SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL— 510(k) K110831

Substantially Equivalent

Sonitus Medical, Inc.

FDA 510(k) clearance K110831 for SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL, Substantially Equivalent on 2011-06-21. Applicant: Sonitus Medical, Inc..

Clearance details

Applicant: Sonitus Medical, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2011-03-25
Decision date: 2011-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.