A Systematic Review of the Safety and Effectiveness of Fully Implantable Middle Ear Hearing Devices

Abstract

The majority of studies were quasi-experimental, prepost comparisons of aided and unaided conditions. Complication rates with the Esteem were higher than with the Carina, and most commonly included taste disturbance. However, device failure was common with the Carina, predominately related to charging difficulties. For both devices, clinically significant improvements in functional gain, speech reception, and speech recognition over the unaided condition were found. In studies comparing the Esteem or Carina to hearing aids, findings were mixed. Although improvements in functional gain were similar to those for hearing aids, speech recognition and quality of life were greater with the implants. Despite limited evidence, these devices seem to offer a relatively safe and effective treatment option, particularly for patients who are medically unable to wear conventional hearing aids.

Carina® and Esteem®: A Systematic Review of Fully Implantable Hearing Devices

“…Clinical conditions like skin problems, malformation of the external ear and otitis can also limit their use [1] , [2] , [4] , [5] . In addition, social factors (social stigma and cosmetic issues) may be mentioned [1] , [3] , [4] .…”

Alternative Fixation of an Active Middle Ear Implant at the Short Incus Process

“…Incus body stimulation provides appropriate gain as a function of degree of hearing loss, indicating that these devices are a viable treatment for moderate-to-severe hearing loss [Jenkins et al, 2004;Zenner and Rodriguez Jorge, 2010;Klein et al, 2012].…”

Delayed facial nerve palsy after surgery for the Esteem®fully implantable middle ear hearing device

“…Therefore, the Esteem Ò surgery carries some risks of complications that include taste disturbances and facial nerve (FN) palsy, both of which are clearly related to damage of the VII cranial nerve [2]. The occurrence of transient palsy has been previously reported to range from 5% to 33% [2][3][4][5], while permanent deficits have been reported to occur in 2% of cases [2].…”