Electrocochleography Function for Monitoring Residual Hearing

Study Overview
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Brief Summary
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This trial is a pilot study to assess the feasibility of using Electrocochleography recorded from a cochlear implant intra-operatively in real time to monitor the progress of its insertion. Correlation between: Observed changes in this signal during surgery and residual hearing loss post-operatively and Recordings of this signal post-operatively and actual pure tone audiometry results will also be assessed.

Detailed Description
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Cochlear Implants (CIs) can provide deaf individuals the ability to hear. CIs are electronics packages inserted into the cochlea (hearing organ). An external processor digitises sound and transmits it to the implant. An electric stimulus from the implant mimics the change in electrical potential normally caused by the movement of stereocilia in the cochlea when a sound occurs. This change generates an impulse along the auditory nerve to the brain resulting in perception of sound. CIs are available in the UK to people who have profound hearing loss. The improvement of CI technology means individuals with less significant losses, or profound losses at only some pitches may now benefit from a CI over a hearing aid. Patients having useful residual hearing has led to interest in better preserving that hearing during surgery. Thus allowing benefit from traditional acoustic amplification in addition to electrical stimulation from the implant. The investigators propose recording a measurement via the implant during surgery and at audiology appointments called a cochlear microphonic using a technique called electrocochleography (ECochG). This is essentially recording the electrical signal generated by the movement of hair cells in the cochlea in response to a sound. It is hypothesised that reduction of this signal during implantation may correspond to cochlea damage occurring and that with development this signal might be useful feedback for surgeons. The signal is known to be correlated to actual hearing ability so a better understanding of this may allow us to fit the acoustic amplification portion of implants in individuals who are unable to respond reliably to a normal hearing test. The purpose of this study is a pilot to assess the correlation between observed changes in this signal during surgery and residual hearing loss post-operatively and the degree correlation between recordings of this signal post-operatively and actual hearing test results.

Official Title
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Evaluation of Intra and Post-operative Electrocochleography for the Monitoring of Residual Hearing

Conditions
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Hearing Loss, Cochlear

Intervention / Treatment
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* Procedure: Electrocochleography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets normal candidacy requirements for cochlear implantation At least 1 year of age at time of consent being given Patent cochlea as verified by CT or MRI scan No cochlear abnormality that might prevent insertion of the electrode array Measurable residual hearing in the ear to be implanted No additional complex needs that would prevent study procedures or normal clinical follow-up protocol being followed AB Implant selected by patient or MDT Written informed consent obtained Exclusion Criteria: Medically complex cases where minimal duration of surgery is required

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pilot Group<br>Intra and Post-operative Electrocochleography | Procedure: Electrocochleography<br>* Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during Cochlear Implant Insertion | Cochlear Microphonic amplitude from real time electrocochleography using the apical cochlear implant electrode during implant insertion. | 1 Year | 
| Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during post-operative audiological appointments | Cochlear Microphonic amplitude recorded from varying electrodes and at varying frequencies post-insertion during each follow-up appointment for the first year. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECochG Correlations | Correlations between Intra and Post-operative cochlear microphonic amplitudes and other normal clinical measures (Impedance, eCAP, PTA, Speech) | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear Implant, Electrocochleography