Earlens Processor & Light Tip

Basic Information

• Brand Name: Earlens Processor & Light Tip
• Primary DI: 00850013007073
• Version / Model: PLEL1X
• Catalog Number: PLEL1X
• Company Name: EARLENS CORPORATION
• Labeler DUNS: 611658795
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 8
• Public Version Date: 2023-02-13
• Public Version Status: Update
• Public Device Record Key: e2ca3a0c-8f24-488d-b8b0-171499ccb3a1
• Distribution End Date: 2022-12-16

Device Description

Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown LT comes in L - Left, R - Right

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PLK	Tympanic Membrane Direct Contact Hearing Aid	Ear, Nose, Throat	874.3315	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62420	Tympanic membrane contact hearing aid ear tip transmitter	An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed inthe external auditory canal to convert electrical signals from a sound processor into light signals orelectromagnetic energy for transmission to another component. The hearing aid is intended tocompensate for mild/severe sensorineural impaired hearing by transmitting transduced soundwaves, via light waves or an oscillating electromagnetic field, to a vibrator component in directcontact with the TM; it may include a custom-made earmould in which it is held in place.	No	Active
62419	Tympanic membrane contact hearing aid sound processor	An electronic component of a tympanic membrane (TM) contact hearing aid designed to be wornbehind-the-ear (BTE) and to receive sound waves and convert them into electrical signals fortransmission to another component. The hearing aid is intended to compensate for mild/severesensorineural impaired hearing by transmitting transduced sound waves, via light waves orelectromagnetic energy, to a vibrator component in direct contact with the TM.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013007073	GS1

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 525 – 795 Millimeter of Mercury
• Type: Handling Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 525 – 795 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius