TRANSEAR BONE CONDUCTION HEARING AID— 510(k) K062404

Substantially Equivalent

Ear Technology Corp.

FDA 510(k) clearance K062404 for TRANSEAR BONE CONDUCTION HEARING AID, Substantially Equivalent on 2006-09-08. Applicant: Ear Technology Corp..

Clearance details

Applicant: Ear Technology Corp.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2006-08-17
Decision date: 2006-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Johnson City, TN, 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.