FDA.reportPublic FDA data

SIGNIA

Primary DI
05714880211535
Brand
SIGNIA
Company
Ws Audiology Usa, Inc.
Model
CROS Styletto IX
Catalog number
21029376
Device description
SET CROS STYLETTO SD DIX BLK S
Published
2024-02-28
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
OSMHearing Aid, Air Conduction With Wireless Technology

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
05714880211535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880211535057148802115355714880211535

GMDN Terms#

Term, Definition table
TermDefinition
Contralateral hearing unitA passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.

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
05714880250695Audio ServiceR Li 4.6210388362026-09-18
05714880250701Audio ServiceR Li 4.6210388372026-09-18
05714880250718Audio ServiceR Li 4.6210388382026-09-18
05714880250725Audio ServiceR Li 4.6210388392026-09-18
05714880250732Audio ServiceR Li 4.6210388402026-09-18
05714880279580SIGNIAPortable Charger Styletto210488882026-08-21
05714880293951SIGNIAPortable Charger Styletto210543022026-08-21
05714880297461SIGNIARemote Control210524172026-08-21
05714880227154SonyCRE-C20210288712024-07-18
05714880215144SonyCRE-C20210288742024-07-01
05714880215151SonyCRE-C20210288752024-07-01
05714880182781SonyCRE-E10210223052023-05-30
05714880182743SonyCRE-C10210222962022-09-12
05714878800291MIRACLE EARMEMINI I 4 5W CIC-R210547572026-07-29
05714878800307MIRACLE EARMEMINI I 5 5W CIC-R210547562026-07-29
05714878800314MIRACLE EARMEMINI I 3 5W CIC-R210547582026-07-29
05714878800352MIRACLE EARMEMINI I 2 5W CIC-R210567122026-07-29
05714880296440SIGNIAKIT Silk C&G 7IX RB210550502026-07-22
05714880296464SIGNIAKIT Silk C&G 7IX RB210550522026-07-22
05714880296488SIGNIAKIT Silk C&G 5IX RB210550542026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296434688GN HearingGn Hearing A/SOSM2026-09-18
05708296434701GN HearingGn Hearing A/SOSM2026-09-18
05708296434718GN HearingGn Hearing A/SOSM2026-09-18
05708296477159GN ReSoundGn Hearing A/SOSM2026-09-18
05708296477166BeltoneGn Hearing A/SOSM2026-09-18
05708296477173GN ReSoundGn Hearing A/SOSM2026-09-18
05708296477180BeltoneGn Hearing A/SOSM2026-09-18
05714880250695Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250701Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250718Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250725Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250732Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
00840388220580Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04