SoundBite

GUDID 06972667660313

The SoundBite Hearing System by Sonitus Medical consists of two main components; a behind the ear (BTE) microphone unit and an in the mouth (ITM) hearing device. Accessories include a system charger and programming software. The BTE uses a digital signal processor to process the sound and a wireless chip to transmit the signals to the hearing device worn in the mouth. The ITM hearing device in turn creates imperceptible vibrations using a piezoelectric actuator that are sent via the teeth, through the skull bones, and ultimately to the cochleae.

Sonitus Medical?Shanghai?Co., ltd.

Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn Bone-conduction hearing aid, tooth-worn

• Primary Device ID: 06972667660313
• NIH Device Record Key: fe1a9732-6666-48f7-b263-b94ed24a4673
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoundBite
• Version Model Number: G3
• Company DUNS: 544488215
• Company Name: Sonitus Medical?Shanghai?Co., ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972667660313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100649

FDA Product Code

• LXB: Hearing Aid, Bone Conduction

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: 2021-04-09
• Device Publish Date: 2021-04-01