FDA.reportPublic FDA data

Serenade Tinnitus Treatment System

Primary DI
00861259000209
Brand
Serenade Tinnitus Treatment System
Company
SOUNDCURE, INC.
Model
900000
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861259000209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861259000209008612590002098612590002090861259000209

GMDN Terms#

Term, Definition table
TermDefinition
In-the-ear air-conduction tinnitus masker, digitalA battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). It typically consists of a miniature sound generator, contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)], that delivers the noise to the eardrum through air. The microphone in some types may measure the level of the background noise and adjust accordingly the masking signal. The digital design of the device allows for the introduction of new tinnitus masking software programs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-938-5745customerservice@soundcure.com

Regulatory Flags#

DUNS number
052252810
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880295719SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880214345Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28