Totally implantable middle ear device for rehabilitation of sensorineural hearing loss: preliminary experience with the Esteem®, Envoy

Conclusion. According to the first series of implanted patients, Esteem 2® technology can be regarded as a safe and reliable system for hearing restoration in case of moderate to severe sensorineural hearing loss. Objectives. To assess the benefit deriving from implantation of a totally implantable middle ear device in subjects affected by moderate to severe sensorineural hearing loss, the Esteem 2® (Envoy Medical), as measured through pure tone audiometry testing carried out during the different postoperative fitting sessions. Patients and methods. Six patients have been operated on since July 2007. Selection was carried out via preoperative audiometric tests and thorough counseling, which considered information on previous experience with conventional hearing aids as well as each patient's motivation to undergo a surgical application. Specific surgical training is needed to accommodate routine surgical steps along with less familiar steps, such as placement of cement material and overall fixation of the system. Results. The surgical procedure took a long time, but a reduced duration was recorded in the last procedure compared with the first one. The implantation process induced a deterioration in hearing thresholds, which fully recovered after activation of the device. A postoperative hearing gain could be measured in all three patients: in this regard, the perceived quality of sound was shown to be better than could be expected by the measurable hearing gain.

[1]  Moisés A Arriaga,et al.  Phase 1 Clinical Trial Results of the Envoy System: A Totally Implantable Middle Ear Device for Sensorineural Hearing Loss , 2004, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.