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) (10)

Premarket Exempt

Yes

Clear

Sontro™ Hearing Aids - 00850016231024 Catalog Number :

Device Description : GREY/990002-SWH; set of Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231048 Catalog Number :

Device Description : GREY/990004-SWH; right replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231055 Catalog Number :

Device Description : GREY/990005-SWH; left replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231079 Catalog Number :

Device Description : GREY/990007-SWH; right (refurbished) replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231086 Catalog Number :

Device Description : GREY/990008-SWH; left (refurbished) replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231116 Catalog Number :

Device Description : BEIGE/99/0011-SWH; set of Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231130 Catalog Number :

Device Description : BEIGE/990013-SWH; right replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231147 Catalog Number :

Device Description : BEIGE/990014-SWH; left replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231161 Catalog Number :

Device Description : BEIGE/990016-SWH; right (refurbished) replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sontro™ Hearing Aids - 00850016231178 Catalog Number :

Device Description : BEIGE/990017-SWH; left (refurbished) replacement for Sontro™ Hearing Aids (Model: AI)

Device Class : 2

Duns Number: 050441605

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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