|Paciente con acúfenos que ha de disfrutar de un equipo EStimME en el futuro|
EStimME is developing a miniaturized implantable system for the treatment of tinnitus via electrical stimulation of the auditory (cochlear) nerve.
The system is implanted in a minimally invasive, atraumatic approach to the middle ear and the implantation is completely reversible.
Electrical stimulation of the cochlea has been shown to be effective in tinnitus suppression with up to 90% success rate, when tested on profound deaf patients using a cochlear implant.
EStimME’s system provides for the first time, a solution for the hearing/hearing impaired that addresses the underlying mechanism of tinnitus, and not just the symptoms of this debilitating condition.
A tiny neurostimulator the size of a grain of rice delivers electrical signals to the cochlear nerve.
The neurostimulator is remotely powered and controlled by an external unit.
A self-expandable stent-like chassis made of nitinol enables easy deployment and a-traumatic fixation of the neurostimulator in the middle ear through the ear-canal.
An external unit enables control of the neurostimulator, and is activated on a predefined daily schedule and according to the patient’s demand.
A clinical trial evaluating the safety and efficacy of the EStimME system is currently under way in Shaare Zedek Medical Center, Jerusalem.
Interim results show electrical stimulation of the cochlear nerve to be safe and effective in achieving tinnitus suppression.
Mechanism of ActionNormally, the peripheral auditory nerve fibers are spontaneously active during silence as a result of the release of neurotransmitters by the inner hair cell synapse.
This release process and the resulting firing patterns of the spiral ganglion have been extensively observed, modeled, and analyzed in the literature , .
The origin of tinnitus lies in the loss of this normal pattern of spontaneous activity, leading to abnormal hyperexcitability of the central auditory system, perceived as sound.
The tinnitus suppression effect of electrical stimulation of the cochlea may involve several mechanisms that affect the activity of the auditory nerve fibers – applying sub-threshold nerve stimuli to influence the excitation threshold of a nerve cell; regaining neural activity in the matching axons of damaged haircells in a way that will not be perceived as sounds; or by generating a masking sound (which is NOT EstimME’s approach).
When implanted, EStimME’s neurostimulator is powered and remotely controlled by the external unit allowing full control over stimulation parameters and achieving optimal patient’s specific stimulus regimen.
The EStimME system is an investigational device, limited to investigational use only.