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瑞典公司 Flow Neuroscience 研发的脑部电刺激穿戴装置已获得美国 FDA 批准,现已可凭处方购买,为美国约六分之一服用抗忧郁药物的成年人提供传统药物之外的非化学疗法选择。该装置佩戴于额头,每天使用 30 分钟并配合应用程式操作,透过向调节情绪的左额叶传送低强度电刺激来改善忧郁症状,为新型脑部穿戴设备的一大代表。

临床试验显示,在 174 名重度忧郁症患者中,使用该装置 10 周后的症状缓解率达 45%,显著高于对照组的 22%,且副作用相对轻微,主要仅为皮肤发红、头痛或短暂注意力问题。相较于费用高达 15,000 美元且必须频繁亲赴诊所的经颅磁刺激(TMS)疗法,该设备让患者能够在专业监督下于居家环境安全使用,亦可作为现有药物治疗的辅助疗法。

该装置自 2019 年在欧洲上市以来已有超过 65,000 人使用,并获英国国民保健署(NHS)进行试点评估。目前在美国可透过实体门诊或远距医疗取得处方,但初期需自费使用,前 10 周费用为 2,200 美元,其后每月需支付 325 美元,Flow 团队现正积极争取纳入健康保险给付,以扩大非药物疗法的普及性。

Swedish company Flow Neuroscience has launched its brain stimulation wearable by prescription in the US, positioning it as a nonchemical alternative to traditional antidepressants for the roughly one in six American adults on medication. Worn on the forehead for 30 minutes daily and operated via an app, the FDA-approved device delivers low-intensity electrical stimulation to the mood-regulating left frontal lobe, representing a new wave of therapeutic brain wearables.

In a clinical trial of 174 patients with major depressive disorder, 45 percent of participants using Flow experienced remission at 10 weeks compared to 22 percent in the sham control group, with only mild reported side effects like skin irritation and headaches. Unlike clinic-based transcranial magnetic stimulation (TMS) that can cost up to $15,000 and requires intensive visits, this headset enables safe, effective home use either independently or alongside existing antidepressant medications.

Having been utilized by over 65,000 patients across Europe since 2019 and currently piloted by the UK's National Health Service, the device is now accessible in the US through in-person and telehealth consultations. However, American patients must currently pay out of pocket—$2,200 for the initial 10 weeks followed by $325 monthly—while the company actively works toward securing health insurance reimbursement to lower financial barriers.

2026-09-16 (Wednesday) · b3b7d29d0367969da2d72c5aefcbaf624e60be12