FDA Device Establishments · JSON-LD · Markdown
FEI 3015527983 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3015527983 |
|---|---|
| Owner / Operator | Soundwave Hearing, LLC (#10060266) |
| Address | 619 Enterprise Dr Ste 205, Oak Brook, IL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QUH |
| Regulation § (21 CFR) | 874.3325 |
| Proprietary names | otoTune app (for iOS); Accessory-Sport Lock; otoTune app (for Android); Accessory-Receiver-In-Canal; Accessory-Ear Dome; Sontro Self-Fitting OTC Hearing Aids |
Source: openFDA. Public-domain (CC0).