FDA.reportPublic FDA data

hearX

Primary DI
00858177007458
Brand
hearX
Company
INTRICON CORPORATION
Model
Lexie
Catalog number
Lexie IOS App
Device description
IOS Hearing Aid Programming App
Published
2020-07-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00858177007458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858177007458008581770074588581770074580858177007458

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).

Contacts#

Phone, Email table
PhoneEmail
+1-651-636-9770udi@intricon.com

Regulatory Flags#

DUNS number
002345767
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00858177007939AudicusONE933369-0162022-12-19
00858177007946AudicusONE93336-0172022-12-19
00858177007953AudicusONE93336-0182022-12-19
00858177007960IntriconLumen 155H93545-0002022-12-19
00858177007977IntriconLumen 155H93546-0002022-12-19
00858177007892AudicusONE93336-0132022-11-10
00858177007908AudicusONE93336-0142022-11-10
00858177007915AudicusONE93336-0152022-11-10
00858177007847BeurerL15593532-0052022-06-30
00858177007854BeurerL15593532-0062022-06-30
00858177007861BeurerL1552022-06-30
00858177007878BeurerL1552022-06-30
00858177007885BeurerL15593532-0092022-06-30
00858177007823PersonaL150i193057-0222022-06-21
00858177007830PersonaL150i193119-0282022-06-21
00858177007779BeurerL15593532-0002022-06-08
00858177007786BeurerL15593532-0012022-06-08
00858177007793BeurerL15593532-0022022-06-08
00858177007809BeurerL15593532-0032022-06-08
00858177007816BeurerL15593532-0042022-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296394029BeltoneGn Hearing A/SOSM2026-10-05
05708296394036BeltoneGn Hearing A/SOSM2026-10-05
05708296394098BeltoneGn Hearing A/SOSM2026-10-05
05708296394104BeltoneGn Hearing A/SOSM2026-10-05
05708296394111BeltoneGn Hearing A/SOSM2026-10-05
05708296394128BeltoneGn Hearing A/SOSM2026-10-05
05708296394135BeltoneGn Hearing A/SOSM2026-10-05
05708296394197BeltoneGn Hearing A/SOSM2026-10-05
05708296394203BeltoneGn Hearing A/SOSM2026-10-05
05708296394210BeltoneGn Hearing A/SOSM2026-10-05
05708296394487BeltoneGn Hearing A/SOSM2026-10-05
05708296394494BeltoneGn Hearing A/SOSM2026-10-05
05708296394555BeltoneGn Hearing A/SOSM2026-10-05
05708296394562BeltoneGn Hearing A/SOSM2026-10-05
05708296394579BeltoneGn Hearing A/SOSM2026-10-05
05708296394586BeltoneGn Hearing A/SOSM2026-10-05
05708296394593BeltoneGn Hearing A/SOSM2026-10-05
05708296394654BeltoneGn Hearing A/SOSM2026-10-05
05708296394661BeltoneGn Hearing A/SOSM2026-10-05
05708296394678BeltoneGn Hearing A/SOSM2026-10-05
05708296397877BeltoneGn Hearing A/SOSM2026-10-05
05708296397884BeltoneGn Hearing A/SOSM2026-10-05
05708296397945BeltoneGn Hearing A/SOSM2026-10-05
05708296397952BeltoneGn Hearing A/SOSM2026-10-05
05708296397969BeltoneGn Hearing A/SOSM2026-10-05
05708296429455BeltoneGn Hearing A/SOSM2026-10-05
05708296429462BeltoneGn Hearing A/SOSM2026-10-05
05708296429523BeltoneGn Hearing A/SOSM2026-10-05
05708296429530BeltoneGn Hearing A/SOSM2026-10-05
05708296429547BeltoneGn Hearing A/SOSM2026-10-05