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  国家集采后确保降价不降质,叠加医保报销患者负担还可减轻

  更多听障人群用上人工耳蜗(民生一线)

  我国听力残疾人约2780万人,随着老龄化程度的加深,这一群体的规模还在不断扩大,听力问题备受关注。当前,人工耳蜗植入是治疗重度、极重度耳聋乃至全聋的有效手段。2025年3月起,全国各地相继执行国家组织人工耳蜗类医用耗材集中带量采购中选政策,人工耳蜗类耗材单套价格降幅明显。对集采中选的人工耳蜗质量,药监部门严格监管,始终坚持“全覆盖”“零容忍”。越来越多的听力残疾人有了听到新“声”的机会。

  ——编者

  从无声到有声

  技术为听障患者打开“声音之门”

  在北京协和医院耳鼻喉科的病房里,听障人士梁杰(化名)的左耳后有一道约4厘米长的伤口,这是因为医生给他装了一个“新耳朵”。“两年前,我先做了右侧人工耳蜗植入手术,之后就一直在等人工耳蜗降价,非常期待左右耳都能清楚听见美妙的声音。”梁杰说。

  4岁那年,梁杰由于听力问题被诊断为大前庭导水管综合征。随着年龄的增长,他的听力波动性、进行性下降。打针、吃中药、针灸,能试的方法全试了,梁杰的听力还是越来越差。

  2023年3月,梁杰又一次感到头晕,右耳佩戴助听器也没有效果。医生再一次建议他植入人工耳蜗。

  “在公共场合,当我发现周围的人嘴巴在动,表情在变,却不知道他们在说什么,就仿佛和他们之间有一道无形的墙。”梁杰说。

  耳朵由外耳、中耳和内耳三部分组成,声音经过外耳传入中耳,振动鼓膜,鼓膜连着3块听小骨,听小骨将振动传导给位于内耳的耳蜗。“微风动涟漪”,在充满液体的耳蜗里,毛细胞会随之摆动,将声音振动转化为神经信号发送给大脑,人们才能听到声音。

  “耳蜗是感知声音的重要器官,耳蜗内的毛细胞一旦受损不可再生,但可以想办法代替它。”北京协和医院耳鼻咽喉头颈外科主任高志强说,人工耳蜗是一种电子装置,分为体外机和体内机两部分——体外机部分用来收集外界的声音信号,植入到患者耳中的体内机部分用电极代替毛细胞,将声音信号转换为电信号直接刺激与听神经相连的螺旋神经节细胞,从而建立听觉通路。

  医学和科技的进步让众多听障患者听见声音。蝉鸣声、鸟叫声、钟表的滴答声、洗衣机的开机声……右耳植入人工耳蜗后,梁杰开始重新建立对各种声音的认知。

  然而,单侧人工耳蜗植入的效果并没有达到梁杰的预期,他无法分辨声音的方向,所有声音都像是从人工耳蜗那边传来的。“双侧人工耳蜗植入要比单侧人工耳蜗植入效果好,可以双侧聆听,满足声源定位。另外,现在还可以选择能支持高场强(3.0T)核磁的新一代人工耳蜗植入体。”医生的话让梁杰对手术有了新期待。

  “双侧重度或极重度感音神经性耳聋患者,助听器佩戴无效或效果不佳的儿童及成人都可以考虑植入人工耳蜗。”高志强说,“总体来说,我国的人工耳蜗手术技术和手术量在国际上均处于领先水平,手术时间需要1—2小时,切口约3—4厘米,术后5—7天即可出院。”

  从不敢想象到触手可及

  成年患者也能享受政策优惠

  1995年,已失聪10年的陆锋以“放手一搏”的心态在北京协和医院接受了人工耳蜗植入,成为中国大陆首位多导人工耳蜗植入者,回归有声世界,人生轨迹也因此改变。虽然人工耳蜗技术不断成熟,但曾经植入人工耳蜗数十万元的医疗费用让不少患者望而却步。

  2018年,国务院印发《关于建立残疾儿童康复救助制度的意见》,首次在国家层面将0至6岁听力残疾儿童康复纳入基本公共服务的制度性安排,明确财政兜底保障。

  “现在,针对听障儿童,相关救助制度和慈善项目等保障渠道都比较通畅,听障儿童有了快乐、健康成长的机会。”中国残联理事、中国聋协原主席杨洋说。

  打破声音的藩篱,生命便能绽放更多精彩。在广西柳州,出生3个月就被医院确诊极重度神经性耳聋的杨骐嘉,植入人工耳蜗后,于2024年考入中国海洋大学;在上海特殊儿童康复中心,一群佩戴人工耳蜗的听障孩子组成了一个合唱团,他们用纯净的声音打动了很多人。

