Development of a Middle Ear Balloon Implant

描述（由申请人提供）：开发一种新型中耳植入物，即“中耳球囊”。该植入物旨在通过在中耳内创建并永久保持空气或气体填充空间来恢复非充气耳朵的听力。咽鼓管功能障碍导致的中耳不通气仅发生在慢性中耳炎（COM）和渗出性中耳炎（OME）中。该植入物作为传导性听力损失的新型治疗方法具有显著的潜力，适用于患有COM的非通气耳患者，以及标准治疗失败的OME患者亚组。 成功的球囊植入物必须易于制造，具有生物相容性，易于通过声音振动压缩，并且必须充当流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原型球囊器械。在第II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有效性; 3）确定适合大规模生产的技术。 完成拟议的II期研究应使我们能够获得FDA的研究器械豁免，并在后续的III期研究中启动前瞻性人体临床试验。 拟定商业应用：所提出的球囊植入物为治疗慢性中耳炎和一些渗出性中耳炎病例中因中耳不通气而导致的传导性听力损失提供了一种新方法。 这种植入物有很大的市场潜力，仅在美国每年估计就有超过65，000件器械。

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.