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SOUNDWAVE HEARING, LLC

Last updated September 17, 2026

Information

Country: US
Address: 619 Enterprise Dr Ste 205, Oak Brook, IL, 60523
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3015527983
DUNS Number: —

Catalogue (29)

Device	Model / Reference	Registries	Class	Status
otoTune app	990019-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991006-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990007-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991012-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991015-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990008-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991005-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990013-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991010-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990016-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991008-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990017-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991013-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991011-SWH	FDA UDI	Class II	Active
otoTune app	990020-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990005-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990002-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991019-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991014-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991004-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991009-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990011-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990014-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991007-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990030-SWH	FDA UDI	Class II	Active
Soundwave Hearing	991016-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990004-SWH	FDA UDI	Class II	Active
Sontro Self-Fitting OTC Hearing Aids	990035-SWH	FDA UDI	Class II	Active
Sontro® OTC Hearing Aids (AI)	K231550	FDA 510(k)	Class II	Active

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