从构想到临床:Sentio骨导植入研发与转化
The Sentio journey: from concept to clinical bone conduction implantation
任柳杰;李辰龙;张天宇
1:复旦大学附属眼耳鼻喉科医院眼耳鼻整形外科
2:复旦大学附属眼耳鼻喉科医院耳鼻喉科研究院
3:国家卫生健康委员会听觉医学重点实验室(复旦大学)
[1] 中华耳鼻咽喉头颈外科杂志编辑委员会,中华医学会耳鼻咽喉头颈外科学分会.骨导助听装置规范命名及系统分类专家共识[J].中华耳鼻咽喉头颈外科杂志,2025,60(4):377-381.
[2] 中国电子音响行业协会助听行业分会,上海市医学会听觉与前庭医学专科分会,中国医疗国际保健交流促进会听力学分会,等.助听器与辅听设备基本性能及使用建议的专家共识[J].听力学及言语疾病杂志,2024,32(6):485-490.
[3] 张天宇,任柳杰,李辰龙,等.中耳力学:骨传导与骨传导助听器[J].听力学及言语疾病杂志,2024,32(5):482-484.
[4] ELLSPERMAN S E,NAIRN E M,STUCKEN E Z.Review of bone conduction hearing devices[J].Audiology Research,2021,11(2):207-219.
[5] SNIK A,AGTERBERG M A.The history of bone-conduction devices[J].ENT & Audiology News,2023,32(5).entandaudiologynews.com/media/33927/entnd23-snik_agterberg-final.pdf The history of bone-conduction devices | ENT & Audiology News.
[6] HOBSON J C,ROPER A J,ANDREW R,et al.Complications of bone-anchored hearing aid implantation[J].The Journal of Laryngology & Otology,2010,124(2):132-136.
[7] KRAAI T,BROWN C,NEEFF M,et al.Complications of bone-anchored hearing aids in pediatric patients[J].International Journal of Pediatric Otorhinolaryngology,2011,75(6):749-53.
[8] H??KANSSON B.The future of bone conduction hearing devices[J].Adv Otorhinolaryngol,2011,71(71):140-52.
[9] TAGHAVI H,H??KANSSON B,REINFELDT S,et al.Technical design of a new bone conduction implant (BCI) system[J].International Journal of Audiology,2015,54(10):736-44.
[10] H??KANSSON B E.The balanced electromagnetic separation transducer:a new bone conduction transducer[J].The Journal of the Acoustical Society of America,2003,113(2):818-25.
[11] H??KANSSON B,REINFELDT S,EEG-OLOFSSON M,et al.A novel bone conduction implant (BCI):engineering aspects and pre-clinical studies[J].International journal of audiology,2010,49(3):203-15.
[12] TAGHAVI H,H??KANSSON B,REINFELDT S.A novel bone conduction implant-analog radio frequency data and power link design[C].In:9th IASTED International Conference on Biomedical Engineering,BioMed 2012,Innsbruck,Austria,2012:327-335.
[13] TAGHAVI H,HKANSSON B,REINFELDT S.Analysis and design of RF power and data link using amplitude modulation of class-E for a novel bone conduction implant[J].IEEE Transactions on Biomedical Engineering,2012,59(11):3050-3059.
[14] H??KANSSON B,EEG-OLOFSSON M,REINFELDT S,et al Percutaneous versus transcutaneous bone conduction implant system:a feasibility study on a cadaver head[J].Otology & Neurotology,2008,29(8):1132-9.
[15] REINFELDT S,H??KANSSON B,TAGHAVI H,et al.Bone conduction hearing sensitivity in normal-hearing subjects:transcutaneous stimulation at BAHA vs BCI position[J].International Journal of Audiology,2014 ,53(6):360-369.
[16] TAGHAVI H,H??KANSSON B,REINFELDT S,et al.Feedback analysis in percutaneous bone-conduction device and bone-conduction implant on a dry cranium[J].Otology & Neurotology,2012,33(3):413-420.
[17] TAGHAVI H,H??KANSSON B,EEG-OLOFSSON M,et al.A vibration investigation of a flat surface contact to skull bone for direct bone conduction transmission in sheep skulls in vivo[J].Otology & Neurotology,2013,34(4):690-698.
[18] EEG-OLOFSSON M,LITH A,H??KANSSON B,et al.Evaluation of bone tissue formation in a flat surface attachment of a bone conduction implant:a pilot study in a sheep model[J].Audiology and Neurotology Extra,2014,4(3):62-76.
[19] REINFELDT S,??STLI P,H??KANSSON B,et al.Study of the feasible size of a bone conduction implant transducer in the temporal bone[J].Otology & Neurotology,2015,36(4):631-637.
[20] JANSSON K J,H??KANSSON B,REINFELDT S,et al.MRI induced torque and demagnetization in retention magnets for a bone conduction implant[J].IEEE Transactions on Biomedical Engineering,2014,61(6):1887-1893.
[21] JANSSON K J,H??KANSSON B,REINFELDT S,et al.Magnetic resonance imaging investigation of the bone conduction implant-a pilot study at 1.5 Tesla[J].Medical Devices:Evidence and Research,2015,8:413-423.
[22] EEG-OLOFSSON M,H??KANSSON B,REINFELDT S,et al.The bone conduction implant—first implantation,surgical and audiologic aspects[J].Otology & Neurotology,2014,35(4):679-685.
[23] REINFELDT S,H??KANSSON B,TAGHAVI H,et al.The bone conduction implant:clinical results of the first six patients[J].International Journal of Audiology,2015,54(6):408-416.
[24] H??KANSSON B,REINFELDT S,PERSSON A C,et al.The bone conduction implant-a review and 1-year follow-up[J].International Journal of Audiology,2019,58(12):945-955.
[25] PERSSON A C,REINFELDT S,H??KANSSON B,et al.Three-year follow-up with the bone conduction implant[J].Audiology and Neurotology,2020 ,25(5):263-275.
[26] REINFELDT S,EEG-OLOFSSON M,JANSSON K J,et al.Long-term follow-up and review of the bone conduction implant[J].Hearing Research,2022 ,421:108503.
[27] RIGATO C,REINFELDT S,H??KANSSON B,et al.Audiometric comparison between the first patients with the transcutaneous bone conduction implant and matched percutaneous bone anchored hearing device users[J].Otology & Neurotology,2016,37(9):1381-1387.

