FDA.reportPublic FDA data

CONNEXX

Primary DI
05714880113778
Brand
CONNEXX
Company
Ws Audiology Usa, Inc.
Model
Smart Key
Catalog number
10939875
Device description
SET SMART KEY
Published
2026-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880113778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880113778057148801137785714880113778

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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.

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05714880214345Audio ServiceR Li T 8.8210250432026-05-28

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.OSM2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880293531SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
05714880297898SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
06945936705688NewSoundXiamen New Sound Technology Co., Ltd.OSM2026-06-02
07613389836325DVD Phonak Target 12.0Sonova AGOSM2026-06-01
07613389836332USB Phonak Target 12.0 USBSonova AGOSM2026-06-01
07613389836349Phonak Target 12.0Sonova AGOSM2026-06-01
07613389842388Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842395Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842401Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389843026Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389917024Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917116Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917123Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
05714880214345Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28