Cochlear Baha SoundArc

510(k) Number

K171088 ↗

FDA product code

LXB

Device class

Class II

Regulation

21 CFR Part 874.3302

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).

• Baha 92141 by Cochlear Bone Anchored Solutions AB
• Baha 92140 by Cochlear Bone Anchored Solutions AB
• ADHEAR Adhesive Adapters, beige, 15 pcs. 34689 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Sophono Bone Conduction Systems (S) Configuration and (M) Configuration by Sophono, Inc.
• OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) by Sophono, Inc.
• Baha SoundArc Medium P807176 by Cochlear
• Bone Conduction Hearing Aid (G41157) by ZDEER TECHNOLOGY (HENAN) CO., LTD
• ADHEAR User Kit, Terra Brown 38198 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• BAHA DIVINO by Entific Medical Systems, Inc.
• SOUNDBITE HEARING SYSTEM BY SONITUS by Sonitus Medical, Inc.

• Cochlear™ Osia® 3(I) Sound Processor

  Class II

  FDA 510(k) K260902 Active Cleared 10 Jul 2026

• Field Bone-Anchored Drill Kit 91053R

  Class II

  FDA 510(k) K955713 Active Cleared 9 Aug 1996 GUDID on market

• Rental Bone-Anchored Drill Kit FUZ180

  Class II

  FDA 510(k) K955713 Active Cleared 9 Aug 1996 GUDID on market

• Custom Sound Pro 7.0 Cd P2002452CD

  Class III

  FDA PMA P970051 Active Approved 25 Jun 1998 GUDID on market

See all devices from Cochlear Americas →