FDA.reportPublic FDA data

Hearing Help Express

Primary DI
00858177007137
Brand
Hearing Help Express
Company
INTRICON CORPORATION
Model
CM1
Catalog number
93237-001
Device description
Hearing Aid Accessory
Published
2018-10-24
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
00858177007137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858177007137008581770071378581770071370858177007137

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
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