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Soundwave Hearing

FDA UDI

Class II (US FDA UDI)

by Soundwave Hearing, Llc

Identity

Trade Name
Soundwave Hearing FDA UDI
Generic Name
Air-conduction hearing aid acoustic tube FDA UDI
Device Name
LEFT-LARGE/991009-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids FDA UDI
Model / Reference
991009-SWH FDA UDI
Description
LEFT-LARGE/991009-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids FDA UDI

Identifiers

Primary DI / UDI-DI
00850016231277 FDA UDI
FDA Product Code
QUH FDA UDI
GMDN Term
Air-conduction hearing aid acoustic tube 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: Air-conduction hearing aid acoustic tube

Soundwave Hearing by Soundwave Hearing, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid acoustic tube.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Soundwave Hearing, Llc

Sources (1)

  • FDA UDI fbff333e-02f9-413f-80d5-86b49464f577 34 fields · synced Jun 8, 2026