contact forte Alpha

The contact forte Alpha is a bone-conduction hearing aid sound processor that converts sound into mechanical vibrations. It attaches magnetically to the Sophono Headband, Softband, or Magnetic Implant and transmits vibrations through the patient's skin and skull to the cochlea. It is intended for patients with conductive, mixed, or single-sided sensorineural hearing loss who can benefit from sound amplification.

The device uses bone conduction technology with a 13 (PR 48, Zinc-Air) battery, maximum output of 114 dBOFL, full-on gain of 51dB, programmable with 16-band 8-channel frequency processing and 4 programs. It has an ABS plastic housing for right or left side application with symmetric design and uses biocompatible materials per ISO 10993 standards. Magnetic attachment mechanism and individual patient fitting via software are included.

ISO 10993 (biocompatibility), IEC 60601-1-2 (electromagnetic compatibility/EMC), and ISO 14971 (risk assessment) are cited. Nonclinical testing included magnetic retention force measurements and output level measurements across clinically relevant configurations.

Both the contact forte Alpha and predicate Sophono Alpha 2 are bone-conduction sound processors with identical intended use, technological approach, and performance characteristics. Comparative testing demonstrated no measurable differences in acoustic gain, output, speech intelligibility, or electromagnetic compatibility. Field testing with five patients showed comparable audiometric thresholds and no subjective hearing differences between devices. Risk assessment per ISO 14971 confirms equivalent safety profiles, and biocompatibility testing demonstrates compliance with applicable standards, establishing that performance and safety remain equivalent to the predicate.