Identity
- Trade Name
- otoTune app FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids FDA UDI
- Model / Reference
- 990020-SWH FDA UDI
- Description
- APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850016231390 FDA UDI
- FDA Product Code
- QUH FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3325 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Audiometric/hearing device software
otoTune app by Soundwave Hearing, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
- CUSTOM SND SUITE 1.3 SERV RELEASE 1 — Cochlear · Class III
- Boots Hearingcare 2 — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- Widex — Widex A/S · Class I
- Nucleus — Cochlear · Class III
- hearX — INTRICON CORPORATION · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soundwave Hearing, Llc
Sources (1)
- FDA UDI 0b8c23ed-d50b-4237-9682-c45bf8871ac6 34 fields · synced May 30, 2026