Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand— 510(k) K250215

Substantially Equivalent

Cochlear

FDA 510(k) clearance K250215 for Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand, Substantially Equivalent on 2025-05-29. Applicant: Cochlear.

Clearance details

Applicant: Cochlear
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2025-01-24
Decision date: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lone Tree, CO, 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.