中文摘要：

目的评估软带或头带佩戴新型经皮传导索菲康骨导助听器对传导性聋或混合性聋、单侧聋患者的助听效果。方法以来自国内4家三级甲等医院的109例传导性或混合性聋患者及11例单侧聋（single-sided deafness,SSD）患者为研究对象,均以纯音测听（≥6岁患者）或听性脑干反应（ABR）（〈6岁患者）评估裸耳听阈后予以头带或软带佩戴索菲康Alpha 2 MPO骨导助听器;并在声场下进行未助听、佩戴当日及佩戴2周后的助听听阈（0.5~4kHz）测试;≥6岁患者进行未助听、佩戴当日及佩戴2周助听下的言语识别阈（speech recognition threshold,SRT）测试,并记录患者佩戴后的不良反应。结果传导性或混合性聋患者中≥6岁患者助听耳裸耳骨导及气导平均听阈均值分别为18.55±8.99、71.45±10.25dB HL,〈6岁组助听耳裸耳骨导及气导ABR阈值均值分别为18.33±8.36、70.80±8.24dB HL;SSD患者助听耳裸耳听阈不能测出;佩戴2周后,三组助听后纯音听阈均值分别为32.21±10.00、37.33±14.15、34.38±10.76dB HL,较未助听时明显改善,差异有统计学意义（P〈0.05）;≥6岁传导性或混合性聋组和SSD组患者佩戴2周后助听下各方向SRT较未助听时均显著降低,差异有统计学意义（P〈0.05）;各组患者均无与佩戴助听器相关的不良皮肤反应等。结论使用软带、头带佩戴索菲康骨导助听器,可有效改善传导性或混合性聋、SSD患者听阈和安静环境下言语识别阈。

英文摘要：

Objective The aim of the study was to evaluate the hearing performance of a new transcutaneous bone conduction hearing aid.Methods One hundred and nine patients with conductive or mix hearing loss and eleven patients with single sided sensorineural hearing loss from four tertiary referral centers were tested under unaided and aided conditions with the sound processors on testbands.Free field test was performed to obtain the hearing thresholds and speech recognition thresholds in quiet.Adverse events were also documented by a self-reported questionnaire.Results（1）Conductive or mixed hearing loss patients：for aged≥6yrs subgroup,the bone conduction PTA average of aided sides was 18.55±8.99 dB HL.For aged6yrs subgroup,the bone conduction ABR hearing threshold average was 18.33±8.36 dB HL.（2）Statistically significant improvements in free field hearing thresholds were seen when compared aided hearing with unaided outcomes.The average PTA（pure tone average in free field）was measuredat32.21±10.00,37.33±14.15,and34.38±10.76 dBHLrespectivelyinconductiveormixedhearing loss aged≥6yrs subgroup,aged6yrs subgroup and SSD subgroup.（3）In aided situations,speech recognition thresholds in quiet were significantly better compared to unaided situation in patients aged≥6yrs.（4）None of patients presented adverse events related to the devices.Conclusion The Sophono bone conduction hearing aid has satisfactory hearing performance and can be considered an alternative device for patients with conductive or mix hearing loss or with SSD.