Earlens Contact Hearing Solution Monaural, Right

GUDID 08500130070277

Inductive Kit containing Right Light Tip & Processor Assembly, 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: 08500130070277
• NIH Device Record Key: 49521bd1-d866-44df-b8ab-19064e49ae67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Contact Hearing Solution Monaural, Right
• Version Model Number: IK01R
• 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	08500130070277 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-14
• Device Publish Date: 2019-05-06

On-Brand Devices [Earlens Contact Hearing Solution Monaural, Right]

• 08500130070277: Inductive Kit containing Right Light Tip & Processor Assembly, Right Tympanic Lens, Charger. Pr
• 00850013007271: Inductive Kit containing Right Light Tip & Processor Assembly, Right Tympanic Lens, Charger. Pr