Identity
- Trade Name
- iHear EON FDA UDI
- Generic Name
- Air-conduction hearing aid, wearable case FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- EON-KIT-STD FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850965008456 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Air-conduction hearing aid, wearable case FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction hearing aid, wearable case
iHear EON by Ihear Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, wearable case.
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class II
- Newsound — Xiamen New Sound Technology Co., Ltd. · Class I
- Newsound — Xiamen New Sound Technology Co., Ltd. · Class II
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class I
- Aqustic — PS Hearing Products Inc · Class I
- Newsound — Xiamen New Sound Technology Co., Ltd. · Class I
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class I
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ihear Medical, Inc.
Sources (1)
- FDA UDI ae588c1d-9656-470c-a7fc-3a2d2aea2ba4 35 fields · synced May 31, 2026