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Introduction
Hearing is an important sense, not just for social communication, but for perceiving and navigating the world around us. Severe-to-profound hearing loss (HL) is the near or total absence of this sense. Cochlear implants (CI) have been transformative in the treatment of severe-to-profound HL. Although there is still considerable variability in hearing outcomes among CI users, most users achieve substantial benefit, and some users achieve speech perception in quiet which is close to that of individuals with normal hearing.
Despite these benefits, CI uptake remains rather low. The WHO estimates that sixty million people worldwide have severe-to-profound HL1, yet only slightly more than one million implantations, cumulatively, have taken place since the first operations several decades ago2. Several reasons for this low uptake have been identified3. One aspect is related to the audio processor. The audio processor is an externally worn device that detects speech and other sounds, encodes these as electrical signals, and transmits them to the implant. As an external device, an audio processor can be lost or damaged. It requires cleaning, maintenance, and additional peripherals to operate. It can interfere with activities such as bathing or swimming. It is also true that the wearing of a hearing prosthesis, a visible marker of disability, can be a source of cosmetic and self-esteem issues4, 5, 6, 7–8.
To solve this set of issues, we have developed and tested the totally implantable CI (TICI, device name: Mi2000). In this device, all components have been integrated into a single implant, which is invisible to the outside. This has required the resolution of numerous technical challenges, not least of which was the development of the subdermal microphone, the implantable power supply, and the transdermal wireless data link, all of which are required to be biocompatible and have operating lifetimes of decades.
The primary objective of this study was to assess the safety of the Mi2000 system in adults who suffer from bilateral severe to profound sensorineural hearing loss. The secondary objectives were to evaluate the initial clinical performance with the Mi2000 by assessing speech perception in quiet and in noise, as well as to assess user experiences with the device through several validated patient-reported outcome measures and a...