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 ID | 00850965008470 |
| NIH Device Record Key | ae588c1d-9656-470c-a7fc-3a2d2aea2ba4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iHear EON |
| Version Model Number | EON-KIT-STD |
| Company DUNS | 080166877 |
| Company Name | IHEAR MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com | |
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com | |
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com | |
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com | |
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com | |
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com | |
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com | |
| Phone | 1-(844)-443-2744 |
| support@ihearmedical.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850965008456 [Primary] |
| GS1 | 00850965008470 [Package] Contains: 00850965008456 Package: Each [1 Units] In Commercial Distribution |
FDA Product Code
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2020-10-13 |
Trademark Results [iHear EON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IHEAR EON 85788542 not registered Dead/Abandoned |
IHear Medical, Inc. 2012-11-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.