FDA.reportPublic FDA data

Lexie Hearing

Primary DI
00858177007595
Brand
Lexie Hearing
Company
INTRICON CORPORATION
Model
CM1
Catalog number
93237-004
Device description
Hearing Aid Accessory
Published
2020-10-16
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
00858177007595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858177007595008581770075958581770075950858177007595

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid enhanced audio device, telecommunication/multimediaA battery-powered device designed to provide high-definition digital wireless audio transmission from an external telecommunication audio source [e.g., television (TV), radio/stereo equipment, mobile phone (cell phone)] to a hearing aid, to enhance the sound quality received by the wearer of the hearing aid. It is typically a hand-held electronic unit, portable or placed in the home, intended to provide features such as artefact-free, echo-free, real-time audio transmission in and sometimes to remotely manage selected features in the hearing aid or external audio source for improved sound quality.

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
false
Serial number
true
Manufacturing date on label
true
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
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
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219432Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28