FDA.reportPublic FDA data

Sontro Self-Fitting OTC Hearing Aids

Primary DI
00850016231048
Brand
Sontro Self-Fitting OTC Hearing Aids
Company
Soundwave Hearing, LLC
Model
990004-SWH
Device description
GREY/990004-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled 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
00850016231048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016231048008500162310488500162310480850016231048

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

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
Serial number
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
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
00850016231307Soundwave Hearing991012-SWH2021-11-01

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