Earlens Contact Hearing Solution, Monaural, Left

Basic Information

• Brand Name: Earlens Contact Hearing Solution, Monaural, Left
• Primary DI: 00850013007264
• Version / Model: IK01L
• Catalog Number: IK01L
• Company Name: EARLENS CORPORATION
• Labeler DUNS: 611658795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-06
• Public Version: 2
• Public Version Date: 2020-05-07
• Public Version Status: Update
• Public Device Record Key: c39cdca4-4d0e-4f63-a494-46e03f9566e2

Device Description

Kit containing Left Ear Tip & Processor Assembly, Left Tympanic Lens, Charger. Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black,

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: MR Unsafe
• 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
62418	Tympanic membrane contact hearing aid	A collection of electronic devices intended to compensate for mild/severe sensorineural impairedhearing by transmitting transduced sound waves, either via light waves or an oscillatingelectromagnetic field, to a vibrator component in direct contact with the tympanic membrane (TM). Itconsists of a behind-the-ear (BTE) sound processor that receives sound waves and converts theminto electrical signals, which are relayed to a light transducer or transmission coil in the external earcanal where they are converted into light or electromagnetic signals, which are transmittedto a transducer on the TM where they are converted to vibrations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013007264	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