Evaluation Study
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The Sophono bone-conduction system: Surgical, audiologic, and quality-of-life outcomes.

We prospectively evaluated the surgical, audiologic, and quality-of-life outcomes in 5 patients-2 men and 3 women, aged 22 to 64 years (mean: 41.8)-who were implanted with the Sophono Alpha 2 MPO Processor. The indications for implantation of this bone-conduction device included recurrent ear canal infections with hearing aids (n = 3), single-sided deafness (n = 1), and patient preference in view of difficulty using a conventional hearing aid (n = 1). In addition to the patient with single-sided deafness, 3 patients had a bilateral mixed hearing loss and 1 had a bilateral conductive hearing loss. Outcomes measures included surgical complications, functional gain (FG), speech discrimination in quiet and noise, and patient satisfaction as determined by the Glasgow Benefit Inventory (GBI) and the Entific Medical Systems bone-anchored hearing aid questionnaire (BAQ). The only postsurgical complication noted was a minor skin reaction and pain in 1 patient that resolved with conservative management. In the 3 patients with the mixed hearing loss, the mean FG was 13.3, 20.0, 11.7, and 11.7 dB at 0.5, 1, 2, and 4 kHz, respectively; in the patient with the bilateral conductive hearing loss, the FG was 10, 25, 10, and 15 dB at the same frequencies. Speech discrimination scores with the Sophono device were comparable to those seen with conventional hearing aids. After implantation, all 5 patients experienced a positive quality-of-life outcome according to the GBI, although 1 of them had only a marginal improvement. On follow-up, all patients reported that they remained satisfied with their implant and that they used their device all day long. We conclude that the Sophono bone-conduction system is a safe and effective option that should be considered for patients with a mixed or conductive hearing loss who are unable to use a conventional hearing aid, as well as for those with single-sided deafness.

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