Earlens Processor & Ear Tip

Basic Information

• Brand Name: Earlens Processor & Ear Tip
• Primary DI: 00850013007233
• Version / Model: PET01X
• Catalog Number: PET01X
• Company Name: EARLENS CORPORATION
• Labeler DUNS: 611658795
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-06
• Public Version: 3
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: 25859da4-bc42-46f1-be82-e2f3a9b9abd9
• 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, Ear Tip comes in L - Left, R - Right

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013007233	GS1

Premarket Submissions

Submission Number	Supplement Number
K182480	000

Storage Conditions

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