iHear EON

GUDID 00850965008470

A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an ear tip that fits inside the the ear canal. 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

IHEAR MEDICAL, INC.

Air-conduction hearing aid, wearable case
Primary Device ID00850965008470
NIH Device Record Keyae588c1d-9656-470c-a7fc-3a2d2aea2ba4
Commercial Distribution StatusIn Commercial Distribution
Brand NameiHear EON
Version Model NumberEON-KIT-STD
Company DUNS080166877
Company NameIHEAR MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-(844)-443-2744
Emailsupport@ihearmedical.com
Phone1-(844)-443-2744
Emailsupport@ihearmedical.com
Phone1-(844)-443-2744
Emailsupport@ihearmedical.com
Phone1-(844)-443-2744
Emailsupport@ihearmedical.com
Phone1-(844)-443-2744
Emailsupport@ihearmedical.com
Phone1-(844)-443-2744
Emailsupport@ihearmedical.com
Phone1-(844)-443-2744
Emailsupport@ihearmedical.com
Phone1-(844)-443-2744
Emailsupport@ihearmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850965008456 [Primary]
GS100850965008470 [Package]
Contains: 00850965008456
Package: Each [1 Units]
In Commercial Distribution

FDA Product Code

OSMHearing Aid, Air Conduction With Wireless Technology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-21
Device Publish Date2020-10-13

Trademark Results [iHear EON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IHEAR EON
IHEAR EON
85788542 not registered Dead/Abandoned
IHear Medical, Inc.
2012-11-27

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