FDA.reportPublic FDA data

Widex

Primary DI
04056839124833
Brand
Widex
Company
Widex A/S
Model
ENJOY E-CIC 110
Catalog number
10980074
Device description
CAM EJY E-CIC 110
Published
2024-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04056839124833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056839124833040568391248334056839124833

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to 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
+4544355600widex@widex.com

Regulatory Flags#

DUNS number
309843613
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880292077WidexALLURE ARRD2 440210488562026-05-22
05714880292084WidexALLURE ARRD2 440210488552026-05-22
05714880292091WidexALLURE ARRD2 440210488542026-05-22
05714880292107WidexALLURE ARRD2 440210488532026-05-22
05714880292114WidexALLURE ARRD2 440210488522026-05-22
05714880292121WidexALLURE ARRD2 440210488512026-05-22
05714880292138WidexALLURE ARRD2 440210488502026-05-22
05714880292145WidexALLURE ARRD2 440210488492026-05-22
05714880292152WidexALLURE ARRD2 440210488482026-05-22
05714880292169WidexALLURE ARRD2 440210488472026-05-22
05714880292176WidexALLURE ARRD2 330210488462026-05-22
05714880292183WidexALLURE ARRD2 330210488452026-05-22
05714880292190WidexALLURE ARRD2 330210488442026-05-22
05714880292206WidexALLURE ARRD2 330210488432026-05-22
05714880292213WidexALLURE ARRD2 330210488422026-05-22
05714880292220WidexALLURE ARRD2 330210488412026-05-22
05714880292237WidexALLURE ARRD2 330210488402026-05-22
05714880292244WidexALLURE ARRD2 330210488392026-05-22
05714880292251WidexALLURE ARRD2 330210488382026-05-22
05714880292268WidexALLURE ARRD2 330210488372026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880296440SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296440SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296600SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296624SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296709SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296716SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.OSM2026-07-22