Cochlear Implants Clinical Trial
Official title:
Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery
Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of
cochlear implants, for patients with Advanced Bionics devices.
The sound recordings created may be useful in aiding the surgeon to better implant the
patient by letting him or her know if they are damaging the ear during implantation in real
time
Patients will be followed up for 1 year post surgery within our trial, and have a further 3
ECochGs performed in the clinic setting, (6 weeks, 6 months, 1 year) through their implants.
Cochlear implant candidature has changed in the past years. Today many cochlear implant
recipients have some low frequency residual hearing in the ear which is to be implanted. To
help preserve hearing, the electrode array must be inserted extremely carefully. It is
desirable to have real-time feedback relating to progress of the electrode insertion.
One possible tool that might provide this is an electrocochleography (ECochG). A brief
low-frequency acoustic tone at a fixed level is delivered to the external ear canal. This
results in normal movements of the outer and the inner hair cells inside the inner ear. These
movements are known to produce small electrical potentials that have been previously been
sensed by a recording electrode placed on the promontory, or surface of the bone in which the
cochlea is located. Averaging of these recordings in synchrony with the acoustic stimulus
allows the small ECochG signal to be reinforced while any physiological or electrical noise
is averaged out. With ECochG measurements different aspects of the auditory system can be
tested. For the investigators work only the cochlear microphonic, generated by the outer hair
cells will be recorded and analysed.
The Advanced Bionics (AB) implant system is uniquely suited to do such measurements. The aim
of the study is to monitor electrode array insertion during surgery and any residual hearing
function over time in using this tool as a comparison to conventional methods. Subjects will
undergo the study procedure of ECochG measurements, alongside additional standard of care
appointments for the research, pure tone audiometry and impedence measurement. Only a 10
minute ECochG measurement will be the additional research component to the patients clinical
routine as mentioned above.
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