Puram Sidharth V, Barber Samuel R, Kozin Elliott D, Shah Parth, Remenschneider Aaron, Herrmann Barbara S, Duhaime Ann-Christine, Barker Fred G, Lee Daniel J
Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, USA Department of Otology and Laryngology, Harvard Medical School, Boston, Massachusetts, USA.
Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, USA.
Otolaryngol Head Neck Surg. 2016 Jul;155(1):133-8. doi: 10.1177/0194599816637599. Epub 2016 Apr 19.
There are no approved Food and Drug Administration indications for pediatric auditory brainstem implant (ABI) surgery in the United States. Our prospective case series aims to determine the safety and feasibility of ABI surgery in pediatric patients <5 years old with congenital deafness at a tertiary North American center. The inclusion criterion was pre- or postlinguistic deafness in children not eligible for cochlear implantation. Seventeen candidates were evaluated (mean ± SD: age, 2.52 ± 0.39 years). Four patients underwent ABI surgery (age, 19.2 ± 3.43 months), including 4 primary procedures and 1 revision for device failure. Spontaneous device failure occurred in another subject postoperatively. No major/minor complications occurred, including cerebrospinal fluid leak, facial nerve injury, hematoma, and nonauditory stimulation. All subjects detected sound with environmental awareness, and several demonstrated babbling and mimicry. Poor durability of older implants underscores need for updated technology.
在美国，食品药品监督管理局尚未批准将小儿听觉脑干植入（ABI）手术用于儿科治疗。我们的前瞻性病例系列旨在确定在北美一家三级医疗中心，对5岁以下先天性耳聋小儿患者进行ABI手术的安全性和可行性。纳入标准为不适合接受人工耳蜗植入的儿童的语前或语后聋。对17名候选者进行了评估（平均±标准差：年龄，2.52±0.39岁）。4例患者接受了ABI手术（年龄，19.2±3.43个月），包括4例初次手术和1例因设备故障进行的翻修手术。另一例受试者术后发生了自发性设备故障。未发生任何严重/轻微并发症，包括脑脊液漏、面神经损伤、血肿和非听觉刺激。所有受试者在具备环境感知能力的情况下都能检测到声音，有几例表现出咿呀学语和模仿行为。旧款植入设备的耐用性较差，凸显了更新技术的必要性。
