To confirm the clinical efficacy and safety of a direct acoustic cochlear implant
Prospective multicenter study.
The study was performed at 3 university hospitals in Europe (Germany, The Netherlands, and Switzerland).
Fifteen patients with severe-to-profound mixed hearing loss because of otosclerosis
or previous failed stapes surgery
Implantation with a Codacs direct acoustic cochlear implant
investigational device (ID) combined with a stapedotomy
with a conventional stapes prosthesis
Main Outcome Measures
Preoperative and postoperative (3 months after activation of the investigational direct acoustic cochlear implant
) audiometric evaluation measuring conventional pure tone and speech audiometry, tympanometry, aided thresholds in sound field and hearing difficulty by the Abbreviated Profile of Hearing Aid Benefit questionnaire.
The preoperative and postoperative air and bone conduction thresholds did not change significantly by the implantation with the investigational Direct Acoustic Cochlear Implant
. The mean sound field thresholds (0.25–8 kHz) improved significantly by 48 dB. The word recognition scores (WRS) at 50, 65, and 80 dB SPL improved significantly by 30.4%, 75%, and 78.2%, respectively, after implantation with the investigational direct acoustic cochlear implant
compared with the preoperative unaided condition. The difficulty in hearing, measured by the Abbreviated Profile of Hearing Aid Benefit, decreased by 27% after implantation with the investigational direct acoustic cochlear implant
Patients with moderate-to-severe mixed hearing loss because of otosclerosis
can benefit substantially using the Codacs investigational device.