Patients with moderate-to-severe mixed hearing loss because of otosclerosis can benefit substantially using the Codacs investigational device.

The aim of this study was to investigate the efficacy of a direct acoustic cochlear implant (DACI) for speech understanding in noise in patients suffering from severe to profound mixed hearing loss (MHL) due to various etiologies compared to the preoperative best-aided condition. The study was performed at five tertiary referral centers in Europe (Belgium, Germany, Poland and Spain). Nineteen adult subjects with severe to profound MHL due to (advanced) otosclerosis, ear canal fibrosis, chronic otitis media, tympanosclerosis or previous cholesteatoma were implanted with a DACI (Codacs™ Investigational Device) combined with a conventional stapes prosthesis. Unaided and aided speech reception scores in quiet and in noise, preoperative and postoperative air and bone conduction thresholds and aided and unaided sound field thresholds were measured prospectively during the study. Subjective benefit analysis was determined through the Abbreviated Profile of Hearing Aid Benefit questionnaire. Quality of life was measured by the Health Utilities Index. All subjects were fitted preoperatively with hearing aids and/or a bone conduction implant on a headband before DACI implantation. This allows direct comparison between different hearing rehabilitation solutions. The mean speech reception threshold in noise improved significantly by 7.9 dB signal-to-noise ratio (SNR) after activation of the DACI compared to the preoperative best-aided condition. For all 19 subjects, a mean postoperative aided speech reception threshold of 2.6 dB SNR (standard deviation: 8.3 dB) was measured. On average, no significant shift in the bone conduction thresholds was noted 4-5 months after implantation. A mean sound field threshold improvement of 46 and 16 dB was measured compared to the preoperative unaided and best-aided condition, respectively. Speech perception tests in quiet showed a mean improvement of the word recognition scores by 65 and 48% at 65 dB SPL compared to the preoperative unaided and best-aided condition, respectively. In summary, DACI provides an effective improvement of the speech perception in noise compared to the best-aided condition in subjects suffering from severe to profound MHL.

Objective:The objectives of the investigation were to evaluate the effect of a sound processor upgrade on the speech reception threshold in noise and to collect long-term safety and efficacy data after 2½ to 5 years of device use of direct acoustic cochlear implant (DACI) recipients.Study Design:The study was designed as a mono-centric, prospective clinical trial.Setting:Tertiary referral center.Patients:Fifteen patients implanted with a direct acoustic cochlear implant.Intervention:Upgrade with a newer generation of sound processor.Main Outcome Measures:Speech recognition test in quiet and in noise, pure tone thresholds, subject-reported outcome measures.Results:The speech recognition in quiet and in noise is superior after the sound processor upgrade and stable after long-term use of the direct acoustic cochlear implant. The bone conduction thresholds did not decrease significantly after long-term high level stimulation.Conclusions:The new sound processor for the DACI system provides significant benefits for DACI users for speech recognition in both quiet and noise. Especially the noise program with the use of directional microphones (Zoom) allows DACI patients to have much less difficulty when having conversations in noisy environments. Furthermore, the study confirms that the benefits of the sound processor upgrade are available to the DACI recipients even after several years of experience with a legacy sound processor. Finally, our study demonstrates that the DACI system is a safe and effective long-term therapy.

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