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，“中耳球囊”。这种植入术旨在通过在中耳内创造并永久维持一个充满空气或气体的空间来恢复非充气耳的听力。由咽鼓管功能障碍引起的不通气中耳只发生在慢性中耳炎（COM）和分泌性中耳炎（OME）中。对于耳部未通气的COM患者和部分标准治疗失败的OME患者，该植入物作为传导性听力损失的新治疗方法具有重要的潜力。

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.