510(k) K231550— Sontro® OTC Hearing Aids (AI)
Substantially EquivalentSoundwave Hearing, LLC
Clearance details
- Applicant
- Soundwave Hearing, LLC
- Product code
- Code QUH
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oak Brook, IL, US
Adverse events under product code QUH
product code QUH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.