Identity
- Trade Name
- America Hears® FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-the-ear FDA UDI
- Device Name
- Elite HA MFI Package - Grey FDA UDI
- Model / Reference
- 556* FDA UDI
- Description
- Elite HA MFI Package - Grey FDA UDI
Identifiers
- Catalog Number
- HLT-ELITE-I-GR FDA UDI
- Primary DI / UDI-DI
- 00810068830279 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Air-conduction hearing aid, receiver-in-the-ear 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, receiver-in-the-ear
America Hears® by Hearing Lab Technology, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, receiver-in-the-ear.
- AGXO — Oticon A/S · Class II
- Oticon — Oticon A/S · Class II
- HHM — Sbo Hearing A/S · Class II
- Oticon — Oticon A/S · Class II
- AGXO — Oticon A/S · Class II
- HHM — Oticon A/S · Class II
- EarQ — Sbo Hearing A/S · Class II
- Oticon — Oticon 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hearing Lab Technology, Llc
Sources (1)
- FDA UDI 5b13a4e2-eead-45b9-bec3-cf3ff9d1bb4a 35 fields · synced Jun 8, 2026