FDA.reportPublic FDA data

TRUHEARING

Primary DI
05714880238280
Brand
TRUHEARING
Company
Ws Audiology Usa, Inc.
Model
TH Premium 7 RIC LI T
Catalog number
21037834
Device description
HA TH PREMIUM 7 RIC LI T GNT
Published
2024-04-22
Public version status
New
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
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880238280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880238280057148802382805714880238280

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe 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
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880295719SIGNIAActive Mini 7IX210541382026-06-08
05714880295726SIGNIAActive Mini 7IX210541492026-06-08
05714880295733SIGNIAActive Mini 5IX210543862026-06-08
05714880295740SIGNIAActive Mini 5IX210543912026-06-08
05714880295788SIGNIAActive Mini 3IX210543872026-06-08
05714880295795SIGNIAActive Mini 3IX210543922026-06-08
05714880295849SIGNIAActive Mini 2IX210543882026-06-08
05714880295856SIGNIAActive Mini 2IX210543942026-06-08
05714880295900SIGNIAActive Mini 1IX210543892026-06-08
05714880295917SIGNIAActive Mini 1IX210543952026-06-08
05714880295986SIGNIAKit Active Mini 7IX210541502026-06-08
05714880296013SIGNIAKit Active Mini 5IX210543972026-06-08
05714880296044SIGNIAKit Active Mini 3IX210543982026-06-08
05714880296075SIGNIAKit Active Mini 2IX210543992026-06-08
05714880296105SIGNIAKit Active Mini 1IX210544002026-06-08
05714880189308SonySony | Hearing Control210222962023-01-20
05714880199420SonySony | Hearing Control WA210263452023-08-31
05714880293531SIGNIAPortable Charger Active Mini210539262026-06-04
05714880297898SIGNIAPortable Charger Active Mini210558862026-06-04
05714880113778CONNEXXSmart Key109398752026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.KLW2026-06-08