* Department of Signals and Systems, Chalmers University of Technology , Gothenburg , Sweden.
Int J Audiol. 2015 Jun;54(6):408-16. doi: 10.3109/14992027.2014.996826. Epub 2015 Feb 23.
To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin.
A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device.
Six patients (age 18-67 years) with mild-to-moderate conductive or mixed hearing loss.
The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses.
The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.
研究一种新型主动经皮设备（骨导植入物，BCI）的听力和生活质量结果，该设备的换能器在完整的皮肤下植入。
一项临床研究，在六个月的随访中进行声场测听和问卷调查，以骨锚式助听器和软带作为参考设备。
六名（18-67 岁）患有轻度至中度传导性或混合性听力损失的患者。
手术过程无意外，无不良事件。第一个假设，即 BCI 与未佩戴设备相比具有统计学上的显著改善，通过纯音平均听力提高 31.0dB、安静时言语识别阈值提高 27.0dB 和噪声中言语识别得分提高 51.2%得到证明。在言语水平上，BCI 的信噪比阈值为-5.5dB。所有 BCI 结果均优于或类似于参考设备结果，APHAB 和 GBI 问卷评分显示与未佩戴设备相比有统计学意义的改善，支持第二个和第三个假设。
BCI 为轻度至中度传导性或混合性听力障碍患者提供了显著的听力康复效果，并且可以在完整的皮肤下安全地植入。
