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

The Cochlear Baha 7 Sound Processor is a bone-conduction hearing aid that converts acoustic sound into electrical signals and mechanical vibrations, transmitting sound directly to the inner ear via the skull bone. It is intended for patients with conductive or mixed hearing loss, single-sided deafness, or those who cannot use air-conduction hearing aids, and can be used with surgical implants or non-surgical retention systems like the Baha SoundBand or Softband.

The Baha 7 Sound Processor is a firmware variant of the Baha 6 Max using the new Dooku3 platform instead of Dooku2. Primary modifications include Bluetooth LE Audio and Auracast support for compatibility with new GN Hearing wireless accessories, an additional lavender color option, and new laser etching. All other components—battery size, materials, actuator, snap coupling, and signal processing features—remain equivalent to the predicate device.

The document cites ISO 10993-1 and ISO 10993-1:2018 for biocompatibility evaluation of patient-contacting materials. No other specific consensus standards (ASTM, IEC) are explicitly named in the summary.

The Baha 7 has identical intended use, external hardware, fundamental operating principles, and biocompatible materials as the Baha 6 Max predicate. Bench testing—including functional, performance, hardware, reliability, environmental, and system/subsystem level testing—demonstrated the Baha 7 does not result in additional safety or efficacy concerns. The firmware upgrades only enhance connectivity through LE Audio support and compatibility with new wireless accessories without modifying core hearing aid functionality, establishing functional equivalence to the predicate.