Aria

GUDID 00817020021126

INTELLIGENT HEARING SYSTEMS CORP.

Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system

• Primary Device ID: 00817020021126
• NIH Device Record Key: e29f3184-df98-417c-9af5-17589b66d802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aria
• Version Model Number: M011160
• Company DUNS: 154870455
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817020021126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023859

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by INTELLIGENT HEARING SYSTEMS CORP.

• 00817020021126 - Aria: 2024-03-19
• 00817020021126 - Aria: 2024-03-19
• 00817020021058 - Bone Vibrator w/ Cable and Headband (B81): 2021-02-18
• 00817020021065 - DD45-300 Headphones: 2021-02-18
• 00817020020808 - SmartEP Software: 2019-07-12
• 00817020020815 - SmartEP-ASSR Software: 2019-07-12
• 00817020020822 - SmartScreener-Plus2 Screener Launch: 2019-07-12
• 00817020020839 - SmartScreener-Plus2 AEP Module: 2019-07-12
• 00817020020846 - SmartScreener-Plus2 OAE Module: 2019-07-12