Development of a Middle Ear Balloon Implant

描述(申请人提供)：开发一种新型中耳植入物--“中耳气球”。这种植入物的目的是通过在中耳内创造并永久保持空气或气体填充的空间来恢复非充气耳朵的听力。咽鼓管功能障碍所致的非充气中耳仅见于慢性中耳炎(COM)和渗出性中耳炎(OME)。该植入物具有显著的潜力，可作为传导性听力损失的新疗法，用于患有非充气耳的COM患者，以及标准治疗失败的OME患者的子集。 成功的球囊植入物必须易于制造，具有生物兼容性，易于通过声音振动进行压缩，并且必须充当液体和气体的物理屏障。在第一阶段，我们成功地开发了符合这些标准的气球装置原型。在第二阶段，我们建议：1)使用动物模型测试长期生物相容性和安全性；2)使用基于实验室的测试评估长期疗效；3)确定适合大规模生产的技术。 拟议的第二阶段研究的完成将使我们能够获得FDA的研究设备豁免，并在后续的第三阶段研究中启动预期的人类临床试验。 建议的商业应用：建议的球囊植入物提供了一种新的方法，用于治疗慢性中耳炎和一些伴有渗出性中耳炎的中耳未充气导致的传导性听力损失。这种植入物有很大的市场潜力，仅在美国估计每年就有超过6.5万台设备。

DESCRIPTION (provided by applicant): Development of a new type of middle ear implant, a "middle ear balloon" is proposed. This implant is intended to restore hearing in non-aerated ears by creating and permanently maintaining an air or gas-filled space within the middle ear. Non-aerated middle ears resulting from eustachian tube dysfunction camonly occur in chronic otitis media (COM) and in otitis media with effusion (OME). The implant has significant potential as novel treatment for conductive hearing loss in patients with COM who have non-aerated ears, and in a subset of patients with OME when standard therapy has failed. A successful balloon implant must be easily fabricated, be biocompatible be easily compressible by sound vibrations, and must act as a physical barrier to fluid and gases. In Phase I, we successfully developed prototype balloon devices that meet these criteria. In Phase II, we propose to: 1) test long-term biocompatibility and safety using animal models; 2) assess long-term efficacy using laboratory-based testing; and 3) identify suitable technology for large scale manufacture. Completion of the proposed Phase II research should enable us to obtain an investigational device exemption from the FDA and to initiate prospective human clinical trials in follow-on, Phase III research. PROPOSED COMMERCIAL APPLICATION: The proposed balloon implant offers a novel method for treating conductive hearing loss due to non-aerated middle ears in chronic otitis media and some cases of otitis media with effusion. There is a large market potential for this implant, estimated at over 65,000 devices annually in the U.S. alone.