Fortell AI Hearing Aid

GUDID 00860014635809

Fortell AI Hearing Aids (Rx, Silver)

Fortell Research Inc.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 00860014635809
• NIH Device Record Key: f880ef84-8276-46ce-9255-b1c17c1535ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortell AI Hearing Aid
• Version Model Number: KITPK-001-SLV
• Company DUNS: 118094664
• Company Name: Fortell Research Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: false
• 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	00860014635809 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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: 2025-12-10
• Device Publish Date: 2025-12-02