FDA.reportPublic FDA data

Soundwave Hearing

Primary DI
00850016231246
Brand
Soundwave Hearing
Company
Soundwave Hearing, LLC
Model
991006-SWH
Device description
RIGHT-LARGE/991006-SWH; replacement RIC for 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
00850016231246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016231246008500162312468500162312460850016231246

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid acoustic tubeA small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. 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
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
00850016231307Soundwave Hearing991012-SWH2021-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388220580Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04