FDA.reportPublic FDA data

otoTune app

Primary DI
00850016231383
Brand
otoTune app
Company
Soundwave Hearing, LLC
Model
990019-SWH
Device description
APP, Bluetooth, otoTune iOS for 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
00850016231383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016231383008500162313838500162313830850016231383

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid/implant system remote controlA battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).

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

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