Identity
- Trade Name
- Earlens Light Driven Hearing Aid, Binaural FDA UDI
- Generic Name
- Tympanic membrane contact hearing aid FDA UDI
- Device Name
- Kit containing Left and Right Light Tip & Processor Assemblies Left and Right Tympanic Lens Charger Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown FDA UDI
- Model / Reference
- BKEL1 FDA UDI
- Description
- Kit containing Left and Right Light Tip & Processor Assemblies Left and Right Tympanic Lens Charger Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown FDA UDI
Identifiers
- Catalog Number
- BKEL1 FDA UDI
- Primary DI / UDI-DI
- 08500130070123 FDA UDI
- FDA Product Code
- PLK FDA UDI
- GMDN Term
- Tympanic membrane contact hearing aid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3315 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Earlens Light Driven Hearing Aid, Binaural by Earlens Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Earlens Corporation
Sources (1)
- FDA UDI 070779fd-0ca0-406e-8fa6-6440e0c0691e 36 fields · synced May 30, 2026