Data / Medical devices / United States / Soundwave Hearing, LLC
Soundwave Hearing, LLC: FDA-registered device maker in Oak Brook, IL, United States, 1 510(k) clearance
Soundwave Hearing, LLC is registered with the FDA (registration 3015527983) in Oak Brook, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015527983
- Address
- 619 Enterprise Dr Ste 205, Oak Brook, IL, United States, 60523
- Owner or operator
- Soundwave Hearing, LLC (10060266)
- Roles
- Specification developer
- First device listed
- November 5, 2023
- Registered through
- 2026
- Brand names listed
- Accessory-Ear Dome, Accessory-Receiver-In-Canal, Accessory-Sport Lock, Sontro Self-Fitting OTC Hearing Aids, otoTune app (for Android), otoTune app (for iOS)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2023 | K231550 | Sontro® OTC Hearing Aids (AI) | QUH | Substantially Equivalent | Soundwave Hearing, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 26, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.