FDA UDI
In Commercial Distribution
🇺🇸 United States
Fortell AI Hearing Aid
DI: 00860014635809
·
Model: KITPK-001-SLV
·
Fortell Research Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fortell AI Hearing Aid
- Primary DI
- 00860014635809
- Version / Model
- KITPK-001-SLV
- Company Name
- Fortell Research Inc.
- Labeler DUNS
- 118094664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-02
- Public Version
- 1
- Public Version Date
- 2025-12-10
- Public Version Status
- New
- Public Device Record Key
- f880ef84-8276-46ce-9255-b1c17c1535ef
Device Description
Fortell AI Hearing Aids (Rx, Silver)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Ear, Nose, Throat | 874.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34671 | Air-conduction hearing aid, behind-the-ear | A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860014635809 | GS1 |