  “人工耳蜗的研发和推广应用已使我国近90%的听障儿童能够听声学语,进入普通学校学习。”杨洋说。

  2024年12月,第五批国家组织高值医用耗材集中带量采购在天津开标产生中选结果,纳入人工耳蜗、外周血管支架两类产品。人工耳蜗方面,参与集采的3家外资企业和2家内资企业全部中选,人工耳蜗类耗材单套(含植入体、言语处理器)价格从平均20余万元降至5万元左右。部分地区还可以叠加医保报销政策,患者的经济负担明显减轻。

  多部门监管,降价格不降质量,确保稳定供应。中选产品的质量安全关系广大患者的切身利益。国家药监部门表示,将人工耳蜗等集采中选产品的质量监管作为监管的重中之重。稳步推进集采中选产品的追溯管理,实现集采中选产品上市后全过程可追溯,监督企业全面排查风险隐患,部署对生产企业开展飞行检查。

  “价格降下来的同时,企业必须继续保证产品质量。”中国医疗器械行业协会技术法规部主任卢大伟说,企业不能为了扩大供货改变耗材生产工艺,只有做好品质控制才能稳定获得收益。

  “近段时间,咨询人工耳蜗相关问题的患者越来越多,尤其是以前无法享受优惠政策的成年人和老年人。他们十分盼望通过植入人工耳蜗重获新‘声’。”高志强说。

  在杨洋看来,从过去纠结自己的经济能力能不能植入人工耳蜗、要不要植入人工耳蜗,转变为可以从自身需求出发选择植入哪一种人工耳蜗,这个变化展现了全社会对听障群体的重视和关爱。

  从听得见到听得清

  植入人工耳蜗还需重视后续训练

  许多人误以为植入人工耳蜗后听力能立刻恢复正常,如同戴上眼镜就能看得清楚。其实植入人工耳蜗,不过是个开始。术后开机、调试和系统的言语康复训练也尤为重要。

  “通常术后3—4周可以开机激活人工耳蜗系统,开机后1年内需5次左右随访调机,1年后每年调机1—2次。”高志强说。

  系统的言语康复训练为什么重要?

  浙江省杭州市余杭区启航公益服务中心秘书长张丽娜长期从事言语康复工作。她介绍,对于自幼依赖视觉沟通方式(如手语或唇读)的语前聋群体来说,他们的大脑听觉皮层需从最基础的声波感知开始,逐步打通语言理解的道路;对于突发性失聪或渐进性听力丧失的成人语后聋群体来说,既要恢复听觉功能,也要修复因失聪而受损的社会联结。

  “成人语后聋群体往往缺乏针对职场需求设计的适应性康复项目,而成人语前聋群体迫切需要能整合听觉与视觉沟通方式的康复师,老年患者则通常缺乏持续性陪伴或体系化的康复机会。破解这些难题需要多方合力。”张丽娜说。

  张丽娜建议,一方面推动社区“康复驿站”的建设,提高言语康复服务的可及性;另一方面,在技术创新层面推进科技赋能,比如开发人工智能语音教练,通过实时发音矫正,构建沉浸式言语康复场景;还可通过纪录片和短视频展示听障人士的康复故事,消除大众对“戴上人工耳蜗就等于恢复”的误解,倡导公众参与到对言语康复的支持当中。

  专业人才队伍也十分重要。“人工耳蜗植入手术需耳显微外科、耳神经外科技术及听力学、康复学等相关知识,国内具备相关资质的医生主要集中在北京、上海、广州一些大医院和省会城市的三甲医院,地区分布不均。”高志强建议,在国家耳科医师规范化培训中强化人工耳蜗相关技术培训,倡导由全国手术经验丰富的人工耳蜗植入中心举办培训班;针对医疗机构专业人员及手术配套设备不足的现状,应加大对应性投入,支持相关机构专业化、系统化发展。

  “听得清是一件很幸福的事情,大家应该进一步增强听力保护意识,养成健康用耳习惯。”杨洋说。一方面,早发现听力损失和耳病是听力有效管理的关键,一旦发现相关问题,尽早就医,以减轻不利影响;另一方面,在日常生活中要有效预防听力损失,使用耳机时,音量应保持在最大音量的60%以下,连续使用耳机时间须少于60分钟。此外,应尽量避免长时间处于高噪声环境,减少对听力的损害。

  (应宁怡参与采写)

  本报记者  易舒冉

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