Earlens Tympanic Lens, Binaural

Basic Information

• Brand Name: Earlens Tympanic Lens, Binaural
• Primary DI: 00850013007257
• Version / Model: ITL01LR
• Catalog Number: ITL01LR
• Company Name: EARLENS CORPORATION
• Labeler DUNS: 611658795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-05-06
• Public Version: 4
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: eb3aa179-f686-4409-b60f-016c1f65fe36

Device Description

Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.

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: 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
62421	Tympanic membrane contact hearing aid tympanic transducer	An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed in direct contact with the TM and to convert signals into vibrations, which are then passed along the normal sound conduction pathway in the middle ear. The TM transducer is non-surgically placed by a healthcare professional in a clinical setting and is intended to remain in situ indefinitely. The hearing aid is intended to compensate for mild/severe sensorineural impaired hearing by transmitting transduced sound waves, via light waves or an oscillating electromagnetic field, 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	00850013007257	GS1
Unit of Use	00850013007332	GS1

Premarket Submissions

Submission Number	Supplement Number
K182480	000

Storage Conditions

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