510(k) K153245— Baha 5 Super Power Sound Processor

Substantially Equivalent

Cochlear Americas

Clearance details

Applicant: Cochlear Americas
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2015-11-09
Decision date: 2016-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

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.