Identity
- Trade Name
- hi Health Innovations FDA UDI
- Generic Name
- Hearing aid enhanced audio device, telecommunication/multimedia FDA UDI
- Device Name
- Hearing Aid Enhanced Audio Device FDA UDI
- Model / Reference
- CM1 FDA UDI
- Description
- Hearing Aid Enhanced Audio Device FDA UDI
Identifiers
- Catalog Number
- 93237-000 FDA UDI
- Primary DI / UDI-DI
- 00858177007083 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Hearing aid enhanced audio device, telecommunication/multimedia 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hearing aid enhanced audio device, telecommunication/multimedia
hi Health Innovations by Intricon Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid enhanced audio device, telecommunication/multimedia.
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- GN Hearing — Gn Hearing A/S · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
- iCube II — Sonova AG · Class II
- UNITRON — Unitron Hearing Division · Class II
- Sonic — Sonic Innovations, Inc. · Class II
- STARKEY HEARING TECHNOLOGIES — Starkey Laboratories Inc. · Class II
- GN Hearing — Gn Hearing A/S · 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
- Intricon Corporation
Sources (1)
- FDA UDI 13f02d14-91a1-4ec4-829c-20816d41a9b5 35 fields · synced May 30, 2026