Earlens Contact Hearing Solution, Binaural IBK01

GUDID 00850013007288

Inductive Kit containing Left and Right Ear Tip & Processor Assemblies Left and Right Tympanic Lens Charger Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black

EARLENS CORPORATION

Tympanic membrane contact hearing aid

• Primary Device ID: 00850013007288
• NIH Device Record Key: 42be9ed5-cdbc-4750-9475-e983aac2e105
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Contact Hearing Solution, Binaural
• Version Model Number: IBK01
• Catalog Number: IBK01
• Company DUNS: 611658795
• Company Name: EARLENS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013007288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182480

FDA Product Code

• PLK: Tympanic Membrane Direct Contact Hearing Aid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-07
• Device Publish Date: 2019-05-06

On-Brand Devices [Earlens Contact Hearing Solution, Binaural]

• 08500130070284: Inductive Kit containing Left and Right Ear Tip & Processor Assemblies Left and Right Tympanic
• 00850013007288: Inductive Kit containing Left and Right Ear Tip & Processor Assemblies Left and Right Tympanic