Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor

Study Overview
=================
Brief Summary
-----------------
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead. The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.

Detailed Description
-----------------
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. Literature showed the EAS stimulation can lead to better speech understanding, especially in noisy situation, and can provide important information about intonating or melodic contours, thus increasing sound quality and music perception. Objectives The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead. The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor. Methods Unaided tonal audiograms are measured for cochlear implant candidates with low frequency residual hearing before and after cochlear implantation with the EVO electrode lead. Aided tonal audiograms and speech intelligibility in quiet and in noise are measured after implantation with the three modes of stimulation (acoustic stimulation AS, electric stimulation ES, and electro-acoustic stimulation EAS).

Official Title
-----------------
Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor

Conditions
-----------------
Cochlear Implant

Intervention / Treatment
-----------------
* Device: cochlear implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agreement to participate Above 18 years old Candidate for cochlear implantation Residual hearing in low frequencies (auditory thresholds better than or equal to 70 dB up to 500 Hz Native or fluent French speaker Exclusion Criteria: No affiliation to social security No agreement Vulnerable patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear implantation<br>Cochlear implantation with EVO electrode lead. This electrode lead has been specially designed for atraumatic surgery, in order to preserve the residual hearing of the patients included in the study. All patients are implanted with the same electrode lead. | Device: cochlear implantation<br>* Surgery is standardized in order to have the same procedure for all patients and to preserve a maximum of residual hearing: Corticosteroïds (1mg/kg solumedrol) at anesthetic induction , mastoidectomy + posterieur tympanostomy , insertion through round window, stop at the first resistance point<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation | Change from pre-implantation pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz at 1 month post implantation with the EVO electrode lead and at 1, 3, 6 and 12 months post-activation | 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of words and phonemes correctly identify with Les listes cochléaires de Lafon presented in quiet with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS). | Percentage of words and phonemes correctly identify with Les listes cochléaires de Lafon when presented in quiet with the three modes of stimulation (AS, ES and EAS). Speech understanding is evaluated at 3, 6 and 12 months post activation | 3, 6 and 12 months post activation | 
| Percentage of words and phonemes correctly identify with Les listes cochléaires de Lafon presented in cocktail party noise with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS). | Percentage of words and phonemes correctly identify with Les listes cochléaires de Lafon when presented in cocktail party noise at 0 and +10 dB Speech to Noise Ratio (SNR) with the three modes of stimulation (AS, ES and EAS). Speech understanding is evaluated at 3, 6 and 12 months post activation | 3, 6 and 12 months post activation | 
| Quality of life questionnaire. Evaluation of satisfaction on a scale from 0 (unsatisfactory) to 10 (satisfactory) of everyday life listening situations. |  | 2 weeks pre op, 3, 6 and 12 months post-activation | 
| Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds |  | 6 and 12 months post activation | 
| Surgery questionnaire evaluating the surgical technique, the presence of problems during surgery, the quality of insertion and surgeon satisfaction with multiple choice questions, close questions and scales from 0 to 10. | Surgery questionnaire evaluating the surgical technique (multiple choice questions), the presence of problems during surgery (multiple choice questions), the difficulty of insertion of the implant (scales from 0 - impossible to 5 - very easy; or 0 -very easy to 5 - impossible on inverted questions), the tools used for the insertion (multiple choice questions), the duration of insertion (secondes or minutes),the number of electrode inserted, the number of attempts to insert, and surgeon satisfaction (multiple choice questions between easy, medium and difficult) | single evaluation at implantation only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroacoustic stimulation