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Electrocochleography (eCochG) is an electrophysiological measurement to evaluate the activity of cochlear hair cells in response to acoustic stimulation. This measure thus reflects the functional state of the cochlea and more specifically the neuronal survival.
Whereas in the normal-hearing subject, eCochG collection requires the introduction of a collection electrode in the middle ear, closest to the cochlea, in the cochlear implant subject, eCochG can be collected through the electrodes of the cochlear implant.
Measured during surgery, eCochGs may help optimize the placement of the electrode array within the cochlea and help in the decision to refer the patient to a conventional cochlear implant or, when residual cochlear activity is detected, to an electro-acoustic implant system.
The main objective of this study is to evaluate the usefulness of intra-operative eCochG collections for the optimization of electrode array placement within the cochlea and then for monitoring the residual hearing and its relationship to hearing performance during the first months of rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear implant candidates with measurable residual hearing | Other | Electrocochleography responses to acoustic will be recorded during the cochlear implantation and the 6 first months of use of the cochlear implant. A pure tone audiometry will be done prior and after the implantation. Speech audiometry will be done twice after the cochlear implantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocochleography | Procedure | Electrocochleographic responses will be evoked using different pure tone sounds delivered through an insert placed in the external auditory duct. The responses will be recorded with the electrodes of the cochlear implant connected to a dedicated interface. Electrocochleographic responses will be collected continuously during the electrode-array insertion at the implantation surgery using 500Hz pure tone and after suturing with 250, 500, 750 and 1000Hz pure tones. Then, electrocochleographic responses to pure tones from 125 to 8000HZ (according to the subject residual hearing) will be recorded 2 weeks, 1 month, 2 months and 4 months after implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Electrocochleographic responses | The amplitudes of electrocochleographic responses (in µV) to the selected acoustic pure tones will be collected. | During surgery to 4 month after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Pure tone thresholds | The perception thresholds (in dB HL) of the selected acoustic pure tones will be collected. No safety issue | before implantation, 2 weeks, 1 month, 2 month and 4 month after implantation |
| Speech audiometry measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hung THAI VAN, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Edouard Herriot | Lyon | 69003 | France |
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| Pure Tone Audiometry | Other | The perception thresholds to 125, 250, 500, 750, 1000, 2000, 4000 and 8000 Hz pure tones will be measured within the month preceding the implantation using the same insert t. Pure tone audiometry with the same frequencies will be done 2 weeks, 1, 2 and 4 months after the implantation. |
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| Speech audiometry | Other | The speech perception will be assessed in silence and in noise in free field 1 and 4 months after implantation. The speech perception in silence will be assessed using monosyllabic words 60 dB SPL. Speech in noise will be assessed using an adaptative test with fixed noise level (60 dB SPL). |
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For the speech audiometry in silence, the percentage of correct recognition of monosyllabic words' list will be collected. For the speech audiometry in noise, the signal noise ratio(s) (in dB) permitting the subject to reach 50% and/or 70% of speech recognition (SRT50 and SRT70) will be estimated.
No safety issue
| 1 month , 4 month |