Cleared Traditional

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

K250215 · Cochlear · Ear, Nose, Throat

May 2025

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K250215 is an FDA 510(k) clearance for the Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand, a Hearing Aid, Bone Conduction (Class II — Special Controls, product code LXB), submitted by Cochlear (Lone Tree, US). The FDA issued a Cleared decision on May 29, 2025, 125 days after receiving the submission on January 24, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3302.

Submission Details

510(k) Number	K250215 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2025
Decision Date	May 29, 2025
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF