TransEar none

GUDID 00810323003806

bone conduction hearing aid -

EAR TECHNOLOGY CORPORATION

Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator Auditory cranial bone vibrator

• Primary Device ID: 00810323003806
• NIH Device Record Key: 4a7bd828-8373-45ac-afb4-462868bd7be1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransEar
• Version Model Number: TE380
• Catalog Number: none
• Company DUNS: 023930584
• Company Name: EAR TECHNOLOGY CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810323003806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050653

FDA Product Code

• LXB: Hearing Aid, Bone Conduction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-08-05
• Device Publish Date: 2016-10-06

On-Brand Devices [TransEar]

• 08103230003802: bone conduction hearing aid -
• 00810323003806: bone conduction hearing aid -