016231383 Catalog Number :

Device Description : APP, Bluetooth, otoTune™, iOS

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

otoTune™ app - 00850016231390 Catalog Number :

Device Description : APP, Bluetooth, otoTune™, Android

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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