Deafness; Perception Clinical Trial
Official title:
Phase I Safety Study for a New Two-Shank Auditory Midbrain Implant (AMI)
The objectives of the clinical study are to implant five deaf patients (those with Neurofibromatosis Type II, NF2) with a new two-shank auditory midbrain implant array (AMI; developed by Cochlear Limited) into the central nucleus of the inferior colliculus in order to assess the safety, reliability, consistency of placement, and performance of the AMI device. The clinical trial is being performed at Hannover Medical School in Germany in collaboration with University of Minnesota (USA) and Cochlear Limited (Australia). The clinical trial is being managed by Hannover Clinical Trial Center in Germany.
Cochlear implants are used in the cochlea (part of the inner ear) where they send electrical
signals for activation of the auditory nerve to restore hearing to deaf patients. For
patients without a functioning auditory nerve, there is an auditory brainstem implant (ABI),
which is placed on the surface of the brainstem in a more central location to restore
hearing. Unfortunately, the hearing performance of the ABI is typically lower than the
performance of the cochlear implant. There are several reasons for the lower success of the
ABI. Due to the tumor and/or tumor removal process for the NF2 condition, there is potential
damage caused at the brainstem level that has been linked to the poorer performance. The
anatomical changes caused by the tumor also make it difficult to properly visualize and place
the ABI surface array into the correct location. In addition, if there is a large tumor that
needs to or has been removed, then there can be a large cavity in the brainstem space with
the possibility that the ABI surface array can move from its initial location over time.
Therefore, for the past 16 years, a new implant has been developed in an international
collaboration that presents electrical stimuli into a midbrain region, the inferior
colliculus. This new implant is called the auditory midbrain implant (AMI). The current
version consists of two shanks with with 11 electrode contacts linearly spaced along each
shank. The two shanks are inserted into the inferior colliculus to align the electrodes along
different pitch layers to be able to stimulate them individually with varying temporal pulse
patterns.
In the period from 2006 to 2010, a former version of the current AMI was implanted and
evaluated in five NF2 deaf patients for hearing restoration. This first AMI implant consisted
of only one shank in contrast with the current two-shank array. Encouragingly, the clinical
trial at that time showed that the AMI was safe for all five patients. All patients achieved
improvements in their hearing capacity, especially in the form of environmental sound
awareness and lip-reading enhancement. One patient additionally attained good speech
perception that is within the upper range of ABI NF2 patients. However, this speech
perception is not yet at the level that can be attained in cochlear implant patients.
Based on these experiences and additional studies in animals, we have developed the second
version of the AMI that consists of two shanks that will be implanted into the inferior
colliculus and is expected to provide significant improvements in hearing performance
compared to the previous AMI by stimulating more effectively across the three-dimensional
inferior colliculus.
The purpose of this clinical trial is to evaluate the safety, reliability, and performance of
the new two-shank AMI in deaf NF2 patients. The ability to consistency place the AMI array
into the inferior colliculus will also be evaluated.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03700268 -
Programming Cochlear Implant With Artificial Intelligence
|
N/A |