FDA.reportPublic FDA data

Soundwave Hearing

Primary DI
00850016231314
Brand
Soundwave Hearing
Company
Soundwave Hearing, LLC
Model
991013-SWH
Device description
TULIP-ONE SIZE (12MM)/991013-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Published
2021-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air Conduction With Wireless Technology
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016231314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016231314008500162313148500162313140850016231314

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, preformedA preformed device designed to fit in an ear canal and through which the acoustic output from a hearing aid is conveyed to the eardrum. It is made of soft synthetic polymer materials and may have various forms (e.g., plug-like, ear shape). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-367-4327support@hearsoundwave.com

Regulatory Flags#

DUNS number
050441605
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016231000Sontro Self-Fitting OTC Hearing Aids990030-SWH2024-05-07
00850016231109Sontro Self-Fitting OTC Hearing Aids990035-SWH2024-05-07
00850016231024Sontro Self-Fitting OTC Hearing Aids990002-SWH2021-11-01
00850016231048Sontro Self-Fitting OTC Hearing Aids990004-SWH2021-11-01
00850016231055Sontro Self-Fitting OTC Hearing Aids990005-SWH2021-11-01
00850016231079Sontro Self-Fitting OTC Hearing Aids990007-SWH2021-11-01
00850016231086Sontro Self-Fitting OTC Hearing Aids990008-SWH2021-11-01
00850016231116Sontro Self-Fitting OTC Hearing Aids990011-SWH2021-11-01
00850016231130Sontro Self-Fitting OTC Hearing Aids990013-SWH2021-11-01
00850016231147Sontro Self-Fitting OTC Hearing Aids990014-SWH2021-11-01
00850016231161Sontro Self-Fitting OTC Hearing Aids990016-SWH2021-11-01
00850016231178Sontro Self-Fitting OTC Hearing Aids990017-SWH2021-11-01
00850016231222Soundwave Hearing991004-SWH2021-11-01
00850016231239Soundwave Hearing991005-SWH2021-11-01
00850016231246Soundwave Hearing991006-SWH2021-11-01
00850016231253Soundwave Hearing991007-SWH2021-11-01
00850016231260Soundwave Hearing991008-SWH2021-11-01
00850016231277Soundwave Hearing991009-SWH2021-11-01
00850016231284Soundwave Hearing991010-SWH2021-11-01
00850016231291Soundwave Hearing991011-SWH2021-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820085n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820092n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820108n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820115n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820122n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820139n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820146n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820153n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820160n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820177n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820184n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820191n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820207n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820214n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820221n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820238n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820245n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820252n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820269n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820276n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820283n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08