FDA UDI
In Commercial Distribution
🇺🇸 United States
Sontro Self-Fitting OTC Hearing Aids
DI: 00850016231048
·
Model: 990004-SWH
·
Soundwave Hearing, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sontro Self-Fitting OTC Hearing Aids
- Primary DI
- 00850016231048
- Version / Model
- 990004-SWH
- Company Name
- Soundwave Hearing, LLC
- Labeler DUNS
- 050441605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-01
- Public Version
- 3
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- d31bc5ac-7103-4395-8a43-0853adb28b53
Device Description
GREY/990004-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | Ear, Nose, Throat | 874.3325 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47169 | Air-conduction hearing aid, receiver-in-canal | A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. 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 | 00850016231048 | GS1 |
Customer Contacts
- Phone
- 833-367-4327
- [email protected]